A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
Phase: PHASE3
Conditions: Alopecia Areata
Sponsor: Pfizer

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Protocol Title: A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY 
INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND 
ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
Protocol Number: B7981032
Amendment Number: 6
Compound Number: PF-06651600
Study Phase: Phase 3
Short Title: Study Evaluating PF-06651600 in Adults and Adolescents with Alopecia Areata
Sponsor Name: Pfizer, Inc
Legal Registered Address: 235 East 42nd Street, New York, NY 10017-5755, USA
Regulatory Agency Identifier Number(s)
Registry
ID
IND
131503
EudraCT
2019-001084-71
Approval Date: 28 March 2022
This document and accompanying materials contain confidential information belonging to Pfizer.  Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes.  In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified.
For Japan only: Upon approval of ritlecitinib for alopecia areata in Japan the terms “clinical 
study/clinical trial” and “study intervention” in the protocol and related documents may also 
be interpreted as “post-marketing clinical study” and “post-marketing study drug,” 
respectively.
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Protocol Amendment Summary of Changes Table
DOCUMENT HISTORY
Document
Date
Original Protocol
03 April 2019
Amendment 1
15 October 2019
Amendment 2
05 February 2020
Amendment 3
28 April 2020
Amendment 4
31 August 2020
Amendment 5
23 April 2021
Amendment 6
28 March 2022
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs.
Amendment 6 (28 March 2022)
Section # and Name
Description of Change
Brief Rationale
Section 1.1 Objectives, Estimands 
and Endpoints; 
Section 1.1 Intervention and 
Duration; 
Section 1.2 Schema; 
Section 1.3.2.1 Treatment period 1: 
Week 2 through Month 24; 
Section 1.3.2.2 Treatment Period 1: 
Month 28 to Month 36; 
Section 1.3.2.3 Treatment Period 2: 
Month 40 to Month 60; Section 4.1 
Overall Design; 
Section 4.2 Scientific Rationale for 
Study Design; 
Section 4.3 Justification for Dose; 
Section 4.4 End of Study 
Definition; 
Section 8.1.2.1.1 Androgenetic 
Alopecia SALT Score; 
Section 8.2.11 Pregnancy Testing; 
Section 9.4.2 Efficacy Analysis; 
Section 10.8.2 Discontinuation
Section 10.13.3.1 Laboratory 
Testing; 
Section 10.14 Appendix 14: 
Management of Participants with a 
Positive Tuberculosis Test Result 
on Day 1 or Annual Tuberculosis 
Testing
Study extension for all 
participants (de novo or 
originating from Study 
B7981015 or B7931005) to 
continue to receive open-label 
50 mg PF-06651600 QD.
Study updated to have 
2 treatment periods in addition to 
follow-up. Treatment up to 
36 months is TP1. TP2 will be of 
variable length for individual 
participants; assuming a 
participant does not require 
discontinuation per protocol, a 
participant may continue to 
receive study intervention in 
TP2 for a maximum of 
24 months or until availability of 
commercial product in their 
country, or until the Sponsor 
terminates the study in that 
country, whichever occurs first.  
Clarifications added throughout 
document regarding the 
extension of the study and its 
impact on endpoint collection, 
analysis, and reporting.
In order to allow study 
participants continued 
access to study 
intervention with 
collection of additional 
long-term safety and 
efficacy data, study 
duration is extended up 
to 60 months (or until 
availability of 
commercial product in 
the country or until the 
sponsor terminates the 
study in that country).
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Section # and Name
Description of Change
Brief Rationale
Section 1.1 Synopsis; 
Section 3 Objectives, Estimands 
and Endpoints
Added secondary safety and 
tolerability objectives. 
Added objectives and 
endpoints as a result of 
the study extension.
Section 3 Objectives, Estimands 
and Endpoints
Added tertiary/exploratory 
efficacy endpoints, patient-
centered outcomes and 
biomarkers. 
Added endpoints as a 
result of the study 
extension.
Section 1.1 Synopsis; 
Section 3 Objectives, Estimands 
and Endpoints
Update language of Alopecia 
Areata Patient Priority Outcomes 
(AAPPO) endpoint. 
Change from baseline in 
Alopecia Areata Patient Priority 
Outcomes (AAPPO) scales 
through Month 36.
This update was made to 
correct the text for 
accuracy.
Section 2.2.2 Non-clinical and 
Phase 1 Efficacy and Safety Data; 
Section 6.1 Study Intervention 
Administered; 
Section 6.2 Preparation/Handling/ 
Storage/Accountability; 
Section 6.4 Study Intervention 
Compliance; 
Section 10.13.4 Appendix 13: 
Study Intervention
PF-06651600 bioequivalence 
between tablets and capsules 
was established in completed 
Phase 1 Study B7981029.
Dosage form, packaging, and 
labeling updated to allow tablet 
or capsule.
The study extension of 
up to 24 months of 
treatment beyond Month 
36 may result in a 
transition of 
PF-06651600 dosage 
form from tablet to 
capsule and from blister 
to bottles.
Section 1.3.3 Early Termination 
and Follow-up; 
Section 10.8.2 Discontinuation
12- lead ECG is not to be 
collected during ET visit for 
participants who have completed 
the Month 36 visit.  
These changes were
made for consistency 
with Section 1.3.2 in 
which 12-lead ECG is 
not collected after 
Month 36.
The sponsor has 
performed an analysis of 
applicable nonclinical 
and clinical data that 
indicate that the risk for 
PF-06651600 to cause 
clinically meaningful 
QT prolongation in 
humans is low.
Section 1.3.2.3 Treatment Period 2: 
Month 40 to Month 60; 
Section 1.3.3 Early Termination 
and Follow-up; 
Section 10.2. Appendix 2: Clinical 
Laboratory Tests; 
Section 10.13.3.1 Laboratory 
Testing
Fasting Lipid Panel is not to be 
collected for participants who 
have completed the Month 36 
visit. 
For participants who have 
completed the Month 36 visit, 
urinalysis will be performed 
These changes were 
made for consistency 
with Section 1.3.2 in 
which fasting lipid 
panel, creatine kinase, 
urine samples, 
urinalysis, urine 
myoglobin, assessment 
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Section # and Name
Description of Change
Brief Rationale
only if considered clinically 
indicated by the investigator. 
Clinical Assessments 
(Assessment of Fingernails 
Affected by AA and CGI-AA) 
and PROs (AAPPO and HADS) 
will not be collected for 
participants who have completed 
the Month 36 visit.
For participants who have 
completed the Month 36 visit, 
creatine kinase and urine 
myoglobin will not be tested.
Urine culture will be performed 
if urinalysis is positive for nitrite 
and/or leukocyte esterase or if 
clinically indicated.
of Fingernails Affected 
by AA, CGI-AA, 
AAPPO and HADS are 
not collected after 
Month 36.
Based on recent safety 
data analyses, it has 
been considered that 
measurements of fasting 
lipid panel, creatine 
kinase, urine myoglobin 
(reactive) and urinalysis 
are no longer warranted 
after Month 36. Note 
that urinalysis can still 
be performed if 
considered clinically 
indicated by the 
investigator.
Assessment of 
Fingernails Affected by 
AA and CGI-AA are 
exploratory endpoints in 
TP1 and AAPPO is a 
secondary endpoint in 
TP1. The collection of 
these measurements is 
not needed beyond 
Month 36. Note that the 
other efficacy endpoints 
will continue to be 
collected in TP2.
Section 4.4.1 Extended Study 
Duration 
Section deleted.
This Section was no 
longer needed based on 
the up to 24 months 
extension of treatment 
added.
Section 5.3.1 Contraception
Added additional clarifications 
on the contraception check.  
If in the event the participant 
discontinues contraception 
method, the Investigator will 
“document the requirement to 
use an alternate 
protocol-specified method, 
including if the participant will 
This update was made to 
provide additional 
clarification on the 
requirements and timing 
for contraception check.
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Section # and Name
Description of Change
Brief Rationale
no longer use abstinence as the 
selected contraception method” 
and “The contraception check 
for WOCBP will be performed 
during each study visit and 
monthly between study visits at 
time of the phone contact to 
check the at-home pregnancy 
test results.”
Section 1.1 Synopsis; 
Section 1.2 Schema; 
Section 1.3.3 Early Termination 
and Follow-up; 
Section 4.1 Overall Design; 
Section 7.1.1 Permanent 
Discontinuation; 
Section 7.1.1.1 Observation Period; 
Section 9.4 Statistical Analyses; 
Section 9.4.2 Efficacy Analyses
Added detail on permanent 
discontinuation and defined the 
Observation Period. Added two 
subsections under Section 7.1 
(Section 7.1.1 and Section 
7.1.1.1).  
If study intervention is 
permanently discontinued, the 
participant will be asked to 
remain in the study after the 
Follow-up visit without study 
intervention and continue to 
comply with study visit 
schedules for approximately 
2 years after the last dose of 
study intervention or until study 
end, whichever occurs first. 
Added in order to collect 
data in participants who 
have discontinued study 
intervention.
Section 8 Study Assessments and 
Procedures
Updated the amount of blood to 
be collected from each 
participant in Study B7981032. 
This change was made 
to align with the 
extended Intervention 
Period for up to 
24 additional months. 
Section 9.4.1 Timing of Analyses; 
Section 9.4.2 Efficacy Analyses; 
Section 9.4.3 Safety Analyses
Added information on analyses 
to be provided in the 
supplemental CSR.
This information was 
added as a result of the 
study extension.
Section 10.14 Appendix 14: 
Management of Participants with a 
Positive Tuberculosis Test Result 
on Day 1 or Annual Tuberculosis 
Testing
Updated the annual visit in 
which study intervention is 
permitted to be re-started
“If study intervention is 
permitted to be re-started, at the 
next annual visit (ie, Month 12, 
24, 36, 48 or 60), a chest 
radiograph is required to be 
performed (a QFT G, T-SPOT, 
or PPD test need not be 
obtained).”
“If study intervention is 
permitted to be re-started, 
This update was made 
for consistency with the 
study extension.
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Section # and Name
Description of Change
Brief Rationale
QFT-G testing (or T-SPOT or 
PPD, if applicable) will be 
required at the next visit per the 
protocol Schedule of Activities
(ie, Month 12, 24, 36, 48 or 60); 
in this case the recent test has 
been effectively deemed a ‘false 
positive’ by the specialist and 
the participant is considered to 
be WITHOUT a true positive 
QFT-G (or T-Spot or PPD, if 
applicable) test result at this 
visit.”
Section 10.10 Appendix 10
Updated timing for which
participants from the main 
B7981032 study can participate 
in the vaccine sub-study
This change was made 
to align with the 
extended Intervention 
Period for up to 
24 additional months.
Section 8.1.3.1. Alopecia Areata 
Patient Priority Outcomes 
(AAPPO)
Updated language to amend 
wording for response categories 
for items from 1 to 11.
This update was made to 
correct the text of 
original protocol.
Section 8.2.9.1 Columbia Suicide 
Severity Rating Scale (C-SSRS); 
Section 10.8.2 Discontinuation
Added details on participants 
with suicidal ideation.
This update was made to 
provide details on 
participants with 
suicidal ideation and 
discontinuation criteria.
Section 9.4 Statistical Analyses
Clarified that data analysis from 
participants who discontinued 
treatment but remained on study 
will be described in the 
statistical analysis plan.
This update was made 
for consistency with 
Section 7.1.
Section 10.1.5.2. 
Adjudication/Review Committee 
Submission
Updated language regarding 
events requiring submission to 
an adjudication/review 
committee.
This update was made to 
provide clarification on 
events requiring 
submission to an 
adjudication/review 
committee.
Section 10.4.3 Women of 
Childbearing Potential
Updated text regarding 
confirmation of post-menopausal 
status during the study.
This update was made to 
provide additional 
clarification on the 
procedure for 
confirming
postmenopausal status.
Section 10.8.1 Monitoring
Updated hemoglobin values 
requiring re-testing.
Based on a recent 
review of clinical safety 
data for PF-06651600 
and a review of cases 
meeting the >2 g/dL 
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Section # and Name
Description of Change
Brief Rationale
change from baseline 
threshold in this study, it 
has been considered that 
this criterion is no 
longer warranted, and 
that a participant's safety 
is adequately monitored 
based on re-testing 
required for hemoglobin 
values <10.0 g/dL.
Section 4.3 Justification for Dose 
Table 1
Mean Clinical AUC and 
Calculated Safety Margin 
updated.
This update was made in 
alignment with 
Investigator Brochure 
version 8.0 December 
2021.
Section 10.11 Appendix 11: 
Discontinuation Criteria for 
Worsening of Alopecia Areata for 
VHP Countries in the EU; 
Section 10.12 Appendix 12: Study 
Intervention Continuation Criteria 
for Adolescents
Clarified the discontinuation 
requirements.
This update was made 
for consistency with 
Section 7.1 in 
Amendment 5.
Section 2.2.3 Clinical Experience; 
Section 2.2.3.2 Phase 2b/3 Study in 
Alopecia Areata; 
Section 2.3 Benefit/Risk 
Assessment
Provided updated numbers of 
participants in Phase 2 and Phase 
3 clinical studies. Added 
information on Phase 2b/3 Study 
B7981015 in Alopecia Areata.
This update was made in 
alignment with 
Investigator Brochure 
version 8.0 December 
2021.
Title Page and Section 10.1.1. 
Regulatory and Ethical 
Considerations
Language added for compliance 
with Japan regulatory 
requirements.
This information was 
added for consistency 
with GCP for J-NDA.
Clinical Trials of 
“unapproved drug” 
should be conducted 
under GCP for J-NDA 
(Article 2, 14, 14(3) etc).
After regulatory 
approval, clinical trials 
of “approved drug” 
should be conducted 
under GCP and GPSP 
for Re-Examination 
(Article 14-4(1), 14-4(4) 
etc).
Section 10.16 Appendix 16: 
Protocol Amendment History
Moved table for Amendment 5 
descriptions of changes and brief 
rationales to this appendix.
Following Pfizer’s 
standard procedure for 
the common protocol 
template.
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Section # and Name
Description of Change
Brief Rationale
Throughout document
Other relatively minor 
administrative/typo/abbreviation
/formatting updates.
Updated for 
grammatical correctness, 
clarity, consistency with 
Pfizer Global Style 
Guide and protocol 
template.
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TABLE OF CONTENTS
LIST OF TABLES...................................................................................................................16
1. PROTOCOL SUMMARY...................................................................................................17
1.1. Synopsis ..................................................................................................................17
1.2. Schema ....................................................................................................................22
1.3. Schedule of Activities (SoA)...................................................................................23
1.3.1. Screening and Day 1...................................................................................24
1.3.2. Intervention Period .....................................................................................31
1.3.2.1. Treatment Period 1: Week 2 to Month 24.................................31
1.3.2.2. Treatment Period 1: Month 28 to Month 36 .............................39
1.3.2.3. Treatment Period 2: Month 40 to Month 60 .............................44
1.3.3. Early Termination and Follow-up ..............................................................49
2. INTRODUCTION ...............................................................................................................56
2.1. Study Rationale .......................................................................................................56
2.2. Background .............................................................................................................56
2.2.1. Drug Development Rationale .....................................................................58
2.2.2. Nonclinical and Phase 1 Efficacy and Safety Data ....................................58
2.2.3. Clinical Experience.....................................................................................59
2.2.3.1. Phase 2a Study in Alopecia Areata ...........................................59
2.2.3.2. Phase 2b/3 Study in Alopecia Areata........................................60
2.3. Benefit/Risk Assessment.........................................................................................62
3. OBJECTIVES, ESTIMANDS AND ENDPOINTS ............................................................63
4. STUDY DESIGN.................................................................................................................67
4.1. Overall Design.........................................................................................................67
4.2. Scientific Rationale for Study Design.....................................................................69
4.3. Justification for Dose ..............................................................................................70
4.4. End of Study Definition ..........................................................................................71
5. STUDY POPULATION......................................................................................................71
5.1. Inclusion Criteria.....................................................................................................72
5.1.1. Inclusion Criteria for De Novo Participants and Those Originating 
from B7931005 or B7981015 with >30 Days between the Index Study 
and Study B7981032........................................................................................72
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5.1.2. Inclusion Criteria for All Participants Originating from B7931005 or 
B7981015.........................................................................................................73
5.1.3. Inclusion Criteria for All Participants.........................................................73
5.2. Exclusion Criteria....................................................................................................75
5.2.1. Exclusion Criteria for Participants Originating from B7981015 with 
≤30 Days between Studies...............................................................................75
5.2.2. Exclusion Criteria for De Novo Participants and Those Originating 
from B7931005 or B7981015 with >30 Days between the Index Study 
and Study B7981032........................................................................................75
5.2.3. Exclusion Criteria for All Participants .......................................................80
5.3. Lifestyle Considerations..........................................................................................82
5.3.1. Contraception..............................................................................................82
5.3.2. Cosmetic Treatments/Applications.............................................................83
5.3.3. Meals and Dietary Restrictions...................................................................83
5.3.4. Caffeine, Alcohol, and Tobacco .................................................................84
5.3.5. Elective Surgery..........................................................................................84
5.4. Screen Failures ........................................................................................................84
6. STUDY INTERVENTION..................................................................................................84
6.1. Study Intervention(s) Administered........................................................................85
6.2. Preparation/Handling/Storage/Accountability ........................................................85
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................86
6.4. Study Intervention Compliance...............................................................................86
6.5. Concomitant Therapy..............................................................................................87
6.5.1. Permitted Concomitant Medications ..........................................................87
6.5.2. Prohibited Concomitant Medications .........................................................88
6.5.3. Vaccinations ...............................................................................................90
6.5.4. Surgery........................................................................................................91
6.6. Dose Modification...................................................................................................91
6.7. Intervention after the End of the Study...................................................................91
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................91
7.1. Discontinuation of Study Intervention ....................................................................91
7.1.1. Permanent Discontinuation.........................................................................91
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7.1.1.1. Observation Period....................................................................91
7.1.2. Temporary Discontinuation........................................................................92
7.2. Participant Discontinuation/Withdrawal from the Study........................................92
7.2.1. Withdrawal of Consent...............................................................................93
7.3. Lost to Follow up ....................................................................................................93
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................93
8.1. Efficacy Assessments..............................................................................................96
8.1.1. Rater Qualifications....................................................................................96
8.1.2. Clinical Assessments ..................................................................................96
8.1.2.1. Severity of Alopecia Tool (SALT)............................................96
8.1.2.2. Eyelash Assessment (ELA).......................................................97
8.1.2.3. Eyebrow Assessment (EBA).....................................................98
8.1.2.4. Assessment of Fingernails Affected by Alopecia Areata..........99
8.1.2.5. Clinician Global Impression - Alopecia Areata (CGI-AA) ......99
8.1.3. Patient Reported Outcome (PRO) / Observer Reported Outcome 
(ObsRO)...........................................................................................................99
8.1.3.1. Alopecia Areata Patient Priority Outcomes (AAPPO)..............99
8.1.3.2. Patient’s Global Impression of Change (PGI-C).....................100
8.1.3.3. Patient's Satisfaction with Hair Growth (P-Sat)......................100
8.1.3.4. Hospital Anxiety and Depression Scale (HADS)....................100
8.1.3.5. EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL 5 
Dimensions-Youth (EQ-5D-Y) .......................................................100
8.1.3.6. 36 -Item Short Form Health Survey Version 2 Acute 
(SF36v2 Acute) ...............................................................................101
8.1.3.7. Alopecia Areata Resource Utilization (AARU)......................101
8.1.3.8. Work Productivity and Activity Impairment: Alopecia 
Areata (WPAI: AA).........................................................................101
8.1.3.9. Behavior Rating Inventory of Executive Function®, 
Second Edition (BRIEF®2).............................................................101
8.1.4. Photography..............................................................................................102
8.2. Safety Assessments ...............................................................................................102
8.2.1. Medical History, Physical Examinations, Height, and Weight ................103
8.2.2. Tanner Stages of Development.................................................................104
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8.2.3. Vital Signs ................................................................................................104
8.2.4. Chest Radiography....................................................................................105
8.2.5. Electrocardiograms...................................................................................105
8.2.6. Audiological Evaluation...........................................................................106
8.2.7. Special Safety Assessment .......................................................................106
8.2.7.1. Suspected Opportunistic Infections.........................................106
8.2.7.2. Dermatological Events ............................................................106
8.2.8. Clinical Safety Laboratory Assessments ..................................................107
8.2.8.1. Tuberculosis Testing ...............................................................108
8.2.8.2. Purified Protein Derivative (PPD) Test...................................110
8.2.8.3. Varicella Zoster Virus Immunoglobulin G Antibody 
(VZV IgG Ab) Testing ....................................................................110
8.2.8.4. Day 1 Viral Screen ..................................................................111
8.2.8.5. Hepatitis B DNA (HBVDNA) Testing ...................................111
8.2.9. Suicidal Ideation and Behavior Risk Monitoring.....................................111
8.2.9.1. Columbia Suicide Severity Rating Scale (C-SSRS) ...............111
8.2.10. Patient Health Questionnaire - 8 Items (PHQ-8)....................................112
8.2.11. Pregnancy Testing ..................................................................................112
8.2.12. Check for Initiation of Menarche (for Premenarchal Females Only).....113
8.3. Adverse Events and Serious Adverse Events........................................................113
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.....114
8.3.1.1. Reporting SAEs to Pfizer Safety.............................................114
8.3.1.2. Recording Non-serious AEs and SAEs on the CRF ...............114
8.3.2. Method of Detecting AEs and SAEs ........................................................115
8.3.3. Follow-up of AEs and SAEs.....................................................................115
8.3.4. Regulatory Reporting Requirements for SAEs.........................................115
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational 
Exposure ........................................................................................................116
8.3.5.1. Exposure During Pregnancy....................................................116
8.3.5.2. Exposure During Breastfeeding ..............................................117
8.3.5.3. Occupational Exposure ...........................................................118
8.3.6. Cardiovascular and Death Events (Not Applicable).................................118
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8.3.7. Disease-Related Events and/or Disease-Related Outcomes not 
Qualifying as AEs or SAEs (Not Applicable) ...............................................118
8.3.8. Adverse Events of Special Interest...........................................................118
8.3.8.1. Lack of Efficacy (Not Applicable)..........................................118
8.3.9. Medical Device Deficiencies (Not Applicable)........................................118
8.3.10. Medication Errors...................................................................................118
8.4. Treatment of Overdose..........................................................................................119
8.5. Pharmacokinetics ..................................................................................................120
8.5.1. Shipment of Pharmacokinetic Samples ....................................................121
8.6. Pharmacodynamics................................................................................................121
8.7. Genetics.................................................................................................................121
8.7.1. Specified Genetics ....................................................................................121
8.7.2. Banked Biospecimens for Genetics..........................................................121
8.8. Biomarkers ............................................................................................................121
8.8.1. Specified Gene Expression (RNA) Research ...........................................121
8.8.2. Specified Protein Research.......................................................................121
8.8.3. Specified Metabolomic Research .............................................................122
8.8.4. Banked Biospecimens for Biomarkers .....................................................122
8.9. Medical Resource Utilization and Health Economics...........................................122
9. STATISTICAL CONSIDERATIONS ..............................................................................122
9.1. Estimands and Statistical Hypotheses...................................................................122
9.1.1. Estimands..................................................................................................122
9.2. Sample Size Determination...................................................................................122
9.3. Populations for Analyses.......................................................................................123
9.4. Statistical Analyses ...............................................................................................123
9.4.1. Timing of the Analyses.............................................................................123
9.4.2. Efficacy Analyses .....................................................................................123
9.4.3. Safety Analyses ........................................................................................124
9.4.4. Other Analyses..........................................................................................125
9.5. Interim Analyses ...................................................................................................126
9.5.1. Data Monitoring Committee (DMC)........................................................126
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS........................................................................................................127
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10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations.............127
10.1.1. Regulatory and Ethical Considerations ..................................................127
10.1.2. Financial Disclosure ...............................................................................128
10.1.3. Informed Consent Process ......................................................................128
10.1.4. Data Protection .......................................................................................129
10.1.5. Committees Structure .............................................................................130
10.1.5.1. Data Monitoring Committee .................................................130
10.1.5.2. Adjudication/Review Committee Submission ......................130
10.1.6. Dissemination of Clinical Study Data ....................................................130
10.1.7. Data Quality Assurance ..........................................................................131
10.1.8. Source Documents..................................................................................133
10.1.9. Study and Site Closure............................................................................133
10.1.10. Publication Policy.................................................................................134
10.1.11. Sponsor’s Qualified Medical Personnel ...............................................134
10.2. Appendix 2: Clinical Laboratory Tests ...............................................................136
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ....................................................................139
10.3.1. Definition of AE .....................................................................................139
10.3.2. Definition of SAE...................................................................................140
10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs....................141
10.3.4. Reporting of SAEs..................................................................................144
10.4. Appendix 4: Contraceptive Guidance ................................................................145
10.4.1. Male Participant Reproductive Inclusion Criteria..................................145
10.4.2. Female Participant Reproductive Inclusion Criteria...............................145
10.4.3. Women of Childbearing Potential ..........................................................145
10.4.4. Contraception Methods...........................................................................146
10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-up Assessments ......148
10.6. Appendix 6: Hepatitis B Testing Algorithm and Full Eligibility Criteria...........150
10.7. Appendix 7: Country-specific Requirements......................................................151
10.7.1. Japan Specific Requirements for HBVDNA Testing.............................151
10.7.2. China Specific Language for Section 8.5 Pharmacokinetics and 
Section 8.6 Pharmacodynamics .....................................................................152
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10.8. Appendix 8: Guidelines for Participant Safety Monitoring and 
Discontinuation........................................................................................................154
10.8.1. Monitoring..............................................................................................154
10.8.2. Discontinuation.......................................................................................155
10.9. Appendix 9: Prohibited and Permitted Concomitant CYP3A Inducers and 
Substrates.................................................................................................................158
10.9.1. Prohibited Concomitant CYP3A Inducers and Substrates .....................158
10.9.2. Permitted Concomitant CYP3A Substrates............................................159
10.10. Appendix 10: Vaccine Sub-Study.....................................................................160
10.11. Appendix 11: Discontinuation Criteria for Worsening of Alopecia Areata 
for VHP Countries in the EU...................................................................................172
10.12. Appendix 12: Study Intervention Continuation Criteria for Adolescents.........173
10.13. Appendix 13: Alternative Measures During Public Emergencies.....................174
10.13.1. Eligibility..............................................................................................174
10.13.2. Telehealth Visits...................................................................................175
10.13.3. Alternative Facilities for Safety Assessments ......................................176
10.13.3.1. Laboratory Testing ..............................................................176
10.13.3.2. Chest Radiography..............................................................179
10.13.3.3. Electrocardiograms..............................................................179
10.13.3.4. Audiological Evaluation......................................................179
10.13.4. Study Intervention ................................................................................179
10.13.5. Home Health Visits...............................................................................181
10.13.6. Adverse Events and Serious Adverse Events.......................................182
10.13.7. Efficacy Assessments ...........................................................................182
10.14. Appendix 14: Management of Participants with a Positive Tuberculosis 
Test Result on Day 1 or Annual Tuberculosis Testing............................................183
10.15. Appendix 15: Abbreviations .............................................................................185
10.16. Appendix 16: Protocol Amendment History.....................................................190
11. REFERENCES ................................................................................................................236
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LIST OF TABLES
Table 1.
PF-06651600 Exposure Margins and No Observed Adverse Effects 
Level .........................................................................................................71
Table 2.
Protocol-Required Safety Laboratory Assessments ...............................136
Table 3.
Vaccine Sub-Study Additional Procedures ............................................161
Table 4.
Study B7981032 Study Intervention Continuation Criteria for 
Adolescents.............................................................................................173
Table 5.
Windows for Remote Visits and Laboratory Sample Collections if 
Required due to Public Emergencies, Including the COVID-19 
Pandemic.................................................................................................178
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1. PROTOCOL SUMMARY
1.1. Synopsis
Protocol Title: A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY 
INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND 
ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
Short Title: Study Evaluating PF-06651600 in Adults and Adolescents with Alopecia Areata
Rationale:
PF-06651600 inhibits JAK3 and members of the tyrosine kinase family expressed in 
hepatocellular carcinoma (TEC) and is being developed as an oral treatment for patients with 
alopecia areata (AA).  Since CD8+ T cells, NK cells and mast cells have all been implicated 
in the pathophysiology of AA, inhibition of TEC kinases has the potential to contribute to 
efficacy in this disease by modulating the functional activity of pathogenic effector cells.
Objectives, Estimands and Endpoints
Primary Objectives
Primary Endpoints

To evaluate the long-term safety and 
tolerability of PF-06651600 in adult 
and adolescent participants with AA. 
Through the time the last participant 
completes the Follow-up visit or 28 days 
after the Month 36 visit:

Incidence of treatment-emergent 
adverse events (TEAEs);

Incidence of serious adverse events 
(SAEs) and adverse events (AEs) 
leading to discontinuation;

Incidence of clinically significant 
abnormalities in vital signs;

Incidence of clinically significant 
abnormalities in clinical laboratory 
values.
Secondary Objectives
Secondary Endpoints

To evaluate the long-term safety and 
tolerability of PF-06651600 in adult 
and adolescent participants with AA. 
Through the time of the last participant 
visit:

Incidence of TEAEs;

Incidence of SAEs and AEs leading 
to discontinuation;
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
Incidence of clinically significant 
abnormalities in vital signs;

Incidence of clinically significant 
abnormalities in clinical laboratory 
values.

To evaluate the long-term efficacy 
of PF-06651600 in adult and 
adolescent participants with AA.

Response based on achieving 
absolute Severity of Alopecia Tool 
(SALT) score ≤10 through 
Month 36, for overall and AA SALT 
score;

Response based on achieving 
absolute SALT score ≤20 through 
Month 36, for overall and AA SALT 
score;

Change from baseline in SALT 
score through Month 36, for overall 
and AA SALT score; 

Response based on achieving at least 
75% improvement in SALT 
(SALT75) from baseline through 
Month 36, for overall and AA SALT 
score;

Response based on achieving at least 
a 2-grade improvement from 
baseline or a score of 3 in Eyebrow 
Assessment (EBA) score through 
Month 36;

Response based on achieving at a 
least 2-grade improvement from 
baseline or a score of 3 in Eyelash 
Assessment (ELA) score through 
Month 36.

To evaluate the effect of 
PF-06651600 on patient-centered 
outcomes and payer relevant 
measures to assess treatment benefit 

PGI-C response defined as PGI-C 
score of “moderately improved or 
greatly improved” through 
Month 36;
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from the patient perspective and to 
demonstrate value.

Change from baseline in Alopecia 
Areata Patient Priority Outcomes 
(AAPPO) scales through Month 36;

Change from baseline in the 
depression subscale score of the 
Hospital Anxiety and Depression 
Scale (HADS) through Month 36;

Change from baseline in the anxiety 
subscale score of the HADS through 
Month 36;

Improvement on HADS among 
participants with a baseline subscale 
score indicative of depression who 
achieved a “normal” subscale score 
indicative of an absence of 
depression through Month 3679,90;

Improvement on HADS among 
participants with a baseline subscale 
score indicative of anxiety who 
achieved a “normal” subscale score 
indicative of an absence of anxiety 
through Month 3679,90.
See Appendix 10 for vaccine sub-study objectives and endpoints.
Overall Design:
Study B7981032 will investigate PF-06651600 in participants with AA.  This is a Phase 3, 
open-label, multi-center, long-term study designed to evaluate the safety and efficacy of 
PF-06651600 in adults and adolescents ≥12 years of age.  Eligible prior participants in the 
index studies B7931005 and B7981015 will be given the opportunity to enroll, as well as 
approximately 450 de novo participants (ie, those who have not previously received study 
intervention in Study B7931005 or B7981015).  It is estimated that a total of approximately
960 participants will be enrolled. 
Disclosure Statement: 
This is a Single Group Treatment study with 1 Arm that has No masking.
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Number of Participants:
Eligible prior participants from the index studies B7931005 and B7981015 will be given the 
opportunity to enroll, as well as approximately 450 de novo participants (ie, those who have 
not previously received study intervention in Study B7931005 or B7981015), for a total of 
approximately 960 participants.
Intervention Groups and Duration:
Prior participants from Studies B7931005 and B7981015 as well as de novo participants will 
be eligible to participate in this study.
Study B7981032 has 2 treatment periods and an observation period.
TP1:

Participants enrolling from B7931005 and B7981015 who received study intervention in 
one of these studies will receive open-label 50 mg QD PF-06651600 for 36 months.

De novo participants (ie, those who have not previously received study intervention in 
study B7931005 or B7981015) will receive open-label 200 mg PF-06651600 QD for 
4 weeks followed by open-label 50 mg QD PF-06651600 for 35 months. 

The total duration of participation TP1 is up to approximately 38 months, including up to 
5 weeks for screening (for de novo participants and participants originating from 
Study B7931005 or B7981015 with 30 days between the last dose in Study B7931005 
or B7981015 and their first visit in Study B7981032), 36 months study intervention, and 
a follow-up period of 4 weeks after completion of TP1 (for participants not continuing to 
TP2) or discontinuation of study intervention (See Schema).  

Participants in countries where PF-06651600 is not commercially available at the time of
their Month 36 visit will have the opportunity to enter TP2, as described below. In this 
case, the Follow-up visit will be completed at the end of their participation in TP2.
TP2: 

TP2 will be of variable length for individual participants; assuming a participant does not 
require discontinuation per protocol, a participant may continue to receive PF-06651600
in TP2 for a maximum of 24 months or until availability of commercial product in their 
country, or until the sponsor terminates the study in that country, whichever occurs first. 

In TP2, participants will receive 50 mg QD PF-06651600. The total duration of 
participation in TP2 is approximately 25 months, including up to 24 months of study 
intervention and a Follow-up period of 4 weeks after completion or discontinuation of 
study intervention (See Section 1.2 Schema).
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Observation Period:

If study intervention is permanently discontinued, the participant will be asked to 
remain in the study after the Follow-up visit without study intervention and continue 
to comply with study visit schedules for approximately 2 years after the last dose of 
study intervention or until study end, whichever occurs first; refer to Section 7.1.1.1
for further details.
Data Monitoring Committee: Yes
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1.2. Schema
Abbreviations: QD = once daily
a.
Participants originating from Study B7931005 or B7981015 are defined as those who received study intervention in 
one of these studies.
b.
Participants with ≤30 days between the first study visit in B7981032 and the last dose in Study B7981015 will not 
require a screening period.
c.
De novo participants are defined as those who did not previously receive study intervention in Study B7931005 or 
B7981015; this includes, but is not limited to, those consented and screened for Study B7931005 or B7981015 but who 
did not receive study intervention in one of these studies.
d.
After completion of TP1 (for participants not continuing to TP2) or discontinuation of study intervention, a Follow-up 
period of 4 weeks will occur. Participants in countries where PF-06651600 is not commercially available at the time 
their Month 36 visit will have the opportunity to enter TP2.
e.
In TP2, after completion or discontinuation of study intervention, a Follow-up period of 4 weeks will occur.
f.
TP2 will be of variable length for individual participants for a maximum of 24 months or until availability of 
commercial product in their country, or until the sponsor terminates the study in that country, whichever occurs first.
g.
If study intervention is permanently discontinued, the participant will be asked to remain in the study after the 
Follow-up visit for the Observation Period without study intervention and continue to comply with study visit 
schedules for approximately 2 years after the last dose of study intervention or until study end, whichever occurs first.
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1.3. Schedule of Activities (SoA)
De novo participants are defined as those who did not previously receive study intervention 
in Study B7931005 or B7981015; this includes, but is not limited to, those consented and 
screened for Study B7931005 or B7981015 but who did not receive study intervention in one 
of these studies.
Participants originating from Study B7931005 or B7981015 are defined as those who 
received study intervention in one of these studies.
A = De novo participants;
B = Participants originating from Study B7931005 or B7981015 with >30 days between the 
first visit of Study B7981032 and the last dose in Study B7931005 or B7981015;
C = Participants originating from Study B7981015 with >14 days to ≤30 days between the 
first visit of Study B7981032 and the last dose in Study B7981015; 
D = Participants originating from Study B7981015 with ≤14 days between the first visit of 
Study B7981032 and the last dose in Study B7981015;
E = All participants originating from Study B7931005;
X = All participants
See Appendix 10 for vaccine sub-study schedule of activities.
If participant visits or procedures are affected by a public emergency, including the 
coronavirus disease 2019 (COVID-19) pandemic, please refer to Appendix 13.
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1.3.1. Screening and Day 1
Screening is only applicable for de novo participants (Group A) and participants originating from Study B7931005 or B7981015 with 
>30 days between the first visit of Study B7981032 and the dose in Study B7931005 or B7981015 (Group B).  The screening visit 
date is defined as the date that informed consent/assent is obtained for Study B7981032.  
Procedures conducted as part of the participant’s routine clinical management (eg, chest x-ray or other appropriate diagnostic imaging 
such as computed tomography or magnetic resonance imaging [MRI]) and obtained before signing of the ICF may be utilized for 
screening or baseline purposes provided the procedures met the protocol-specified criteria and were performed within the time frame 
defined in the SoA.  This includes procedure(s) which were completed for participants consented and screened for study B7981015 
but who did not receive study intervention in study B7981015.  Separate informed consent/assent for Study B7981032 must be 
obtained prior to use of data in Study B7981032 per Section 10.1.3.
Procedure
Screening
Day 1
Notes
Visit Window (±Days)
None
None
Visit Identifier
1
2
Day
-35 to -1
1
Enrollment procedures
Informed consent/assent
A, B
C, D
Must be obtained before the participant is enrolled in the study per 
Section 10.1.3
Inclusion and exclusion 
criteria
A, B
X
Demography
A, B
C, D
Medical history 
A, B
C, D
Refer to the CRF completion guidelines for specific information regarding 
medical history information to be collected for each group of participants.  
Section 8.2.1
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Procedure
Screening
Day 1
Notes
AA disease history, 
smoking and alcohol 
history
A, B
Section 8.2.1
Medical procedures
Full physical examination, 
including dermatological 
full body examination
A, B
A, B
Section 8.2.1
Targeted physical 
examination
C
Section 8.2.1
Vital signs
A, B
A, B, C
Section 8.2.3
12-lead ECG
A, B
A, B
Section 8.2.5
Height and weight
A, B
A, B
Height will not be collected at the Day 1 visit in participants who are 18 
years of age at this visit (ie, height will only be collected at screening in 
these participants).  Section 8.2.1
Tanner Stages of 
Development
X
For participants who are <18 years of age at the Day 1 visit in 
Study B7981032.  Section 8.2.2
Chest radiograph
A, B
Chest radiograph (ie, chest x-ray or other appropriate diagnostic imaging 
such as CT or MRI) must be taken at screening if not performed within 3 
months prior to the screening visit.  Exclusion Criterion 19 in Section 5.2.2, 
Section 8.2.4
Audiological Evaluation
A, B
De novo participants and participants originating from Study B7931005 or 
B7981015 with >30 days between the first visit of Study B7981032 and the 
last dose in Study B7931005 or B7981015 must have a full audiological 
assessment completed at screening or within 8 weeks prior to Day 1.  
Section 8.2.6
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Procedure
Screening
Day 1
Notes
Laboratory
Hematology and Serum 
Chemistry
A, B
A, B, C
Section 8.2.8, Appendix 2
Fasting Lipid Panel
A, B
Section 8.2.8, Appendix 2
Urinalysis
A, B
A, B, C
Appendix 2
Serum FSH
A, B
To confirm postmenopausal status in females under 60 years old who are not 
using hormonal contraception or hormonal replacement therapy.  This test is 
not to be performed for WOCBP.  Appendix 2, Section 10.4.3
Pregnancy test (WOCBP 
only)
A, B
X
Day 1 test does not need to be performed for participants with testing in 
Study B7931005 or B7981015 on the same day as the Study B7981032 
Day 1 visit.  Section 8.2.11, Appendix 2, Appendix 4
HIV testing
A, B
Appendix 2
Hepatitis B and Hepatitis C 
Screening
A, B
Appendix 2
HBVDNA (applicable 
countries)
A, B
For de novo participants and participants originating from Study B7931005 
or B7981015 with >30 days between the first visit of Study B7981032 and 
the last dose in the index study, testing will be dependent on the screening 
results from Study B7981032.  See Appendix 7 for Japan specific 
requirements.  Section 8.2.8.5, Appendix 6
Varicella Zoster Virus 
immunoglobulin G 
antibody (VZV IgG Ab) 
(adolescents only, if 
applicable)
A, B
VZV IgG Ab is only required in adolescent participants 12 to <18 years of 
age without documented evidence of having received varicella vaccination 
(2 doses).  Serological testing must be performed for VZV IgG Ab only in 
the absence of documented evidence of having received varicella 
vaccination (2 doses) per Exclusion #16. Section 8.2.8.3, Appendix 2
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Procedure
Screening
Day 1
Notes
Collection of sample for 
potential viral screen
A, E
For participants from Study B7981015 a sample will be collected for Study 
B7981032 if it was tested in Study B7981015.  Section 8.2.8.4, Appendix 2
Screening tuberculosis test
A, B
Exclusion Criterion 19 in Section 5.2.2, Section 8.2.8.1, Section 8.2.8.1.2, 
Appendix 2
Day 1 tuberculosis 
testing/chest radiograph
C, D
Section 8.2.8.1, Section 8.2.8.1.2, Appendix 2
Pharmacodynamics markers
FACS-TBNK
A, B
Section 8.6
Immunoglobulins (IgA, 
IgG, IgM)
A, B
Section 8.6
Trial treatment
IRT registration
A, B
C, D
IRT study intervention 
assignment
X
Study intervention 
dispensing
X
Section 6.2
Study intervention 
administration
X
Section 6.1
Clinical assessments 
SALT
A, B
A, B
Section 8.1.2.1.
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Procedure
Screening
Day 1
Notes
AA eligibility assessment
A, B
A, B
Scalp hair loss due to AA to be assessed to verify eligibility for de novo 
participants and participants originating from Study B7931005 or B7981015 
with >30 days between the first visit of Study B7981032 and the last dose of 
study intervention in Study B7931005 or B7981015.  Section 8.1.2.1.2.
EBA and ELA
A, B
A, B
Section 8.1.2.2, Section 8.1.2.3
Photography
A, B
A, B
Section 8.1.4
Assessment of Fingernails 
Affected by AA
A, B, E
Collected at Day 1 in all de novo participants, all participants originating 
from B7931005, and participants originating from Study B7981015 with 
>30 days between the first visit of B7981032 and the last dose in Study 
B7981015.  Section 8.1.2.4
CGI-AA
A, B
A, B
Section 8.1.2.5
C-SSRS
A, B
A, B, C
For de novo participants and participants originating from B7931005 or 
B7981015 with >30 days between the last dose in the prior study and the 
first visit in Study B7981032 the C-SSRS for screening and Day 1 visits will 
be used at screening and Day 1.
For participants originating from B7981015 with >14 days to 30 days 
between the last dose in the prior study and the first visit in Study 
B7981032, the C-SSRS for visits after Day 1 will be used  and the results 
must be evaluated against the protocol discontinuation criteria in 
Section 10.8.2 before the participant is assigned to study intervention.
Section 8.2.9
Patient reported outcomes
AAPPO
A, B, E
Section 8.1.3.1
PHQ-8
A, B
Section 8.2.10
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Procedure
Screening
Day 1
Notes
HADS
A, B, E
Section 8.1.3.4
SF36v2 Acute
A, B, E
Section 8.1.3.6
EQ-5D-5L (adults) or 
EQ-5D-Y (adolescents)
A, B, E
Participants who are <18 years at the time of the Day 1 visit of B7981015 or 
B7981032 will use the EQ-5D-Y (age for participants from B7931005 will 
be based on their age on Day 1 of B7981032).  Section 8.1.3.5
AARU
A, B, E
For participants originating from Study B7981015 with <3 months between 
the Day 1 visit of Study B7981032 and the last visit at which the AARU was 
performed in Study B7981015, the AARU will not be collected until the 
Month 3 visit (ie, the AARU will not be collected at the Day 1 visit for this 
group).
For de novo participants, all participants originating from B7931005, and 
participants originating from Study B7981015 with 3 months between the 
Day 1 visit of Study B7981032 and the last visit at which the AARU was 
performed in Study B7981015, the AARU will be collected at Day 1. 
Section 8.1.3.7
WPAI: AA
A, B, E
Adolescents aged 12 to <18 years at the time of the Day 1 visit of B7981015 
or B7981032 will not complete this assessment.  Section 8.1.3.8
Observer Reported Outcomes
BRIEF®2
X
Only in countries where the BRIEF®2 questionnaire is available and only 
for participants who are <18 years of age at the time of the Study B7981032 
Day 1 visit.  The parent/caregiver will complete the questionnaire.
Section 8.1.3.9
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Procedure
Screening
Day 1
Notes
Other
Prior and current 
concomitant medications 
and treatment(s) 
monitoring 
A, B
X
Adverse event monitoring
A, B
X
On Day 1, for participants originating from Study B7931005 or B7981015, 
AEs (for the time in between studies and at Day 1 of Study B7981032) must 
be compared against B7981032 discontinuation criteria. Participants with 
AEs meeting the B7981032 protocol discontinuation criteria cannot be 
enrolled in the B7981032 Study
Contraception check for 
WOCBP
A, B
X
Check for initiation of 
menarche 
A, B
X
For premenarchal females only.  Section 8.2.12
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1.3.2. Intervention Period
1.3.2.1. Treatment Period 1: Week 2 to Month 24
For procedures to be performed in TP1 from Month 28 to Month 36, refer to Section 1.3.2.2.
For procedures to be performed in TP2 from Month 40 to Month 60, refer to Section 1.3.2.3.
Procedure
Intervention Period (Months)
Notes
Visit
Week 2
1
3
6
9
12
15
18
21
24
Visit Window 
(Days)
3
3
7
7
7
7
7
7
7
7
Visit Identifier
3
4
5
6
7
8
9
10
11
12
Day
15
31
91
181
271
361
451
541
631
721
Medical procedures
Full physical 
examination, 
including 
dermatological full 
body examination
X
X
X
X
Section 8.2.1
Targeted physical 
examination
X
X
X
X
X
Section 8.2.1
Vital signs
X
X
X
X
X
X
X
X
X
Section 8.2.3
12-lead ECG
X
X
X
X
Section 8.2.5
Height and weight
X
X
X
X
Height will not be collected from participants who are 
≥18 years of age at the time of the visit.  Section 8.2.1
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Procedure
Intervention Period (Months)
Notes
Visit
Week 2
1
3
6
9
12
15
18
21
24
Tanner Stages of 
Development
X
X
For participants who were <18 years of age at the Day 1 visit 
in Study B7981032.  Tanner stages will be collected at visit(s) 
after the Day 1 visit only until the participant has reached a 
score of 5 on all applicable domains.  For participants with 
AU (ie, total loss of hair on the scalp, face and body) at the 
Day 1 visit for whom the stage for pubic hair cannot be 
reliably assessed, the Tanner stages will be collected at visit(s) 
after the Day 1 visit only until the participant has reached a 
score of 5 on the remaining applicable domain (ie, breasts for 
females and genitalia for males).  
Section 8.2.2.
Audiological 
Evaluation
X
X
X
X
Section 8.2.6
Laboratory
Hematology and 
Serum Chemistry
X
X
X
X
X
X
X
X
X
X
Section 8.2.8, Appendix 2
Fasting Lipid 
Panel
X
X
X
X
X
X
Section 8.2.8, Appendix 2
Urinalysis
X
X
X
X
X
X
Appendix 2
Pregnancy test 
X
X
X
X
X
X
X
X
X
X
For WOCBP only.  Monthly urine pregnancy tests will be 
performed by the participant between scheduled study visits 
starting after the Month 1 visit through the Month 24 visit.  
The pregnancy testing between visits may occur outside of the 
study site.  Site personnel will contact participants (or their 
legally authorized representative, if appropriate) via telephone 
between study visits to obtain monthly pregnancy test result 
and ensure this contact and the result of the pregnancy test are 
recorded in participant source documentation and CRF.  
Section 8.2.11, Appendix 2, Appendix 4
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Procedure
Intervention Period (Months)
Notes
Visit
Week 2
1
3
6
9
12
15
18
21
24
HBVDNA 
(applicable 
countries)
X
X
X
X
X
X
X
X
For de novo participants and participants originating from 
Study B7931005 or B7981015 with >30 days between the 
first visit of Study B7981032 and the last dose in the index 
study, testing will be dependent on the screening results from 
Study B7981032.
For participants originating from Study B7981015 with 
30 days between the first visit of Study B7981032 and the 
last dose in the index study, testing will be dependent on 
screenings result from the index study.  See Appendix 7 for 
Japan specific requirements.  Section 8.2.8.5, Appendix 6
Annual 
tuberculosis 
testing/chest 
radiograph
X
X
Section 8.2.8.1, Section 8.2.8.1.2, Appendix 2
FACS-TBNK 
samples collected 
for possible reflex 
testing
X
X
X
X
X
X
X
X
Appendix 2
Pharmacodynamics markers
FACS-TBNK
X
X
Section 8.6
Immunoglobulins 
(IgA, IgG, IgM)
X
X
Section 8.6
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Procedure
Intervention Period (Months)
Notes
Visit
Week 2
1
3
6
9
12
15
18
21
24
Trial treatment
Study intervention 
dispensing
X
X
X
X
X
X
X
X
X
X
At the Week 2 visit, the participant will return the package 
containing the study intervention which was dispensed at the 
Day 1 visit for accountability.  The Day 1 package will then 
be returned to the participant for administration and 
dispensing at the Week 2 visit.  Section 6.2
Study intervention 
administration
X
X
X
X
X
X
X
X
X
X
Section 6.1
Study intervention 
accountability and 
compliance
X
X
X
X
X
X
X
X
X
X
Section 6.2, Section 6.4
Clinical assessments
SALT
X
X
X
X
X
X
X
X
X
For participants with known androgenetic alopecia, this 
includes a separate assessment of scalp hair loss due to 
androgenetic alopecia at the final on-therapy visit for each 
treatment period (ie, at Month 36 or Early Termination in 
TP1, and at Month 60, the last on-therapy visit, or Early 
Termination in TP2).  Section 8.1.2.1
EBA and ELA
X
X
X
X
X
X
Section 8.1.2.2, Section 8.1.2.3
Photography
X
X
X
X
X
Section 8.1.4
Assessment of 
Fingernails 
Affected by AA
X
X
X
X
X
X
Section 8.1.2.4
CGI-AA
X
X
X
X
X
X
X
Section 8.1.2.5
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Procedure
Intervention Period (Months)
Notes
Visit
Week 2
1
3
6
9
12
15
18
21
24
C-SSRS
X
X
X
X
X
X
X
X
X
Section 8.2.9
Patient reported outcomes
AAPPO
X
X
X
X
X
X
X
Section 8.1.3.1
PGI-C and P-Sat
X
X
X
X
X
X
X
Section 8.1.3.2, Section 8.1.3.3
HADS
X
X
X
X
X
X
X
Section 8.1.3.4
SF36v2 Acute
X
X
X
X
X
X
Section 8.1.3.6
EQ-5D-5L (adults) 
or EQ-5D-Y 
(adolescents)
X
X
X
X
X
Participants who are <18 years at the time of the Day 1 visit 
of B7981015 or B7981032 will use the EQ-5D-Y (age for 
participants from B7931005 will be based on their age on 
Day 1 of B7981032).  Participants who reach the age of 
18 years during Study B7981032 will continue to use the 
EQ-5D-Y for the remainder of the study.  Section 8.1.3.5
AARU
X
X
X
X
X
X
X
X
Section 8.1.3.7
WPAI: AA
X
X
X
X
X
Adolescents aged 12 to <18 years at the time of the Day 1 
visit of B7981015 or B7981032 will not complete this 
assessment.  Section 8.1.3.8
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Procedure
Intervention Period (Months)
Notes
Visit
Week 2
1
3
6
9
12
15
18
21
24
Observer Reported Outcomes
BRIEF®2
X
X
X
X
Only in countries where the BRIEF®2 questionnaire is 
available and only for participants who are <18 years of age at 
the time of the Study B7981032 Day 1 visit.  The 
parent/caregiver will complete the questionnaire.
For participants who have already started the study when the 
BRIEF®2 questionnaire is approved and available for use at 
the participant’s site, the BRIEF®2 questionnaire will be 
administered at the next scheduled study visit and then at the 
remaining visits per the Schedule of Activities for the 
BRIEF®2.
The BRIEF®2 questionnaire will not be collected for 
participants who are ≥18 years of age at the time of the visit.
Section 8.1.3.9
Pharmacokinetic
PK sampling
X
X
Month 1: Predose, 1 hour post dose (±15 min).
Month 3: Predose, 0.5 (±10 min) and 3 hours (±30 min) post 
dose.  Section 8.5  
If samples are not collected at the Month 3 visit, then they 
should be collected at the next study visit.
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Procedure
Intervention Period (Months)
Notes
Visit
Week 2
1
3
6
9
12
15
18
21
24
Other
Study intervention 
continuation 
criteria for 
adolescents
X
X
Refer to Appendix 12 for full study intervention criteria to be 
assessed in participants aged ≥12 to <18 years at the time of 
the Day 1 visit of B7981015 (for the participants originating 
from B7981015) or the Day 1 visit of B7981032 (for de novo 
participants).
For those participants who have completed the B7981032 
Month 3 visit but not the Month 6 visit at the time of Protocol 
Amendment 4 approval for a site, only the Month 6 criteria 
will be checked at the scheduled Month 6 visit.
For participants who have already completed the B7981032 
Month 6 visit at the time of Protocol Amendment 4 approval 
for a site, the Month 6 criteria must be checked at the next 
scheduled visit.
Prior and current 
concomitant 
medication(s) and 
treatment(s) 
monitoring 
X
X
X
X
X
X
X
X
X
X
Adverse event 
monitoring
X
X
X
X
X
X
X
X
X
X
Contraception 
check for WOCBP
X
X
X
X
X
X
X
X
X
X
The contraception check will also be performed monthly 
between study visits at the time of the phone contact to check 
the at-home pregnancy test results (see Section 8.2.11 for 
information on pregnancy testing).
Section 5.3.1
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Procedure
Intervention Period (Months)
Notes
Visit
Week 2
1
3
6
9
12
15
18
21
24
Check for 
initiation of 
menarche 
X
X
X
X
X
X
X
X
X
X
For premenarchal females only.  Section 8.2.12
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1.3.2.2. Treatment Period 1: Month 28 to Month 36
For procedures to be performed in TP1 from Week 2 to Month 24, refer to Section 1.3.2.1.
For procedures to be performed in TP2 from Month 40 to Month 60, refer to Section 1.3.2.3.
Procedure
Intervention Period (Months)
Notes
Visit
28
32
36
Visit Window (Days)
7
7
7
Visit Identifier
14
15
16
Day
841
961
1081
Medical procedures
Full physical examination, 
including dermatological 
full body examination
X
Section 8.2.1
Targeted physical 
examination
X
X
Section 8.2.1
Vital signs
X
X
X
Section 8.2.3
12-lead ECG
X
Section 8.2.5
Height and weight
X
Height will not be collected from participants who are ≥18 years of age at the time of the 
visit.  Section 8.2.1
Tanner Stages of 
Development
X
For participants who were <18 years of age at the Day 1 visit in Study B7981032, Tanner 
stages will be collected at visit(s) after the Day 1 visit only until the participant has reached 
a score of 5 on all applicable domains.  For participants with AU (ie, total loss of hair on the 
scalp, face and body) at the Day 1 visit for whom the stage for pubic hair cannot be reliably 
assessed, the Tanner stages will be collected at visit(s) after the Day 1 visit only until the 
participant has reached a score of 5 on the remaining applicable domain (ie, breasts for 
females and genitalia for males).  
Section 8.2.2.
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Procedure
Intervention Period (Months)
Notes
Visit
28
32
36
Audiological Evaluation
X
Section 8.2.6
Laboratory
Hematology and Serum 
Chemistry
X
X
X
Section 8.2.8, Appendix 2
Fasting Lipid Panel
X
Section 8.2.8, Appendix 2
Urinalysis
X
Appendix 2
Pregnancy test 
X
X
X
For WOCBP only.  Monthly urine pregnancy tests will be performed by the participant 
between scheduled study visits starting after the Month 1 visit through the Month 36 visit.  
The pregnancy testing between visits may occur outside of the study site.  Site personnel 
will contact participants (or their legally authorized representative, if appropriate) via 
telephone between study visits to obtain monthly pregnancy test result and ensure this 
contact and the result of the pregnancy test are recorded in participant source documentation 
and CRF.  Section 8.2.11, Appendix 2, Appendix 4
HBVDNA (applicable 
countries)
X
X
X
For de novo participants and participants originating from Study B7931005 or B7981015 
with >30 days between the first visit of Study B7981032 and the last dose in the index 
study, testing will be dependent on the screening results from Study B7981032.
For participants originating from Study B7981015 with 30 days between the first visit of 
Study B7981032 and the last dose in the index study, testing will be dependent on 
screenings result from the index study.  See Appendix 7 for Japan specific requirements.  
Section 8.2.8.5, Appendix 6
Annual tuberculosis 
testing/chest radiograph
X
Section 8.2.8.1, Section 8.2.8.1.2, Appendix 2
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Procedure
Intervention Period (Months)
Notes
Visit
28
32
36
FACS-TBNK samples 
collected for possible reflex 
testing
X
X
Appendix 2
Pharmacodynamics markers
FACS-TBNK
X
Section 8.6
Immunoglobulins (IgA, 
IgG, IgM)
X
Section 8.6
Trial treatment
Study intervention 
dispensing
X
X
X
Study intervention will only be dispensed and administered at the Month 36 visit for 
participants continuing to TP2.
Study intervention 
administration
X
X
X
Study intervention will only be dispensed and administered at the Month 36 visit for 
participants continuing to TP2.
Section 6.1
Study intervention 
accountability and 
compliance
X
X
X
Section 6.2, Section 6.4
Clinical assessments
SALT
X
X
X
For participants with known androgenetic alopecia, this includes a separate assessment of 
scalp hair loss due to androgenetic alopecia at the final on-therapy visit for each treatment 
period (ie, at Month 36 or Early Termination in TP1, and at Month 60, the last on-therapy 
visit, or Early Termination in TP2).  
Section 8.1.2.1
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Procedure
Intervention Period (Months)
Notes
Visit
28
32
36
EBA and ELA
X
Section 8.1.2.2, Section 8.1.2.3
Photography
X
Section 8.1.4
Assessment of Fingernails 
Affected by AA
X
Section 8.1.2.4
CGI-AA
X
Section 8.1.2.5
C-SSRS
X
X
X
Section 8.2.9
Patient reported outcomes
AAPPO
X
Section 8.1.3.1
PGI-C and P-Sat
X
Section 8.1.3.2, Section 8.1.3.3
HADS
X
Section 8.1.3.4
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Procedure
Intervention Period (Months)
Notes
Visit
28
32
36
Observer Reported Outcomes
BRIEF®2
X
X
X
Only in countries where the BRIEF®2 questionnaire is available and only for participants 
who are <18 years of age at the time of the Study B7981032 Day 1 visit.  The 
parent/caregiver will complete the questionnaire.
For participants who have already started the study when the BRIEF®2 questionnaire is 
approved and available for use at the participant’s site, the BRIEF®2 questionnaire will be 
administered at the next scheduled study visit and then at the remaining visits per the 
Schedule of Activities for the BRIEF®2.
The BRIEF®2 questionnaire will not be collected for participants who are ≥18 years of age 
at the time of the visit.
Section 8.1.3.9
Other
Prior and current 
concomitant medication(s) 
and treatment(s) 
monitoring 
X
X
X
Adverse event monitoring
X
X
X
Contraception check for 
WOCBP
X
X
X
The contraception check will also be performed monthly between study visits at the time of 
the phone contact to check the at-home pregnancy test results (see Section 8.2.11 for 
information on pregnancy testing).
Section 5.3.1
Check for initiation of 
menarche 
X
X
X
For premenarchal females only.  Section 8.2.12
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1.3.2.3. Treatment Period 2: Month 40 to Month 60
For procedures to be performed in TP1 from Week 2 to Month 24, refer to Section 1.3.2.1.
For procedures to be performed in TP1 from Month 28 to Month 36, refer to Section 1.3.2.2.
Procedure
Intervention Period (Months)
Notes
Visit
40
44
48
52
56
60
Visit Window (±Days)
±7
±7
±7
±7
±7
±7
Visit Identifier
17
18
19
20
21
22
Day
1201
1321
1441
1561
1681
1801
Medical procedures
Full physical examination, 
including dermatological 
full body examination
X
X
Section 8.2.1
Targeted physical 
examination
X
X
X
X
Section 8.2.1
Vital signs
X
X
X
X
X
X
Section 8.2.3
Height and weight
X
X
Height will not be collected from participants who are 
≥18 years of age at the time of the visit.  Section 8.2.1
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Procedure
Intervention Period (Months)
Notes
Visit
40
44
48
52
56
60
Tanner Stages of 
Development
X
X
For participants who were <18 years of age at the Day 1 visit 
in Study B7981032, Tanner stages will be collected at visit(s) 
after the Day 1 visit only until the participant has reached a 
score of 5 on all applicable domains.  For participants with AU 
(ie, total loss of hair on the scalp, face and body) at the Day 1 
visit for whom the stage for pubic hair cannot be reliably 
assessed, the Tanner stages will be collected at visit(s) after the 
Day 1 visit only until the participant has reached a score of 5 
on the remaining applicable domain (ie, breasts for females and 
genitalia for males).  
Section 8.2.2
Audiological Evaluation
X
X
Section 8.2.6
Laboratory
Hematology and Serum 
Chemistry
X
X
X
X
X
X
For participants who have completed the Month 36 visit, 
creatine kinase will not be tested.
Section 8.2.8, Appendix 2
Urinalysis
X
X
X
X
X
X
For participants who have completed the Month 36 visit, 
urinalysis will be performed only if considered clinically 
indicated by the investigator.
Appendix 2
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Procedure
Intervention Period (Months)
Notes
Visit
40
44
48
52
56
60
Pregnancy test 
X
X
X
X
X
X
For WOCBP only.  Monthly urine pregnancy tests will be 
performed by the participant between scheduled study visits 
starting after the Month 1 visit through the Month 60 visit.  
The pregnancy testing between visits may occur outside of the 
study site.  Site personnel will contact participants (or their 
legally authorized representative, if appropriate) via telephone 
between study visits to obtain monthly pregnancy test result 
and ensure this contact and the result of the pregnancy test are 
recorded in participant source documentation and CRF. 
Section 8.2.11, Appendix 2, Appendix 4
HBVDNA (applicable 
countries)
X
X
X
X
X
X
For de novo participants and participants originating from 
Study B7931005 or B7981015 with >30 days between the first 
visit of Study B7981032 and the last dose in the index study, 
testing will be dependent on the screening results from Study 
B7981032.
For participants originating from Study B7981015 with 
≤30 days between the first visit of Study B7981032 and the last 
dose in the index study, testing will be dependent on 
screenings result from the index study.  See Appendix 7 for 
Japan specific requirements.  Section 8.2.8.5, Appendix 6
Annual tuberculosis 
testing/chest radiograph
X
X
Section 8.2.8.1, Section 8.2.8.1.2, Appendix 2
FACS-TBNK samples 
collected for possible
reflex testing
X
X
X
X
Appendix 2
Pharmacodynamics markers
FACS-TBNK
X
X
Section 8.6
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Procedure
Intervention Period (Months)
Notes
Visit
40
44
48
52
56
60
Immunoglobulins (IgA, 
IgG, IgM)
X
X
Section 8.6
Trial treatment
Study intervention 
dispensing
X
X
X
X
X
Study intervention 
administration
X
X
X
X
X
Section 6.1
Study intervention 
accountability and 
compliance
X
X
X
X
X
X
Section 6.2, Section 6.4
Clinical assessments
SALT
X
X
X
X
X
X
For participants with known androgenetic alopecia, this 
includes a separate assessment of scalp hair loss due to 
androgenetic alopecia at the final on-therapy visit for each 
treatment period (ie, at Month 36 or Early Termination in TP1, 
and at Month 60, the last on-therapy visit, or Early Termination 
in TP2).
Section 8.1.2.1
EBA and ELA
X
X
Section 8.1.2.2, Section 8.1.2.3
Photography
X
X
Section 8.1.4
C-SSRS
X
X
X
X
X
X
Section 8.2.9
Patient reported outcomes
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Procedure
Intervention Period (Months)
Notes
Visit
40
44
48
52
56
60
PGI-C and P-Sat
X
X
Section 8.1.3.2, Section 8.1.3.3
Observer Reported Outcomes
BRIEF®2
X
X
X
X
X
X
Only in countries where the BRIEF®2 questionnaire is 
available and only for participants who are <18 years of age at 
the time of the Study B7981032 Day 1 visit.  The 
parent/caregiver will complete the questionnaire.
For participants who have already started the study when the 
BRIEF®2 questionnaire is approved and available for use at 
the participant’s site, the BRIEF®2 questionnaire will be 
administered at the next scheduled study visit and then at the 
remaining visits per the Schedule of Activities for the 
BRIEF®2.
The BRIEF®2 questionnaire will not be collected for 
participants who are ≥18 years of age at the time of the visit.
Section 8.1.3.9
Other
Prior and current 
concomitant medication(s) 
and treatment(s) 
monitoring 
X
X
X
X
X
X
Adverse event monitoring
X
X
X
X
X
X
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Procedure
Intervention Period (Months)
Notes
Visit
40
44
48
52
56
60
Contraception check for 
WOCBP
X
X
X
X
X
X
The contraception check will also be performed monthly 
between study visits at the time of the phone contact to check 
the at-home pregnancy test results (see Section 8.2.11 for 
information on pregnancy testing).
Section 5.3.1
Check for initiation of 
menarche 
X
X
X
X
X
X
For premenarchal females only. Section 8.2.12
1.3.3. Early Termination and Follow-up
If study intervention is permanently discontinued, the participant will be asked to remain in the study after the Follow-up visit without 
study intervention and continue to comply with study visit schedules for approximately 2 years after the last dose of study intervention
or until study end, whichever occurs first. Refer to Section 7.1.1.1 for further details.
Procedure
ET
Follow-up
Notes
ET visit will be performed on the last day the participant takes the study intervention or as soon as 
possible thereafter.
Follow-up visit is 28 days after last dose
Visit Window (Days)
7
+7
Visit Identifier
13
Day
EOS
Medical procedures
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Procedure
ET
Follow-up
Notes
ET visit will be performed on the last day the participant takes the study intervention or as soon as 
possible thereafter.
Follow-up visit is 28 days after last dose
Full physical examination,
including dermatological full 
body examination
X
Section 8.2.1
Targeted physical examination
X
Section 8.2.1
Vital signs
X
X
Section 8.2.3
12-lead ECG
X
Section 8.2.5
12-lead ECG is not to be collected during ET visit for participants who have completed the 
Month 36 visit.  
Height and weight
X
Section 8.2.1
Tanner Stages of Development
X
For participants who were <18 years of age at the Day 1 visit in Study B7981032, Tanner stages will 
be collected at visit(s) after the Day 1 visit only until the participant has reached a score of 5 on all 
applicable domains.  For participants with AU (ie, total loss of hair on the scalp, face and body) at 
the Day 1 visit for whom the stage for pubic hair cannot be reliably assessed, the Tanner stages will 
be collected at visit(s) after the Day 1 visit only until the participant has reached a score of 5 on the 
remaining applicable domain (ie, breasts for females and genitalia for males).  
Does not need to be collected if performed within 2 months of the ET visit.  
Section 8.2.2.
Audiological Evaluation
X
Section 8.2.6
Laboratory
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Procedure
ET
Follow-up
Notes
ET visit will be performed on the last day the participant takes the study intervention or as soon as 
possible thereafter.
Follow-up visit is 28 days after last dose
Hematology and Serum 
Chemistry
X
X
For participants who have completed the Month 36 visit, creatine kinase will not be tested.
Section 8.2.8, Appendix 2
Fasting Lipid Panel
X
Fasting Lipid Panel is not to be collected during ET visit for participants who have completed the 
Month 36 visit.  
Section 8.2.8, Appendix 2
Urinalysis
X
X
For participants who have completed the Month 36 visit, urinalysis will be performed only if 
considered clinically indicated by the investigator during ET and Follow-up visits.
Appendix 2
Pregnancy test (WOCBP only)
X
X
Section 8.2.11, Appendix 2, Appendix 4
HBVDNA (applicable 
countries)
X
For de novo participants and participants originating from Study B7931005 or B7981015 with 
>30 days between the first visit of Study B7981032 and the last dose in the index study, testing will 
be dependent on the screening results from Study B7981032.
For participants originating from Study B7981015 with 30 days between the first visit of Study 
B7981032 and the last dose in the index study, testing will be dependent on screening result from the 
index study.  See Appendix 7 for Japan specific requirements.  Section 8.2.8.5, Appendix 6
FACS-TBNK samples collected 
for possible reflex testing
X
Appendix 2
Pharmacodynamics markers
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Procedure
ET
Follow-up
Notes
ET visit will be performed on the last day the participant takes the study intervention or as soon as 
possible thereafter.
Follow-up visit is 28 days after last dose
FACS-TBNK
X
Section 8.6
Immunoglobulins (IgA, IgG, 
IgM)
X
Section 8.6
Trial treatment
Study intervention 
accountability and compliance 
X
Section 6.2, Section 6.4
Clinical assessments
SALT
X
For participants with known androgenetic alopecia, this includes a separate assessment of scalp hair 
loss due to androgenetic alopecia.  Section 8.1.2.1
EBA and ELA
X
Section 8.1.2.2, Section 8.1.2.3
Photography
X
Section 8.1.4
Assessment of Fingernails 
Affected by AA
X
Section 8.1.2.4
Assessment of Fingernails affected by AA is not to be collected during ET visit for participants who 
have completed the Month 36 visit.  
CGI-AA
X
Section 8.1.2.5
CGI-AA is not to be collected during ET visit for participants who have completed the Month 36 
visit.    
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Procedure
ET
Follow-up
Notes
ET visit will be performed on the last day the participant takes the study intervention or as soon as 
possible thereafter.
Follow-up visit is 28 days after last dose
C-SSRS
X
Section 8.2.9
Patient reported outcomes
AAPPO
X
Section 8.1.3.1
AAPPO is not to be collected during ET visit for participants who have completed the Month 36 
visit.  
PGI-C and P-Sat
X
Section 8.1.3.2, Section 8.1.3.3
HADS
X
Section 8.1.3.4
HADS is not to be collected during ET visit for participants who have completed the Month 36 visit.  
SF36v2 Acute
X
Section 8.1.3.6
The SF36v2 Acute is not to be collected at the ET visit for participants who have completed the 
Month 24 visit.
EQ-5D-5L (adults) or EQ-5D-Y 
(adolescents)
X
Participants who are <18 years at the time of the Day 1 visit of B7981015 or B7981032 will use the 
EQ-5D-Y (age for participants from B7931005 will be based on their age on Day 1 of B7981032).  
Participants who reach the age of 18 years during Study B7981032 will continue to use the 
EQ-5D-Y for the remainder of the study.  Section 8.1.3.5
The EQ-5D-5L and EQ-5D-Y are not to be collected at the ET visit for participants who have 
completed the Month 24 visit.
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Procedure
ET
Follow-up
Notes
ET visit will be performed on the last day the participant takes the study intervention or as soon as 
possible thereafter.
Follow-up visit is 28 days after last dose
AARU
X
Section 8.1.3.7
The AARU is not to be collected at the ET visit for participants who have completed the Month 24 
visit.
WPAI: AA
X
Adolescents aged 12 to <18 years at the time of the Day 1 visit of B7981015 or B7981032 will not 
complete this assessment.  Section 8.1.3.8
The WPAI:AA is not to be collected at the ET visit for participants who have completed the 
Month 24 visit.
Observer Reported Outcomes
BRIEF®2
X
Only in countries where the BRIEF®2 questionnaire is available and only for participants who are 
<18 years of age at the time of the Study B7981032 Day 1 visit. The parent/caregiver will complete 
the questionnaire.
The BRIEF®2 questionnaire will not be collected for participants who are ≥18 years of age at the 
time of the visit.
Does not need to be collected if already performed within 2 months of the ET visit. 
Section 8.1.3.9
Other
Prior and current concomitant 
medication(s) and treatment(s) 
monitoring 
X
X
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Procedure
ET
Follow-up
Notes
ET visit will be performed on the last day the participant takes the study intervention or as soon as 
possible thereafter.
Follow-up visit is 28 days after last dose
Adverse event monitoring
X
X
Contraception check for 
WOCBP
X
X
Check for initiation of menarche 
X
X
For premenarchal females only.  Section 8.2.12
Abbreviations: AA = alopecia areata; AAPPO = Alopecia Areata Patient Priority Outcomes; AARU = Alopecia Areata Resource Utilization; 
BRIEF®2 = Behavior Rating Inventory of Executive Function®, Second Edition; CGI-AA = Clinician Global Impression - Alopecia Areata; 
C-SSRS = Columbia Suicide Severity Rating Scale; EBA = Eyebrow Assessment; ECG = electrocardiogram; ELA = Eyelash Assessment; 
EQ-5D-5L = EuroQoL 5 Dimensions; EQ-5D-Y = EuroQoL 5 Dimensions-Youth; EOT = End of Treatment; ET = Early Termination; 
FACS-TBNK = fluorescence-activated cell sorting for T-cells, B-cells, and natural killer (NK) cells; FSH = follicle stimulating hormone; HADS = Hospital 
Anxiety and Depression Scale; HBVDNA = hepatitis B viral DNA; Hep B = hepatitis B; Hep C = hepatitis C; HEENT = head, eyes, ears, nose and throat; 
HIV = human immunodeficiency virus; Ig = Immunoglobulin; IRT = Interactive Response Technology; PGI-C = Patient’s Global Impression of Change; 
PHQ-8 = Patient Health Questionnaire – 8 items; PK = Pharmacokinetic; P-Sat = Patient’s Satisfaction with Hair Growth;  SALT = Severity of Alopecia Tool; 
SF36v2 = 36-Item Short Form Health Survey version 2; TP1 = Treatment Period 1; TP2 = Treatment Period 2; VZV IgG Ab = varicella zoster virus 
immunoglobulin G antibody; WOCBP = women of childbearing potential; WPAI:AA = Work Productivity and Activity Impairment: Alopecia Areata.
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2. INTRODUCTION
PF-06651600 is an orally bioavailable, small molecule that is currently being investigated in 
patients with alopecia areata (AA).  PF-06651600 inhibits Janus kinase 3 (JAK3) and the 
tyrosine kinase family members expressed in hepatocellular carcinoma (TEC) (BTK, BMX, 
ITK, TEC, TXK), by irreversibly blocking the adenosine triphosphate (ATP) binding site 
with high selectivity over the other three JAK isoforms (JAK1, JAK2, and tyrosine kinase 2 
[TYK2]) as well as over the broader kinome.  PF-06651600 potently inhibits signaling of the 
common gamma ()-chain receptors for interleukin (IL)-15 and IL-21, which have been 
implicated in the pathogenic pathways of AA.1  Additionally, PF-06651600 inhibits the 
cytotoxic function of cluster of differentiation (CD)8+ T cells and natural killer (NK) cells 
which have also been implicated in the pathogenic process of AA.2,3  This inhibition may be 
mediated through mechanisms dependent on JAK3 and TEC kinase family members.4-6
See Appendix 10 for vaccine sub-study introduction.
2.1. Study Rationale
PF-06651600 is being developed as an oral treatment for patients with AA based on its 
mechanism of action, and the clinical results obtained in Phase 1 and Phase 2 studies as 
outlined below.  This study is specifically designed to evaluate the long-term safety, 
tolerability and efficacy of PF-06651600 in adults and adolescents with AA.  
See Appendix 10 for vaccine sub-study rationale.
2.2. Background
AA is a chronic relapsing T-cell mediated autoimmune disorder characterized by 
non-scarring hair loss affecting children and adults across all ages, races, and sexes.7,8  AA is 
associated with other immune diseases including asthma, allergic rhinitis, atopic dermatitis, 
and autoimmune diseases such as thyroiditis and vitiligo.8
CD8+ T cells, NK cells, and mast cells are involved in the pathogenesis of AA.  The possible 
inflammatory pathways in AA include cytokines from the type 1 helper T cell (TH1) axis, 
including interferon (IFN) alpha (), IFN gamma (), and IFN-induced protein 
10 (IP-10).9,10  Mouse models have shown that IL-2 and IL-15 play a role in the initiation of 
auto-reactive CD8+ cells that attack hair follicles.1  IL-12 and IL-23 may also play a role in 
the pathogenesis of AA.11
Clinical presentation of AA can be limited to small, circular patches of scalp hair loss (patchy 
hair loss, alopecia focalis), involve complete loss of hair on the scalp (alopecia totalis [AT]), 
or total loss of hair on the scalp, face, and body (alopecia universalis [AU]).12  Patchy 
alopecia is the most common form of AA which may develop into the more extensive and 
often treatment-resistant forms of AA, especially with earlier age of onset.13 It is estimated 
that AA affects as many as 6 to 7 million individuals in the US8 and 147 million worldwide.14
Further, there is evidence that AA can become refractory to JAK inhibition if it has been 
present for a substantial period of time.  Specifically, a recent case series demonstrated that 
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AA patients whose current episode of AT or AU had lasted more than 10 years were highly 
non-responsive to off-label tofacitinib treatment in comparison with patients with shorter 
duration.15
Depression, anxiety, and panic disorders are often observed in patients with AA and the 
coping mechanisms of AA patients mirror those of grief and bereavement.16,17  A substantial 
body of evidence demonstrates a widespread impact of AA on the psychological health of 
both adult and pediatric patients with AA, including impairment in self-esteem, increased 
incidence of anxiety and depressive disorders and other psychological conditions,18-22
problems with social relations,23 decreased health-related quality of life (HRQoL) and 
general quality of life (QoL), as well as the QoL of their families.24-32
AA is a disease with significant pediatric prevalence, in addition to the burden of disease 
seen in adults, and ample evidence is available on the impact of AA on the mental health of 
adolescent patients.  In a United States (US) study, children with AA had more psychological 
problems than those without AA.  Specifically, those with AA exhibited more anxiety, 
depression, tendencies to withdraw, aggression, and delinquency.  In addition, children with 
AA were more likely to exhibit somatic problems as well as problems in social relations and 
in attention span.  Girls with AA seem to be affected more in dimensions of total problems, 
anxiety/depression, and internalizing/externalizing syndromes.  Children with AA were also 
less likely to have experienced positive life events in the year prior to exhibiting AA 
symptoms.23
In addition to experiencing a significant mental health burden, children with AA report 
experiencing other negative impacts to their QoL.  Specifically, 75% of children aged 
15-19 years reported instances of effects on QoL, 50% reported that the disease limited their 
participation in activities, 40% reported instances of bullying, and 35% reported that others 
noticed and commented on their condition.  Rates of decrement in QoL, limitations on 
participation in activities, and bullying were heightened in older children ages 15-19 years 
compared to younger children.33
Given the finding that complete scalp hair loss with duration >10 years in adults is less likely 
to respond to treatment, it is conceivable that pursuing treatment in younger patients with 
stable, severe AA may prevent future irreversible hair loss.15 Additionally, an earlier age of 
first onset has been reported to correspond to an increased lifetime risk of extensive disease.  
Differences in treatment responses are not expected for adolescent versus adult AA patients 
as suggested in 2 reports of tofacitinib (off-label use).15,34
No drugs have been approved for the treatment of AA in most countries/regions, including 
the United States and the European Union (EU).  Review of the treatment guidelines and 
recommendations indicate that a number of off-label therapies are frequently used after 
assessing factors such as the age of the patient, disease extent, and disease duration.  There is 
neither a cure for AA nor is there a therapy convincingly demonstrated to induce and sustain 
remission long term.35-39
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2.2.1. Drug Development Rationale
The JAK family, including JAK1, JAK2, JAK3 and TYK2, is a group of cytoplasmic 
tyrosine kinases that mediate signal transduction via interactions with Type 1 and Type 2 
cytokine receptors critical for leukocyte activation, proliferation, survival and function.40,41  
Upon binding of the cytokine to its receptor, the associated JAKs are activated, and 
phosphorylate each other and the receptor.  The phosphorylated receptors serve as docking 
sites for the signal transducer and activator of transcription (STAT) family of transcription 
factors.  The STATs are phosphorylated and subsequently translocate to the nucleus where 
they bind to specific gene promoters to activate transcription of a range of target genes.40,41
JAK1 pairs with JAK3 to mediate -common cytokine signaling and also with JAK2 or 
TYK2 to transmit the signals of additional cytokines important in inflammation and immune 
responses including IL-2, IL-4, IL-5, IL-6, IL-12, IL-13, IL-15, IL-21, IL-23, IL-31, IFN, 
and IFN.41
The cytokine signaling pathways of IFNand IL-15, among others, can be blocked via JAK 
inhibition, supporting the rationale of a JAK inhibitor in the treatment of AA.42 Treatment 
with the JAK inhibitors tofacitinib and ruxolitinib are reported to reverse AA in a mouse 
model.2  Clinically, there are case reports and case series reporting that these JAK inhibitors 
demonstrate efficacy in AA.2,15,43-49
The tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family of protein 
kinases consists of five members (Bruton’s tyrosine kinase [BTK], bone marrow tyrosine 
kinase on chromosome X [BMX], interleukin 2 inducible T cell kinase [ITK], TEC and 
tyrosine kinase expressed in T cells [TXK]) primarily expressed in hematopoietic cells.50,51 T 
cells express three TEC kinases, ITK, TEC and TXK that are activated downstream of the T 
cell receptor (TCR). BTK plays crucial roles in B cell development and function and is 
activated downstream of the B cell receptor (BCR). Additionally, TEC kinases have 
overlapping roles in mediating activation signals in NK cells, mast cells and other 
hematopoietic cells.52  Since CD8+ T cells, NK cells and mast cells have all been implicated 
in the pathophysiology of AA2,3,10,53 inhibition of TEC kinases has the potential to contribute 
to efficacy in this disease by modulating the functional activity of pathogenic effector cells.
Based on the mechanism of action of PF-06651600, this candidate is expected to inhibit the 
signaling of multiple soluble cytokines and signaling pathways contributing to the AA 
pathogenesis.
2.2.2. Nonclinical and Phase 1 Efficacy and Safety Data
The no observed adverse effect levels (NOAELs) in the 6-month rat and second 9-month dog 
studies were 200 and 10 mg/kg/day, respectively.  In the second 9-month dog toxicity study, 
the NOAEL of 10 mg/kg/day was based on adverse over-immunosuppression and axonal 
dystrophy (not axonal degeneration) in the central nervous system and peripheral nervous 
system at ≥20 mg/kg/day, accompanied by functional auditory deficits (brainstem auditory 
evoked potentials [BAEP]) at the highest dose of 40 mg/kg/day (a 29-fold exposure multiple 
relative to the clinical dose of 50 mg).  The area under the concentration time curve (AUC) 
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exposure margins in this second 9-month dog study at the NOAEL at study end were 
approximately 1.5× and 6.5× relative to the predicted exposures at the 200 mg and 50 mg 
clinical doses, respectively (refer to Table 1).
The potential for PF-06651600 to be involved in drug-drug interactions (DDI) is being 
investigated.  If results exclude a clinically meaningful DDI (eg, relative to AUC [area under 
the curve]) between PF-65551600 and a perpetrator or victim drug then that perpetrator or 
victim drug will no longer be prohibited as a prior or concomitant medication based on DDI; 
this information will be communicated via an administrative letter. Refer to Exclusion 
Criterion 25, Section 6.5.2, and Section 10.9.1 for medications prohibited to be used prior to 
and during the study.
PF-06651600 bioequivalence between tablets and capsules was established in completed 
Phase 1 Study B7981029.
Data from nonclinical and Phase 1 clinical studies, including pharmacokinetics, 
bioavailability and food effect, support the planned clinical trials with PF-06651600.  For a 
complete description of these studies please refer to the current version of the Investigator’s 
Brochure (IB).
2.2.3. Clinical Experience
There are complete and ongoing Phase 2 and Phase 3 studies with PF-06651600 in a number 
of disease indications. 42 participants with rheumatoid arthritis (RA) were exposed to 
PF-06651600 in the Phase 2a Study B7981006. 150 participants with ulcerative colitis were 
exposed to PF-06651600 in the Phase 2b Study B7981005.  364 and 238 participants with 
vitiligo in Phase 2b Study B7981019 were exposed to PF-06651600 in the dose-ranging 
period and in the extension period, respectively.  48 participants were exposed to 
PF-06651600 in the Phase 2a AA Study B7931005 in the initial 24-week period, and 
715 participants with AA were treated with PF-06651600 in the Phase 2b/3 Study B7981015, 
with key results presented below.  There is an ongoing study in participants with Crohn’s 
disease (Phase 2a Study B7981007).
For description and/or results of these studies, please refer to the current version of the 
PF-06651600 IB.  
2.2.3.1. Phase 2a Study in Alopecia Areata
Study B7931005 was a Phase 2a, double-blind, placebo-controlled, multicenter study to 
evaluate the efficacy and safety profile of PF-06651600 and PF-06700841 (a TYK2/JAK1 
inhibitor) compared with placebo in adult (18-75 years old) participants with AA with scalp 
hair loss of ≥50% at baseline.  The study consisted of an initial 24-week double-blind 
treatment period, an up to 12-month extension period, and a 6-month cross-over open label 
extension period.  A total of 142 participants were randomized to study treatment: 
47 participants received placebo, 48 participants received PF-06651600, and 47 participants 
received PF-06700841.
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During the initial 24-week treatment period, participants randomized to PF-06651600 were 
treated with 200 mg QD during a 4-week induction phase followed by dosing with 50 mg QD 
in a maintenance phase.  The primary efficacy endpoint in the study was change from 
baseline in Severity of Alopecia Tool (SALT) score at Week 24.  Analysis of the initial 
24-week treatment period provided data on both efficacy and safety, and indicated clinical 
improvement with PF-06651600.  PF-06651600 met the primary endpoint of change from 
baseline (CFB) in SALT score.  The Mixed Model for Repeated Measures (MMRM) 
estimates for PF-06651600 compared to placebo at Week 24 for SALT mean CFB (95% CI) 
were 33.6 [95% CI= (21.4, 45.7); Hochberg p (1-sided) <0.0001].  PF-06651600 
differentiated from placebo (statistically significant), as early as Week 6.  The placebo 
response was almost negligible.  PF-06651600 also differentiated from placebo on the 
proportion of responders in absolute SALT score ≤10, eyelash assessment (ELA) and 
eyebrow assessment (EBA). 
During the initial 24-week treatment period of Study B7931005, there were no deaths and no 
participant in the PF-06651600 treatment group experienced a serious adverse event (SAE).  
The proportion of participants who experienced treatment-emergent adverse events (TEAEs) 
in the placebo treatment group (74.5%) was comparable with the PF-06651600 treatment 
group (62.5%).  The TEAEs reported in more than 5% of participants with AA receiving 
PF-06651600 were headache, infections of upper respiratory tract, acne, diarrhea, nausea, 
and skin infections.  The majority of events were mild.  No serious infections, malignancies, 
cases of herpes zoster, or cases of herpes simplex were reported in the PF-06651600 group.
Hematological changes were observed in both active groups during the induction and 
maintenance periods, but were not associated with clinically relevant TEAEs. During the 
induction period, when participants received PF-06651600 200 mg QD for 4 weeks, 
decreases in mean platelet and lymphocyte counts (-18% and -24% mean CFB, respectively) 
were observed in the PF-06651600 group.  During the maintenance period, when participants 
received 50 mg QD for 20 weeks, there was improvement in the platelet and lymphocyte 
counts in the PF-06651600 group (-10% and -9% mean CFB, respectively, at Week 24).  
Neutrophil counts were increased at Week 4 (12% CFB) and Week 24 (10% CFB) in the 
PF-06651600 treatment group.  Two participants in the PF-06651600 group discontinued due 
to TEAEs (blood creatine phosphokinase increase and angioedema).
The final study results, including the results of the two extension periods, are described in the 
current version of the PF-06651600 IB. 
2.2.3.2. Phase 2b/3 Study in Alopecia Areata
B7981015 was a Phase 2b/3, randomized, double blind, placebo controlled, dose ranging 
study to investigate PF-06651600 in both adolescent (≥12 to <18 years old) and adult 
(≥18 years old) participants with ≥50% scalp hair loss due to AA. The study had a maximum 
duration of approximately 57 weeks. This included an up to 5-week Screening period, a 
48-week treatment period, and a 4-week follow up period. The treatment period was 
comprised of a placebo-controlled period that included a 4-week loading phase and a 
20-week maintenance phase, followed by a 24-week extension phase.
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Eligible participants were randomized to blinded PF-06651600 and matching placebo in a 
2:2:2:2:1:1:1 (200 mg/50 mg, 200 mg/30 mg, 50 mg, 30 mg, 10 mg, placebo-200 mg/50 mg, 
and placebo-50 mg, respectively) manner for a total of 7 treatment sequences. All 
participants began dosing during the loading phase according to their assigned sequence. 
Following the 4-week loading phase, participants continued dosing according to their 
assigned sequence in the 20-week maintenance phase. At the end of the maintenance phase, 
placebo treated participants were advanced in a prespecified, blinded manner to one of 
2 active treatment sequences for the remainder of the treatment period (through Week 48).
PF-06651600 200/50 mg, 200/30 mg, 50 mg and 30 mg were significantly superior to 
placebo at Week 24 on clinician-assessed and patient-reported endpoints related to scalp hair 
regrowth (including response based on absolute SALT ≤20, response based on absolute
SALT ≤10, and PGI-C response). Exposure response modelling based on SALT ≤20 and 
SALT ≤10 response at Week 24 showed a positive relationship between dose and response. 
PF-06651600 200/50 mg, 200/30 mg, 50 mg and 30 mg were also nominally superior to 
placebo at Week 24 in producing improvement in eyebrows and eyelashes. Continued 
improvement in efficacy endpoints was seen between Week 24 and Week 48.
The proportion of participants who experienced all-causality TEAEs was similar across 
treatment groups up to Week 24 (placebo-controlled period) and up to Week 48 (overall). 
The most frequently reported TEAEs in any group included nasopharyngitis, headache, and 
upper respiratory tract infection. Up to week 24, the incidence of nasopharyngitis, folliculitis, 
urticaria, dizziness, upper respiratory tract infection and urinary tract infection was higher in 
participants treated with PF-06651600 (particularly 200/50 mg and 200/30 mg) than placebo.  
Most TEAEs were mild to moderate in severity. Fourteen (14) participants experienced 16 
SAEs up to Week 48:

200/50 mg (4 participants): appendicitis; empyema and sepsis; invasive lobular breast 
carcinoma, spontaneous abortion.

200/30 mg (2 participants): appendicitis; chemical poisoning and suicidal behavior.

50 mg (2 participants): breast cancer; pulmonary embolism.

30 mg (1 participant): diverticulitis.

10 mg (2 participants): suicidal behavior; eczema.

Placebo-200/50 mg: no SAEs.

Placebo-50 mg (3 participants): spontaneous abortion; conversion disorder; heavy
menstrual bleeding. These treatment-emergent SAEs were all reported during the 
Placebo-Controlled Period.
Of the 16 SAEs, 12 were considered by the investigator as unrelated to study intervention. 
The 4 SAEs that were considered related to study intervention in the opinion of the 
investigator were sepsis and empyema (both in 1 participant); breast cancer; and eczema. 
There were no deaths in the study. 
Treatment with PF-06651600 was associated with changes in hematological parameters, 
some of which were dose dependent. In the first weeks of the study, there were slight, 
transient decreases in hemoglobin and small, variable changes in neutrophil and leukocyte 
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levels. Small, early decreases in platelets were observed with PF-06651600 treatment; these 
levels remained stable up to Week 48. Dose-dependent early decreases in absolute 
lymphocyte levels, CD3 (T lymphocytes) and T lymphocyte subsets (CD4 and CD8) were 
observed. There was a dose-dependent early decrease in CD16/56 (NK cells), particularly in 
groups who had received a 200 mg loading dose of PF‑06651600 for 4 weeks. Overall, there 
were no clinically meaningful effects of PF-06651600 on ALT, AST, bilirubin, or alkaline 
phosphatase. The incidence of elevation in hepatic enzymes was low and not dose dependent. 
Up to Week 48, there were no potential Hy’s law cases.
For a complete description and results of this study, please refer to the current version of the 
PF‑06651600 IB.  
2.3. Benefit/Risk Assessment
PF-06651600 is an immunomodulator and, as such, can be associated with the potential risk 
of infection (including serious infection), opportunistic infections, and viral reactivation.  The 
risk of infection is monitored and evaluated in clinical studies of PF-06651600. 
In animals, PF-06651600 administration was associated with effects on fetal development 
including skeletal and visceral organ malformations, and lower fetal body weights. It is not 
known whether PF-06651600 is secreted into human milk.  Because of the investigational 
nature of PF-06651600, it should not be administered to pregnant women, breastfeeding 
women, or fertile women of childbearing potential who are unwilling or unable to use 
contraception as defined in the study protocol.  Men in the study are not required to use birth 
control because PF-06651600 is not likely to transfer to a partner through semen at 
pharmacologically relevant levels.
In the Phase 2a proof-of-concept Study B7931005 in adult participants with AA, 
PF-06651600 met its primary endpoint of improvement in SALT score relative to placebo at 
Week 24.  PF-06651600 appeared generally safe and well tolerated.  Reductions in platelet 
counts and lymphocyte counts were observed during treatment with 200 mg QD, but were 
not considered clinically meaningful and improved after switching to 50 mg QD during the 
maintenance phase of the study.  
These clinical data, including the pivotal Phase 2b/3 B7981015 study described in
Section 2.2.3.1, indicate that PF-06651600 at doses up to 200 mg QD for 4 weeks followed 
by 50 mg QD, has a favorable benefit: risk profile and provides meaningful clinical benefit in 
a serious disease with no approved treatment options.  This study will extend the analysis of 
benefit: risk for up to 5 years.
The benefit of evaluating PF-06651600 in adolescents was demonstrated in Study B7981015 
and is additionally supported by prevalence of AA in adolescents, the significant 
psychological burden of the disease in this population, and a case series suggesting that 
extended duration of AA appears to increase likelihood of being refractory to off-label 
tofacitinib treatment.
See Appendix 10 for vaccine sub-study benefit/risk assessment.
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More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events of PF-06651600 may be found in the current version of the 
PF-06651600 IB, which is the single reference safety document (SRSD) for this study. 
3. OBJECTIVES, ESTIMANDS AND ENDPOINTS
Objectives
Endpoints
Primary

To evaluate the long-term safety and 
tolerability of PF-06651600 in adult 
and adolescent participants with 
AA. 
Through the time the last participant 
completes the Follow-up visit or 28 days 
after the Month 36 visit:

Incidence of treatment-emergent 
adverse events (TEAEs);

Incidence of serious adverse events 
(SAEs) and adverse events (AEs) 
leading to discontinuation;

Incidence of clinically significant 
abnormalities in vital signs;

Incidence of clinically significant 
abnormalities in clinical laboratory 
values.
Secondary
To evaluate the long-term safety and 
tolerability of PF-06651600 in adult and 
adolescent participants with AA. 
Through the time of the last participant visit:
Incidence of TEAEs;
Incidence of SAEs and AEs leading 
to discontinuation;
Incidence of clinically significant 
abnormalities in vital signs;
Incidence of clinically significant 
abnormalities in clinical laboratory 
values.
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Objectives
Endpoints

To evaluate the long-term efficacy 
of PF-06651600 in adult and 
adolescent participants with AA.

Response based on achieving 
absolute Severity of Alopecia Tool 
(SALT) score ≤10 through 
Month 36, for overall and AA SALT 
score;

Response based on achieving 
absolute SALT score ≤20 through 
Month 36, for overall and AA SALT 
score;

Change from baseline in SALT score 
through Month 36, for overall and 
AA SALT score; 

Response based on achieving at least 
75% improvement in SALT 
(SALT75) from baseline through 
Month 36, for overall and AA SALT 
score;

Response based on achieving at least 
a 2-grade improvement from 
baseline or a score of 3 in Eyebrow 
Assessment (EBA) score through 
Month 36;

Response based on achieving at least 
a 2-grade improvement from 
baseline or a score of 3 in Eyelash 
Assessment (ELA) score through 
Month 36.

To evaluate the effect of 
PF-06651600 on patient-centered 
outcomes and payer relevant 
measures to assess treatment benefit 
from the patient perspective and to 
demonstrate value.

PGI-C response defined as PGI-C 
score of “moderately improved” or 
“greatly improved” through 
Month 36;

Change from baseline in Alopecia 
Areata Patient Priority Outcomes 
(AAPPO) scales through Month 36;

Change from baseline in the 
depression subscale score of the 
Hospital Anxiety and Depression 
Scale (HADS) through Month 36;
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Objectives
Endpoints

Change from baseline in the anxiety 
subscale score of the HADS through 
Month 36;

Improvement on HADS among 
participants with a baseline subscale 
score indicative of depression who 
achieved a “normal” subscale score 
indicative of an absence of 
depression through Month 3679,90;

Improvement on HADS among 
participants with a baseline subscale 
score indicative of anxiety who 
achieved a “normal” subscale score 
indicative of an absence of anxiety 
through Month 3679,90.
Tertiary/Exploratory

To evaluate the long-term efficacy 
of PF-06651600 in adult and 
adolescent participants with AA.

Response based on achieving at least 
50% improvement in SALT 
(SALT50) from baseline through 
Month 36, for overall and AA SALT 
score;

Absolute SALT scores through 
Month 36, for overall and AA SALT 
score.
For all scheduled timepoints after Month 36 
through Month 60:

Response based on achieving 
absolute SALT score ≤10, for overall 
and AA SALT score;

Response based on achieving 
absolute SALT score ≤20, for overall 
and AA SALT score;

Change from baseline in SALT 
score, for overall and AA SALT 
score; 

Response based on achieving at least 
a 2-grade improvement from 
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Objectives
Endpoints
baseline or a score of 3 in EBA 
score;

Response based on achieving at least 
a 2-grade improvement from 
baseline or a score of 3 in ELA 
score.

To evaluate the effect of 
PF-06651600 on patient-centered 
outcomes and payer relevant 
measures to assess treatment benefit 
from the patient perspective and to 
demonstrate value.

Change from baseline in EuroQoL 
5 dimensions (EQ-5D-5L) or 
EuroQoL 5 dimensions-Youth 
(EQ-5D-Y) through Month 24;

Improvement on PGI-C defined as 
“slightly improved”, “moderately 
improved”, or “greatly improved” 
through Month 36;

Improvement on Patient’s 
Satisfaction with Hair Growth 
(P-Sat) items defined as slightly, 
moderately, or very satisfied through 
Month 36;

Change from baseline in Alopecia 
Areata Resource Utilization 
(AARU)through Month 24;

Change from baseline in Work 
Productivity and Activity 
Impairment items: Alopecia Areata 
(WPAI: AA) through Month 24.

Change from baseline in 36-Item 
Short Form Health Survey version 2 
Acute (SF36v2 Acute) through 
Month 24;

Behavior Rating Inventory of 
Executive Function (BRIEF®2) 
index scores through Month 36.

PGI-C response defined as PGI-C 
score of “moderately improved” or 
“greatly improved” after Month 36 
through Month 60;

Improvement on P-Sat items defined 
as slightly, moderately, or very 
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Objectives
Endpoints
satisfied after Month 36 through 
Month 60;

BRIEF®2 index scores after 
Month 36 through Month 60.

To evaluate the long-term efficacy 
of PF-06651600 in AA nail disease 
over time.

Change from baseline in fingernails 
affected by AA through Month 36.

To evaluate the long-term effect of 
PF-06651600 on the clinician global 
impression of severity of scalp hair 
loss.

Change from baseline in the 
Clinician Global 
Impression - Alopecia Areata 
(CGI-AA) through Month 36.

To evaluate pharmacodynamic and 
disease-related biomarkers over 
time.

Change from baseline in lymphocyte 
subsets (T-cell, B-cell, and natural 
killer [NK] cells) through Month 36;

Change from baseline in 
immunoglobulins (IgA, IgG, IgM) 
through Month 36.

Change from baseline in lymphocyte 
subsets (T-cell, B-cell, and NK cells) 
after Month 36 through Month 60;

Change from baseline in 
immunoglobulins (IgA, IgG, IgM) 
after Month 36 through Month 60.
PK Objectives

To characterize the 
pharmacokinetics of PF-06651600.

Plasma concentrations of 
PF-06651600 at Month 1 and 
Month 3.
See Section 9.4.1 and Section 9.4.2 for baseline definition for analyses of efficacy and safety, 
respectively.
See Appendix 10 for vaccine sub-study objectives and endpoints.
4. STUDY DESIGN
4.1. Overall Design
Study B7981032 will investigate PF-06651600 in participants with AA.  This is a Phase 3, 
open-label, multicenter, long-term study designed to evaluate the safety and efficacy of 
PF-06651600 in adults and adolescents ≥12 years of age. The maximum duration of 
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participation of any individual participant will be approximately 62 months. The study 
consists of two treatment periods, TP1 and TP2. 
TP1:
TP1 includes up to a 5-week screening period, a 36-month open-label treatment period, and a 
4-week follow-up period after completion of TP1 (for participants not continuing to TP2) or 
discontinuation of study intervention (see Schema).  Eligible participants will be given the 
opportunity to enroll from the index studies B7931005 and B7981015, as well as de novo 
participants (ie, those who have not previously received study intervention in Study 
B7931005 or B7981015).
It is estimated that a total of approximately 960 participants will be enrolled.  This will 
include eligible prior participants from the index studies B7931005 and B7981015, as well as 
approximately 450 de novo participants (ie, those who have not previously received study 
intervention in Study B7931005 or B7981015).
To be eligible to enroll in this study, participants enrolling from Study B7931005 or 
B7981015 must not have had any events meeting the B7981032 discontinuation criteria or 
discontinued for safety-related events.  In addition, participants enrolling from Study 
B7931005 must have taken their last dose of PF-06700841 (a TYK2/JAK1 inhibitor) in 
Study B7931005 >12 weeks prior to the B7981032 Day 1 visit.  There is no necessary 
washout period for participants who took PF-06651600 in Study B7931005 or B7981015.  
Participants enrolling from B7981015 must have completed ≥34 weeks of study intervention.  
De novo participants ≥12 to <18 years of age must have a clinical diagnosis of AA with no 
other etiology of hair loss other than androgenetic alopecia with ≥50% terminal hair loss of 
the scalp due to AA at both the screening and Day 1 visits which, in the opinion of the 
investigator, is appropriate for systemic therapy.  De novo participants ≥18 years of age and 
participants originating from Study B7931005 or B7981015 with 30 days between the last 
dose in Study B7931005 or B7981015 and their first visit in Study B7981032 must have a 
clinical diagnosis of AA with no other etiology of hair loss other than androgenetic alopecia 
with ≥25% terminal hair loss of the scalp due to AA at both the screening and Day 1 visits 
which, in the opinion of the investigator, is appropriate for systemic therapy.  The full list of 
eligibility criteria for the study is included in Section 5.
Screening will occur within 35 days prior to the first dose of study intervention to confirm 
that selection criteria for the study are met for de novo participants and participants 
originating from Study B7931005 or B7981015 with 30 days between the last dose in Study 
B7931005 or B7981015 and their first visit in Study B7981032.  
Participants enrolling from B7931005 and B7981015 will receive open-label 50 mg 
PF-06651600 QD for 36 months and de novo participants will receive open-label 200 mg 
PF-06651600 QD for 4 weeks followed by open-label 50 mg PF-06651600 QD for 
35 months.  
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Following the last dose of study intervention, both discontinued and completed participants 
not continuing to TP2 will enter into a 4-week follow-up period for safety monitoring.  
Participants in countries where PF-06651600 is not commercially available at the time of
their Month 36 visit will have the opportunity to enter TP2, as described below. In this case, 
the Follow-up visit will be completed at the end of their participation in TP2. 
TP2:
TP2 will be of variable length for individual participants; assuming a participant does not 
require discontinuation per protocol, a participant may continue to receive PF-06651600 in 
TP2 for a maximum of 24 months or until availability of commercial product in their 
country, or until the sponsor terminates the study in that country, whichever occurs first.
In TP2, participants will receive 50 mg QD PF-06651600. The total duration of participation 
in TP2 is approximately 25 months, including up to 24 months of study intervention, and a 
Follow-up period of 4 weeks after completion or discontinuation of study intervention (See
Section 1.2 Schema). 
Observation Period:
If study intervention is permanently discontinued, the participant will be asked to remain in 
the study after the Follow-up visit without study intervention and continue to comply with 
study visit schedules for approximately 2 years after the last dose of study intervention or 
until study end, whichever occurs first; refer to Section 7.1.1.1 for further details.
Vaccine Sub-study:
See Appendix 10 for vaccine sub-study design.
4.2. Scientific Rationale for Study Design
This study is being conducted to evaluate the long-term safety and efficacy of PF-06651600 
dosed 50 mg QD over a 60-month maximum treatment duration.  Because in the 
proof-of-concept Study B7931005 participants naïve to prior PF-06651600 treatment 
received the initial 200 mg QD loading dose for 4 weeks, followed by the 50 mg QD dose, 
this regimen will be provided to de novo participants in this study.
In addition to safety, another objective of this study is to evaluate long-term efficacy in this 
population.  To evaluate efficacy, response will be assessed based on SALT, an instrument 
that is widely used to assess severity of AA by visual determination of the amount of 
terminal hair loss and summing across four views of the scalp (left side, right side, back and 
top; range 0-100%).54,55  This tool has been well accepted and used in multiple AA clinical 
trials (NCT02691117; NCT01950780; NCT01797432; in addition to Study B7981015, 
NCT03732807) as a reliable and reproducible measure of AA severity.15,43,47,56
Inclusion of patients with ≥25% terminal scalp hair loss due to AA in this study, which the 
investigator has additionally determined to be appropriate for systemic therapy, is considered 
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to be justified.  While there is not a generally accepted definition of mild, moderate, and 
severe AA, interviews of dermatologists and patients with an AA history of ≥50% scalp hair 
loss indicated that scalp hair loss >20% represents moderate to very severe hair loss.57
The total sample size for the study is estimated to be approximately 960 participants.
4.3. Justification for Dose
This study will evaluate PF-06651600 administered at a loading dose of 200 mg QD for 
4 weeks followed by a maintenance dose of 50 mg QD for a maximum of 59 months for 
de novo participants and at a dose of 50 mg QD for a maximum of 60 months for participants 
enrolling from studies B7931005 and B7981015.  The rationale for the selection of the doses 
and regimens is based on:

Efficacy and safety results for the initial 24 weeks of PF-06651600 treatment from 
Study B7931005 in participants with AA.

Dose/Exposure response relationships observed for PF-06651600 relevant 
biomarkers.

Safety results for PF-06651600 from Study B7981006 in participants with RA.

Exposure margins of proposed clinical doses relative to nonclinical no observed 
adverse effect level (NOAEL)/lowest observed adverse effect level (LOAEL) 
exposures (Table 1). 
An analysis of the initial 24 weeks (primary objective) of the ongoing Phase 2a Study 
B7931005 was performed at Week 24.  In that study, PF-06651600 was evaluated at 200 mg 
QD for 4 weeks followed by 50 mg QD for 20 weeks compared to placebo.  Both safety and 
efficacy data from the analysis suggest that this dosing regimen of PF-06651600 is 
appropriate for further investigation.
The need for a loading-dose regimen for de novo participants is based on the hypothesis that 
maximal inhibition of the relevant immunomodulatory pathways at the beginning of 
treatment can more rapidly initiate clinical response, which can be sustained by the 
subsequent lower maintenance dose.  The 200 mg dose chosen as the loading dose is 
expected to produce a >70% IL-15 and IL-21 in vitro signaling inhibition, with ~40% 
reduction in IP-10 levels from baseline.  The 200 mg dose has demonstrated acceptable 
safety over 4 weeks in B7931005 in AA participants and 8 weeks in B7981006 in moderate 
to severe RA participants.  
The maintenance dose of 50 mg for de novo participants and participants continuing from 
studies B7931005 and B7981015 is expected to produce ~30-40% IL-15 and IL-21 based on 
in vitro signaling inhibition, with ~18% reduction in IP-10 in vivo levels from baseline.  The 
50 mg maintenance dose demonstrated acceptable safety over a 20-week period in 
Study B7931005 in AA participants. 
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Exposure margins of the proposed clinical doses relative to the nonclinical no observed 
adverse effect level (NOAEL) exposures are summarized in Table 1.
Table 1.
PF-06651600 Exposure Margins and No Observed Adverse Effects Level
Dose/Route
Mean AUC in 
Dogs (unbound, 
ng•hr/ml)
Mean Clinical 
AUC (unbound,
ng•hr/ml)  
Calculated 
Safety Margin
Safety Exposure Margins for Human 200 mg QD Dose in AA patients
Dog 2-month 
toxicology (Study 1)
NOAEL:
45 mg/kg oral
44100
5310
8.3
Dog 9-month 
toxicology (Study 2)
NOAEL:
10 mg/kg oral
7940
5310
1.5
Safety Exposure Margins for 50 mg QD Dose in AA patients
Dog 2-month 
toxicology
NOAEL:
45 mg/kg oral
44100
1070
41
Dog 9-month 
toxicology (Study 2)
NOAEL:
10 mg/kg oral
7940
1070
7.4
Abbreviations: AUC = area under the concentration-time curve; NOAEL = no observed adverse effect level; 
QD = once daily.
4.4. End of Study Definition
A participant is considered to have completed the study:

If participant has completed all phases of TP1, including follow-up visit and does not 
continue to TP2 due to local commercial availability of PF-06651600 for AA; OR

If participant has completed all phases of TP2, including Follow-up visit; OR

If participant discontinued from the study during TP2 due to local commercial 
availability of PF-06651600 for AA.
The primary completion date (PCD) is defined as the date when the last participant completes 
the Follow-up visit or 28 days after the Month 36 visit.  The end of the study is defined as the 
date of the last visit of the last participant in the study.
5. STUDY POPULATION
While B7981015 is enrolling, participants who are eligible for B7981015 may not be 
enrolled directly into Study B7981032 (for sites enrolling participants into both Study 
B7981015 and Study B7981032).
De novo participants are eligible to be included in the study only if all of the inclusion and 
exclusion criteria listed below apply (unless specified otherwise).
The inclusion and exclusion criteria listed below for all participants originating from Study 
B7931005 or B7981015 need to be applied, unless specified otherwise.
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For participants originating from Study B7931005 or B7981015 with >30 days between the 
first visit of Study B7981032 and the last dose of the index Study, adverse events, laboratory 
results, medical conditions and prior and current treatments occurring during those studies 
and at any time between those studies and Study B7981032 must also be checked against all 
of the Study B7981032 entry criteria listed below.
For participants originating from Study B7981015 with ≤30 days between the first visit of 
Study B7981032 and the last dose of the index study, adverse events, laboratory results, 
medical conditions and prior and current treatments during those studies and at any time 
between those studies and Study B7981032 must also be checked against the Study 
B7981032 safety discontinuation criteria (see Appendix 8, Section 10.8.2).  Participants 
meeting the B7981032 protocol safety discontinuation criteria must not be enrolled in Study 
B7981032.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
NOTE: There are certain eligibility requirements specific to participants within Voluntary 
Harmonisation Procedure (VHP) countries in the EU.  The VHP countries participating in 
this study are: Czech Republic, Germany, Hungary, Poland, and Spain.
See Appendix 10 for vaccine sub-study inclusion/exclusion criteria.
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following applicable 
criteria apply:
5.1.1. Inclusion Criteria for De Novo Participants and Those Originating from 
B7931005 or B7981015 with >30 Days between the Index Study and Study B7981032
The following inclusion criteria must be met for de novo participants and those originating 
from B7931005 and B7981015 with >30 days from the first study visit of Study B7981032 
and the last dose in the index study.
Type of Participant and Disease Characteristics
1. Participants must meet the following AA criteria:

Have a clinical diagnosis of AA with no other etiology of hair loss (including, but 
not limited to traction and scarring alopecia, telogen effluvium).  Androgenetic 
alopecia coexistent with AA is allowed provided that the following criteria are 
met;

For de novo participants ≥12 to <18 years of age at the time of signing of the 
informed consent/assent: ≥50% terminal scalp hair loss due to AA (including AT 
and AU), as measured by SALT, at both the screening and Day 1 visits which, in 
the opinion of the investigator, is appropriate for systemic therapy;
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
For de novo participants ≥18 years of age at the time of signing of the informed 
consent/assent and participants originating from B7931005 or B7981015 with >30 
days between the index study and Study B7981032: ≥25% terminal scalp hair loss 
due to AA (including AT and AU), as measured by SALT, at both the screening 
and Day 1 visits which, in the opinion of the investigator, is appropriate for 
systemic therapy;

Hair loss must be carefully reviewed to verify the required percentage of terminal 
scalp hair loss is due to AA (ie, SALT [AA] score is ≥25% or ≥50%, as 
applicable).  

If, in cases of concomitant AA and androgenetic alopecia, it cannot be verified 
that the participant has the required SALT (AA) score, then the participant 
must be excluded from the study.

No evidence of terminal scalp hair regrowth in areas affected by AA within 
6 months of both the screening and Day 1 visits (for de novo participants only);

Current episode of terminal scalp hair loss due to AA ≤10 years (for de novo 
participants only).

When determining the duration of “current episode of terminal scalp hair 
loss”, the initiation of the current episode should be the last time when the 
patient had substantial scalp hair (regardless of whether that hair growth 
occurred spontaneously or was the result of interventional treatment).
5.1.2. Inclusion Criteria for All Participants Originating from B7931005 or B7981015
The following inclusion criteria must be met for all participants originating from B7931005 
and B7981015.
Prior B7931005 or B7981015 Clinical Study Experience
2. Participants enrolling from Study B7931005 must have:

Taken the last dose of PF-06700841 (a TYK2/JAK1 inhibitor) in Study B7931005 
>12 weeks prior to the Study B7981032 Day 1 visit.
3. Participants enrolling from Study B7981015 must have:

Completed ≥34 weeks of study intervention.
5.1.3. Inclusion Criteria for All Participants
The following inclusion criteria must be met for all participants.
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Age
4. All participants must be ≥12 years of age, at the time they or their parent or guardian 
signs the informed consent. Participants below the age of 18 years will only be 
enrolled into this study if permitted by the sponsor, local competent authority, and
institutional review board (IRB)/ethics committee (EC).  Otherwise, only participants 
18 years or older (or age by applicable reviewer) will be enrolled in those countries, 
regions or sites.  Within the VHP countries in the EU, de novo participants must be 
aged 18 through 74 years at the time of informed consent (see Section 5 for a list of 
VHP countries participating in this study).  Within the UK, participants must be 
18 years of age or older.
Sex
5. Male or Female
For all participants contraceptive use by men or women should be consistent with local 
regulations regarding the methods of contraception for those participating in clinical 
studies.
a.
Male participants:
No contraceptive measures required.
b. Female participants:

A female participant is eligible to participate if she is not pregnant or breastfeeding, 
and at least one of the following conditions applies:

Is not a woman of childbearing potential (WOCBP), see Appendix 4
(Section 10.4.3)
OR

Is a WOCBP and using a contraceptive method that is highly effective, with a 
failure rate of <1%, as described in Appendix 4 (Section 10.4.4) during the 
intervention period and for at least 28 days after the last dose of study 
intervention. The investigator should evaluate the effectiveness of the 
contraceptive method in relationship to the first dose of study intervention.

A WOCBP must have a negative highly sensitive (Appendix 2) pregnancy test 
(urine or serum as required by local regulations) at the Day 1 visit before the first 
dose of study intervention.  

If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum 
pregnancy test is required. In such cases, the participant must be excluded from 
participation if the serum pregnancy result is positive. 
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
The investigator is responsible for review of medical history, menstrual history, 
and recent sexual activity to decrease the risk for inclusion of a woman with an 
early undetected pregnancy. 
Informed Consent
6. All participants must be capable of giving signed informed consent/assent as 
described in Appendix 1 which includes compliance with the requirements and 
restrictions listed in the informed consent form (ICF) and in this protocol.
7. All participants must be willing and able to comply with scheduled visits, treatment 
plan, laboratory tests, and other study procedures.
Prior/Concomitant Therapy
8. If receiving permitted concomitant medications for any reason other than AA, 
participants should be on a stable regimen, which is defined as not starting a new drug 
or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1.  
Participants must be willing to stay on a stable regimen during the duration of the 
study (see Section 6.5). 
9. All participants must agree to avoid prolonged exposure to the sun and not to use 
tanning booths, sun lamps or other ultraviolet light sources during the study.
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply.
5.2.1. Exclusion Criteria for Participants Originating from B7981015 with ≤30 Days 
between Studies
Participants originating from B7981015 with ≤30 days from the first study visit of Study 
B7981032 and the last dose in the index study are excluded from the study if any of the 
following criteria apply.
1. During Study B7981015 or in the period between the index study and Study 
B7981032, presence of safety events meeting discontinuation criteria in Appendix 8, 
Section 10.8.2 (eg, serious infections, laboratory results, ECG results).
2. Discontinuation from Study B7981015 for safety-related events.  Participants 
discontinued from Study B7981015 due to issues other than safety-related events 
must be discussed with the sponsor prior to enrollment in Study B7981032.
5.2.2. Exclusion Criteria for De Novo Participants and Those Originating from 
B7931005 or B7981015 with >30 Days between the Index Study and Study B7981032
De novo participants and those originating from B7931005 and B7981015 with >30 days 
from the first study visit of Study B7981032 and the last dose in the index study are excluded 
from the study if any of the following criteria apply.
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Medical Conditions
3. Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, 
etc).
4. Active systemic diseases that may cause hair loss (eg, lupus erythematosus, 
thyroiditis, systemic sclerosis, lichen planus, etc).
5. Any psychiatric condition including recent or active suicidal ideation or behavior 
that meets any of the following criteria: 
a.
Suicidal ideation associated with actual intent and a method or plan in the past 
year: “Yes” answers on items 4 or 5 of the Columbia Suicide Severity Rating 
Scale (C-SSRS) (Section 8.2.9). 
b. For participants who had previous history of suicidal behaviors in the past >1 year 
to <5 years: “Yes” answer (for events that occurred in the past 5 years) to any of 
the suicidal behavior items of the C-SSRS or any lifetime history of serious or 
recurrent suicidal behavior, a risk assessment must be performed, and 
documented, by a qualified mental health professional to assess whether it is safe 
for the participant to participate in the trial.
c.
The presence of any current major psychiatric disorder that is not explicitly 
permitted in the inclusion/exclusion criteria. 
d. Clinically significant depression as indicated by a Patient Health 
Questionnaire-8 Items (PHQ-8) total score ≥15 (Section 8.2.10).
NOTE: For any participant who has significant depression or any suicidal behavior, 
the participant will not be assigned to study intervention and should be referred for 
appropriate evaluation and treatment.
6. Have hearing loss with progression over the previous 5 years, or sudden hearing 
loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere’s 
disease, labyrinthitis, or other auditory condition that is considered acute, 
fluctuating or progressive.

Participants originating from Study B7931005 or B7981015 with occurrences of 
any of the above either during the index study or between the end of the index 
study and Study B7981032 can only be enrolled in Study B7981032 with prior 
approval of the sponsor.
7. Current or recent history of clinically significant severe, progressive, or 
uncontrolled renal (including but not limited to active renal disease or recent kidney 
stones), hepatic, hematological, gastrointestinal, metabolic, endocrine (particularly 
thyroid disease which can be associated with hair loss), pulmonary, cardiovascular, 
psychiatric, immunologic/rheumatologic or neurologic disease; or have any other 
severe acute or chronic medical or psychiatric condition or laboratory abnormality 
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that may increase the risk associated with study participation or study intervention 
administration, or interfere with the interpretation of study results; or in the opinion 
of the investigator or Pfizer (or designee), the participant is inappropriate for entry 
into this study, or unwilling/unable to comply with study procedures (Section 8) 
and Lifestyle Considerations (Section 5.3).
8. Any present malignancies or history of malignancies with the exception of 
adequately treated or excised non metastatic basal cell or squamous cell cancer of 
the skin or cervical carcinoma in situ.
9. History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) 
related lymphoproliferative disorder, history of lymphoma, history of leukemia, or 
signs and symptoms suggestive of current lymphatic or lymphoid disease.
10. History (single episode) of disseminated herpes zoster or disseminated herpes 
simplex, or a recurrent (more than one episode of) localized, dermatomal herpes 
zoster.
11. History of systemic infection requiring hospitalization, parenteral antimicrobial 
therapy, or as otherwise judged clinically significant by the investigator within 
6 months prior to Day 1 (for criteria regarding Tuberculosis [TB] infection, see 
Exclusion Criterion 19 in Section 5.2.2).
12. Known immunodeficiency disorder or a first-degree relative with a hereditary 
immunodeficiency.
13. Positive serology for human immunodeficiency virus (HIV) at screening.
14. Significant trauma or major surgery within 1 month of the first dose of study 
intervention.
15. Considered in imminent need for surgery.  Participants with elective surgery 
scheduled can only be enrolled in Study B7981032 with the approval of the 
sponsor.  
16. Adolescent participants 12 to <18 years of age without one of the following:

Documented evidence of having received the varicella vaccine (2 doses); or

Evidence of prior exposure to varicella zoster virus (VZV) based on serological 
testing (ie, a positive VZV immunoglobulin G antibody [VZV IgG Ab] result) at 
screening.
Note: Serological testing must be performed for VZV IgG Ab only in the absence 
of documented evidence of having received varicella vaccination (2 doses).  If 
serological testing is performed in the presence of documented evidence of having 
received varicella vaccination (2 doses), participants are eligible to enter the study 
regardless of the result of serological testing.
This criterion is not applicable to sites where enrollment of adolescent 
participants is not permitted (see Inclusion #4).
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17. Active acute or chronic infection requiring treatment with oral antibiotics, antivirals, 
antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1 or any 
active infection not meeting other exclusion criteria within 1 week prior to Day 1.  
NOTE: participants may be rescreened after the infection resolves.
18. Infection with hepatitis B or hepatitis C viruses according to protocol-specific testing 
algorithm. 
a.
For hepatitis B, participants will undergo testing for hepatitis B surface 
antigen (HBsAg) and hepatitis B core antibody (HBcAb).  Participants who 
are HBsAg positive will not be eligible for this study.  Participants who are 
HBsAg negative but HBcAb positive will be reflex tested for hepatitis B 
surface antibody (HBsAb).  Participants who are HBsAg negative but HBcAb 
positive and HBsAb negative will not be eligible for the study. Additional 
reflex testing for hepatitis B virus deoxyribonucleic acid testing (HBVDNA) 
is also required for participants who are HBsAg negative and HBcAb positive 
in countries in which Hepatitis B prevalence has been reported at a rate of 
>5.0% or if required by local standard of care.   Please refer to Appendix 6 for 
testing algorithm, reflex testing, and full eligibility criteria.  Refer to 
Appendix 7 for Japan specific requirements.
b. For hepatitis C, all participants will undergo testing for hepatitis C antibody 
(HCVAb) during screening.  Participants who are HCVAb positive will be 
reflex-tested for hepatitis C ribonucleic acid (HCV RNA).  Participants who 
are HCVAb and HCV RNA positive are not eligible for the study. 
19. Have evidence of untreated or inadequately treated active or latent Mycobacterium 
tuberculosis (TB) infection as evidenced by the following:
a.
A positive QuantiFERON®-TB Gold In-Tube test (QFT-G) or positive or 
borderline T-SPOT®.TB (T-Spot test) performed within the 3 months prior to 
Day 1 (Visit 2).  If the laboratory reports the test as indeterminate, the test 
should be repeated.  If the result of the repeat test is indeterminate, a purified 
protein derivative (PPD) test may be substituted for the QFT-G test or T-Spot 
test only with approval from the Pfizer Medical Monitor on a case-by-case 
basis.
b. Chest radiograph (ie, chest x-ray or other appropriate diagnostic imaging such 
as computed tomography or MRI) with changes suggestive of active TB 
infection within 3 months prior to Screening.  Chest radiograph should be 
performed according to local standards of care or country-specific guidelines.
c.
History of either untreated or inadequately treated latent or active TB 
infection.
If a participant has previously received an adequate course of therapy for either 
latent (9 months of isoniazid in a locale where rates of primary multi-drug 
resistant TB infection are <5% or an acceptable alternative regimen) or active 
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(acceptable multi-drug regimen) TB infection, neither a QFT-G test, a T-Spot test, 
nor a PPD test need be obtained.  Details of the previous course of therapy 
(eg, medication(s) used, dose, duration of therapy) should be documented in the 
source documentation.
A chest radiograph (ie, chest x-ray or other appropriate diagnostic imaging such 
as computed tomography or MRI) must be obtained at screening if not done 
within the 3 months prior to screening (see Section 8.2.4).  To be considered 
eligible for the study, the chest radiograph must be negative for active TB 
infection. 
A participant who is currently being treated for active TB infection must be 
excluded from the study.
A participant who is being treated for latent TB infection can only be enrolled 
with confirmation of current incidence rates of multi-drug resistant TB infection, 
documentation of an adequate treatment regimen, and prior approval of the 
sponsor.
Diagnostic Assessments
20. Abnormal findings on the screening chest radiographs (eg, chest x-ray) including, but 
not limited to, presence of active TB, infection, cardiomyopathy, or malignancy.  
NOTE: Chest radiograph examination may be performed up to 3 months prior to 
Screening visit.  Documentation of the reading by a qualified radiologist or 
pulmonologist must be available in the source documentation.
21. ANY of the following conditions at screening:
a.
Screening 12-lead electrocardiogram (ECG) that demonstrates:

Clinically significant abnormalities requiring treatment (eg, acute 
myocardial infarction, serious tachy- or brady-arrhythmias) or indicating 
serious underlying heart disease (eg, cardiomyopathy, Wolff-Parkinson–
White syndrome); 

Confirmed QT corrected using Fridericia’s correction factor (QTcF) 
prolongation (>450 milliseconds).
b. Long QT Syndrome, a family history of Long QT Syndrome, or a history of 
Torsades de Pointes (TdP). 
22. ANY of the following abnormalities in clinical laboratory tests at screening, as 
assessed by the study-specific laboratory and confirmed by a single repeat, if deemed 
necessary:
a.
Absolute neutrophil count <1.2 x 109/L (<1200/mm3);
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b. Hemoglobin <11.0 g/dL or hematocrit <33%; 
c.
Platelet count <150 × 109/L (<150,000/mm3);
d. Absolute lymphocyte count of <0.8 x 109 /L (<800/mm3); 
e.
Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 based on the 
Cockcroft-Gault formula adjusted for the body surface area;
f.
Enzymes aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 
values >2 × upper limit of normal (ULN);
g. Total bilirubin >1.5 × ULN; participants with Gilbert's syndrome would be 
eligible for this study provided the direct bilirubin is ≤ULN;
h. In the opinion of the investigator or Pfizer (or designee), have any clinically 
significant laboratory abnormality that that could affect interpretation of study 
data or the participant’s participation in the study.
Prior/Concurrent Clinical Study Experience
23. Discontinuation from Study B7931005 or B7981015 for safety-related events. 
Participants discontinued from Study B7931005 or B7981015 due to issues other than 
safety-related events must be discussed with the sponsor prior to enrollment in 
Study B7981032.
5.2.3. Exclusion Criteria for All Participants
The following exclusion criteria are applicable to all participants, who are excluded from the 
study if any of the following criteria apply. 
Prior/Concomitant Therapy
24. Anticipated treatment with prohibited concomitant medication(s) (Section 6.5.2 and 
Appendix 9) during the course of the study.
25. Received any of the following treatment regimens specified in the timeframes 
outlined below:
a.
At any time: previous use of any non-B-cell selective lymphocyte-
depleting agent (eg, alefacept, alemtuzumab).
b. Within 6 months of first dose of study intervention or 5 half-lives (if 
known), or until lymphocyte count returns to normal, whichever is longer: 
any B-cell-depleting agents including but not limited to rituximab.
c.
Within 12 weeks of first dose of study intervention or 5 half-lives (if 
known), whichever is longer: 

Any JAK inhibitor for use in any disease indication (other than 
PF-06651600 received in Study B7931005 or B7981015); 

Other immunomodulatory biologic agents.
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Note: Discontinuation of any JAK inhibitor due to a treatment-related 
safety event is exclusionary.
d. Within 8 weeks of first dose of study intervention or within 5 half-lives 
(if known), whichever is longer:

Other systemic treatments that could affect AA including:

Immunosuppressants (eg, cyclosporine A, azathioprine, 
methotrexate [MTX], sulfasalazine, mycophenolate mofetil 
[MMF], everolimus, ibrutinib).

Intralesional, oral, or injectable steroids.

Oral minoxidil.
e.
Within 6 weeks of first dose of study intervention: vaccination with live 
or attenuated live vaccine.
f.
Within 4 weeks of first dose of study intervention: Ultraviolet B (UVB) 
phototherapy, Psoralen Ultraviolet A (PUVA) therapy, other phototherapy, 
contact immunotherapy (eg, diphenylcyclopropenone [DPCP], squaric 
acid dibutylester [SADBE], and 1-chloro-2,4-dinitrobenzene [DNCB]), 
topical irritants (eg, anthralin), and liquid nitrogen cryotherapy.
g. Within 4 weeks of first dose of study intervention or 5 half-lives (if 
known), whichever is longer: prohibited Cytochrome P450, family 3, 
subfamily A (CYP3A) inducers as described in Appendix 9.
h. Within 2 weeks of first dose of study intervention: topical steroids (eg, 
steroid cream, steroid ointment) on areas under assessment (ie, scalp, 
eyebrows, eyelashes, and fingernails).
i.
Within 1 week of first dose of study intervention:

Herbal medications with either unknown properties or pharmaceutical 
properties that impact AA.

Prohibited CYP3A substrates as described in Appendix 9 (within 
7 days or 5 half-lives, whichever is longer).
26. For participants without concomitant androgenetic alopecia, receipt of any of the 
following treatment regimens specified in the timeframes outlined below.  
Participants with known androgenetic alopecia receiving the following treatments for 
androgenetic alopecia must have been receiving the treatment(s) at a stable dose and 
regimen for at least 6 months prior to the Day 1 visit of Study B7981032 and plan to 
take them at a stable dose and regimen throughout Study B7981032; participants with 
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androgenetic alopecia who wish to withdraw from these permitted treatments prior to 
the study must meet the washout criteria stated below.
a.
Within 8 weeks of first dose of study intervention or within 5 half-lives 
(if known), whichever is longer:

5α-Reductase inhibitors (5-ARIs) (eg, finasteride, dutasteride) unless 
used for androgenetic alopecia.

Spironolactone unless taken for androgenetic alopecia or a medical 
condition other than AA (eg, hypertension).
b. Within 2 weeks of first dose of study intervention: topical treatments not 
otherwise prohibited (eg, medicated shampoo, minoxidil) on areas under 
assessment (ie, scalp, eyebrows, eyelashes, and fingernails) that could 
affect AA unless used for androgenetic alopecia.
Prior/Concurrent Clinical Study Experience
27. Participation in studies other than B7931005 or B7981015 involving investigational 
products (eg, drugs or vaccines) within 8 weeks (12 weeks for JAK inhibitors other 
than PF-06651600 received in Study B7931005 or B7981015) or within 5 half-lives 
(if known), whichever is longer, prior to study entry and/or during study participation.
Other Exclusions
28. Investigator site staff members directly involved in the conduct of the study and their 
family members, site staff members otherwise supervised by the investigator, or 
participants who are Pfizer employees, including their family members, directly 
involved in the conduct of the study.
29. Participants with shaved heads must not enter the study until hair has grown back and 
is considered stable by the investigator.
30. Have an active history of alcohol or substance abuse within 1 year prior to Day 1. 
31. Donation of blood in excess of 500 mL within 8 weeks prior to Day 1.
5.3. Lifestyle Considerations
5.3.1. Contraception
The investigator or his or her designee, in consultation with the participant (and the 
parent/legal guardian if required for adolescent participants), will confirm that the participant 
has selected an appropriate method of contraception for the individual participant and her 
partner(s), if applicable, from the permitted list of contraception methods (see Appendix 4, 
Section 10.4.4) and will confirm that the participant has been instructed in its consistent and 
correct use.  At time points indicated in the Schedule of Activities (Section 1.3), the 
investigator or designee will inform the participant (and the parent/legal guardian if required 
for adolescent participants) of the need to use highly effective contraception consistently and 
correctly from the time of the Screening visit and through 28 days after the last dose of study 
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intervention.  The conversation and the participant’s affirmation will be documented in the 
participant’s chart (participants need to affirm their consistent and correct use of at least 1 of 
the selected methods of contraception).  In addition, the investigator or designee will instruct 
the participant to call immediately if the selected contraception method is discontinued and 
document the requirement to use an alternate protocol-specified method, including if the 
participant will no longer use abstinence as the selected contraception method, or if 
pregnancy is known or suspected in the participant or partner. The contraception check for 
WOCBP will be performed during each study visit and monthly between study visits at the 
time of the phone contact to check the at-home pregnancy test results (see Section 8.2.11).
5.3.2. Cosmetic Treatments/Applications
Following the Screening visit and through 28 days after the last dose of study intervention, 
participants must not shave the hair on the scalp, eyebrows, or eyelashes.  Participants 
wishing to keep their hair short are permitted to do so and an appropriate length should be 
discussed with the investigator to allow for assessment of hair re-growth.
In addition, the following applies to other cosmetic treatments/applications:
1. Hair transplants and tattooing of scalp, eyebrows, and eyelashes, including 
procedures such as microblading, are not permitted during the course of study but 
these procedures performed prior to screening may not, in the investigator’s opinion, 
exclude a participant from enrollment.
2. Hair prosthetics (eg, wigs, hair extensions) are permitted but must be removed for 
clinical assessments of AA at all study visits.
3. Hair dye is permitted to be used during the study but participants should be 
discouraged from undergoing any hair dying process for 7 days prior to a study visit.
4. Mascara and false eyelashes are permitted but must be removed for clinical 
assessments of AA at all study visits.  The use of false eyelashes with adhesive should 
be discouraged, where possible, due to the risk of eyelash loss during removal.
5. Nail polish/varnish is permitted but must be removed for assessments of fingernails 
affected by AA.
6. False fingernails or gel applications to the fingernails should be discouraged, where 
possible, due to the risk of damage to the participant’s natural fingernails, and must 
be removed for clinical assessments of fingernails at all study visits.
5.3.3. Meals and Dietary Restrictions
On study visit days when lipid panel will be collected (see Schedule of Activities), 
participants must comply with fasting requirements for at least 8 hours prior to the visit.  
Water and permitted non-study medications are allowed (Section 8.2.8).
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5.3.4. Caffeine, Alcohol, and Tobacco
Participants will abstain from using tobacco products or ingesting caffeine- or 
xanthine- containing products (eg, coffee, tea, cola drinks, and chocolate) for at least 
30 minutes before pulse rate and blood pressure measurements.
5.3.5. Elective Surgery
From the time of the Screening visit through 28 days after the last dose of study intervention, 
no elective surgery should occur without first consulting with the sponsor.  Preferably, 
elective surgery should occur before the study or be delayed until participation in the study is 
completed.  Participants who require elective surgery should temporarily discontinue study 
intervention for one week prior to the surgical procedure and remain off study intervention 
after the surgical procedure until sutures/staples are removed.  If absorbing sutures or 
chemical closure methods are utilized, study intervention can be resumed when the operative 
site is sufficiently healed and risk of infection is minimal.  Per Section 6.4, if the participant 
interrupts study intervention for >14 consecutive days, this must be discussed with the 
sponsor for possible withdrawal from the study.  Refer to Section 6.5.4 for additional 
guidance regarding surgeries.
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently assigned to study intervention. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure participants to meet 
the Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to 
respond to queries from regulatory authorities. Minimal information includes demography, 
screen failure details, eligibility criteria, and any serious adverse event (SAE).
For de novo participants and participants originating from B7931005 or B7981015 with 
>30 days prior to enrolling in Study B7981032, screening laboratory tests with abnormal 
results may be repeated once to confirm abnormal results (with the same screening number); 
the last value will be used to determine eligibility.  If results return to normal within the 
5-week screening period, the participant may enter the study.
De novo participants and participants originating from B7931005 or B7981015 with 
>30 days prior to enrolling in Study B7981032 who do not meet the criteria for participation 
in this study (screen failure) may be rescreened (with a new screening number) following an 
agreement with the sponsor.
6. STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, or medical device(s) intended to be administered to a study participant according to 
the study protocol.
See Appendix 10 for vaccine sub-study information.
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6.1. Study Intervention(s) Administered
Participants enrolling from B7931005 and B7981015 who received study intervention in one 
of these studies will receive open-label PF-06651600 50 mg QD. 
De novo participants (ie, those who have not previously received study intervention in Study 
B7931005 or B7981015) will receive open-label PF-06651600 200 mg QD for 4 weeks 
followed by open-label 50 mg PF-06651600 QD.  
ARM Name
PF-06651600 200 mg QD (4 week loading 
dose for de novo participants only) 
PF-06651600 50 mg 
QD
Intervention 
Name
PF-06651600
PF-06651600
Type 
Small molecule
Small molecule
Dosage Form
Tablet
tablet or capsule
Dose Strength
50 mg
50 mg
Dosage
50 mg – 4 tablets
50 mg – 1 tablet or 1 
capsule
Route of 
Administration
Oral
Oral
Sourcing
Provided centrally by the sponsor.
Provided centrally by 
the sponsor.
Packaging and 
Labeling
Study Intervention will be provided in blister 
cards. Each blister card will be labeled as 
required per country requirement. 
Study intervention 
will be provided in 
blister cards (for 
tablets) or bottles (for 
capsules). Each blister 
card and each bottle 
will be labeled as 
required per country 
requirement. 
Abbreviations: QD = once daily
Participants will swallow the study intervention whole, and will not manipulate or chew the 
study intervention prior to swallowing.  
6.2. Preparation/Handling/Storage/Accountability
1. The study intervention will be dispensed using an Interactive Response Technology 
(IRT) management system at each visit as specified in the Schedule of Activities.  At 
the Week 2 visit, the participant will return the package containing the study 
intervention which was dispensed at the Day 1 visit for accountability.  The Day 1 
package will then be returned to the participant for administration and dispensing at 
the Week 2 visit.  
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2. A qualified staff member will dispense the study intervention in blister cards or 
bottles via unique container numbers.  The participant/caregiver should be instructed 
to maintain the product in the blister cards or bottles provided throughout the course 
of dosing and return the blister cards or bottles to the site at the next study visit.  Site 
staff will instruct participants on the proper storage requirements for study 
intervention that is taken home. 
3. The investigator or designee must confirm appropriate temperature conditions have 
been maintained during transit for all study intervention received and any 
discrepancies are reported and resolved before use of the study intervention.
4. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention. All study 
intervention must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with the labeled storage conditions with 
access limited to the investigator and authorized site staff.
5. The investigator, institution, or the head of the medical institution (where applicable) 
is responsible for study intervention accountability, reconciliation, and record 
maintenance (ie, receipt, reconciliation, and final disposition records).
6. Further guidance and information for the final disposition of unused study 
interventions are provided in the Investigational Product Manual.
6.3. Measures to Minimize Bias: Randomization and Blinding
Open-label using 
central study 
intervention 
assignment via 
(IVRS/IWRS)
This is an open-label study; however, the specific intervention to be 
taken by a participant will be assigned using an Interactive Voice 
Response System /Interactive Web Response Systems 
(IVRS/IWRS). The site will contact the IVRS/IWRS prior to the 
start of study intervention administration for each participant. The 
site will record the intervention assignment on the applicable case 
report form, if required. 
6.4. Study Intervention Compliance
Participant compliance with study intervention will be assessed at each visit. Compliance 
with the dosing of study intervention will be monitored and verified by delegated site 
personnel through a combination of counting returned tablets or capsules, and discussion 
with the participant, which will be documented in the source documents.  Deviation(s) from 
the prescribed dosage regimen should be recorded in the electronic Case Report Form 
(eCRF).  When study intervention is administered at the clinic, it will be administered by the 
appropriately designated staff at the investigator site.
Participants should take the tablets or capsules, orally according to the dosing instructions 
provided with the study intervention. Participants will be encouraged to take the study 
intervention in the morning whenever possible. Participants should take the study 
intervention at approximately the same time every day.  However, for study visit days, 
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participants are to be instructed to refrain from dosing at home, and are to take the dose in the 
clinic.
If a dose is missed and the interval to the next dose is <8 hours, the missed dose should not 
be administered. If a dose is missed and the interval to the next dose is ≥8 hours, the missed 
dose should be administered.
The study intervention may be temporarily withheld for a maximum of 14 consecutive days 
at the discretion of the investigator. Participants interrupting study intervention for 
>14 consecutive days for any reason must be discussed with the sponsor for possible 
withdrawal from the study.  For participants who are considering elective surgery refer to 
Section 5.3.5 regarding information on temporary withholding of study intervention for 
elective surgery.
If compliance is <80%, the investigator or designee is to counsel the participant and ensure 
steps are taken to improve compliance.  If the participant is over-compliant (>120%) with 
study intervention (intentional or accidental), the investigator or designee is to counsel the 
participant and ensure correct understanding of the study intervention dosing regimen.  The 
investigator should contact the Pfizer Study Clinician promptly with any over-compliance 
that may potentially impact the safe use of study intervention or that may result in a SAE.
6.5. Concomitant Therapy
Medications/treatments that are taken in the screening period (after informed consent is 
obtained and before the first dose of study intervention) as well as any 
medications/treatments taken for the treatment of AA at any time prior to the screening visit 
will be documented as prior medications/treatments.  Medications/treatments taken after the 
first dose of study intervention has been administered will be documented as concomitant 
medications/treatments.
Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, 
and/or herbal supplements) that the participant is receiving at the time of enrollment or 
receives during the study must be recorded along with:

Reason for use

Dates of administration including start and end dates

Dosage information including dose and frequency
The Medical Monitor should be contacted if there are any questions regarding concomitant or 
prior therapy.
6.5.1. Permitted Concomitant Medications
For the purposes of this protocol, dietary supplements are defined as vitamins, minerals, and 
purified food substances with pharmaceutical properties.  Vitamins, minerals and purified 
food substances are allowed in amounts not known to be associated with adverse effects 
(such as hypervitaminosis).
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A participant who is receiving a permitted concomitant medication for any reason must be on 
a locally-approved medication and dose for the treated indication, and this must be 
documented on the case report form (CRF).  
With the exception of those medications prohibited for use in Section 6.5.2, CYP3A 
inhibitors are permitted to be used during the study.  Sensitive and moderate sensitive 
CYP3A substrates permitted to be used during the study are listed in Section 10.9.2.
Acetaminophen may be used intermittently (not to exceed 3.0 g/day).  
Participants are not allowed any other investigational drugs or treatments during the study. 
Participants with known androgenetic alopecia may receive the following treatments 
provided that the dose and regimen are held stable for at least 6 months prior to the Day 1 
visit of Study B7981032 and throughout Study B7981032.  Participants who wish to 
withdraw from these treatments prior to the study must meet the washout criteria in 
Section 5.2.3.  

Systemic treatments: 5-ARIs (eg, finasteride, dutasteride), spironolactone. 

Topical treatments: medicated shampoo, minoxidil.  
In cases other than those described above for androgenetic alopecia, participants should 
refrain from starting new or changing doses of permitted prescription or non-prescription 
drugs, vitamins, and dietary supplements within 7 days or 5 half-lives (whichever is longer) 
prior to Day 1 and prior to study visits throughout the study, unless otherwise noted below. 
Participants should report any changes to permitted medications during the study to the 
investigator as soon as they occur.  Medication changes must be documented in the 
participant’s record and CRF. 
Unless a prohibited medication or treatment, participants may be administered any other 
medications necessary for the treatment of concomitant medical disorders as deemed 
necessary by the treating physician.  Following Day 1, addition of concomitant medications 
or any change in the dosage should be limited to those considered medically essential.
6.5.2. Prohibited Concomitant Medications
Participants will abstain from all prohibited medications as described in Section 5.2 and 
Appendix 9 from the time period described in Section 5.2 and through 28 days after the last 
dose of study intervention.  Medically necessary medications should not be discontinued 
without prior evaluation of acceptable alternatives, including consultation with prescribing 
health professional.
Participants should be instructed at each visit to contact the study site investigator promptly if 
there are any intended changes or additions to concomitant medications. 
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All medications and treatments that could affect AA must be discontinued from the 
time period described in Section 5.2 and through 28 days after the last dose of study 
intervention (with the exception of those listed in Section 6.5.1 for participants with 
androgenetic alopecia).  During this time period, if it is discovered that a participant has 
been taking a medication or treatment that could affect AA, the investigator should contact 
the sponsor for each case to determine whether the participant should be discontinued. 
Participants must also avoid prolonged exposure to the sun and avoid the use of tanning 
booths, sun lamps or other ultraviolet light sources from the time of the Screening visit and 
through 28 days after the last dose of study intervention.
Prohibited Concomitant Medications/Treatments:
The following medications and treatments are prohibited for use from the time period 
described in Section 5.2 and through 28 days after the last dose of study intervention.  
Participants with androgenetic alopecia are not allowed to start or change the dose or regimen 
of treatments permitted for androgenetic alopecia during the study.  Participants who are 
treated with any prohibited medication or treatment during the course of the study may be 
discontinued after discussion with the sponsor.  NOTE: Examples provided do not represent 
an all-inclusive list of medications and treatments.  If there is a question about whether a 
particular medication is prohibited, the medication should be discussed with the sponsor.

Medications and treatments that could affect AA:

JAK inhibitors for use in any disease indication.

Immunosuppressants (eg, cyclosporine A, azathioprine, methotrexate [MTX], 
sulfasalazine, mycophenolate mofetil [MMF], everolimus, ibrutinib).

Intralesional, oral or injectable steroids.

Oral minoxidil.

5-ARIs (eg, finasteride, dutasteride) unless used for androgenetic alopecia.

Spironolactone unless taken for androgenetic alopecia or a medical condition 
other than AA (eg, hypertension).

Other systemic treatments that could affect AA.

Topical steroids (eg, steroid cream, steroid ointment) on areas under assessment 
(ie, scalp, eyebrows, eyelashes, and fingernails).

Topical treatments (eg, medicated shampoo, minoxidil) that could affect AA on 
areas under assessment (ie, scalp, eyebrows, eyelashes, and fingernails) unless 
used for androgenetic alopecia.
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
Phototherapy (eg, Ultraviolet B [UVB] phototherapy, Psoralen Ultraviolet A 
[PUVA]).

Topical irritants (eg, anthralin), and liquid nitrogen cryotherapy.

Contact immunotherapy (eg, diphenylcyclopropenone [DPCP], squaric acid 
dibutylester [SADBE], and 1-chloro-2,4-dinitrobenzene [DNCB]).

Cosmetic treatments/applications as described in Section 5.3.2. 

Medications with potential drug-drug interactions or potential safety concerns:

Lymphocyte-depleting agents/therapies, including both non-B-cell selective and 
B-cell-depleting agents (eg, alefacept, alemtuzumab, rituximab).

Other biologics with immunomodulatory properties.

Live attenuated vaccines: restrictions on vaccinations are described in more detail 
in Section 6.5.3.

Moderate to potent CYP3A inducers (See Section 10.9.1).

Specific sensitive to moderate sensitive CYP3A substrates as listed in 
Section 10.9.1.

Herbal medications with either unknown properties or pharmaceutical properties 
that impact AA.

Investigational products (eg, drugs or vaccines).
6.5.3. Vaccinations
Vaccination with live attenuated virus is prohibited within the 6 weeks prior to the first dose 
of study intervention, while receiving study intervention, and for 6 weeks after the last dose 
of study intervention.  Similarly, current routine household contact with individuals who 
have been vaccinated with live vaccine components should be avoided while receiving study 
intervention and for 6 weeks after the last dose of study intervention.  Following vaccination 
with live component vaccines, the virus may be shed in bodily fluids, including stool, and 
there is a potential risk that the virus may be transmitted. 
Such vaccines include but are not limited to: FluMist® (intranasal influenza vaccine), 
attenuated rotavirus vaccine, varicella (chickenpox) vaccine, attenuated typhoid fever 
vaccine, oral polio vaccine, measles, mumps, rubella (MMR) vaccine, vaccinia (smallpox) 
vaccine, and Zostavax® (zoster vaccine live). 
Vaccines (including COVID-19 vaccines) that are not live attenuated are permitted.
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6.5.4. Surgery
From the time of the Screening visit through 28 days after the last dose of study intervention, 
no elective surgery should occur without first consulting with the Pfizer Medical Monitor or 
designee.  Preferably, elective surgery should occur before the study or be delayed until 
participation in the study is completed.  Refer to Section 5.3.5 for guidelines regarding 
temporary withholding of study intervention prior to and after elective surgery.
The Pfizer Medical Monitor or designee should be notified if a participant requires surgery 
(including dental surgery) during the study to determine whether the participant should 
discontinue from the study and/or discontinue study intervention prior to the surgical 
procedure.  The Pfizer Medical Monitor or designee should be notified as soon as possible if 
a participant undergoes a surgical procedure without first informing the study staff.
6.6. Dose Modification
Dose modification of the study intervention is not permitted in this study.  For information on 
temporary withholding of study intervention (see Section 6.4).
6.7. Intervention after the End of the Study
There is no intervention required by the protocol following the end of the study.  
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
7.1.1. Permanent Discontinuation
In rare instances, it may be necessary for a patient to permanently discontinue study 
intervention.  Reasons for permanent discontinuation of study intervention are included in 
Appendix 8, Section 10.8.2, Appendix 11, and Appendix 12.
Note that discontinuation of study intervention does not represent withdrawal from the study.  
If study intervention is permanently discontinued, the participant will remain in the study to 
be evaluated for the assessments at the Early Termination and Follow-up visits.    See the 
Schedule of Activities for data to be collected at the time of discontinuation of study 
intervention and follow-up for any further evaluations that need to be completed.
In the event of discontinuation of study intervention, it must be documented on the 
appropriate CRF/in the medical records whether the participant is discontinuing further 
receipt of study intervention or also from study procedures, post-treatment study follow-up, 
and/or future collection of additional information.
7.1.1.1. Observation Period
Participants will be asked to remain in the study after the Follow-up visit without study 
intervention. The Period during which participants are in the study after having permanently 
discontinued study intervention is referred to as the Observation Period. During this period 
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participants will continue to comply with study visit schedules for approximately 2 years or 
until study end, whichever occurs first. At visits during the Observation Period, only the 
SALT, ELA, EBA, PGI-C, and concomitant medications/treatments will be collected at the 
visits specified in the applicable SoAs in Section 1.3.2; AE and SAE reporting will follow 
the guidelines in Section 8.3. 
Participants will complete the final visit in the Observation Period approximately 2 years 
after the last dose of study intervention or at study end, whichever occurs first, as follows:

at the protocol-scheduled visit 24 months after the last dose of study intervention, OR

at the next scheduled visit after the 24-month time point (if no scheduled visit falls at 
the 24-month time point), OR 

at study end
For example, if the last dose of study intervention occurs around the time of Month 21 then 
the final visit in the Observation Period would be conducted at Month 48 (ie, the next 
scheduled visit occurring 24 months after Month 21).  
7.1.2. Temporary Discontinuation
See Section 5.3.5 and Section 6.4.
7.2. Participant Discontinuation/Withdrawal from the Study
At the time of discontinuing from the study, if possible, an early discontinuation visit should 
be conducted.  See the Schedule of Activities for assessments to be collected at the time of 
study discontinuation and follow up and for any further evaluations that need to be 
completed. 
The early discontinuation visit applies only to participants who are enrolled/randomized and 
then are prematurely withdrawn from the study.  Participants should be questioned regarding
their reason for withdrawal.  
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly.
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations should be performed and no 
additional data should be collected.  The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.
Lack of completion of all or any of the withdrawal/early termination procedures will not be 
viewed as protocol deviations so long as the participant’s safety was preserved.
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7.2.1. Withdrawal of Consent
Participants who request to discontinue receipt of study intervention will remain in the study 
and must continue to be followed for protocol-specified follow-up procedures.  The only 
exception to this is when a participant specifically withdraws consent for any further contact 
with him or her or persons previously authorized by the participant to provide this 
information.  Participants should notify the investigator in writing of the decision to 
withdraw consent from future follow-up, whenever possible.  The withdrawal of consent 
should be explained in detail in the medical records by the investigator, as to whether the 
withdrawal is only from further receipt of study intervention or also from study procedures 
and/or posttreatment study follow-up, and entered on the appropriate CRF page.  In the event 
that vital status (whether the participant is alive or dead) is being measured, publicly 
available information should be used to determine vital status only as appropriately directed 
in accordance with local law.
7.3. Lost to Follow up
A participant will be considered lost to follow-up if he or she repeatedly fails to return for
scheduled visits and is unable to be contacted by the study site.
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit:

The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study.

Before a participant is deemed lost to follow up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts should be documented 
in the participant’s medical record.

Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 
8. STUDY ASSESSMENTS AND PROCEDURES

Study procedures and their timing are summarized in the Schedule of Activities. Protocol
waivers or exemptions are not allowed.  Visit windows are based on Day 1 visit.

Immediate safety concerns should be discussed with the sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
study intervention.

All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria.  The investigator will maintain a screening log to 
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record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.

Adherence to the study design requirements, including those specified in the Schedule of 
Activities, is essential and required for study conduct.

Participants will have up to 35 days of a screening period prior to the first dose of study 
intervention to confirm that they meet the participant selection criteria for the study.  The 
investigator (or an appropriate delegate at the investigator site) will obtain informed 
consent from each participant (or parent(s)/legal guardian and assent from the participant, 
as appropriate) in accordance with the procedures described in Section 10.1.3.

For de novo participants and participants originating from B7931005 or B7981015 with 
>30 days between the first visit of Study B7981032 and the last dose in Study B7931005 
or B7981015, all screening and Day 1 evaluations must be completed and reviewed to 
confirm that potential participants meet all eligibility criteria prior to randomizing the 
participant in Impala. For participants who previously participated in Study B7931005 or 
B7981015, adverse events, laboratory results, medical conditions and prior and current 
treatments occurring during those studies and in any time elapsed between those studies 
and Study B7981032 must be checked against the Study B7981032 entry criteria.

Procedures conducted as part of the participant’s routine clinical management (eg, chest 
x-ray or other appropriate diagnostic imaging such as computed tomography or MRI) and 
obtained before signing of the ICF may be utilized for screening or baseline purposes 
provided the procedures met the protocol-specified criteria and were performed within 
the time frame defined in the SoA.  This includes procedure(s) which were completed for 
participants consented and screened for Study B7981015 but who did not receive study 
intervention in Study B7981015.  Separate informed consent/assent for Study B7981032 
must be obtained prior to use of data in Study B7981032 per Section 10.1.3.

The investigator will maintain a screening log to record details of all participants 
screened and to confirm eligibility or record reasons for screening failure, as applicable.

Due to audiological evaluation and possible need for tuberculin testing and chest 
radiograph, screening procedures may be performed over more than 1 visit within the 
35 days prior to the Day 1 visit for de novo participants and participants with >30 days 
between the first in Study B7981032 and the last dose in Study B7931005 or B7981015.

To assure consistency and reduce variability, visits should occur at approximately the 
same time of day throughout the study.  Participants should be encouraged to attend visits 
in the morning and prior to the participant’s dosing of study intervention as participants 
will receive their dose at the clinic during their study visit. 

Urine pregnancy test must be performed at each visit (and must be negative) prior to 
dosing with the study intervention for female participants of childbearing potential 
through follow-up (see Appendix 4 and Section 8.2.11).  
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
The patient-reported and observer reported outcome assessments should be completed 
before the other evaluations or treatments at the clinical visits whenever it is possible.  
The clinician global impression-alopecia areata (CGI-AA) should be completed after 
other clinical assessments of alopecia areata (ie, SALT, EBA, ELA, and assessment of 
fingernails affected by AA) whenever it is possible.  Vital signs and electrocardiograms 
(ECGs) should be performed before any laboratory blood collection.  All other 
evaluations (unless noted otherwise) do not need to be performed in any specific order.

Participants are required to fast for at least 8 hours prior to all visits that include fasting 
lipid profile panel testing.  During the fasting period, participants should refrain from all 
food and liquids (water and medications other than study intervention are permitted). 

Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described.  However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to 
perform the test.  In these cases, the investigator must take all steps necessary to ensure 
the safety and well-being of the participant.  When a protocol-required test cannot be 
performed, the investigator will document the reason for the missed test and any 
corrective and preventive actions that he or she has taken to ensure that required 
processes are adhered to as soon as possible.  The study team must be informed of these 
incidents in a timely manner.

For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site 
prior to initiation of the study.

The maximum amount of blood collected from each participant over the duration of TP1, 
including all assessments at the screening and follow-up visits, will be approximately 
280 mL. The maximum amount of blood collected from each participant over the 
duration of TP2, including all assessments at the follow-up visit, will be approximately 
140 mL. The maximum amount of blood collected from each participant over the 
duration of the 5-year study, including all assessments at the screening and follow-up 
visits, will be approximately 400 mL.  Participants not requiring laboratory testing at the 
screening and/or Day 1 visits per the Schedule of Activities will not require the full 
amount of blood to be collected.  Repeat or unscheduled samples may be taken for safety 
reasons or for technical issues with the samples.

There may be instances when copies of medical records are requested by Pfizer (eg, for 
safety monitoring, follow-up of adverse events or laboratory abnormalities, review of 
local laboratory results, event adjudication).  In this case, all participant identifiers, with 
the exception of the participant number, must be redacted on the copies of medical 
records before submission to Pfizer or a third party such as an adjudication committee.

Refer to Appendix 8 for guidelines on participant safety monitoring and discontinuation.
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
Refer to Appendix 11 for information on discontinuation criteria for worsening AA in 
VHP countries in the EU.

Refer to Appendix 12 for information on study intervention continuation criteria for 
adolescents.

Refer to Appendix 13 for guidelines on alternative measures during public emergencies, 
including the COVID-19 pandemic. 
8.1. Efficacy Assessments
8.1.1. Rater Qualifications
Diagnosis of AA must be performed by a qualified dermatologist (board certified or 
equivalent) who has experience with AA.  The assessment of fingernails affected by AA 
must be performed by a qualified dermatologist (board certified or equivalent).  An 
experienced and qualified physician or healthcare professional may be permitted to perform 
the other clinical evaluations of alopecia (ie, SALT, ELA, EBA, and CGI-AA).  The C-SSRS 
may be performed by site staff.  For all assessments, the rater must be formally delegated to 
perform this assessment by the PI and receive training (with proper documentation) on the 
protocol and applicable assessment scales prior to performing these evaluations.
To assure consistency and reduce variability, the same rater should assess dermatological 
clinical evaluations for a given procedure and for an individual participant throughout the 
study (eg, one rater performs all SALT evaluations throughout the study).  The same rater 
must assess the SALT and CGI-AA for an individual participant.  A back-up experienced and 
qualified, protocol-trained rater will only be allowed in special situations when the 
designated rater is unable to perform the evaluation. Use of the back-up rater will be 
documented.
8.1.2. Clinical Assessments
Refer to Section 5.3.2 for information regarding cosmetic treatments and applications which 
must be adhered to during the study.
8.1.2.1. Severity of Alopecia Tool (SALT)
Severity of Alopecia Tool (SALT) is a quantitative assessment of alopecia severity based on 
scalp terminal hair loss59.  The overall SALT score, which does not distinguish the reason for 
hair loss, will be collected at visits shown in the Schedule of Activities.
Score parameters utilize a visual aid showing the division of the scalp hair into four 
quadrants (back, top of scalp, and both sides), with each of the four quadrants given an 
accurate determination of the % of scalp surface area covered, representing 24%, 40%, 18%, 
and 18% of the total scalp surface area, respectively.
For information on photography required for this protocol, see Section 8.1.4.
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Hair prosthetics (eg wigs, hair extensions) must be removed for clinical assessments of AA at 
all study visits.
8.1.2.1.1. Androgenetic Alopecia SALT Score
In addition to the overall amount of scalp terminal hair loss, scalp hair loss due to 
androgenetic alopecia will be assessed using the SALT tool.  This will only be collected for 
participants with known androgenetic alopecia.  The androgenetic alopecia SALT score 
(SALT AGA) is only required to be assessed at the final on-therapy visit for each treatment 
period (ie, in TP1 at Month 36 or Early Termination, and in TP2 at Month 60, the last 
on-therapy visit, or Early Termination) per the Schedule of Activities.
8.1.2.1.2. Alopecia Areata Eligibility Assessment
In addition to the overall amount of scalp terminal hair loss, scalp hair loss due to alopecia 
areata will be assessed at the screening and Day 1 visits to verify eligibility of de novo 
participants and participants originating from Study B7931005 or B7981015 with >30 days 
between the first visit of Study B7981032 and the last dose of study intervention in 
Study B7931005 or B7981015.
8.1.2.2. Eyelash Assessment (ELA)
The eyelash assessment (ELA) is a numeric rating scale (NRS) developed to characterize 
eyelash hair loss.  The numeric rating scale ranges from 0 (none) to 3 (normal) as described 
below. 
Score
Description
0
None Eyelash

No eyelashes of both right and left upper and lower eyelashes.
1
Minimal Eyelash

Modestly or severely decreased density of and/or large gap(s) in one or both upper 
eyelashes.
2
Moderate Eyelash

Normal density of both upper eyelashes without gap(s), and decreased density or gap(s) is 
present in one or both lower eyelashes, OR

Normal density of both upper eyelashes with short gap(s), OR

Mildly decreased density of one or both upper eyelashes with or without short gap(s).
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Score
Description
3
Normal Eyelash

Normal density of both right and left upper and lower eyelashes from near medial canthus 
to near lateral canthus without any gap(s).
NOTE: 

Density of lower eyelashes is usually less than upper eyelashes.

A short gap does not significantly distort the appearance of the eyelash (es).

Moderate Eyelash score does not require presence of lower eyelashes.
8.1.2.3. Eyebrow Assessment (EBA)
The eyebrow assessment (EBA) is an NRS developed to characterize eyebrow hair loss.  The 
numeric rating scale ranges from 0 (none) to 3 (normal). 
Score
Description
0
None Eyebrow

No eyebrow hair.
1
Minimal Eyebrow

Normal or decreased density of one or both eyebrows with large gap(s).

Severely decreased density of one or both eyebrows with or without gap(s).
2
Moderate Eyebrow

Normal density of both eyebrows with short gap(s) that does not significantly distort the 
appearance of the eyebrows, OR

Mildly decreased density of eyebrows with or without short gap(s), OR 

Moderately decreased density of eyebrows without short gap(s).  There is visual definition 
of eyebrows at a distance of 3 feet. 
3
Normal Eyebrow

Normal density of both right and left eyebrows spanning usual length (ie, from glabella to 
near temple) and width.  There are no gap(s).
NOTE: 

Density of lateral aspect of eyebrows may be mildly less than medial eyebrows.

A short gap does not significantly distort the appearance of the eyebrow(s).
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8.1.2.4. Assessment of Fingernails Affected by Alopecia Areata
The number of fingernails affected by AA will be counted at Day 1 in all de novo 
participants, all participants originating from B7931005, and participants originating from 
Study B7981015 with >30 days between the first visit of B7981032 and the last dose in 
Study B7981015.  The number of affected fingernails will be counted at subsequent visits for 
all participants (Schedule of Activities).  Fingernails may have any of the following changes 
to be considered “affected”: nail pitting; trachyonychia (roughening of nail surface); 
onychorrhexis (brittle nails); koilonychia (transverse and longitudinal concavity of nail, ie, 
“spoon shaped”); onychomadesis (separation of nail plate from nail bed); longitudinal 
ridging or striations; leuconychia (white lines or spots in nail plate); red spotting of the 
lunulae.61-78
Photographs may be taken of affected nails at the Day 1 visit and during study treatment at 
investigator’s discretion.
Nail polish/varnish, false fingernails, and gel applications must be removed for assessments 
of fingernails affected by AA.
8.1.2.5. Clinician Global Impression - Alopecia Areata (CGI-AA)
The Clinician Global Impression - Alopecia Areata (CGI-AA) is a single clinician-reported 
item developed to assess clinical impression of severity of scalp hair loss. The rater is asked 
to rate the participant’s current hair loss on a scale ranging from “None (no hair loss)” to 
“Very severe or complete hair loss” with higher scores indicating more severe hair loss. The 
CGI-AA should be completed after other clinical assessments of alopecia areata (ie, SALT, 
EBA, ELA, and assessment of fingernails affected by AA), whenever it is possible. 
8.1.3. Patient Reported Outcome (PRO) / Observer Reported Outcome (ObsRO)
Participant completed questionnaires in this study include the AAPPO, PGI-C, P-Sat, HADS, 
EQ-5D-5L, EQ-5D-Y, SF36v2 Acute, AARU, and WPAI: AA.  The BRIEF®2 is a 
parent/caregiver completed questionnaire.  Every effort should be made to have the 
participant complete all patient reported outcome (PRO) questionnaires and the participant’s 
parent/caregiver complete the observer reported outcome (ObsRO) questionnaire before any 
other evaluations.  All PROs/ObsROs should be completed as shown in the Schedule of 
Activities.
8.1.3.1. Alopecia Areata Patient Priority Outcomes (AAPPO)
The Alopecia Areata Patient Priority Outcomes (AAPPO) scale is an 11-item
self-administered questionnaire that measures hair loss, emotional symptoms, and activity 
limitations over the past week.  This measure was developed based on qualitative patient 
input as well as review of other data sources (eg, literature, expert input, other existing 
measures, etc.).  The first 4 items of the tool, which cover hair loss from the scalp, eyebrows, 
eyelashes, and body, ask the patient to describe the current amount of hair loss using a 5-
point response scale that ranges from “no hair loss” to “complete (do not have any [insert 
body location/type of hair]).” Items 5-8 are an assessment of emotional symptoms. Response 
choices on these items are scored from “0=never” to “4=always.” Items 9-11 are an 
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assessment of activity limitations, with response choices scored from 0="not at all" to 
4="completely (did not do any [insert activity] because of hair loss)”.
8.1.3.2. Patient’s Global Impression of Change (PGI-C)
The Patient’s Global Impression of Change (PGI-C) asks the participant to evaluate the 
improvement or worsening of their AA as compared to the start of the study using a 
single-item, “Since the start of the study, my alopecia areata has: …”.  The participants will 
select one of seven responses ranging from “greatly improved” to “greatly worsened.”  De 
novo participants should refer to the start of Study B7981032 and participants originating 
from Study B7931005 or B7981015 should refer to the start of the index study.  
8.1.3.3. Patient's Satisfaction with Hair Growth (P-Sat)
The Patient’s Satisfaction with Hair Growth (P-Sat) asks the participant to evaluate his/her 
satisfaction with the hair that has regrown since the start of the study.  This measure is 
comprised of three items asking about satisfaction with the “amount” and “quality” of hair as 
well as “overall” satisfaction with the hair.  The participants will select one of seven 
responses ranging from “very satisfied” to “very dissatisfied.”  De novo participants should 
refer to the start of Study B7981032 and participants originating from Study B7931005 or 
B7981015 should refer to the start of the index study.
8.1.3.4. Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a validated 14-item PRO measure 
used to assess states of anxiety and depression over the past week.  Items are rated on a 
4-point severity scale.  The HADS produces 2 scales, one for anxiety (HADS-A) and one for 
depression (HADS-D), differentiating the two states with established normal score cut-offs90. 
The instrument has been validated for use by adolescents aged 12 and older.79
8.1.3.5. EuroQoL 5 Dimensions (EQ-5D-5L) and EuroQoL 5 Dimensions-Youth 
(EQ-5D-Y)
The EuroQoL 5 Dimensions (EQ-5D-5L)  is a validated, standardized, generic instrument 
that is the most widely used preference-based HRQoL questionnaire in cost-effectiveness and 
health technologies assessment (HTA).80-82  The measure is a well-established instrument 
used to measure health states and utilities in various disease areas.  The measure contains 
5 items that cover mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression, as well as a visual analogue scale.  A version of the instrument 
specifically developed and validated for use by youths aged 12 to <18 years is called the 
EuroQoL 5 Dimensions-Youth (EQ-5D-Y) will be used for adolescent participants.  
Participants who are <18 years at the time of the Day 1 visit of B7981015 or B7981032 will 
use the EQ-5D-Y (age for participants from B7931005 will be based on their age on Day 1 of 
B7981032) per the Schedule of Activities.  Participants who reach the age of 18 years during 
Study B7981032 will continue to use the EQ-5D-Y for the remainder of the visits at which 
the EQ-5D-Y is collected per the Schedule of Activities.
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8.1.3.6. 36 -Item Short Form Health Survey Version 2 Acute (SF36v2 Acute)
The 36-Item Short Form Health Survey version 2 Acute (SF36v2 Acute) is a validated 
generic health status measure which measures concepts of HRQoL over the past week.  It is 
36 items and measures 8 general health domains: physical functioning, role limitations due to 
physical health, bodily pain, general health perceptions, vitality, social functioning, role 
limitations due to emotional problems, and mental health.  These domains can also be 
summarized as physical and mental component summary scores.
8.1.3.7. Alopecia Areata Resource Utilization (AARU)
The Alopecia Areata Resource Utilization (AARU) is a PRO that measures the resource 
utilization associated with AA.  The AARU is a 3-item questionnaire which asks participants 
about medical or nonmedical practitioner visits, cosmetic covering of hair loss, and career 
impact they may have had over the past 3 months.
8.1.3.8. Work Productivity and Activity Impairment: Alopecia Areata (WPAI: AA)
The Work Productivity and Activity Impairment: Alopecia Areata (WPAI: AA) is a validated 
scale that was developed to measure the effect on work productivity and regular activities 
during the past 7 days, which has been modified specifically for participants with AA.  The 
WPAI: AA will be completed by adult participants aged ≥18 years only.  Adolescents aged 
12 to <18 years at the time of the Day 1 visit of B7981015 or B7981032 will not complete 
this assessment (age for participants from B7931005 will be based on their age on Day 1 of 
B7981032).
8.1.3.9. Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2)
Only in countries where the questionnaire is available.
The Behavior Rating Inventory of Executive Function®, Second Edition (BRIEF®2), that 
will be used in this study is an ObsRO parent/caregiver completed scale designed to assess 
executive behaviors in children and adolescents.  The BRIEF®2 will be used in this study to 
monitor neuropsychological development and executive functions in adolescents.  The 
BRIEF®2 scales assess how well the child is demonstrating behavioral or emotional control, 
initiating activity, engaging in planful and well-organized problem solving, and monitoring 
one’s own social success and problem-solving outcomes.  The BRIEF®2 consists of 63 items 
and yields scores on nine scales, with the Inhibit and Self-Monitor scales comprising the 
Behavior Regulation Index (BRI), the Shift and Emotional Control scales comprising the 
Emotional Regulation Index (ERI), and the Initiate, Working Memory, Plan/Organize, Task 
Monitor, and Organization of Materials scales comprising the Cognitive Regulation Index 
(CRI).91,92
For participants who are <18 years of age at the time of the Study B7981032 Day 1 visit, the 
parent/caregiver will complete the BRIEF®2 questionnaire.  The same parent/caregiver 
should complete the questionnaire at each visit throughout the study whenever possible.
For participants who have already started the study when the BRIEF®2 questionnaire is 
approved and available for use at the participant’s site, the BRIEF®2 questionnaire will be 
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administered at the next scheduled study visit and then at the remaining visits per the 
Schedule of Activities for the BRIEF®2.  For example, if the BRIEF®2 was approved for 
use at a site between an adolescent participant’s Month 12 and Month 15 visit, the BRIEF®2 
would be completed at the Month 15 visit and then at the Month 18 and subsequent visits per 
the Schedule of Activities.
Once a participant reaches ≥18 years of age, this assessment will no longer be required.  At 
the Early Termination visit, if the BRIEF®2 was administered within 2 months of the Early 
Termination visit, it does not need to be collected. 
BRIEF®2 should be administered as shown in the Schedule of Activities. 
8.1.4. Photography
Photographs of study participants will be obtained (according to the separately provided 
Photography Instructions) at various time points as shown in the Schedule of Activities.  
Photographic services will be provided through a central photography lab selected by the
sponsor.  Detailed procedures to assure photographic quality and consistency will be 
provided separately in a central photography laboratory instruction manual.
Scalp areas photographed should be recorded in study documents so that the same scalp 
region(s) will be photographed at all time points as applicable.  Photographs of eyelashes and 
eyebrows will also be taken.  Photographs of affected fingernails may be taken at the 
investigator’s discretion. 
The photographs taken of any participant may be reviewed by an independent consultant(s) 
to confirm SALT scores.
8.2. Safety Assessments
Planned time points for all safety assessments are provided in the Schedule of Activities.  
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety issues.
Safety monitoring and discontinuation criteria are provided in Appendix 8.
For the purposes of safety monitoring and discontinuation, baseline values will be defined as 
follows:

For de novo participants and participants originating from Study B7931005 or 
B7981015 with >30 days between the first visit of Study B7981032 and the last dose 
in Study B7931005 or B7981015:

Baseline values will be defined as the values from Day 1 of Study B7981032 (or 
from screening of Study B7981032 for evaluations not performed at Day 1).
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
For participants originating from Study B7981015 with ≤30 days between the first 
visit of Study B7981032 and the last dose in Study B7981015:

Baseline values will be defined as the values from Day 1 of B7981015 (or from 
screening of Study B7981015 for evaluations not performed at Day 1).
8.2.1. Medical History, Physical Examinations, Height, and Weight

Complete AA disease history includes collection of details of AA at screening for 
de novo participants and participants originating from B7931005 or B7981015 with 
>30 days between the first visit of Study B7981032 and the last dose in Study 
B7931005 or B7981015: AA history, AA diagnosis, pattern of scalp hair loss, body 
hair loss, nail involvement, the use of topical treatments, systemic treatments and 
other treatments for AA.  

Medical history, including, but not limited to, comorbid conditions, history of drug, 
alcohol, tobacco use, dermatologic history, and infection will be collected at 
screening or Day 1 (as applicable per the Schedule of Activities).  Refer to the CRF 
completion guidelines for specific information regarding medical history 
information to be collected for each group of participants.

Smoking status and alcohol consumption will also be collected for de novo 
participants and participants originating from B7931005 or B7981015 with 
>30 days between the first visit of Study B7981032 and the last dose in Study 
B7931005 or B7981015. 

Height and weight will be measured without the participant wearing shoes or 
outerwear.  Height (inches or centimeters) and weight (lbs or kgs) will be measured 
and recorded in the source document at various time points according to Schedule of 
Activities.  After the screening visit, height will not be collected from participants 
who are ≥18 years of age at the time of the visit.

Complete physical examinations must be performed by the investigator, sub 
investigator or a qualified health professional per local guidelines.  Complete 
physical examinations consist of assessments of general appearance; skin; head, 
eyes, ears, nose, and throat (HEENT); mouth, heart; lungs; abdomen; extremities; 
neurologic function, back, and lymph nodes.  In addition, dermatological full body 
exam must be performed by the investigator, sub investigator or a qualified health 
professional per local guidelines.  Dermatological examinations should also include 
visual inspection of the breasts and external genitalia.

Targeted physical examinations must be performed by the investigator, 
sub-investigator or a qualified health professional per local guidelines and should 
include skin, heart, lung, and abdomen, neurologic function, and examination of 
body systems where there are symptom complaints by the participant. 
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
When dermatologic adverse events are identified on physical exam, additional 
procedures may be required.  Please refer to Section 8.2.7.2 for additional details.

Participants with clinically meaningful changes from baseline in neurologic signs or 
symptoms should be referred to a neurologist to undergo a formal neurologic 
evaluation.
8.2.2. Tanner Stages of Development
Determination of physical and sexual maturation will be performed using the Tanner stages 
of development 84 for participants who are <18 years of age at the Day 1 visit in 
Study B7981032.  For these participants, Tanner stages will be collected at visit(s) after the 
Day 1 visit only until the participant has reached a score of 5 on all applicable domains.  For 
participants with AU (ie, total loss of hair on the scalp, face and body) at the Day 1 visit for 
whom the stage for pubic hair cannot be reliably assessed, the Tanner stages will be collected 
at visit(s) after the Day 1 visit only until the participant has reached a score of 5 on the 
remaining applicable domain (ie, breasts for females and genitalia for males).  The 
assessment will be performed by an investigator, sub investigator or a qualified health 
professional per local guidelines in the presence of a parent/legal guardian or clinic staff 
member other than the person performing the exam. 
The Tanner stages will be assigned by the qualified site staff based on the exam.  At the end 
of the exam, the qualified site staff will assign the best estimate Tanner stage for each 
domain.  In the case of differential maturation within a domain, the higher Tanner stage 
should be assigned.  
8.2.3. Vital Signs

Oral, tympanic, axillary, or temporal artery temperature, pulse rate, and blood 
pressure will be assessed.  It is preferred that body temperature be collected using 
the tympanic or oral methods; however, the axillary and temporal artery methods 
are also permitted.  The same method should be used consistently throughout the 
study.  Vital signs should be performed before laboratory blood collection and ECG.

Blood pressure and pulse measurements will be assessed in a chair, back supported, 
and arms bared (free of restrictions such as rolled-up sleeves, etc.) and supported at 
heart level.  Measurements should be taken on the same arm at each visit (preferably 
non-dominant) with a completely automated device.  Manual techniques will be 
used only if an automated device is not available.  Blood pressure (BP) will be 
measured using a standard calibrated blood pressure measuring device.  A BP 
device that uses multiple cuff sizes based on the arm circumference is the required 
type of device.  The appropriate cuff size for the participant must be used to ensure 
accurate measurement.  The arm circumference at the midpoint of the length of the 
upper arm should be measured to determine the appropriate cuff size in accordance 
with the specifications of the BP measuring device.  The same properly sized and 
calibrated blood pressure cuff will be used to measure blood pressure each time. 
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
Pulse rate should be measured at approximately the same time as BP for a minimum 
of 30 seconds.

Blood pressure and pulse rate measurements should be preceded by at least 
5 minutes of rest for the participant in a quiet setting without distractions 
(eg, television, cell phones). Participants should refrain from smoking or ingesting 
caffeine during the 30 minutes preceding the measurements.
8.2.4. Chest Radiography
Chest X-ray (posterior-anterior and lateral views are recommended, however local guidelines
should be followed) or other appropriate diagnostic image (ie, computed tomography or 
magnetic resonance imaging [MRI]) must be taken at screening or within 3 months prior to 
screening visit for de novo participants and participants originating from Study B7931005 or 
B7981015 with >30 days between the first visit of Study B7981032 and the last dose in 
Study B7931005 or B7981015.  The chest radiograph must be read by a qualified radiologist 
or pulmonologist prior to the Day 1 visit for confirmation of eligibility per Section 5.2.2.  
Documentation of the reading by the qualified radiologist or pulmonologist must be available 
in the source documentation.
8.2.5. Electrocardiograms

Single 12-lead ECG will be obtained as outlined in the Schedule of Activities using 
an ECG machine that automatically calculates the heart rate and measures PR, QRS, 
QT, and QTcF intervals (or using an ECG machine which does not automatically 
calculate QTcF intervals, with the site’s qualified medical personnel performing the 
calculation with the QTcF calculator provided by the sponsor). Refer to Appendix 8
for QTcF withdrawal criteria and any additional QTcF readings that may be 
necessary.

ECG should be performed before laboratory blood collection. 

All scheduled ECGs should be performed after the participant has rested quietly for 
at least 10 minutes in a supine position and prior to any blood collection.

A paper or digital copy of the ECG should be filed in the participant’s chart and 
must be available to the sponsor upon request

To ensure safety of the participants, qualified medical personnel will review all 
ECGs and make comparisons to the baseline measurements as defined in 
Section 8.2. Any clinically significant changes will be recorded and evaluated 
further, as clinically warranted.  In some cases, it may be appropriate to repeat 
abnormal ECGs to rule out improper lead placement as contributing to the ECG 
abnormality.
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8.2.6. Audiological Evaluation
All participants will have an audiological evaluation at times specified in the Schedule of 
Activities.  When possible, the participant should have the evaluation performed at the same 
evaluation center during the study. 
A full audiological evaluation must be completed at screening or within 8 weeks prior to 
Day 1 for de novo participants and those with >30 days between Study B7981032 and the 
last dose in Study B7931005 or B7981015.  This evaluation includes: audiological history, 
otoscopic examination, pure tone audiometry, air and bone conduction, speech audiometry, 
and immittance audiometry.  All screening audiological evaluation results must be available 
prior to Day 1 to assess eligibility for de novo participants and those with >30 days between 
Study B7981032 and the last dose in Study B7931005 or B7981015.  
At subsequent visits, updated audiological history, otoscopic examination, and pure tone 
audiometry will be performed for all participants; based upon results, additional audiological 
assessments may be required.
For participants who terminate early from the study, efforts must be made to complete the 
audiological evaluation.
If there is a clinically meaningful, treatment-emergent decline in hearing from the baseline 
measurements (as defined in Section 8.2), the participant must be promptly evaluated by a 
medically qualified specialist to assess for possible causes.  Evaluation results should then be 
discussed with the sponsor to determine if the participant should be discontinued from the 
study.  Discontinued participants must be followed up off-treatment with appropriate testing 
at regular intervals, until hearing recovers or is determined to be clinically stable. 
Refer to the most current version of the Audiological Evaluation Study Guide for details on 
audiological evaluation.  All procedures must be performed according to the Audiological 
Evaluation Study Guide.
8.2.7. Special Safety Assessment
8.2.7.1. Suspected Opportunistic Infections
In the event of a suspected opportunistic infection, every effort should be made to identify 
the pathogen utilizing laboratory or other methods appropriate to the clinical situation.
8.2.7.2. Dermatological Events
All participants will have a dermatological full body exam at Screening Visit and as noted in 
the Schedule of Activities.
8.2.7.2.1. Herpetiform Rash
For any occurrence of a suspected herpetiform rash (eg, herpes zoster and herpes simplex) or 
eczema herpeticum specimens for viral deoxyribonucleic acid (DNA) analysis will be 
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obtained: a swab of the affected area will be collected for confirmation.  Details for this 
collection will be provided in the laboratory manual.
8.2.7.2.2. Potential Drug-Related Rash and Unexplained Rash
All potential drug-related reports of rash will be followed up until resolution or clinically 
stable or in agreement with the sponsor. 
All events of rash should be treated according to international and local guidelines for the 
treatment of rash, eg, where appropriate, topical corticosteroids and/or agents such as 
antibiotics or antivirals could be prescribed. 
All participants reporting an unexplained skin rash should undergo a formal comprehensive 
dermatologic evaluation.  In addition, the participant will be asked to rate the severity of 
pruritus within the last 24 hours on a scale from 0 (No itching) to 10 (Worst possible itching).  
A 4 mm punch biopsy will be taken unless there is a clear, non-drug related etiology 
(eg, infection, including herpes virus, pre-existing condition) or other clinical rationale (eg, if 
the rash is present on the face it may not be appropriate to take a biopsy) or participant 
refuses to have biopsy performed.  The biopsy will be sent to the local laboratory for 
histological investigation of the rash in order to gain insight into potential etiology of the 
rash.
In addition to a biopsy of suspected drug-related rash, a swab (for microbiological 
assessment) of the affected area will also be taken for culture and sensitivity to assess (at the 
local laboratory) for any bacterial, fungal, or viral pathogens, if applicable.
Photographs of the rash will be taken.
All de-identified biopsy results, culture results, photographs, and any additional relevant test 
results should be forwarded to the sponsor for review.  This should occur within 30 days of 
receipt of results by the principal investigator (PI).
8.2.8. Clinical Safety Laboratory Assessments
See Appendix 2 for the list of clinical laboratory tests to be performed and to the Schedule of 
Activities for the timing and frequency.  All protocol-required laboratory assessments, as 
defined in Appendix 2, must be conducted in accordance with the laboratory manual and the 
SoA. Unscheduled clinical laboratory measurements may be obtained at any time during the 
study to assess any perceived safety issues.

Participants must abstain from all food and drink (except water and non-study 
medications) for a minimum of 8-hours prior to fasting lipid profile panel collection 
according to Schedule of Activities.  All other labs (including pharmacokinetic [PK] 
sample collections) do not require fasting.

The investigator must review the laboratory report, document this review, and 
record any clinically relevant changes from baseline (as defined in Section 8.2) 
occurring during the study in the adverse events (AE) section of the CRF. The 
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laboratory reports must be filed with the source documents. Clinically significant
abnormal laboratory findings are those which are not associated with the underlying 
disease, unless judged by the investigator to be more severe than expected for the 
participant's condition.

All laboratory tests with values considered clinically significantly abnormal during 
participation in the study should be repeated until the values return to normal or 
baseline or are no longer considered clinically significant by the investigator or 
medical monitor.

If such values do not return to normal/baseline within a period of time judged 
reasonable by the investigator, the etiology should be identified and the sponsor 
notified.

See Appendix 6 for suggested actions and follow-up assessments in the event of 
potential drug-induced liver injury.

All protocol-required laboratory assessments, as defined in Appendix 2, must be 
conducted in accordance with the laboratory manual and the Schedule of 
Activities.

If laboratory values from non-protocol specified laboratory assessments 
performed at the institution’s local laboratory require a change in participant 
management or are considered clinically significant by the investigator (eg, SAE 
or AE or dose modification), then the results must be recorded in the CRF.
8.2.8.1. Tuberculosis Testing
QuantiFERON®-TB Gold In-Tube (QFT-G) test is the preferred testing method; however, the 
T-SPOT®.TB (T-Spot) test is also permitted.  
The QFT-G test is an in vitro diagnostic test using a peptide cocktail simulating early 
secreted antigenic target of 6 kiloDalton (ESAT-6), culture filtrate protein 10 kiloDalton 
(CFP-10), and TB 7.7 proteins to stimulate cells in heparinized whole blood.  Detection of 
interferon-gamma by Enzyme-Linked Immunosorbent Assay (ELISA) is used to identify in 
vitro responses to these peptide antigens that are associated with M. tuberculosis infection.  
The T-Spot test is also an in vitro diagnostic test; however, it differs in that it uses a peptide 
cocktail simulating ESAT-6 and CFP-10 proteins to stimulate peripheral blood mononuclear 
cells.  Both the QFT-G test and the T-Spot test are indirect tests for M. tuberculosis infection 
(including disease) and are intended for use in conjunction with risk assessment, radiography 
and other medical and diagnostic evaluations.
A blood sample will be collected for either the QFT-G or the T-Spot testing.  The site must 
determine which test will be performed as sample collection and processing guidelines differ.  
QFT-G testing will be performed at the central laboratory and T-Spot testing will be 
performed at the site’s local laboratory.  Following QFT-G sample processing, the sample 
will be shipped to the central laboratory for testing.  The procedure for processing and 
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preparing the sample for shipment is described fully in the laboratory manual, which will be 
provided to investigators.
In addition to TB testing as specified in this clinical protocol, a chest X-ray will be 
performed as described in Section 8.2.4.
8.2.8.1.1. Screening Tuberculosis Testing
During the screening period, it must be determined and documented that de novo participants 
and participants originating from Study B7931005 or B7981015 with >30 days between the 
first visit of Study B7981032 and the last dose in Study B7931005 or B7981015 do not have 
evidence of untreated or inadequately treated active or latent infection with Mycobacterium 
tuberculosis (TB) per Exclusion criteria 19 in Section 5.2.2.  The results of TB screening 
conducted in the within 3 months prior to Day 1 visit or during the screening period must be 
documented in study records prior to Day 1 (Visit 2).
8.2.8.1.2. Day 1 and Annual Tuberculosis Testing
TB testing will be conducted at Day 1 for participants originating from Study B7981015 with 
≤30 days between the first visit of Study B7981032 and the last dose in Study B7981015, and 
annually after Day 1 in all participants as described below.  
For participants WITHOUT either a positive QFT-G (or T-Spot or PPD) result during prior 
testing (including screening visits in Study B7931005, B7981015 or B7981032, as 
applicable) or a history of previous treatment for active or latent TB, the following testing 
will be conducted: 

QFT-G test or T-Spot test per Section 8.2.8.1.  If the laboratory reports the test as 
indeterminate, the test should be repeated.  If the result of the repeat test is 
indeterminate, a purified protein derivative (PPD) test may be substituted for the 
QFT-G test or T-Spot test only with approval from the Pfizer Medical Monitor on a 
case-by-case basis.

Participants with a positive result must have a chest radiograph or other appropriate 
diagnostic image (ie, computed tomography or MRI) performed.  The chest 
radiograph must be read by a qualified radiologist or pulmonologist.

Participants with a positive result must have study intervention temporarily withheld 
until it is confirmed by a specialist (eg, pulmonologist or infectious disease specialist) 
if the participant has latent or active TB and, if applicable, the treatment plan has 
been approved by the Pfizer Medical Monitor as described below.  The actual 
decision to restart treatment, if applicable, must be approved by Pfizer.  For additional 
details regarding the process to be followed for participants with a positive TB test 
result, refer to Appendix 14.

Participants with a negative laboratory result do not require a chest radiograph.
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For participants WITH either a positive QFT-G (or T-Spot or PPD) result during prior testing 
(including screening visits in Study B7931005, B7981015 or B7981032, as applicable) or a 
history of previous treatment for active or latent TB, the following testing will be conducted: 

Neither a QFT-G test, T-Spot test, nor a PPD test need be obtained.

A chest radiograph or other appropriate diagnostic image (ie, computed tomography 
or MRI) must be performed.  The chest radiograph must be read by a qualified 
radiologist or pulmonologist.  
Participants with a chest radiograph indicative of active TB must have study intervention 
withheld until it is confirmed by a specialist (eg, pulmonologist or infectious disease 
specialist) whether the participant has active TB as described below.
Participants identified as potentially having latent TB (positive QFT-G, T-Spot, or PPD test 
result and negative chest radiograph for active TB) or active TB must be referred to a 
specialist (eg, pulmonologist or infectious disease specialist) for evaluation (see Appendix 14
for additional details).  If active TB is diagnosed by the specialist, the participant must be 
permanently withdrawn from study intervention.  If latent TB is diagnosed by the specialist, 
the participant may re-start the study intervention while receiving treatment for latent TB 
only with approval from the Pfizer Medical Monitor.  For participants taking the study 
intervention during their treatment for latent TB, the only acceptable treatment is isoniazid 
(INH).
8.2.8.2. Purified Protein Derivative (PPD) Test
If the QFT-G test or T-Spot test cannot be performed, or if the results from the reference 
laboratory are indeterminate, then participants may be screened using the PPD Tuberculin 
Test (Mantoux method), with the approval of the Pfizer Medical Monitor. 
Participants must have the PPD test administered and evaluated by a health care professional 
48 to 72 hours later in order to be eligible for the study, unless performed and documented 
within the last 12 weeks.  The test should be performed and interpreted as negative according 
to local standards (eg, induration of <5 mm).
8.2.8.3. Varicella Zoster Virus Immunoglobulin G Antibody (VZV IgG Ab) Testing
VZV Ig Ab testing (as described in the lab manual) is only required in adolescent de novo 
participants and those originating from Study B7931005 or B7981015 with >30 days 
between the first visit of Study B7981032 and the last dose in Study B7931005 or B7981015 
who are 12 to <18 years of age without documented evidence of having received the varicella 
vaccine (2 doses).  Serological testing must be performed for VZV IgG Ab only in the 
absence of documented evidence of having received varicella vaccination (2 doses) per 
Exclusion #16.
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8.2.8.4. Day 1 Viral Screen
A serum sample will be collected at Day 1 and submitted to the central lab for de novo 
participants, all participants from Study B7931005, and participants whose sample was tested 
in Study B7981015.  The sample will be stored and analyzed at a later date only at the 
sponsor’s request.  In certain cases of suspected viral infection (eg, disseminated herpes 
zoster or varicella), the sponsor may request to analyze the sample to determine if the 
participant had exposure to that virus.  Additional sample collection instructions and details 
regarding sample destruction will be provided in the lab manual.  The retained samples will 
be destroyed upon participant completion of this study.
8.2.8.5. Hepatitis B DNA (HBVDNA) Testing
For participants in countries in which hepatitis B prevalence has been reported at a rate of 
>5.0%85 or if required by local standard of care, HBVDNA testing will be performed as 
reflex testing for the following (refer to Appendix 7 for Japan specific requirements):

At screening for de novo participants or participants originating from Study 
B7931005 or B7981015 with >30 days between the first visit of Study B7981032 and 
the last dose in Study B7931005 or B7981015 who are HbcAb positive at the 
B7981032 screening.
In addition, for participants in those regions for which hepatitis B prevalence has been 
reported as a rate of >5.0% or if required by local standard of care, HBVDNA testing will be 
performed at additional time points as outlined in the Schedule of Activities for participants 
who were enrolled with a positive HBcAb and a negative HBVDNA at screening of the 
applicable study:

B7981032: de novo participants and participants originating from Study B7931005 or 
B7981015 with >30 days between the first visit of Study B7981032 and the last dose 
in Study B7931005 or B7981015.

B7981015: participants with ≤30 days between the first visit of Study B7981032 and 
the last dose in Study B7981015.
Testing at additional time points may be performed as per the local standard of care.  Refer to 
Appendix 6 for testing algorithm, reflex testing, and full eligibility criteria for de novo 
participants and participants with >30 days between the first visit of Study B7981032 and the 
last dose in Study B7931005 or B7981015 and Study B7981032.  
8.2.9. Suicidal Ideation and Behavior Risk Monitoring
8.2.9.1. Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a validated tool to evaluate suicidal ideation and behavior. 
There are 2 versions of the C-SSRS to be utilized in this study - “C-SSRS for screening and 
Day 1 visits” and “C-SSRS for any visits after Day 1”.  The version used is dictated by the 
actual study visit and the patient population (See the Schedule of Activities).
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For de novo participants and participants originating from Study B7931005 or B7981015
with >30 days between the first visit of Study B7981032 and the last dose in Study 
B7931005 or B7981015: At the screening or Day 1 visits, the C-SSRS for screening and 
Day 1 visits will be used and the results must be evaluated against Exclusion Criterion 5.  
For participants originating from Study B7981015 with >14 days to ≤30 days between the 
first visit of Study B7981032 and the last dose in Study B7981015: The C-SSRS for visits 
after Day 1 will be used at the Day 1 visit and the results must be evaluated against the 
protocol discontinuation criteria in Appendix 8 before the participant is assigned to study 
intervention.  If the answers meet the discontinuation criteria, the participant will not be 
included in the study.
For all participants who screen failure due to suicidal behavior, the participant should be 
referred for appropriate evaluation and treatment.
For all participants with suicidal ideation associated with actual intent and a method or plan 
in the past year: At any visits after Day 1, if there are “yes” answers on items 4, 5, or on any 
question in the suicidal behavior section of the C-SSRS, the participant will be discontinued 
from the study and referred to a mental health professional for appropriate evaluation and 
treatment or immediately referred to the Emergency Room at the investigator’s judgement.
8.2.10. Patient Health Questionnaire - 8 Items (PHQ-8)
The Patient Health Questionnaire – 8 items (PHQ-8) is a patient reported questionnaire that 
consists of 8 items to assess participant depression level.  De novo participants and 
participants originating from Study B7931005 or B7981015 with >30 days prior to enrolling 
in Study B7981032 with clinically significant depression as noted by a PHQ-8 total score
≥15 at screening must not be enrolled in the study.
8.2.11. Pregnancy Testing 
Pregnancy tests are required to be done (if applicable) as specified in the Schedule of 
Activities. 
Pregnancy tests must have a sensitivity of at least 25 mIU/mL.  Pregnancy tests should be 
urine pregnancy tests.  In the event that urine pregnancy tests are not permitted at an 
institution, serum pregnancy tests can be utilized.  Pregnancy tests will be performed in 
WOCBP at the times listed in the Schedule of Activities.  Following a negative pregnancy 
test result at screening, appropriate contraception must be verified and a second negative 
pregnancy test result will be required at the Day 1 visit prior to the participant receiving the 
study intervention.  
In addition to pregnancy tests performed at the site, site personnel will instruct applicable 
participants to complete monthly urine pregnancy tests between study visits starting after the 
Month 1 visit through the Month 60 visit.  The pregnancy testing between visits may occur 
outside of the study site.  Urine pregnancy kits will be provided to participants (or their 
legally authorized representative, if appropriate) at each study visit (starting at Month 1) and 
site personnel will instruct participants (or their legally authorized representative, if 
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appropriate) on when and how to administer the pregnancy test and how to interpret the 
result.  The participants (or their legally authorized representative, if appropriate) will be 
given enough kits to cover the monthly testing between visits (for example, at least 2 kits 
should be given at the Month 3 visit).  Site personnel will be required to document the 
discussion, including confirmation of participant’s willingness to perform the required urine 
pregnancy tests and understanding of how to perform the test as well as how to interpret the 
test result.  In addition, site personnel will contact participants (or their legally authorized 
representative, if appropriate) via telephone between study visits to obtain monthly 
pregnancy test result and ensure that this contact and the result of the pregnancy test are 
recorded in participant’s source documentation and the CRF.
Pregnancy tests will also be done whenever 1 menstrual cycle is missed during the active 
treatment period (or when potential pregnancy is otherwise suspected) and at the end of the 
study.  Pregnancy tests may also be repeated if requested by IRBs/ ECs or if required by local 
regulations.  If a urine test cannot be confirmed as negative (eg, an ambiguous result), a 
serum pregnancy test is required.  In such cases, the participant must be excluded if the 
serum pregnancy result is positive.  In the case of a positive confirmed pregnancy, the 
participant will be withdrawn from administration of study intervention but may remain in 
the study for follow-up.
8.2.12. Check for Initiation of Menarche (for Premenarchal Females Only)
In female participants who are premenarchal at the start of the study, the investigator must 
confirm with the participant at every visit whether menarche has started since the last visit.  
If menarche has started, the participant must now be considered of childbearing potential; 
therefore, from that point forward and starting with the current visit, the participant will be 
required to establish willingness and ability to comply with contraception requirements 
(Appendix 4) and to undergo contraception checks and pregnancy testing according to the 
Schedule of Activities.  In addition, the investigator or designee will instruct the participant 
to contact the site immediately if the participant begins menarche between study visits.
8.3. Adverse Events and Serious Adverse Events
The definitions of an AE or SAE can be found in Appendix 3.
AE will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the 
participant's legally authorized representative).
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE, or that caused the participant to 
discontinue the study intervention/study (Section 7 and Appendix 8).
Each participant (or/parent/legal guardian/legally authorized representative) will be 
questioned about the occurrence of AEs in a nonleading manner.
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In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion. 
8.3.1. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before the participant’s participation in the study (ie, before undergoing 
any study-related procedure and/or receiving study intervention), through and including a 
minimum of 28 calendar days after the last administration of the study intervention, except as 
indicated below.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
Medical occurrences that begin before the start of study intervention but after obtaining 
informed consent will be recorded on the Medical History/Current Medical Conditions 
section of the case report form (CRF) not the AE section.
Follow up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator, and Pfizer concurs with that assessment.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant permanently discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the CT SAE Report Form.  Investigators are not obligated to actively seek AE 
or SAE after the participant has concluded study participation. However, if the investigator 
learns of any SAE, including a death, at any time after a participant has completed the study, 
and he/she considers the event to be reasonably related to the study intervention, the 
investigator must promptly report the SAE to Pfizer using the CT SAE Report Form.
8.3.1.1. Reporting SAEs to Pfizer Safety 
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the CT (Clinical Trials) SAE Report Form
immediately upon awareness and under no circumstance should this exceed 24 hours, as 
indicated in Appendix 3. The investigator will submit any updated SAE data to the sponsor 
within 24 hours of it being available.
8.3.1.2. Recording Non-serious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF.  
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The investigator is to record on the CRF all directly observed and all spontaneously reported 
(by the participant) AEs and SAEs.
8.3.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.3.3. Follow-up of AEs and SAEs
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality.  Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided.  In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is given in Appendix 3.
8.3.4. Regulatory Reporting Requirements for SAEs

Prompt notification by the investigator to the sponsor of a SAE is essential so that 
legal obligations and ethical responsibilities towards the safety of participants and 
the safety of a study intervention under clinical investigation are met.

The sponsor has a legal responsibility to notify both the local regulatory authority 
and other regulatory agencies about the safety of a study intervention under clinical 
investigation. The sponsor will comply with country-specific regulatory 
requirements relating to safety reporting to the regulatory authority, Institutional 
Review Boards (IRB)/Ethics Committees (EC), and investigators.

Investigator safety reports must be prepared for suspected unexpected serious 
adverse reactions (SUSARs) according to local regulatory requirements and sponsor 
policy and forwarded to investigators as necessary.

An investigator who receives SUSARs or other specific safety information 
(eg, summary or listing of SAEs) from the sponsor will review and then file it along 
with the SRSD(s) for the study and will notify the IRB/EC, if appropriate according 
to local requirements.
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8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the study intervention under study during pregnancy or breastfeeding and 
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator 
awareness.
8.3.5.1. Exposure During Pregnancy
An EDP occurs if:

A female participant is found to be pregnant while receiving or after discontinuing study 
intervention.

A male participant who is receiving or has discontinued study intervention exposes a 
female partner prior to or around the time of conception.

A female is found to be pregnant while being exposed or having been exposed to study 
intervention due to environmental exposure.  Below are examples of environmental 
exposure during pregnancy:  

A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by ingestion, inhalation, or skin 
contact.

A male family member or healthcare provider who has been exposed to the study 
intervention by ingestion, inhalation, or skin contact then exposes his female 
partner prior to or around the time of conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred.  The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy). 

If EDP occurs in a participant or a participant’s partner, the investigator must report 
this information to Pfizer Safety on the CT SAE Report Form and an EDP
Supplemental Form, regardless of whether an SAE has occurred.  Details of the 
pregnancy will be collected after the start of study intervention and until 28 days after 
the last dose. 

If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the CT SAE Report Form and EDP Supplemental 
Form.  Since the exposure information does not pertain to the participant enrolled in 
the study, the information is not recorded on a CRF; however, a copy of the completed 
CT SAE Report Form is maintained in the investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome.  The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
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follow-up to the initial EDP Supplemental Form.  In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
Abnormal pregnancy outcomes are considered SAEs.  If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly (in a live-born baby, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death), the investigator should follow the procedures 
for reporting SAEs.  Additional information about pregnancy outcomes that are reported to 
Pfizer Safety as SAEs follows: 

Spontaneous abortion including miscarriage and missed abortion;

Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the study intervention. 
Additional information regarding the EDP may be requested by the sponsor.  Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays).  In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner.  The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.
8.3.5.2. Exposure During Breastfeeding
An exposure during breastfeeding occurs if:

A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention.

A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure).  An example of environmental 
exposure during breastfeeding is a female family member or healthcare provider who 
reports that she is breastfeeding after having been exposed to the study intervention by 
inhalation or skin contact.  
The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours 
of the investigator’s awareness, irrespective of whether an SAE has occurred.  The 
information must be reported using the CT SAE Report Form.  When exposure during 
breastfeeding occurs in the setting of environmental exposure, the exposure information does 
not pertain to the participant enrolled in the study, so the information is not recorded on a 
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CRF.  However, a copy of the completed CT SAE Report Form is maintained in the 
investigator site file.
An exposure during breastfeeding report is not created when a Pfizer drug specifically 
approved for use in breastfeeding women (eg, vitamins) is administered in accord with 
authorized use.  However, if the infant experiences an SAE associated with such a drug 
administration, the SAE is reported together with the exposure during breastfeeding.
8.3.5.3. Occupational Exposure 
An occupational exposure occurs when a person has unplanned direct contact with the study 
intervention, which may or may not lead to the occurrence of an AE. Such persons may 
include healthcare providers, family members, and other roles that are provided in the trial 
participant’s care.
The investigator must report occupational exposure to Pfizer Safety within 24 hours of the 
investigator’s awareness, regardless of whether there is an associated SAE.  The information 
must be reported using the CT SAE Report Form.  Since the information does not pertain to a 
participant enrolled in the study, the information is not recorded on a CRF; however, a copy 
of the completed CT SAE Report Form is maintained in the investigator site file. 
8.3.6. Cardiovascular and Death Events (Not Applicable)
8.3.7. Disease-Related Events and/or Disease-Related Outcomes not Qualifying as AEs 
or SAEs (Not Applicable)
8.3.8. Adverse Events of Special Interest
Refer to Section 8.2.7 for definitions of adverse events of special interest (AESIs).
All AESIs must be reported as an AE or SAE following the procedures described in 
Section 8.3.1 through Section 8.3.4.  An AESI is to be recorded as an AE or SAE on the 
CRF.  In addition, an AESI that is also an SAE must be reported using the CT SAE Report 
Form.
8.3.8.1. Lack of Efficacy (Not Applicable)
This section is not applicable as the study intervention administered is not approved for use.
8.3.9. Medical Device Deficiencies (Not Applicable)
8.3.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Exposures to the study intervention under study may occur in clinical trial settings, such as 
medication errors.
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Safety Event
Recorded on the CRF
Reported on the CT SAE Report 
Form to Pfizer Safety Within 24 
Hours of Awareness
Medication errors 
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
Medication errors include:

Medication errors involving participant exposure to the study intervention;

Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant.
For further clarification, a medication error is:

Any preventable event causing or leading to inappropriate medication use or patient 
harm;

When patient misunderstood, could not read, was not aware of, or not given dosing 
instructions.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
In the event of a medication dosing error, the sponsor should be notified within 24 hours.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and non-serious, are recorded on an AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.
8.4. Treatment of Overdose
For this study, any dose of PF-06651600 greater than 800 mg within a 24-hour time period 
will be considered an overdose.
There is no specific antidote or specific treatment for an overdose.
In the event of an overdose, the investigator should:
1. Contact the Medical Monitor within 24 hours.
2. Closely monitor the participant for any AE/SAE and laboratory abnormalities for at 
least 5 half-lives or 28 calendar days after the overdose of PF-06651600 (whichever 
is longer).
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3. Obtain a plasma sample for PK analysis within 4 days from the date of the last dose 
of study intervention if requested by the Medical Monitor (determined on a case-by-
case basis).
4. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF.
5. Overdose is reportable to Safety only when associated with a SAE.
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the Medical Monitor based on the clinical evaluation of the participant.
8.5. Pharmacokinetics
During all study periods, blood samples (~2 mL) to provide plasma for PK analysis will be 
collected into appropriately labeled tubes containing dipotassium ethylenediaminetetraacetic 
acid (K2EDTA) anticoagulant at times specified in the Schedule of Activities section of the 
protocol.
Blood will be collected at the time points identified in the Schedule of Activities section of 
the protocol.  All efforts will be made to obtain the pharmacokinetic samples at the exact 
nominal time relative to dosing.  For each blood sample collection, the allowable windows 
are as follows for time post dose: 0.5 hr (±10 min), 1 hr (±15 min) and 3 hr (±30 min).  The 
date and exact time of the sample collection is to be noted on the source document and data 
collection tool (eg, CRF), as well as the date and time of the previous dose.  Samples 
obtained outside the windows specified in the Schedule of Activities will be considered a 
protocol deviation.

The plasma will be stored in appropriately labeled screw-capped polypropylene tubes 
at approximately -20°C or colder within 1 hour of collection.

Further details regarding the collection, processing, storage and shipping of the blood
samples will be provided in the lab manual.

Samples will be analyzed using a validated analytical method in compliance with 
Pfizer standard operating procedures. 

The PK samples must be processed and shipped as indicated to maintain sample 
integrity.  Any deviations from the PK processing steps, including any actions taken, 
must be documented and reported to the sponsor.  On a case-by-case basis, the sponsor 
may make a determination as to whether sample integrity has been compromised.  
Any sample deemed outside of established stability, or of questionable integrity, will 
be considered a protocol deviation.

As part of understanding the pharmacokinetics of the study intervention, samples may 
be used for metabolite identification and/or evaluation of the bioanalytical method.  
These data will be used for internal exploratory purposes and will not be included in 
the clinical report. These additional exploratory analyses will not be performed on 
samples collected from participants at sites in China; refer to Section 10.7.2.
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8.5.1. Shipment of Pharmacokinetic Samples
The shipment address and assay lab contact information will be provided to the Investigator 
site prior to initiation of the study.  The central laboratory will provide collection materials 
and directions for packaging and shipment of samples and will forward samples to the 
contract analytical laboratory. 
8.6. Pharmacodynamics
Blood samples (~2.5 mL) will be collected for measurements of immunoglobulin (Ig) (IgA, 
IgG, IgM) at the time points listed in the Schedule of Activities.
Blood samples (~5.0 mL) will be collected by fluorescence activated cell sorting (FACS) 
analysis to identify T cell, B cell, and natural killer (NK) cell (FACS-TBNK) subsets at the 
time points listed in the Schedule of Activities.
As part of understanding the PD of the study intervention, samples may be used for 
evaluation of the bioanalytical method, as well as for other internal exploratory purposes. 
These additional exploratory analyses will not be performed on samples collected from 
participants at sites in China; refer to Section 10.7.2.
Samples will be analyzed using fit for purpose or validated analytical methods in compliance 
with applicable Pfizer standard operating procedures.  The pharmacodynamic (PD) samples 
must be processed and shipped as indicated in the instructions provided to the investigator 
site to maintain sample integrity.  Any deviations from the PD sample handling procedure 
(eg, sample collection and processing steps, interim storage or shipping conditions), 
including any actions taken, must be documented and reported to the sponsor.  On a 
case-by-case basis, the sponsor may make a determination as to whether sample integrity has 
been compromised.
8.7. Genetics
8.7.1. Specified Genetics
Genetics (specified analyses) are not evaluated in this study.
8.7.2. Banked Biospecimens for Genetics. 
Banked biospecimens for genetics are not included in this study.
8.8. Biomarkers
Biomarkers are not evaluated in this study.
8.8.1. Specified Gene Expression (RNA) Research Specified gene expression (RNA) 
research is not included in this study.
8.8.2. Specified Protein Research
Specified protein research is not included in this study.
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8.8.3. Specified Metabolomic Research
Specified metabolomic research is not included in this study.
8.8.4. Banked Biospecimens for Biomarkers
Banked biospecimens for biomarkers are not included in this study.
8.9. Medical Resource Utilization and Health Economics
Medical resource utilization and health economics data, associated with medical encounters, 
will be collected in the CRF by the investigator and study-site personnel for all participants 
throughout the study.  Protocol-mandated procedures, tests, and encounters are excluded.
The data collected may be used to conduct exploratory economic analyses and will include:

Data collected in the Alopecia Areata Resource Utilization (AARU)

Number and duration of medical care encounters, including surgeries, and other 
selected procedures (inpatient and outpatient)

Duration of hospitalization (total days or length of stay, including duration by wards 
[eg, intensive care unit])

Number and type of diagnostic and therapeutic tests and procedures
9. STATISTICAL CONSIDERATIONS
See Appendix 10 for vaccine sub-study statistical considerations.
9.1. Estimands and Statistical Hypotheses
There is no formal statistical hypothesis testing for this study.
9.1.1. Estimands
Not applicable to this study.
9.2. Sample Size Determination
Sample size is not based on any formal hypothesis testing but instead driven by the 
regulatory requirement for the safety database.  Sample size is determined by the number of 
participants who enroll from the Phase 2a Study (B7931005) and participants who enroll 
from the Phase 2b/3 Study (B7981015), as well as the number of de novo participants 
enrolled.  It is estimated that a total of approximately 960 participants will be enrolled in 
Study B7981032, including approximately 450 de novo participants. The number of de novo 
participants enrolled may be modified based on the actual number of participants who 
continue from Study B7931005 and Study B7981015 into Study B7981032. 
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9.3. Populations for Analyses
For purposes of analysis, the following populations are defined:
Population
Description
Enrolled 
All participants who sign the ICF. 
Safety
The Safety Analysis Set (SAS) is defined as all participants who received 
at least 1 dose of study intervention.  
Efficacy
The Full Analysis Set (FAS) is defined as all participants, regardless of 
whether they received study intervention.  
PK 
The PK concentration population is defined as all enrolled participants who 
received at least 1 dose of PF-06651600 and in whom at least 
1 concentration value is reported.
9.4. Statistical Analyses
The statistical analysis plan will be developed and finalized before database lock and will 
describe the participant populations to be included in the analyses, and procedures for
accounting for missing, unused, and spurious data. Data analysis for participants who 
permanently discontinued treatment but remained in the study (Section 7.1.1) will be 
described in the statistical analysis plan. This section is a summary of the planned statistical 
analyses of the primary and secondary endpoints.
9.4.1. Timing of the Analyses
The PCD clinical study report (CSR) will include analyses of the following:   

All safety data collected through the PCD (Section 4.4).

Efficacy data collected for the time points as specified in the applicable SoAs through the 
Month 36 visit for each participant.
The supplemental CSR will include analyses of the following:

All safety data collected in the entire study.

Efficacy data collected for the time points post Month 36 visit, as specified in the 
applicable SoA of TP2.
9.4.2. Efficacy Analyses
For the purpose of analysis of efficacy measures for the participants originating from the 
index studies, the baseline values are defined as the Day 1 values from Study B7981015 or 
B7931005. For assessments which were not collected in the respective index study, the 
baseline value is defined as the value collected on Day 1 of Study B7981032. For the de novo 
participants, the baseline values are defined as the values collected on Day 1 of Study 
B7981032. 
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PCD CSR
Endpoint
Statistical Analysis Methods
Primary
There are no primary efficacy endpoints. 
Secondary
Efficacy analyses are descriptive in nature (such as number and percent, mean, standard 
deviation) at each visit where measured; there will be no formal hypothesis testing, 
though 95% two-sided confidence intervals will be reported.  Displays by de-novo 
participants (ie, those who did not receive study intervention in either Study B7931005 or 
B7981015) and participants originating from Study B7931005 or B7981015 (ie, those 
who received study intervention in either Study B7931005 or B7981015) will also be 
included. 
For participants who permanently discontinue from study intervention but remain in the 
study, efficacy data collected during the observation period (see Section 7.1.1.1) will be 
included in efficacy listings, but not in the efficacy summaries.
Further details will be specified in the statistical analysis plan.
Exploratory
Will be described in the statistical analysis plan.
Supplemental CSR
Endpoint
Statistical Analysis Methods
Primary
There are no primary efficacy endpoints. 
Secondary
There are no secondary efficacy endpoints.
Exploratory
Efficacy analyses are descriptive in nature There will be no formal hypothesis testing. 
For participants who permanently discontinue from study intervention but remain in the 
study, efficacy data collected during the observation period (see Section 7.1.1.1) will be 
included in efficacy listings, but not in the efficacy summaries.
Further details will be specified in the statistical analysis plan.
For both the PCD CSR and the supplemental CSR the endpoints for SALT include both the 
SALT overall and SALT AA scores.
The SALT overall score includes any hair loss regardless of etiology (eg, including scalp hair 
loss due to both androgenetic alopecia and AA).  The SALT AGA score only takes into 
account scalp hair loss due to androgenetic alopecia.  The SALT AA score at each visit will 
be calculated as follows using the applicable SALT AGA score collected at the last visit of 
the treatment period (as defined in Section 8.1.2.1.1):
SALT AA Score = SALT overall score – SALT AGA score
9.4.3. Safety Analyses
All safety analyses will be performed on the Safety Population.  For the purpose of analysis 
of safety measures for the participants with ≤30 days between the first visit of Study 
B7981032 and the last dose of study intervention in the index studies, the baseline values are 
defined as the Day 1 values from Study B7981015 or B7931005.  For the de novo 
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participants and participants with >30 days between the first visit of Study B7981032 and the 
last dose of study intervention in the index study, the baseline values are defined as the 
values collected on Day 1 of Study B7981032.
PCD CSR 
Endpoint
Statistical Analysis Methods
Primary
The primary endpoints of incidence of TEAEs, SAEs, and AEs leading to discontinuation, 
clinically significant abnormalities in vital signs, and clinically significant abnormalities 
in laboratory values will be summarized using descriptive measures such as numbers and 
percentages. The safety summaries will be reported for all participants, as well as by 
de-novo participants (ie, those who did not receive study intervention in either Study 
B7931005 or B7981015) and participants originating from Study B7931005 or B7981015 
(ie, those who received study intervention in either Study B7931005 or B7981015).  
No formal statistical hypotheses will be tested.
Further details will be specified in the Statistical Analysis Plan.
Secondary
There are no secondary safety endpoints. 
Exploratory
There are no exploratory safety endpoints.
Supplemental CSR
Endpoint
Statistical Analysis Methods
Primary
There are no primary safety endpoints.
Secondary
The secondary endpoints of incidence of TEAEs, SAEs, and AEs leading to 
discontinuation, clinically significant abnormalities in vital signs, and clinically 
significant abnormalities in laboratory values will be summarized using descriptive 
measures.  The safety summaries will be reported for all participants, as well as by de 
novo participants and participants originating from Study B7931005 or B7981015.  
No formal statistical hypotheses will be tested.
Further details will be specified in the statistical analysis plan.
Exploratory
There are no exploratory safety endpoints.
9.4.4. Other Analyses 
The PK concentration population is defined as all enrolled participants who received at least 
1 dose of PF-06651600 and in whom at least 1 concentration value is reported.
PK concentrations listings and summary by visit and nominal collection time will be 
provided.  A population PK model will be developed to characterize the PK and estimate PK 
parameters.  The detailed analysis plans will be described in a separate pharmacometric 
analysis plan.
Analyses of pharmacodynamic and disease-related biomarkers will be described in the 
statistical analysis plan.
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9.5. Interim Analyses
Interim analyses may be performed for study monitoring for internal decision making, due to 
regulatory requests, or to support regulatory submissions.  Interim analyses, if any, will 
primarily be for safety though some measures of efficacy may be analyzed.  As no statistical 
hypotheses will be tested in this study, there are no issues of protecting the Type I error rate.
9.5.1. Data Monitoring Committee (DMC)
This study will use an external data monitoring committee (E-DMC).  The E-DMC will be 
responsible for ongoing monitoring of the safety of participants in the study according to the 
charter.  The recommendations made by the E-DMC to alter the conduct of the study will be 
forwarded to Pfizer for final decision.  Pfizer will forward such decisions, which may include 
summaries of aggregate analyses of endpoint events and of safety data that are not endpoints, 
to regulatory authorities, as appropriate.
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations

This study will be conducted in accordance with the protocol and with the 
following:
o
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines
o
Applicable International Council for Harmonisation (ICH) Good Clinical Practice 
(GCP) Guidelines
o
Applicable laws and regulations, including applicable privacy laws.
o
For Japan only: After approval (if relevant) in Japan by MHLW, this study will be 
conducted according to GPSP in addition to GCP.

The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant 
documents (eg, advertisements) must be reviewed and approved by the sponsor and 
submitted to an IRB/IEC by the investigator and reviewed and approved by the 
IRB/IEC before the study is initiated.

Any amendments to the protocol will require IRB/IEC approval before 
implementation of changes made to the study design, except for changes necessary 
to eliminate an immediate hazard to study participants.

The investigator will be responsible for the following:
o
Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC
o
Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures
o
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 Code of Federal Regulations (CFR), ICH guidelines, the 
IRB/IEC, European regulation 536/2014 for clinical studies (if applicable), and all 
other applicable local regulations

In the event of any prohibition or restriction imposed (ie, clinical hold) by an 
applicable regulatory authority in any area of the world, or if the investigator is 
aware of any new information that might influence the evaluation of the benefits 
and risks of the study intervention, Pfizer should be informed immediately.

In addition, the investigator will inform Pfizer immediately of any urgent safety 
measures taken by the investigator to protect the study participants against any 
immediate hazard, and of any serious breaches of this protocol or of ICH GCP that 
the investigator becomes aware of.
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10.1.2. Financial Disclosure
Investigators and sub-investigators will provide the sponsor with sufficient, accurate 
financial information as requested to allow the sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate regulatory authorities. 
Investigators are responsible for providing information on financial interests during the 
course of the study and for 1 year after completion of the study.
10.1.3. Informed Consent Process

The investigator or his/her representative will explain the nature of the study to the 
participant (and his/her legally authorized representative for adolescents) and 
answer all questions regarding the study.  The participant (and his/her legally 
authorized representative for adolescents) should be given sufficient time and 
opportunity to ask questions and to decide whether or not to participate in the trial.

As appropriate, children may be given the opportunity to meet privately with a 
member of the site staff to ask confidential questions and to decline assent for 
confidential reasons, which, at their request, would not be shared with their 
parent/guardian, unless required by local law.

Participants (and their legally authorized representative for adolescents) must be 
informed that their participation is voluntary. Participants (and their legally 
authorized representative, defined as parent(s)/legal guardian, for adolescents) will 
be required to sign a statement of informed consent/assent that meets the 
requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance 
Portability and Accountability Act (HIPAA) requirements, where applicable, and 
the IRB/IEC or study center.

The investigator must ensure that each study participant or his or her legally
authorized representative is fully informed about the nature and objectives of the 
study, the sharing of data related to the study and possible risks associated with 
participation, including the risks associated with the processing of the participant’s 
personal data. The participant must be informed that his/her personal study-related 
data will be used by the sponsor in accordance with local data protection law. The 
level of disclosure must also be explained to the participant.

The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities.

The investigator further must ensure that each study participant or his or her legally 
authorized representative is fully informed about his or her right to access and 
correct his or her personal data and to withdraw consent for the processing of his or 
her personal data.
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
The medical record must include a statement that written informed consent 
(including the legally authorized representative [parent/guardian] consent and 
child/adolescent assent [if deemed appropriate by local ethics review] for 
adolescents) was obtained before the participant was enrolled in the study and the 
date the written consent was obtained. For adolescents, the medical record should 
also describe how the clinical investigator determined that the person signing the 
ICF was the participant’s legally authorized representative (parent/guardian). The 
authorized person obtaining the informed consent must also sign the ICF.

Participants (and their legally authorized representative for adolescents) must be re-
consented (and re-assented, if appropriate) to the most current version of the ICF(s) 
during their participation in the study.

Minor participants must be re-consented if they reach the age of majority during the 
course of the study, in order to continue participating, where required by local 
regulations.

A copy of the ICF(s) must be provided to the participant (and the participant’s 
legally authorized representative for adolescents).

Participants who are rescreened are required to sign a new ICF.
10.1.4. Data Protection

All parties will comply with all applicable laws, including laws regarding the 
implementation of organizational and technical measures to ensure protection of 
participant data.

Participants’ personal data will be stored at the study site in encrypted electronic 
and/or paper form and will be password protected or secured in a locked room to 
ensure that only authorized study staff have access.  The study site will implement 
appropriate technical and organizational measures to ensure that the personal data 
can be recovered in the event of disaster.  In the event of a potential personal data 
breach, the study site shall be responsible for determining whether a personal data 
breach has in fact occurred and, if so, providing breach notifications as required by 
law.

To protect the rights and freedoms of natural persons with regard to the processing 
of personal data, participants will be assigned a single, participant-specific 
numerical code. Any participant records or datasets that are transferred to the 
sponsor will contain the numerical code; participant names will not be transferred. 
All other identifiable data transferred to the sponsor will be identified by this single, 
participant-specific code. The study site will maintain a confidential list of 
participants who participated in the study, linking each participant’s numerical code 
to his or her actual identity. In case of data transfer, the sponsor will protect the 
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confidentiality of participants’ personal data consistent with the Clinical Study 
Agreement and applicable privacy laws.
10.1.5. Committees Structure
10.1.5.1. Data Monitoring Committee
See Section 9.5.1.
10.1.5.2. Adjudication/Review Committee Submission
Events requiring submission to an adjudication/review committee, including opportunistic 
infections, cardiovascular, neurological/audiological or malignancy events, will be identified 
by the Pfizer Study Team or designee during the review of participant data listings or by site 
monitors during routine monitoring of participant’s study records.  Additionally, events 
requiring submission to an adjudication/review committee will be made by the study site and 
communicated to Pfizer or designee. Additional types of events for review and adjudication 
may be identified by Pfizer.  The Pfizer Study Team or designee will notify the study site of 
any such events should they be identified.
The Pfizer Study Team or designee will provide a listing of specific documents needed to 
support event adjudication by the Adjudication/Review Committees.  Obtaining and 
submitting the documentation will be the responsibility of the study site.  Event 
documentation will vary with the event requiring adjudication and may include (but not be 
limited to): hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic 
tests, pathology reports, autopsy reports, imaging reports (eg, MRI) and death certificate 
information, as applicable.  These documents may be reviewed by Pfizer.
10.1.6. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT, and/or 
www.pfizer.com, and other public registries in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs.
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted.   These results are 
submitted for posting in in accordance with the format and timelines set forth by US law.
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EudraCT
Pfizer posts the clinical trial results on EudraCT for all Pfizer-sponsored interventional 
studies in accordance with the format and timelines set forth by EU requirements. 
www.pfizer.com
Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used 
to identify individual participants have been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are 
posted to www.clinicaltrials.gov.
Documents within marketing authorization packages/submissions
Pfizer complies with the European Union Policy 0070, the proactive publication of clinical 
data to the EMA website. Clinical data, under Phase 1 of this policy, includes clinical 
overviews, clinical summaries, CSRs, and appendices containing the protocol and protocol 
amendments, sample CRFs, and statistical methods.  Clinical data, under Phase 2 of this 
policy, includes the publishing of individual participant data.  Policy 0070 applies to new 
marketing authorization applications submitted via the centralized procedure since 
01 January 2015 and applications for line extensions and for new indications submitted via 
the centralized procedure since 01 July 2015.
Data Sharing
Pfizer provides researchers secure access to patient-level data or full CSRs for the purposes 
of “bona-fide scientific research” that contribute to the scientific understanding of the 
disease, target, or compound class.  Pfizer will make available data from these trials 
24 months after study completion.  Patient-level data will be anonymized in accordance with 
applicable privacy laws and regulations.  CSRs will have personally identifiable information 
redacted.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses.  Research teams must include a biostatistician.  Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.7. Data Quality Assurance

All participant data relating to the study will be recorded on printed or electronic 
CRF unless transmitted to the sponsor or designee electronically (eg, laboratory 
data). The investigator is responsible for verifying that data entries are accurate and 
correct by physically or electronically signing the CRF.

The investigator must maintain accurate documentation (source data) that supports 
the information entered in the CRF.
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
The investigator must ensure that the CRFs are securely stored at the study site in 
encrypted electronic and/or paper form and are password protected or secured in a 
locked room to prevent access by unauthorized third parties.

The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents. 
This verification may also occur after study completion. It is important that the 
investigator(s) and their relevant personnel are available during the monitoring visits 
and possible audits or inspections and that sufficient time is devoted to the process.

Monitoring details describing strategy (eg, risk-based initiatives in operations and 
quality such as Risk Management and Mitigation Strategies and Analytical Risk-
Based Monitoring), methods, responsibilities and requirements, including handling 
of noncompliance issues and monitoring techniques (central, remote, or on-site 
monitoring) are provided in the Monitoring Plan and contracts.

The sponsor or designee is responsible for the data management of this study 
including quality checking of the data.

Study monitors will perform ongoing source data verification to confirm that data 
entered into the CRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements.

Records and documents, including signed ICFs, pertaining to the conduct of this 
study must be retained by the investigator for 15 years after study completion unless 
local regulations or institutional policies require a longer retention period. No 
records may be destroyed during the retention period without the written approval of 
the sponsor. No records may be transferred to another location or party without 
written notification to the sponsor. The investigator must ensure that the records 
continue to be stored securely for so long as they are maintained.

When participant data are to be deleted, the investigator will ensure that all copies 
of such data are promptly and irrevocably deleted from all systems.

The investigator(s) will notify sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study.  Furthermore, the investigator will 
cooperate with sponsor or its agents to prepare the investigator site for the 
inspection and will allow sponsor or its agent, whenever feasible, to be present 
during the inspection.  The investigator site and investigator will promptly resolve 
any discrepancies that are identified between the study data and the participant's 
medical records.  The investigator will promptly provide copies of the inspection 
findings to sponsor or its agent.  Before response submission to the regulatory 
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authorities, the investigator will provide sponsor or its agents with an opportunity to 
review and comment on responses to any such findings.
10.1.8. Source Documents

Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected. Source documents are filed at the 
investigator’s site.

Data reported on the CRF or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must 
be explained. The investigator may need to request previous medical records or 
transfer records, depending on the study. Also, current medical records must be 
available.

Definition of what constitutes source data can be found in the Clinical Monitoring 
Plan.
10.1.9. Study and Site Closure
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time upon notification to contract 
research organization (CRO) if requested to do so by the responsible IRB/IEC or if such
termination is required to protect the health of Study Participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:

Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines

Inadequate recruitment of participants by the investigator

Discontinuation of further study intervention development
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements.  The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
Study termination is also provided for in the clinical study agreement.  If there is any conflict 
between the contract and this protocol the contract will control as to termination rights.
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10.1.10. Publication Policy

The results of this study may be published or presented at scientific meetings by the 
Investigator after publication of the overall study results or one year after end of the 
study (or study termination), whichever comes first. 

The investigator agrees to refer to the primary publication in any subsequent 
publications such as secondary manuscripts, and submit all manuscripts or abstracts 
to the sponsor 30 days before submission. This allows the sponsor to protect 
proprietary information and to provide comments and the Investigator will, on 
request, remove any previously undisclosed confidential information before 
disclosure, except for any study- or Pfizer intervention-related information 
necessary to the appropriate scientific presentation or understanding of the study 
results.

For all publications relating to the study, the Investigator will comply with 
recognized ethical standards concerning publications and authorship, including 
those established by the International Committee of Medical Journal Editors.

The sponsor will comply with the requirements for publication of the overall study 
results covering all Investigator sites. In accordance with standard editorial and 
ethical practice, the sponsor will support publication of multicenter studies only in 
their entirety and not as individual site data. In this case, a coordinating investigator 
will be designated by mutual agreement.

Authorship of publications for the overall study results will be determined by 
mutual agreement and in line with International Committee of Medical Journal 
Editors authorship requirements.

If publication is addressed in the clinical study agreement, the publication policy set 
out in this section will not apply.
10.1.11. Sponsor’s Qualified Medical Personnel
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the supporting study documentation. 
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, participants are provided with a contact card.  The contact card 
contains, at a minimum, protocol and study intervention identifiers, participant study 
numbers, contact information for the investigator site, and contact details for a contact center 
in the event that the investigator site staff cannot be reached to provide advice on a medical 
question or problem originating from another healthcare professional not involved in the 
participant’s participation in the study.  The contact number can also be used by investigator 
staff if they are seeking advice on medical questions or problems; however, it should be used 
only in the event that the established communication pathways between the investigator site 
and the study team are not available.  It is therefore intended to augment, but not replace, the 
established communication pathways between the investigator site and the study team for 
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advice on medical questions or problems that may arise during the study.  For sites other than 
a Pfizer clinical research unit (CRU), the contact number is not intended for use by the 
participant directly, and if a participant calls that number, he or she will be directed back to 
the investigator site.
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10.2. Appendix 2: Clinical Laboratory Tests

The tests detailed in Table 2 will be performed by the central laboratory.

Local laboratory results are only required in the event that the central laboratory 
results are not available in time for either study intervention administration and/or 
response evaluation. If a local sample is required, it is important that the sample for 
central analysis is obtained at the same time. Additionally, if the local laboratory 
results are used to make either a study intervention decision or response evaluation, 
the results must be entered into the CRF.

Protocol-specific requirements for inclusion or exclusion of participants are detailed 
in Section 5 of the protocol.

Additional tests may be performed at any time during the study as determined 
necessary by the investigator or required by local regulations.

Pregnancy Testing 
1. Refer to Section 5.1 Inclusion Criteria and Section 8.2.11 Pregnancy Testing 
for screening pregnancy criteria.
2. For details of timing of recommended pregnancy testing see the Schedule of 
Activities.
Table 2.
Protocol-Required Safety Laboratory Assessments
Laboratory 
Assessments
Parameters
Hematology
Platelet Count
RBC Indices:
MCV
MCH
Reticulocytes
White blood cell (WBC) 
count with Differential:
Total neutrophils
Lymphocytes1
Monocytes
Eosinophils
Basophils
Red blood cell (RBC) 
Count
Hemoglobin
Hematocrit
Clinical 
Chemistry1
Blood urea 
nitrogen (BUN) 
Creatinine
Glucose
Potassium 
Sodium 
Calcium
Chloride
Total CO2 or 
bicarbonate
Aspartate 
Aminotransferase
(AST)
Alanine 
Aminotransferase
(ALT)
Alkaline 
phosphatase 
Direct and Indirect 
bilirubin
Total Bilirubin
Uric Acid 
Total Protein
Albumin
Creatine Kinase2
Follow-up testing 
for potential DILI 
cases3
Routine 
Urinalysis4

pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte 
esterase by dipstick

Microscopic examination5 and urine culture6
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Table 2.
Protocol-Required Safety Laboratory Assessments
Laboratory 
Assessments
Parameters
Other Screening 
Tests

FSH7

Pregnancy tests8

HIV9

HBsAg

HBcAb

HBsAb10

HBVDNA11

HCVAb

HCVRNA12

VZV13

QFT-G test or T-Spot test14

Viral Screen15

Skin biopsies/swabs16

Fasting Lipid profile17
The results of each test must be entered into the CRF.
NOTES:
1.
After the screening visit, participants with absolute lymphocyte counts <500/mm3 (0.5 × 109/L) will be 
reflex tested for FACS TBNK until the absolute lymphocyte count resolves or stabilizes at a level acceptable 
to the investigator and the sponsor.
2.
In addition to re-testing creatine kinase >3 × ULN, urine myoglobin will be performed as reflex testing 
for any participant with a creatine kinase >10 × ULN for visits on or before Month 36. For participants who 
have completed the Month 36 visit, creatine kinase and urine myoglobin will not be tested.
3.
In cases of suspected potential drug-induced-liver-injury (DILI), follow-up testing should be performed 
according to requirements in Appendix 5.
4. For participants who have completed the Month 36 visit, urine samples and urinalysis will be performed 
only if considered clinically indicated by the investigator.
5. Only if urinalysis is performed and urine dipstick is positive for blood, nitrites, leukocyte esterase, and/or 
protein.
6. Urine culture will be performed if urinalysis is positive for nitrite and/or leukocyte esterase or if clinically 
indicated.
7. To confirm postmenopausal status in females under 60 years old who are not using hormonal 
contraception or hormonal replacement therapy (HRT). This test is not to be performed for WOCBP. Refer to 
Section 10.4.3.
8. Pregnancy tests (urine) for women of childbearing potential.  In the event that urine pregnancy tests are not 
permitted at an institution, serum pregnancy tests can be utilized.
9. HIV testing per local regulations.  Participants who are positive for HIV antibodies will be screen failed.
10. HBsAb will be performed as reflex testing for any participant who is HBsAg negative but HBcAb 
positive (refer to Appendix 6 for information regarding which screening laboratory results should be used to 
determine whether HBVDNA testing should be performed).  For Japan only: In addition to HBsAg and 
HBcAb, HBsAb testing will be performed at screening for participants in Japan who are de novo participants 
or participants originating from study B7981015 with >30 days between the first visit of study B7981032 and 
the last dose in study B7981015 rather than as a reflex test.  For Japan specific requirements see Appendix 7.  
For all other countries, please refer to Appendix 6 for testing algorithm, reflex testing, and full eligibility 
criteria.
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Table 2.
Protocol-Required Safety Laboratory Assessments
Laboratory 
Assessments
Parameters
11. HBVDNA testing will be performed at the time points stated in the Schedule of Activities for participants 
who were enrolled with a positive HBcAb and a negative HBVDNA in those regions for which Hep B 
prevalence has been reported at a rate of >5.0% or if required by local standard of care (refer to 
Section 8.2.8.5 for information regarding which screening laboratory results should be used to determine 
whether HBVDNA testing should be performed).  Testing at additional time points may be performed as per 
the local standard of care.  For Japan specific requirements see Appendix 7.  For all other countries refer to 
Appendix 6 for testing algorithm, reflex testing, and full eligibility criteria.
12. HCVRNA will be performed as reflex testing for any participant who is HCVAb positive.
13. VZV Ig Ab testing is required to confirm eligibility only in adolescent participants 12 to <18 years of age 
without documented evidence of having received the varicella vaccine (2 doses).  Serological testing must be 
performed for VZV IgG Ab only in the absence of documented evidence of having received varicella 
vaccination (2 doses) per Exclusion #16.
14. The QFT-G test is preferred; however, the T-Spot test is also permitted as described in Section 8.2.8.1.  A 
PPD test can be substituted for the QFT-G test or T-Spot test only under specific circumstances described in 
Exclusion criterion 19 in Section 5.2.2 and Section 8.2.8.1.2.
15. A serum sample will be collected at Day 1 and submitted to the central lab.  The sample will be stored 
and analyzed at a later date only at the sponsor’s request.  In certain cases of suspected viral infection (eg, 
disseminated herpes zoster or varicella), the sponsor may request to analyze the sample to determine if the 
participant had exposure to that virus.
16. When required in cases of skin rash adverse events.  See applicable sections for herpetiform rash 
(Section 8.2.7.2.1) and potential drug related rash (Section 8.2.7.2.2).
17. Lipid profile panel will include total cholesterol, low density lipoprotein (LDL), high density lipoprotein 
(HDL), and triglycerides.  A minimum of 8-hour fasting is required for lipid profile evaluation. Lipid profile 
panel will not be tested after the Month 36 visit.
Investigators must document their review of each laboratory safety report.
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10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting
10.3.1. Definition of AE
AE Definition

An AE is any untoward medical occurrence in a patient or clinical study 
participant, temporally associated with the use of study intervention, whether or not 
considered related to the study intervention.

NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention.
Events Meeting the AE Definition

Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) 
or other safety assessments (eg, ECG, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically 
significant in the medical and scientific judgment of the investigator.  Any 
abnormal laboratory test results that meet any of the conditions below must be 
recorded as an AE:

Is associated with accompanying symptoms.

Requires additional diagnostic testing or medical/surgical intervention.

Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy.

Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition.

New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.

Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
an AE/SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae.
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Events NOT Meeting the AE Definition

Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.

The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition.

Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE.

Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).

Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) 
present or detected at the start of the study that do not worsen.
10.3.2. Definition of SAE
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death 
due to progression of disease).
A SAE is defined as any untoward medical occurrence that, at any dose:
a.
Results in death
b.
Is life-threatening
The term 'life-threatening' in the definition of 'serious' refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event, that 
hypothetically might have caused death, if it were more severe.
c.
Requires inpatient hospitalization or prolongation of existing hospitalization

In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious.

Hospitalization for elective treatment of a pre-existing condition that did not worsen 
from baseline is not considered an AE.
d.
Results in persistent disability/incapacity

The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.
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
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Other situations:

Medical or scientific judgment should be exercised in deciding whether SAE reporting 
is appropriate in other situations such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but may jeopardize the 
participant or may require medical or surgical intervention to prevent one of the other 
outcomes listed in the above definition. These events should usually be considered 
serious.

Examples of such events include invasive or malignant cancers, intensive treatment in 
an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug dependency or 
drug abuse.

Suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-
pathogenic, is considered serious.  The event may be suspected from clinical symptoms 
or laboratory findings indicating an infection in a patient exposed to a Pfizer product.  
The terms “suspected transmission” and “transmission” are considered synonymous.  
These cases are considered unexpected and handled as serious expedited cases by 
pharmacovigilance personnel.  Such cases are also considered for reporting as product 
defects, if appropriate.
10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording adverse events on the CRF 
and for reporting serious adverse events on the Clinical Trial (CT) Serious Adverse Event 
(SAE) Report Form to Pfizer Safety.  These requirements are delineated for 3 types of 
events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the study 
intervention under study during pregnancy or breastfeeding, and occupational exposure.  
It should be noted that the CT SAE Report Form for reporting of SAE information is not 
the same as the AE page of the CRF.  When the same data are collected, the forms must be 
completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE 
Report Form for reporting of SAE information.
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Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
SAE
All
All
Non-serious AE
All
None
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding, and 
occupational exposure
All AEs/SAEs associated 
with exposure during 
pregnancy or breastfeeding
Occupational exposure is not 
recorded.
All (And EDP supplemental 
form for EDP) 
Note:  Include all SAEs 
associated with exposure 
during pregnancy or 
breastfeeding. Include all 
AEs/SAEs associated with 
occupational exposure. 
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostics reports) 
related to the event.

The investigator will then record all relevant AE/SAE information in the CRF.

It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of completion of the CT SAE Report 
Form/AE/SAE CRF page.

There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 
exception of the participant number, must be redacted on the copies of the medical 
records before submission to Pfizer Safety.

The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE/SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories:

Mild: An event that is easily tolerated by the participant, causing minimal 
discomfort and not interfering with everyday activities.

Moderate: An event that causes sufficient discomfort and interferes with normal 
everyday activities.
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
Severe: An event that prevents normal everyday activities. An AE that is assessed 
as severe should not be confused with a SAE. Severe is a category utilized for 
rating the intensity of an event; and both AEs and SAEs can be assessed as severe.
An event is defined as ‘serious’ when it meets at least 1 of the predefined outcomes 
as described in the definition of an SAE, NOT when it is rated as severe.
Assessment of Causality

The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out.

The investigator will use clinical judgment to determine the relationship.

Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated.

The investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment.

For each AE/SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE/SAE and has provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is 
very important that the investigator always make an assessment of causality 
for every event before the initial transmission of the SAE data to the sponsor.  

The investigator may change his/her opinion of causality in light of follow-up 
information and send a SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.

If the investigator does not know whether or not the study intervention caused the 
event, then the event will be handled as “related to study intervention” for reporting 
purposes, as defined by the sponsor" and "In addition, if the investigator determines 
that an SAE is associated with study procedures, the investigator must record this 
causal relationship in the source documents and CRF, and report such an 
assessment in the dedicated section of the CT SAE Report Form and in accordance 
with the SAE reporting requirements.
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Follow-up of AEs and SAEs

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the AE or SAE as fully as 
possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other health care providers.

If a participant dies during participation in the study or during a recognized follow-
up period, the investigator will provide Pfizer Safety with a copy of any 
post-mortem findings including histopathology.

New or updated information will be recorded in the originally completed CRF.

The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the information.
10.3.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via CT SAE Report Form

Facsimile transmission of the CT SAE Report Form is the preferred method to 
transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the CT SAE Report Form sent by overnight mail or 
courier service.

Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Report Form within the designated reporting time 
frames.
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10.4. Appendix 4: Contraceptive Guidance 
10.4.1. Male Participant Reproductive Inclusion Criteria
There are no contraceptive methods required for male participants in this study, because 
PF-06651600 is not likely to transfer to a partner through semen at pharmacologically 
relevant blood levels.
10.4.2. Female Participant Reproductive Inclusion Criteria
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at 
least 1 of the following conditions applies:

Is not a WOCBP (see definitions below in Section 10.4.3).

OR

Is a WOCBP and using a contraceptive method (see Section 10.4.4) that is highly 
effective (with a failure rate of <1% per year), as described below during the 
intervention period and for at least 28 days after the last dose of study 
intervention, which corresponds to the time needed to eliminate any reproductive 
safety risk of the study intervention(s).  The investigator should evaluate the 
effectiveness of the contraceptive method in relationship to the first dose of study 
intervention.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 
10.4.3. Women of Childbearing Potential
A woman is considered fertile following menarche and until becoming post-menopausal 
unless permanently sterile (see below).
Note: If the childbearing potential changes after start of the study (eg, a premenarchal female 
participant experiences menarche) or the risk of pregnancy changes (eg, a female participant 
who is not heterosexually active becomes active), the participant must discuss this with the 
investigator, who should determine if a female participant must begin a highly effective 
method of contraception as outlined in Section 10.4.4.  If fertility is unclear (eg, amenorrhea 
in adolescents or athletes) and a menstrual cycle cannot be confirmed before first dose of 
study intervention, additional evaluation should be considered.
Women in the following categories are not considered WOCBP
1. Premenarchal
2. Premenopausal female with 1 of the following:

Documented hysterectomy

Documented bilateral salpingectomy
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
Documented bilateral oophorectomy
For individuals with permanent infertility due to an alternate medical cause other than 
the above, (eg, Müllerian agenesis, androgen insensitivity), investigator discretion 
should be applied to determining study entry.
Note: Documentation for any of the above conditions can come from the site 
personnel’s review of the participant’s medical records, medical examination, or 
medical history interview. The method of documentation should be recorded in the 
participant’s medical record for the study.
3. Postmenopausal female

A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause.  In addition, a high follicle stimulating hormone (FSH) 
level in the postmenopausal range must be used to confirm a postmenopausal 
state in women under 60 years old and not using hormonal contraception or 
hormonal replacement therapy (HRT). This test is not to be performed for 
WOCBP (refer to Schedule of Activities Section 1.3).  

Females on HRT and whose menopausal status is in doubt will be required to use 
one of the non-estrogen hormonal highly effective contraception methods if they 
wish to continue their HRT during the study. Otherwise, they must discontinue 
HRT to allow confirmation of postmenopausal status before study enrollment.

To confirm post-menopausal status, females taking hormonal contraception or 
HRT must discontinue these for at least 2 weeks prior to performing FSH testing 
and must remain abstinent during this period until post-menopausal status is 
confirmed.
10.4.4. Contraception Methods
Contraceptive use by women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
Highly Effective Contraceptive Methods 
1. Oral, injectable, or implantable progestogen-only hormone contraception associated 
with inhibition of ovulation.
2. Intrauterine device (IUD).
3. Intrauterine hormone-releasing system (IUS).
4. Bilateral tubal occlusion or bilateral tubal ligation.
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5. Oral, intravaginal, transdermal, or injectable combined (estrogen- and progestogen-
containing) hormonal contraception associated with inhibition of ovulation used in 
combination with a barrier method. 
Acceptable barrier methods include:

Male or female condom with or without spermicide;

Cervical cap, diaphragm, or sponge with spermicide;
Male condom and female condoms should not be used together (due to risk of failure 
with friction).
6. Vasectomized partner.
Vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the WOCBP and the absence of sperm has been 
confirmed.  If not, an additional highly effective method of contraception should be 
used.  The spermatogenesis cycle is approximately 90 days.
7. Sexual abstinence.
Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention.  The reliability of sexual abstinence needs to be evaluated 
in relation to the duration of the study and the preferred and usual lifestyle of the 
participant.
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10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-up Assessments
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury, but adapt 
are termed “adaptors.”  In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome.  These participants fail to adapt and therefore are 
"susceptible" to progressive and serious liver injury, commonly referred to as drug-induced 
liver injury (DILI).  Participants who experience a transaminase elevation above 3 times the 
upper limit of normal (× ULN) should be monitored more frequently to determine if they are 
an “adaptor” or are “susceptible.”
In the majority of DILI cases, elevations in aspartate aminotransferase (AST) and/or alanine 
aminotransferase (ALT) precede total bilirubin (TBili) elevations (>2 × ULN) by several 
days or weeks.  The increase in TBili typically occurs while AST/ALT is/are still elevated 
above 3 × ULN (ie, AST/ALT and TBili values will be elevated within the same lab sample).  
In rare instances, by the time TBili elevations are detected, AST/ALT values might have 
decreased.  This occurrence is still regarded as a potential DILI.  Therefore, abnormal 
elevations in either AST OR ALT in addition to TBili that meet the criteria outlined below 
are considered potential DILI (assessed per Hy’s law criteria) cases and should always be 
considered important medical events, even before all other possible causes of liver injury 
have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions (See Section 8.2 for the 
definition of baseline values to be used for the following criteria).  Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values:

Participants with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value 
>2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available;

For participants with baseline AST OR ALT OR TBili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:
o
Preexisting AST or ALT baseline values above the normal range: AST or ALT
values >2 times the baseline values AND >3 × ULN; or >8 × ULN (whichever is 
smaller).
o
Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches >3 × ULN 
(whichever is smaller).
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor.   The participant 
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should return to the investigator site and be evaluated as soon as possible, preferably within 
48 hours from awareness of the abnormal results.  This evaluation should include laboratory 
tests, detailed history, and physical assessment.
In addition to repeating measurements of AST and ALT and TBili for suspected cases of 
Hy’s Law, additional laboratory tests should include albumin, creatine kinase (CK), direct 
and indirect bilirubin, gamma-glutamyl transferase (GGT), prothrombin time 
(PT)/international normalized ratio (INR), total bile acids, and alkaline phosphatase. 
Consideration should also be given to drawing a separate tube of clotted blood and an 
anticoagulated tube of blood for further testing, as needed, for further contemporaneous 
analyses at the time of the recognized initial abnormalities to determine etiology.  A detailed 
history, including relevant information, such as review of ethanol, acetaminophen (either by 
itself or as a coformulated product in prescription or over-the-counter medications), 
recreational drug, supplement (herbal) use and consumption, family history, sexual history, 
travel history, history of contact with a jaundiced person, surgery, blood transfusion, history 
of liver or allergic disease, and potential occupational exposure to chemicals, should be 
collected.  Further testing for acute hepatitis A, B, C, D, and E infection and liver imaging 
(eg, biliary tract) and collection of serum sample for acetaminophen drug and/or protein 
adduct levels may be warranted.
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the liver function test (LFT) abnormalities has yet been found.  Such 
potential DILI (Hy’s law) cases are to be reported as SAEs, irrespective of availability 
of all the results of the investigations performed to determine etiology of the LFT 
abnormalities.  
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.
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10.6. Appendix 6: Hepatitis B Testing Algorithm and Full Eligibility Criteria 
All de novo participants and participants originating from Study B7931005 or B7981015 
with >30 days between the first visit of Study B7981032 and the last dose in Study 
B7931005 or B7981015 will undergo the following screening for hepatitis B for eligibility.  
See Appendix 7 for Japan specific requirements.
For participants in countries in which hepatitis B prevalence has been reported at a 
rate of >5.0%* or if required by local standard of care, participants will be tested as 
follows:
1. At screening, HBsAg and HBcAb will be tested:  
a.
If both tests are negative, the participant is eligible for study inclusion.
b. If HBsAg is positive, the participant must be excluded from participation in the 
study.
c.
If HBsAg is negative and HBcAb is positive, HBsAb and HBVDNA reflex 
testing is required: 
i.
If HBsAb is negative, the participant must be excluded from participation in 
the study;
ii. If HBVDNA is detected, the participant must be excluded from participation 
in the study;
iii. If HBsAb is positive and HBVDNA is undetectable, the participant is eligible 
for study inclusion.  If the participant is included in the study, for subsequent 
visits HBVDNA testing must be performed according to the Schedule of 
Activities.
For participants in all other countries, participants will be tested as follows:
2. At screening, HBsAg and HBcAb will be tested:
a.
If both tests are negative, the participant is eligible for study inclusion.
b. If HBsAg is positive, the participant must be excluded from participation in the 
study.
c.
If HBsAg is negative and HBcAb is positive, HBsAb reflex testing is required: 
i.
If HBsAb is negative, the participant must be excluded from participation in 
the study;
ii. If HBsAb is positive, the participant is eligible for study inclusion.  If the 
participant is included in the study, for subsequent visits no hepatitis B testing is 
required.
* The Polaris Observatory Collaborators.  Global prevalence, treatment, and prevention of hepatitis B virus 
infection in 2016: a modelling study.  Lancet Gastroenterol Hepatol. 2018;3(6):383-403.
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10.7. Appendix 7: Country-specific Requirements
10.7.1. Japan Specific Requirements for HBVDNA Testing
At screening, HBsAg, HBcAb and HBsAb will be tested for participants in Japan who are de 
novo participants or participants originating from Study B7981015 with >30 days between 
the first visit of Study B7981032 and the last dose in Study B7981015:
a.
If all three tests are negative, the participant is eligible for study inclusion. 
b. If HBsAg is positive, the participant must be excluded from participation in the study.
c.
If HBsAg is negative, HBcAb is positive and HBsAb is negative, the participant must 
be excluded from participation in the study.
d. If HBsAg is negative, HBcAb is negative and HBsAb is positive, and prior 
hepatitis B virus (HBV) vaccination is unequivocally documented, the participant is 
eligible for the study and does not require HBVDNA monitoring during the study. 
e.
If HBsAg is negative, HBcAb is negative and HBsAb is positive, and no unequivocal 
documentation of prior HBV vaccination is available, the participant is required to 
undergo HBVDNA reflex testing:
i.
If HBVDNA is detected, the participant must be excluded from 
participation in the study;
ii.
If HBVDNA is undetectable, the participant is eligible for study inclusion. 
If the participant is included in the study, for subsequent visits HBVDNA 
testing must be performed according to the Schedule of Activities.
f.
If HBsAg is negative, HBcAb is positive and HBsAb is positive, the participant is 
required to undergo HBVDNA reflex testing:
i.
If HBVDNA is detected, the participant must be excluded from 
participation in the study;
ii.
If HBVDNA is undetectable, the participant is eligible for study inclusion. 
If the participant is included in the study, for subsequent visits HBVDNA 
testing must be performed according to the Schedule of Activities.
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10.7.2. China Specific Language for Section 8.5 Pharmacokinetics and Section 8.6 
Pharmacodynamics
Section 8.5 Pharmacokinetics and Section 8.6 Pharmacodynamics are updated to remove 
exploratory analyses performed on pharmacokinetic and pharmacodynamic blood samples 
collected from participants at sites in China.
Section 8.5 Pharmacokinetics 
During all study periods, blood samples (~2 mL) to provide plasma for PK analysis will be 
collected into appropriately labeled tubes containing dipotassium ethylenediaminetetraacetic 
acid (K2EDTA) anticoagulant at times specified in the Schedule of Activities section of the 
protocol.
Blood will be collected at the time points identified in the Schedule of Activities section of 
the protocol.  All efforts will be made to obtain the pharmacokinetic samples at the exact 
nominal time relative to dosing.  For each blood sample collection, the allowable windows 
are as follows for time post dose: 0.5 hr (±10 min), 1 hr (±15 min) and 3 hr (±30 min).  The 
date and exact time of the sample collection is to be noted on the source document and data 
collection tool (eg, CRF), as well as the date and time of the previous dose.  Samples 
obtained outside the windows specified in the Schedule of Activities will be considered a 
protocol deviation.

The plasma will be stored in appropriately labeled screw capped polypropylene tubes at 
approximately -20°C or colder within 1 hour of collection.

Further details regarding the collection, processing, storage and shipping of the blood 
samples will be provided in the lab manual.

Samples will be analyzed using a validated analytical method in compliance with Pfizer 
standard operating procedures. 

The PK samples must be processed and shipped as indicated to maintain sample integrity.  
Any deviations from the PK processing steps, including any actions taken, must be 
documented and reported to the sponsor.  On a case-by-case basis, the sponsor may make 
a determination as to whether sample integrity has been compromised.  Any sample 
deemed outside of established stability, or of questionable integrity, will be considered a 
protocol deviation.
Section 8.6 Pharmacodynamics
Blood samples (~2.5 mL) will be collected for measurements of immunoglobulin (Ig) (IgA, 
IgG, IgM) and by fluorescence activated cell sorting (FACS) analysis to identify T cell, B 
cell, and natural killer (NK) cell subsets and at the time points listed in the Schedule of 
Activities.
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Samples will be analyzed using fit for purpose or validated analytical methods in compliance 
with applicable Pfizer standard operating procedures.  The pharmacodynamic (PD) samples 
must be processed and shipped as indicated in the instructions provided to the investigator 
site to maintain sample integrity.  Any deviations from the PD sample handling procedure 
(eg, sample collection and processing steps, interim storage or shipping conditions), 
including any actions taken, must be documented and reported to the sponsor.  On a case by 
case basis, the sponsor may make a determination as to whether sample integrity has been 
compromised.
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10.8. Appendix 8: Guidelines for Participant Safety Monitoring and Discontinuation
These guidelines for participant safety monitoring and discontinuation are to be applied to all 
participants in Study B7981032.  Additional individual participant monitoring is at the 
discretion of the investigator and dependent on any perceived safety concerns.  Unscheduled 
clinical labs may be obtained at any time during the study to assess such concerns, and a 
participant may be withdrawn at any time at the discretion of the investigator.
For the purposes of safety monitoring and discontinuation, baseline values will be defined as 
follows:

For de novo participants and participants originating from Study B7931005 or 
B7981015 with >30 days between the first visit of Study B7981032 and the last dose 
in Study B7931005 or B7981015:

Baseline values will be defined as the values from Day 1 of Study B7981032 (or 
from screening of Study B7981032 for evaluations not performed at Day 1).

For participants originating from Study B7981015 with ≤30 days between the first 
visit of Study B7981032 and the last dose in Study B7981015:

Baseline values will be defined as the values from Day 1 of Study B7981015 (or 
from screening of Study B7981015 for evaluations not performed at Day 1).
10.8.1. Monitoring
All potential treatment-related events of rash will be followed up until resolution or 
agreement with Pfizer. 
The following laboratory abnormalities require re-testing until resolution or agreement 
with Pfizer:
Laboratory 
Variable
Laboratory Value
Re-testing 
Timeframec
Hematology
Absolute Neutrophil 
Count
<1000/mm3 (<1.0 × 109/L)
Within 1 week
Hemoglobin
<10.0 g/dL (<6.21 mmol/L or <100 g/L) 
Within 1 week
Platelet count
<100,000/mm3 (<100 × 109/L)
Within 1 week
Absolute Lymphocyte 
Counta
<600/mm3 (<0.6 × 109/L)
Within 1 week
Serum Chemistry
Creatine kinaseb
>3 × ULN
Within 1 week
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Laboratory 
Variable
Laboratory Value
Re-testing 
Timeframec
Aspartate 
aminotransferase
See section Appendix 5 for potential cases of drug-induced 
liver injury.
Within 48 hours
Alanine 
aminotransferase
See section Appendix 5 for potential cases of drug-induced 
liver injury.
Within 48 hours
Total bilirubin
See section Appendix 5 for potential cases of drug-induced 
liver injury.
Within 48 hours
a.
After the screening visit, participants with absolute lymphocyte count <500/mm3 (0.5 × 109/L) will be 
reflex-tested for FACS-TBNK until the absolute lymphocyte count resolves or stabilizes at a level acceptable 
to the investigator and sponsor.
b.
In addition to re-testing creatine kinase >3 × ULN, urine myoglobin will be performed as reflex testing 
for any participant with creatine kinase >10 × ULN for visits on or before Month 36. For participants who 
have completed the Month 36 visit, creatine kinase and urine myoglobin will not be tested. 
c.  Based on awareness of the abnormal results.
In case of positive urine pregnancy test, the participant will have study intervention 
interrupted and a serum sample collected on the same day (or as soon as possible) and 
submitted to the central laboratory for pregnancy testing.
In the case of either a positive QFT-G, T-Spot, or PPD test result or chest x-ray indicative of 
active TB, the participant must have study intervention temporarily withheld until it is 
confirmed by a specialist (eg, pulmonologist or infectious disease specialist) whether the 
participant has active or latent TB.  In the case of active TB, study intervention must be 
permanently withdrawn.  If latent TB is diagnosed by the specialist, the participant may 
re-start study intervention only with approval by the Pfizer Medical Monitor as described in 
Section 8.2.8.1.2 and Section 10.14. 
10.8.2. Discontinuation
Treatment will be discontinued and the participant withdrawn from this study 
following completion of the Early Termination visit and the Follow-up Visit (whenever 
possible) for:
Adverse Events:

Serious infections, defined as any infection (viral, bacterial, and fungal) requiring 
parenteral antimicrobial therapy or hospitalization for treatment or meeting other 
criteria that require the infection to be classified as serious adverse event;

Treatment-related SAEs;

Clinically meaningful, treatment-emergent declines in hearing from baseline (refer to 
Audiometry Study Guide for details) are to be discussed with the sponsor for 
possible withdrawal from study;
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
Other serious or severe AEs, at the discretion of the investigator or sponsor.
ECG Findings (up to Month 36 Visit):

Confirmed QTcF >500 milliseconds;

Confirmed increase from baseline in QTcF of >60 milliseconds.
Study intervention Interruptions:

Participants interrupting study intervention for more than 14 consecutive days are to
be discussed with the sponsor for possible withdrawal from the study.
Laboratory Abnormalities:
All the following laboratory abnormalities require discontinuation if they are confirmed by 
retest. Refer to the re-testing timeframes for laboratory abnormalities in Section 10.8.1. 

Absolute Neutrophil Count <750/mm3 (<0.75 × 109/L).

Hemoglobin <9.0 g/dL (<5.59 mmol/L or <90 g/L) or a decrease of >30% from 
baseline (either criterion or both).

Platelet count <75,000/mm3 (<75.0 × 109/L).

Absolute Lymphocyte Count <500/mm3 (<0.5 × 109/L).
NOTE: After the screening visit, participants with absolute lymphocyte count <500/mm3 (0.5 
× 109/L) will be reflex tested for FACS-TBNK until the absolute lymphocyte count resolves 
or stabilizes at a level acceptable to the investigator and sponsor.

Creatine kinase >10 × ULN (for visits on or before Month 36).
NOTE: In addition to re-testing creatine kinase >3 × ULN, urine myoglobin will be 
performed as reflex testing for any participant with creatine kinase >10 × ULN for visits on 
or before Month 36. For participants who have completed the Month 36 visit, creatine kinase 
and urine myoglobin will not be tested.

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that meet ANY
of the following:

>3 times the upper limit of normal with at least one total bilirubin value >2 times 
the ULN;

>3 times the upper limit of normal accompanied by signs or symptoms consistent 
with hepatic injury (eg, new onset elevated PT/INR); 
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
Two sequential AST or ALT elevations >5 times ULN, regardless of total 
bilirubin or accompanying signs or symptoms.
NOTE: In each case, there is a need for additional investigations, such as review of ethanol, 
recreational drug and dietary supplement consumption; testing for acute hepatitis A, B or C 
infection and biliary tract imaging should be promptly discussed with the sponsor or 
designee.
Pregnancy:

Female participants confirmed as pregnant during the study (see Section 8.3.5).
Prohibited Medications:

Participants who are treated with any prohibited medication during the course of the 
study may require discontinuation.  Participants who are administered a prohibited 
medication are to be discussed with the sponsor for possible withdrawal from the 
study.
Suicidal Ideation:

Participants with suicidal ideation associated with actual intent and a method or plan 
in the past year: a “yes” answer on items 4, 5, or on any question in the suicidal 
behavior section of the C-SSRS must be discontinued.  The participant must be 
referred to a mental health professional for appropriate evaluation and treatment or 
immediately referred to the Emergency Room at the investigator’s judgement.  
Discontinuation/End of Treatment Monitoring:
Any participant meeting discontinuation criteria must enter into the Follow-up Period with 
their first follow-up visit occurring 1 week after their last dose whenever possible, until the 
event has returned to normal or baseline levels or is deemed clinically stable.  The procedures 
scheduled for Early Termination Visit will be performed on the last day the participant takes 
the study intervention or as soon as possible thereafter.  The only exception to this is when a 
participant specifically withdraws consent for any further contact with him or her or persons 
previously authorized by the participant to provide this information.  Additional follow-up 
visits may occur as needed until any clinically relevant abnormalities or adverse events have 
resolved, returned to a baseline state, or are deemed clinically stable. 
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10.9. Appendix 9: Prohibited and Permitted Concomitant CYP3A Inducers and 
Substrates
Please note that this list addresses only CYP3A inducers and CYP3A substrates.  Other 
prohibited medications for this trial are listed in Section 6.5.2.  Refer to Section 6.5.1 for 
additional information regarding permitted medications for this trial, including CYP3A 
inhibitors.
This is not an all-inclusive list.  Study personnel should stay current and consult with their 
pharmacy to exclude all concomitant medications that are moderate to potent CYP3A 
inducers or sensitive or moderate sensitive CYP3A substrates.  If a medication is a sensitive 
or moderate sensitive CYP3A substrate and is not listed below as prohibited or permitted, 
consultation with the sponsor is required.
10.9.1. Prohibited Concomitant CYP3A Inducers and Substrates
Sensitive CYP3A Substrates##
Moderate Sensitive CYP3A 
Substrates§
Moderate to Potent CYP3A 
Inducers**
Dasatinib
Aprepitant
Avasimibe#
Dronedarone
Eliglustat
Bosentan
Ebastine
Pimozide
Barbiturates
Lomitapide
Rilpivirine
Carbamazepine#
Nisoldipine
Efavirenz 
Sirolimus
Etravirine
Tacrolimus
Mitotane#
Tolvaptan
Modafinil
Nafcillin
Phenobarbital#
Phenytoin#
Rifabutin#
Rifampin #
St. John’s Wort#
Talviraline
** All prohibited drugs that are CYP3A inducers require at least a 28 day or 5 half-lives (whichever is 
longer) washout prior to the first dose of study intervention.
In a situation where appropriate medical care of a participant requires the use of a prohibited CYP3A 
inducer: Moderate to potent inducers of CYP3A are not permitted in the study EXCEPT in emergency 
situations.  Note: Mitotane is not permitted for any duration due to its long half-life; however, if necessary 
mitotane may be used in an emergency, however the participant will then be discontinued from the study.  
Topical (including skin or mucous membranes) application of antimicrobial and antifungal medications is 
permitted.
# 
Notated as potent inducers. 
## Sensitive CYP3A substrates are drugs that demonstrate an increase in concentration-time curve (AUC) 
of ≥5-fold with strong index inhibitors of a given metabolic pathway in clinical drug-drug interaction (DDI) 
studies.
§ 
Moderate sensitive substrates are drugs that demonstrate an increase in AUC of ≥2 to <5-fold.
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10.9.2. Permitted Concomitant CYP3A Substrates 
Sensitive CYP3A Substrates##
Moderate Sensitive CYP3A 
Substrates§
Alfentanil 
Midazolam
Alprazolam
Avanafil
Naloxegol
Atorvastatin
Buspirone
Quetiapine
Colchicine
Darifenacin
Sildenafil
Rivaroxaban
Eletriptan
Simvastatin
Tadalafil
Eplerenone
Ticagrelor
Felodipine
Triazolam
Lovastatin
Vardenafil
Lurasidone
## Sensitive CYP3A substrates are drugs that demonstrate an increase in concentration-time curve (AUC) 
of ≥5-fold with strong index inhibitors of a given metabolic pathway in clinical drug-drug interaction (DDI) 
studies.
Topical (including skin or mucous membranes) application of antimicrobial and antifungal medications is 
permitted.
§ 
Moderate sensitive substrates are drugs that demonstrate an increase in AUC of ≥2 to <5-fold.
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10.10. Appendix 10: Vaccine Sub-Study
Sub-Study Title:
A Study of Immune Responses Following Administration of Meningococcal and Tetanus 
Vaccines in Adult Participants with Alopecia Areata Receiving PF-06651600.
SUMMARY
The purpose of this sub-study is to evaluate the effect of PF-06651600 50 mg QD on primary 
immune responses to the meningococcal group C polysaccharide of a meningococcal (groups 
A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine, and on 
secondary (booster) immune responses to tetanus toxoid administered in a tetanus and 
diphtheria toxoids and acellular pertussis (Tdap) vaccine in adult participants with AA.  The 
effect of PF-06651600 treatment on the safety of meningococcal ACWY and Tdap 
vaccinations will also be evaluated.  The participants can be enrolled to receive both vaccines 
or one of the two vaccines.  Not all countries participating in the B7981032 study will be 
included in this sub-study.  The vaccine sub-study will be performed at sites in the US, 
Canada, and Australia.  Note: the vaccine sub-study will not be conducted at sites within the 
VHP countries in the EU (ie, Czech Republic, Germany, Hungary, Poland, and Spain).
Participants in this sub-study must have received at least 6 months of treatment with 
PF-06651600 50 mg QD in the main B7981032 study.  They will continue to receive the 
study intervention (PF-06651600 50 mg QD) in the main B7981032 study while participating 
in the vaccine sub-study.  The sub-study will be approximately 1 month (standardized 
30 days) in duration and visits will occur at baseline and at Month 1.  The sub-study baseline 
will occur at the same time as a scheduled main B7981032 study visit on or after Month 6 
(for participants originating from Study B7931005 or B7981015) or after Month 7 (for 
de novo participants), and before or at Month 56 of the main B7981032 study.
SCHEDULE OF ACTIVITIES
Procedures to be performed in addition to activities described in Section 1.3.
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Table 3.
Vaccine Sub-Study Additional Procedures
Procedure
Sub-Study Baseline
(Day 1)
Sub-Study Month 1
(Day 31)
Notes
Baseline visit must 
occur at a scheduled 
study visit in the main 
B7981032 study.
Visit
1
2
Window
None
+5 days
Informed consent
X
Separate informed 
consent for vaccine 
sub-study required.
Review Inclusion and 
Exclusion criteria
X
Collect pre-
vaccination blood 
samples for titersa
X
Administer Tdap 
and/or meningococcal 
ACWY vaccinationsb
X
Collect post-
vaccination blood 
samples for titersc
X
Physical Examination
X
X
For Day 1, targeted or 
full exam as per 
scheduled visit in 
main B7981032 study; 
for Month 1, targeted 
exam
Vital signs 
X
X
For Day 1, as per 
scheduled visit in 
main B7981032 study
Laboratory testing: 
hematology & serum 
chemistry
X
X
For Day 1, as per 
scheduled visit in 
main B7981032 study
Adverse event 
monitoring
X
X
Drug accountability
X
X
Abbreviations: ACWY = groups A, C, W-135 and Y; Tdap = tetanus and diphtheria toxoids and acellular 
pertussis.
a.
Pre-vaccination blood samples for titers will be collected based on the vaccine(s) to be administered to 
the participant on Day 1.
b.
Participants may receive both vaccines, only Tdap vaccine, or only meningococcal ACWY vaccine.
c.
Post-vaccination blood samples for titers will be collected based on the vaccine(s) received by the 
participant on Day 1.
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INTRODUCTION
The United States Centers for Disease Control and Prevention (CDC) guidelines for 
vaccination recommend administration of various vaccines, including tetanus toxoid and 
meningococcal vaccines as well as boosters, over the lifetime of the individual.1  
PF-06651600 affects the signaling of several cytokines thought to be important in humoral 
and cellular immunity via blockade of the JAK3 enzyme.  In addition, PF-06651600 inhibits 
members of the TEC family of kinases which may also contribute to its immunomodulatory 
properties. The effects of PF-06651600 on immunogenicity following vaccination has not 
been evaluated.  Findings from the sub-study will inform whether vaccination during 
PF-06651600 treatment could affect generation of primary or secondary (ie, booster) 
immunogenicity responses.  The sub-study findings will therefore be useful for informing 
clinical practice of PF-06651600 in patients with AA.
The sub-study will assess immunogenicity to tetanus (administered as Tdap) booster 
vaccination and meningococcal C polysaccharide (administered as meningococcal ACWY) 
primary vaccination in adult participants with AA undergoing treatment with PF-06651600 
in Study B7981032.
Information for PF-06651600 is provided in the current version of the IB.  More detailed 
information about the known and expected benefits and risks and reasonably expected AEs 
of the Tdap and meningococcal ACWY vaccinations may be found in the current versions of 
the US prescribing information (USPI) for Adacel2 and MENVEO3, respectively.  The actual 
local product labels for the vaccinations used at each site should be referenced.
Sub-Study Rationale
Vaccination with Tdap allows evaluation of the effects of PF-06651600 on secondary 
(booster) immune response since tetanus is a common vaccination in children/adolescents 
and most adults should have received at least one primary tetanus immunization. CDC 
guidelines recommend one dose of Tdap and then boosters with tetanus and diphtheria 
toxoids (Td) vaccine every 10 years.1
Vaccination with meningococcal ACWY allows evaluation of the effects of PF-06651600 on 
primary immune responses.  Meningococcal vaccination is currently uncommon in adults 
because routine meningococcal vaccination in the US started in 2005.4-6  It is, however, 
recommended per CDC guidelines for administration to adolescents (and high susceptibility 
adults) to offer protection from meningococcal serogroups A, C, Y and W-135 disease. The 
immunologic correlate of clinical protection by meningococcal vaccines is serum bactericidal 
activity (SBA).7,8  For assessment of the immune response to the meningococcal vaccine, 
functional antibodies will be analyzed in SBA assays using human complement with strains 
representing meningococcal serogroup C. The immunogenicity to serogroup C will be 
evaluated in this study as it has the most clinical relevance in North America.9
Immunogenicity for both Tdap and meningococcal ACWY reported in the product labels was 
evaluated approximately 1 month after administration (ie, at 28 days2,3 post vaccination). 
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An effect of Tdap adsorbed vaccination or meningococcal ACWY vaccination on AA disease 
activity or disease course is not expected.  It is therefore considered acceptable to add the 
vaccine sub-study to the main B7981032 study.
Risk/Benefit Assessment 
The administration of tetanus vaccine as a booster in adults is consistent with vaccine 
guidelines worldwide.  The response to booster vaccination with tetanus is expected to 
provide information on immunogenicity for secondary immune responses to a T-dependent 
antigen (as contained in Tdap) during treatment with PF-06651600.  For adults, the 
administration of meningococcal ACWY vaccination as a primary vaccine has been 
recommended by CDC for individuals with additional risk factors or other special situations.1  
The response to meningococcal vaccination is expected to provide findings on 
immunogenicity for a primary immune response (in individuals previously not vaccinated or 
infected) during treatment with PF-06651600. 
Administration of the vaccines during PF-06651600 treatment may potentially result in 
reduced immunogenicity to Tdap and meningococcal ACWY vaccinations. Concentrations of 
antibodies against specific vaccine antigens will be measured to evaluate the effect of 
PF-06651600 on immunogenicity.
In the Tdap adsorbed product information, the most frequent adverse reactions reported in 
>5% of adults following a second vaccination included: injection site reactions (including 
pain, swelling and erythema), myalgia, headache and malaise.2  In the meningococcal groups 
A, C, W-135 and Y oligosaccharide diphtheria CRM197 conjugate vaccine product 
information, the most common adverse reactions reported in >5% of adults following 
primary vaccination included injection site reactions (including pain, erythema, and 
induration), headache, myalgia, malaise, nausea, and arthralgia.3  Other than the risks 
described in the product information, no unique risks related to vaccination are expected.  
Overall, the benefit-risk of the immunogenicity sub-study in B7981032 participants is 
considered favorable.
STUDY OBJECTIVES AND ENDPOINTS
Objectives
Endpoints
Primary

Evaluate immune response to Tdap 
vaccination in AA participants treated 
with PF-06651600.

Proportion of participants achieving a 
booster response, defined as 1) ≥4-fold 
rise in anti-tetanus toxoid IgG antibody 
concentration at Month 1 if the 
pre-vaccination concentration was 
≤2.7 IU/mL; 2) ≥2-fold rise in 
anti-tetanus toxoid IgG antibody 
concentration at Month 1 if the 
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Objectives
Endpoints
pre-vaccination concentration was 
>2.7 IU/mL.
Secondary

Evaluate immune response to 
meningococcal ACWY vaccination in 
AA participants treated with 
PF-06651600.

Proportion of participants achieving 
≥1:8 human serum bactericidal activity 
(hSBA) (in participants with 
undetectable pre-vaccination assay 
titers) at Month 1 post-vaccination for 
serogroup C.

Evaluate immune responses to Tdap and 
meningococcal ACWY vaccinations 
based on other vaccine response 
endpoints in AA participants treated 
with PF-06651600.
Tdap vaccination:

Proportion of participants with anti-
tetanus antibody level ≥1.0 IU/mL on 
Month 1.

Proportion of participants with anti-
tetanus antibody level 0.1 IU/mL on 
Month 1.

Proportion of participants with ≥4× 
increase in anti-tetanus antibody level 
from baseline.

Fold increase in anti-tetanus levels 
above baseline values at Month 1.

Geometric mean concentrations (GMCs) 
of anti-tetanus antibody levels on Month 
1.
Meningococcal ACWY vaccination:

Proportion of participants achieving 
≥1:4 hSBA (in participants with 
undetectable pre-vaccination assay 
titers) at Month 1 post-vaccination for 
serogroup C.

Geometric mean titers (GMTs) of 
antibodies for serogroup C at baseline 
and on Month 1.
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Objectives
Endpoints

Evaluate safety of tetanus and 
meningococcal ACWY vaccinations in 
AA participants treated with 
PF-06651600.

Incidence of SAEs and AEs.

Incidence of SAEs and AEs leading to 
discontinuation.
STUDY DESIGN
This is a sub-study evaluating immunogenicity to vaccine antigens following Tdap and 
meningococcal ACWY vaccinations in adult participants with AA enrolled in the main 
B7981032 study.  The participants can be enrolled to receive both vaccines or one of the two 
vaccines as follows:

Participants who meet the eligibility criteria for both vaccines should be enrolled to 
receive both vaccines.

Participants who meet the eligibility criteria only for Tdap vaccine should be enrolled to 
receive Tdap vaccine only.

Participants who meet the eligibility criteria only for meningococcal ACWY vaccine 
should be enrolled to receive meningococcal ACWY vaccine only.
It is estimated that a total of approximately 60 participants eligible to receive the Tdap 
vaccine, with or without the meningococcal ACWY vaccine, will be enrolled in this 
sub-study.  The sub-study participants will continue their participation and study treatment as 
assigned in the main B7981032 study.  Study participants are required to provide a separate 
informed consent for the vaccine sub-study.  All eligible participants participating in the 
sub-study must continue with all study assessments of the main study per the B7981032 
Schedule of Activities.
PARTICIPANT SELECTION
The following eligibility criteria are designed to select participants for whom participation in 
the sub-study is considered appropriate.  All relevant medical and non-medical conditions 
should be taken into consideration when deciding whether this sub-study is suitable for a 
specific participant.
Sub-Study Inclusion Criteria for All Participants
B7981032 participants in select countries/sites only will be included in this sub-study.  The 
vaccine sub-study will be performed at sites in the US, Canada and Australia.  Note: the 
vaccine sub-study will not be conducted at sites within the VHP countries in the EU 
(ie, Czech Republic, Germany, Hungary, Poland, and Spain).  Participant eligibility should 
be reviewed and documented by an appropriately qualified member of the investigator’s 
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study team before participants are included in the sub-study. Participants need to maintain 
eligibility to continue receiving study intervention (PF-06651600) in the main B7981032 
study in order to participate in the sub-study. In addition, participants must meet all of the 
following inclusion criteria to be eligible for enrollment into the sub-study:
1. Male or female AA participants in B7981032 who, at the time of consent for this 
sub-study, are: 

≥18 to ≤55 years of age, if receiving both vaccines or only meningococcal 
ACWY vaccine;

≥18 to ≤64 years of age, if receiving only Tdap vaccine.
2. Participants who have received PF-06651600 50 mg QD for ≥6 months in Study 
B7981032:
a.
For participants who received study intervention in study B7931005 or 
B7981015: ≥6 months after first dose of study intervention in study B7981032;
b. For de novo participants: ≥7 months after first dose of study intervention in study 
B7981032. 
3. In the preceding time in B7981032, participant is compliant with receiving study 
intervention described in Section 6.4.  In addition, participant should not miss any 
dose of PF-06651600 for at least 7 consecutive days just prior to Day 1 of this sub-
study.
4. Evidence of personally signed and dated informed consent document indicating that 
the participant has been informed of all pertinent aspects of the sub-study.  A separate 
informed consent for this sub-study is required (see Section 10.1.3 for informed 
consent process).
5. Participants who are willing and able to comply with scheduled procedures for this 
sub-study.
Additional Sub-Study Inclusion Criterion for Participants Receiving Tdap Vaccine
(With or Without Meningococcal ACWY Vaccine)
6. Must have had prior tetanus vaccination ≥5 years before Day 1 of the sub-study.
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Sub-Study Exclusion Criteria for All Participants
Excluded will be participants with:
1. History of any severe AE associated with any vaccination.
2. Safety concerns at time of vaccination, including anyone with unresolved laboratory 
abnormalities meeting monitoring criteria.
3. History of Guillain-Barre syndrome or brachial neuritis.
4. Presence of any unstable neurological conditions or history of seizures.
5. The following conditions are temporary or self-limiting and a participant may 
participate in the vaccine sub-study once the condition(s) has/have resolved, no other 
exclusion criteria are met, and following consultation with the Pfizer study clinician:
a.
Current febrile illness (oral temperature ≥38°C [100.4°F]) or other acute illness 
within 48 hours before sub-study vaccine administration. 
b. Receipt of antibiotic therapy for acute illness within 72 hours before sub-study 
vaccine administration. 
6. Any other acute or chronic medical or psychiatric condition that may increase the risk 
associated with sub-study participation or vaccine administration or that may interfere 
with the interpretation of sub-study results and, in the judgment of the investigator or 
Pfizer (or designee), would make the participant inappropriate for entry into this 
sub-study.
Additional Sub-Study Exclusion Criteria for Participants Receiving Tdap Vaccine 
(With or Without Meningococcal ACWY Vaccine)
7. Hypersensitivity to any component of the Tdap vaccine.
8. History of Arthus-type hypersensitivity reactions after previous dose of tetanus 
vaccines.
9. Any condition that would make participant unsuitable for receiving the Tdap vaccine 
based upon product information.
Additional Sub-Study Exclusion Criteria for Participants Receiving Meningococcal 
ACWY Vaccine (With or Without Tdap Vaccine)
10. Prior history of meningococcal ACWY vaccination or history of meningococcal 
disease.
11. Hypersensitivity to any component of the meningococcal ACWY vaccine.
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12. Any condition that would make participant unsuitable for receiving the 
meningococcal ACWY vaccine based upon product information.
STUDY INTERVENTION
Enrolled participants will either receive single doses of both Tdap and meningococcal 
ACWY vaccines, or a single dose of only one of the two vaccines, per the applicable product 
labels.  Study treatment with PF-06651600 50 mg QD will continue as per the main 
B7981032 study.
Study Intervention Supplies
ARM Name
Tdap
Meningococcal ACWY
Intervention Name
Tetanus, diphtheria and 
pertussis vaccine
Meningococcal (Groups A, C, 
W-135 and Y) Oligosaccharide 
Diphtheria CRM197 conjugate 
vaccine
Type 
Vaccine
Vaccine
Dosage Form
Injectable
Injectable
Dose Strength
See local product information
See local product information
Dosage
See local product information
See local product information
Route of Administration
Intramuscular injection
Intramuscular injection
IMP or Non-IMP
Non-IMP
Non-IMP
Sourcing
Sourcing to be determined for 
each country in which the sub-
study is run based on local 
requirements/guidelines
Sourcing to be determined for 
each country in which the sub-
study is run based on local 
requirements/guidelines
Packaging and Labeling
Provided in commercial 
package
Provided in commercial 
package
Abbreviations: IMP = investigational medicinal product.
Administration
A single dose of Tdap vaccine will be administered to the participants who are eligible to 
receive the Tdap vaccine (ie, those who meet eligibility criteria for all participants and for 
those receiving Tdap vaccine) on Day 1 of the sub-study.  A locally approved vaccine 
product containing tetanus, diphtheria and pertussis must be used.  The Tdap vaccine must be 
administered by the intramuscular route.  For complete instructions regarding storage and 
administration, please refer to the product label.
A single dose of meningococcal ACWY vaccine will be administered to the participants who 
are eligible to receive the meningococcal ACWY vaccine (ie, those who meet eligibility 
criteria for all participants and for those receiving meningococcal ACWY vaccine) on Day 1 
of the sub-study.  A locally approved vaccine product containing meningococcal (Groups A, 
C, W-135 and Y) oligosaccharide diphtheria CRM197 conjugate must be used.  The 
meningococcal vaccine must be administered by the intramuscular route.  For complete 
instructions regarding storage and administration, please refer to the product label.
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In participants who receive both vaccines, the meningococcal ACWY vaccine may be given 
at the same time as the Tdap vaccination but in a separate injection site, preferably in a 
different limb.  The two vaccines must not be mixed in the same syringe.
The participant should be observed for at least 30 minutes after vaccine administration to 
assess any acute reactions.
Compliance
Administration of both vaccines will be verified by review of source documents by the study 
monitor.  Participants will continue with protocol-specified procedures in the main study.
ASSESSMENTS
Assessments are to be performed as described in Section 8 and according to the Schedule of 
Activities in the main B7981032 study protocol and the Schedule of Activities in the vaccine 
sub-study.
ADVERSE EVENT REPORTING
See Section 8.3 and Appendix 3 of the main B7981032 study.
STATISTICAL CONSIDERATIONS
Data analysis for the vaccine sub-study will be conducted when all enrolled participants have 
completed or withdrawn from this sub-study. Results from this analysis are considered final 
for the sub-study.
Methodologies for summary and statistical analyses of data collected in this sub-study are 
summarized here and further detailed in the statistical analysis plan (SAP) for this sub-study 
which will be dated and maintained by Pfizer.
Sample Size Determination
With 60 participants receiving the Tdap vaccine (with or without the meningococcal ACWY 
vaccine), assuming a similar observed immune response rate as reported in the product label 
(74.5% of participants achieving booster response as defined by anti-tetanus toxoid antibody 
levels pre-vaccination and on Month 1), the estimated half width of 95% confidence interval 
(CI) is 11% for the response rate to Tdap vaccination.  The probability of observing at least 
65% booster response rate for the tetanus vaccination is approximately 95.4%, assuming the 
booster response rate of 74.5%. 
Analysis of Immunogenicity Endpoints
For the immunogenicity endpoints, two Full Analysis Sets (FAS) will be defined depending 
on the vaccine(s) received. The Full Analysis Set for Tdap (FAS-Tdap) is defined as all 
participants who receive the Tdap vaccine (with or without the meningococcal ACWY 
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vaccine); the Full Analysis Set for ACWY (FAS-ACWY) is defined as all participants who 
receive the meningococcal ACWY vaccine (with or without the Tdap vaccine). 
The primary analysis will be descriptive in nature; there will be no formal hypothesis testing, 
although 95% two-sided CIs will be generated.  The analyses for endpoints related to the 
Tdap vaccine will be based on the FAS-Tdap, whereas the analyses for endpoints related to 
the meningococcal ACWY vaccine will be based on the FAS-ACWY.
The number and percentage of participants who achieve the defined immune responses will 
be presented for the primary endpoint and binary secondary endpoints with 95% two-sided 
CIs based on Clopper-Pearson exact method. 
For GMCs of anti-tetanus toxoid antibody concentrations, GMTs for meningococcal 
serogroup C antibody titers, and fold increases in anti-tetanus toxoid antibody levels above 
baseline values, geometric mean and 95% CI based on back transformation of the 
log-transformed data will be provided.
Safety Analysis
Safety analyses for this sub-study will be based on the Safety Analysis Set (SAS) defined as 
all participants from this sub-study who receive at least 1 dose of the vaccine (Tdap or 
meningococcal ACWY). All safety data from this sub-study will be reported using a similar 
approach and methods as the main study (see Section 9.4.3).
Interim Analysis
No interim analysis is planned for this sub-study.
REFERENCES FOR VACCINE SUB-STUDY
1. CDCWebsite. cdc.gov/vaccines/schedules/index.html. Accessed 19 Sep 2019.
2. Adacel [USPI]. Toronto Ontario Canada: Sanofi Pasteur Limited; 2020. 
3. MENVEO [USPI]. Sovicille (SI), Italy: GSK Vaccines, Srl; 2020.
4. Centers for Disease Control and Prevention. 2010. Active bacterial core surveillance 
report, emerging infections program network., Neisseria meningitis, 2009.
5. Whalen CM, Hockin JC, Ryan A, et al. The changing epidemiology of invasive 
meningococcal disease in Canada, 1985 through 1992. Emergence of a virulent clone of 
Neisseria meningitis. JAMA 1995;273(5):390-4.
6. Bettinger JA, Scheifele DW, Le Saux N, et al. The impact of childhood meningococcal 
serogroup C conjugate vaccine programs in Canada. Pediatr Infect Dis J 
2009;28(3):220-4.
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7. Goldschneider, I, Gotschlich, EC, Artenstein MS. Human immunity to the 
meningococcus. I. The role of humoral antibodies. J Exp Med 1969; 129(6):1307-26.
8. Gotschlich EC, Goldschneider I, Arenstein MS. Human immunity to meningococcus. IV. 
Immunogenicity of group A and group C meningococcal polysaccharides in human 
volunteers. J Exp Med 1969;129(6): 1367-84.
9. Harrison LH, Granoff DM, Pollard A. Meningococcal capsular group A, C, W and Y 
conjugate vaccines. Plotkin’s Vaccines 7th ed.  Elsevier Inc, 2018: p.619-43.
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10.11. Appendix 11: Discontinuation Criteria for Worsening of Alopecia Areata for 
VHP Countries in the EU
Within the VHP countries in the EU, participants who meet the following criteria at Month 6 
or any subsequent visit of Study B7981032 must be permanently discontinued from study 
intervention and complete the Early Termination visit and the Follow-up Visit (whenever 
possible).  The VHP countries participating in this study are: Czech Republic, Germany, 
Hungary, Poland, and Spain.
Status at Baseline*
Action at Month 6 or any subsequent visit
AT/AU
Discontinuation not required
SALT AA >75
Discontinuation not required
SALT AA ≥25 to ≤75
Discontinuation required if AA “worsening”, defined as 
change from baseline* in absolute SALT overall score ≥25
points
* Baseline values are defined as follows:

For de novo participants and participants originating from Study B7931005 or B7981015 with >30 
days between the first visit of Study B7981032 and the last dose in Study B7931005 or B7981015:
o
Baseline values will be defined as the values from Day 1 of Study B7981032 (or from 
screening of Study B7981032 for evaluations not performed at Day 1).

For participants originating from Study B7981015 with ≤30 days between the first visit of Study 
B7981032 and the last dose in Study B7981015:
o
Baseline values will be defined as the values from Day 1 of Study B7981015 (or from 
screening of Study B7981015 for evaluations not performed at Day 1).
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10.12. Appendix 12: Study Intervention Continuation Criteria for Adolescents
Adolescent participants ≥12 to <18 years of age at the time of the Day 1 visit (in B7981032 
for de novo participants or in B7981015 for participants originating from Study B7981015) 
must meet the following criteria in Study B7981032 in order to continue study intervention.  
Adolescent participants who do not meet the following criteria must be permanently 
discontinued from study intervention and complete the Early Termination visit and the 
Follow-up Visit.  
Table 4.
Study B7981032 Study Intervention Continuation Criteria for Adolescents
Group
Criteria at Month 3 or any prior 
visit* in Study B7981032**
Criteria at Month 6 or any prior 
visit* in Study B7981032+
De novo participants
Not applicable
Absolute SALT score ≤20
Participants originating from 
Study B7981015
Improvement of ≥50% in absolute 
SALT score from the SALT score 
at Day 1 in Study B7981015.  
For example, a participant with a 
B7981015 Day 1 SALT score of 
78 must have a SALT score of 
≤39 at the B7981032 Month 3 or 
prior visit in order to continue 
study intervention.
Absolute SALT score ≤20
*    For participants originating from Study B7981015 with ≤30 days between the last dose in B7981015 and 
the first visit in B7981032, prior visits include the B7981015 Week 48 or Early Termination visit.
**  For participants who have completed the B7981032 Month 3 visit but not the Month 6 visit at the time of 
Protocol Amendment 4 approval for a site, only the Month 6 criteria will be checked at the scheduled Month 
6 visit and will be based on achieving the SALT ≤20 score at the Month 6 visit or any prior visits.
+
For participants who have already completed the B7981032 Month 6 visit at the time of Protocol 
Amendment 4 approval for a site, the Month 6 criteria must be checked at the next scheduled visit and will be 
based on achieving the SALT ≤20 score at that visit or any prior visits.
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10.13. Appendix 13: Alternative Measures During Public Emergencies
The alternative study measures described in this section are to be followed during public 
emergencies, including the coronavirus disease 2019 (COVID-19) pandemic. This appendix 
applies for the duration of the COVID-19 pandemic globally and will become effective for 
other public emergencies only upon written notification from Pfizer. NOTE: Any deviations 
from the Schedule of Activities or the protocol (eg, missed or partially completed procedures 
or assessments) must be reported to the sponsor in a timely manner and will be reported by 
the sponsor as a protocol deviation.
Procedures which are missed due to disruptions related to a public emergency, including the 
COVID-19 pandemic, are required to be performed at the next available opportunity, even if 
outside of a protocol-specified visit window.
Use of these alternative study measures are expected to cease upon the return of business as 
usual circumstances (including the lifting of any quarantines and travel bans/advisories). 
10.13.1. Eligibility
While severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) testing is not 
mandated for this study, local clinical practice standards for testing should be followed. A de 
novo patient or a participant originating from B7931005 and B7981015 with >30 days from 
the first study visit of Study B7981032 and the last dose in the index study should be 
excluded if he/she has a positive test result for SARS-CoV2 infection, is known to have 
asymptomatic infection, or is suspected of having SARS-CoV2. De novo patients and 
participants originating from B7931005 and B7981015 with >30 days from the first study 
visit of Study B7981032 and the last dose in the index study with active infections are 
excluded from study participation per Exclusion #17.  When the infection resolves, the 
patient may be considered for re-screening. 
For de novo participants and participants originating from Study B7931005 or B7981015 
with >30 days between the first visit in Study B7981032 and the last dose in Study 
B7931005 or B7981015 and who are being considered for enrollment into Study B7981032:

The participant must be able to perform all Screening and Day 1 procedures per the 
Schedule of Activities at the study site and/or designated ancillary facility (eg, for 
audiological evaluations and chest radiographs) in order to determine whether the 
participant meets eligibility criteria for Study B7981032.  This includes collection and 
resulting of laboratory assessments through the central laboratory vendor.

The participant must meet eligibility criteria for Study B7981032.

It must be anticipated that the participant will be able to have the B7981032 Week 2 and 
Month 1 safety laboratory tests collected/performed at the study site or an alternative 
clinical laboratory facility according to the windows in Table 5 in Section 10.13.3.1.
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
If a participant does not meet the criteria described above, the participant cannot be 
enrolled in the B7981032 study.
For participants originating from Study B7981015 with ≤30 days between the first visit of 
Study B7981032 and the last dose in Study B7981015 and who are being considered for 
enrollment into Study B7981032:

The participant must meet eligibility criteria for Study B7981032.

The participant must be able to have safety laboratory tests collected at their final visit in 
Study B7981015 at the study site or an alternative clinical laboratory facility.

The participant (if a WOCBP) must be able to have pregnancy testing performed at their 
final visit in Study B7981015 and the Day 1 visit in B7981032 (if applicable) at the study 
site, at an alternative clinical laboratory facility, or at the participant’s home.

The participant must be able to have the Day 1 tuberculosis test collected between the 
time of signing consent/assent for B7981032 and the Week 2 visit (inclusive) at the study 
site or an alternative clinical laboratory facility.  

It must be anticipated that the participant will be able to have the B7981032 Week 2 and 
Month 1 safety laboratory tests collected/performed at the study site or an alternative 
clinical laboratory facility according to the windows in Table 5 in Section 10.13.3.1.

For participants who are not able to complete all required B7981015 Week 48 or Early 
Termination procedures and/or B7981032 Day 1 procedures per the respective protocol, 
these cases must be discussed with the Pfizer B7981032 study team prior to the final visit 
in Study B7981015 to obtain agreement that the participant may be suitable for entry into 
B7981032. 

If a participant does not meet the criteria described above, the participant cannot enter the 
B7981032 study.
10.13.2. Telehealth Visits
In the event that in-clinic study visits cannot be conducted, every effort should be made to 
follow up on the safety of study participants at scheduled visits per the Schedule of 
Activities or unscheduled visits. Telehealth visits may be used to continue to assess 
participant safety and collect data points. Telehealth includes the exchange of healthcare 
information and services via telecommunication technologies (e.g., audio, video, video-
conferencing software) remotely, allowing the participant and the investigator to 
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communicate on aspects of clinical care, including medical advice, reminders, education, and 
safety monitoring. The following assessments must be performed during a telehealth visit:  

Review dosing logs and record study intervention(s), including doses taken and any 
interruptions in intake of study intervention (ie, missed doses) since the last contact, and 
calculate compliance.

Review and record any AEs and SAEs since the last contact. Refer to Section 8.3.

Review and record any new concomitant medications or changes in concomitant 
medications since the last contact.

For WOCBP: Review and record contraceptive method and results of pregnancy testing. 
Confirm that the participant is adhering to the contraception method(s) required in the 
protocol Appendix 4, Section 10.4.4. Refer to Section 8.2.11 of the protocol and 
Section 10.13.3.1 of this appendix regarding pregnancy tests and to Section 5.3.1 of this 
protocol regarding contraception checks.

For premenarchal female participants: Check for initiation of menarche per 
Section 8.2.12 of this protocol.

Collection of updated audiological history (Part 1 in the Audiometry Study Guide 
Worksheet for Post Day 1 visits) at visits requiring audiological evaluation.

Body temperature and collection method (eg, oral, tympanic, axillary, or temporal), and 
pulse rate (measured by study participant/caregiver).

Administration of the C-SSRS performed by a qualified rater.  Per Section 8.2.9.1, if 
there are “yes” answers on items 4 or 5 of the suicidal ideation section or on any question 
in the suicidal behavior section of the C-SSRS, the participant will be discontinued from 
the study and referred to a mental health professional for appropriate evaluation and 
treatment.

NOTE:  If the investigator determines that additional evaluation is warranted based on 
the information collected during the remote visit described above, follow-up is required 
to be performed, with results submitted to and reviewed by the investigator prior to 
shipping study intervention to the participant.
Study participants must be reminded to promptly notify site staff about any change in their 
health status.
10.13.3. Alternative Facilities for Safety Assessments
10.13.3.1. Laboratory Testing
With the exceptions noted in Section 10.13.1 of this appendix for Screening and Day 1, if a 
study participant is unable to visit the site for protocol-specified safety laboratory 
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evaluations, testing may be conducted at a local laboratory if permitted by local 
regulations. The local laboratory may be a standalone institution or within a hospital. 
Collection of blood and urine samples may also be performed at the participant’s home per 
Section 10.13.5 of this appendix.  The following safety laboratory evaluations may be 
performed at a local laboratory or in the participant’s home:  

Hematology

Serum chemistry 

Lipid panel (for visits on or before Month 36)

Urinalysis (for visits after Month 36, urinalysis will be performed only if considered
clinically indicated by the investigator)

Pregnancy testing (for WOCBP)

Day 1 and annual tuberculosis testing

Refer to the Schedule of Activities for visits at which these tests are required and to 
Appendix 2 for additional details regarding these tests.  
If it is not possible for the participant to have the above tests completed within the visit 
window specified in the Schedule of Activities, an extended window may be allowed to 
collect samples for these laboratory tests, provided that the investigator has performed the 
remote visit as described above, assessed each case, and determined that it would not 
increase risk to a participant.  The extended windows for laboratory sample collection for 
each study visit are noted in Table 5.  These windows apply only to laboratory samples 
collected during interruptions due to public emergencies, including the COVID-19 pandemic, 
based upon written notification from Pfizer.  If the laboratory samples are not collected 
within the specified extended window for the visit, the participant must temporarily withhold 
study intervention until the required laboratory samples can be collected. 
If a local laboratory is used, qualified study site personnel must order, receive, and review 
results. Site staff must collect the local laboratory reference ranges and certifications/
accreditations for filing at the site. Laboratory test results are to be provided to the site staff 
as soon as possible and must be received and reviewed by the investigator within 14 days 
after they are collected in order to determine eligibility to continue dosing. In addition, 
laboratory test results from the previous visit must be available and reviewed by the 
investigator prior to shipping study intervention at the current visit.  The local laboratory 
reports must be filed in the participant’s source documents/medical records. Relevant data 
from the local laboratory report must be recorded on the CRF. 
Special attention should be paid to ensure that laboratory results are checked against the 
Guidelines for Participant Safety Monitoring and Discontinuation in Appendix 8 and that 
required follow-up is performed as applicable.
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If a participant requiring pregnancy testing cannot visit a local laboratory for pregnancy 
testing, a home urine pregnancy testing kit with a sensitivity of at least 25 IU/mL may be 
used by the participant to perform the test at home, if compliant with local regulatory 
requirements. Urine pregnancy test results may be collected based on information provided 
by the participant (or their legally authorized representative, if appropriate) during the remote 
visit.  The urine pregnancy test result must be available prior to dispensing or shipping 
study intervention to a participant.  The pregnancy test outcome must be documented in 
the participant’s source documents/medical records and relevant data recorded on the CRF. 
Confirm that the participant is adhering to the contraception method(s) required in the 
protocol. 
NOTE: Pregnancy testing (for WOCBP) between scheduled study visits and study site 
contact with participants to obtain pregnancy test results is required to continue as outlined in 
the Schedule of Activities and Section 8.2.11 of the protocol.
Table 5.
Windows for Remote Visits and Laboratory Sample Collections if 
Required due to Public Emergencies, Including the COVID-19 Pandemic
Visit (Day in Study)
Remote Visit Window 
(Day in Study)a
Lab Collection Window 
(Day in Study)b
Week 2 (Day 15)
±3 days (Day 12-18)
±3 days (Day 12-18)
Month 1 (Day 31)
±3 days (Day 28-34)
-3 / +30 days (Day 28-61)
Month 3 (Day 91)
±7 days (Day 84-98)
-14 / +30 days (Day 77-121)
Month 6 (Day 181)
±7 days (Day 174-188)
-14 / +30 days (Day 167-211)
Month 9 (Day 271)
±7 days (Day 264-278)
-14 / +30 days (Day 257-301)
Month 12 (Day 361)
±7 days (Day 354-368)
-14 / +30 days (Day 347-391)
Month 15 (Day 451)
±7 days (Day 444-458)
-14 / +30 days (Day 437-481)
Month 18 (Day 541)
±7 days (Day 534-548)
-14 / +30 days (Day 527-571)
Month 21 (Day 631)
±7 days (Day 624-638)
-14 / +30 days (Day 617-661)
Month 24 (Day 721)
±7 days (Day 714-728)
-14 / +30 days (Day 707-751)
Month 28 (Day 841)
±7 days (Day 834-848)
-14 / +30 days (Day 827-871)
Month 32 (Day 961)
±7 days (Day 954-968)
-14 / +30 days (Day 947-991)
Month 36 (Day 1081)
±7 days (Day 1074-1088)
-14 / +30 days (Day 1067-1111)
Month 40 (Day 1201)
±7 days (Day 1194-1208)
-14 / +30 days (Day 1187-1231)
Month 44 (Day 1321)
±7 days (Day 1314-1328)
-14 / +30 days (Day 1307-1351)
Month 48 (Day 1441)
±7 days (Day 1434-1448)
-14 / +30 days (Day 1427-1471)
Month 52 (Day 1561) 
±7 days (Day 1554-1568)
-14 / +30 days (Day 1547-1591)
Month 56 (Day 1681)
±7 days (Day 1674-1688)
-14 / +30 days (Day 1667-1711)
Month 60 (Day 1801)
±7 days (Day 1794-1808)
-14 / +30 days (Day 1787-1831)
a.
These are the same as the windows in the protocol Schedule of Activities (Section 1.3.2). 
b.
Laboratory results must be received and reviewed by the investigator within 14 days after they are 
collected to determine eligibility to continue dosing. In addition, laboratory test results from the previous 
visit must be available and reviewed by the investigator prior to shipping study intervention at the current 
visit.
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10.13.3.2. Chest Radiography
For de novo participants and participants with >30 days between the first visit in Study 
B7981032 and the last dose in Study B7931005 or B7981015, the Screening chest radiograph 
must be performed at the study site or designated ancillary center per Section 8.2.4.
If the participant requires a Day 1 (for participants with ≤30 days between the first visit in 
Study B7981032 and the last dose in Study B7981015) or annual chest radiograph (for all 
participants) per Section 8.2.4 and is unable to visit the study site or designated ancillary 
center for the chest radiograph, the participant may visit an alternative facility to have the 
chest radiograph performed. Qualified study site personnel must order, receive, and review 
results. 
10.13.3.3. Electrocardiograms
For de novo participants and participants with >30 days between the first visit in Study 
B7981032 and the last dose in Study B7931005 or B7981015, the Screening and Day 1 ECG 
must be performed at the study site or designated ancillary center per Section 8.2.5.  For 
ECGs after Day 1 (all participants), if the participant is unable to visit the study site for an 
ECG, the participant may visit an alternative facility to have the ECG performed according to 
the guidelines in Section 8.2.5. Qualified study site personnel must order, receive, and review 
results. 
10.13.3.4. Audiological Evaluation
For de novo participants and participants with >30 days between the first visit in Study 
B7981032 and the last dose in Study B7931005 or B7981015, the Screening audiological 
evaluation must be performed at the study site or designated ancillary center per Section 
8.2.6.  For visits requiring audiological evaluations after Day 1 (all participants), if the 
participant is unable to visit the study site or designated ancillary center for an audiological 
evaluation, the audiological history (Part 1 in the Audiometry Study Guide Worksheet for 
Post Day 1 visits) must be collected during the remote visit per Section 10.13.2 of this 
appendix (or home health visit per Section 10.13.5).  The audiological evaluation must be 
performed per Section 8.2.6 at the next available opportunity, even if outside of a protocol-
specified visit window.
10.13.4. Study Intervention
If the safety of a trial participant is at risk because they cannot complete required evaluations 
or adhere to critical mitigation steps, then discontinuing that participant from study 
intervention must be considered.
Study intervention may be shipped by courier to study participants if permitted by local 
regulations and in accordance with storage and transportation requirements for the study 
intervention. Pfizer does not permit the shipment of study intervention by mail. The tracking 
record of shipments and the chain of custody of study intervention must be kept in the 
participant’s source documents/medical records.
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If a third-party courier engaged by Pfizer or Pfizer’s CRO is used for shipping the study 
intervention, written consent must be documented in the informed consent document prior to 
shipping study intervention.  If a third-party courier engaged by Pfizer or Pfizer’s CRO is not 
used for shipping the study intervention, consent must be verbally obtained (or per local 
guidelines/regulations) and documented in site’s source documents prior to shipping study 
intervention.  
Prior to shipping study intervention to a participant, 1) consent must be obtained and 
documented as described above, 2) all required safety information listed in Section 10.13.2
must have been collected and reviewed by the investigator, 3) the required laboratory tests 
from the previous visit must have been reviewed by the investigator, and 4) any additional 
evaluation (if requested based on investigator judgment) must have been performed, with 
results submitted to and reviewed by the investigator.
Study intervention cannot be shipped to the participant and must be temporarily discontinued 
if 1) the laboratory tests from the previous visit have not been reviewed by the investigator 
OR 2) after reviewing the required information (including that from a remote visit), the 
investigator cannot make an assessment of whether it is safe for the participant to continue 
study intervention.  Refer to Section 6.4 regarding temporary withholding of study 
intervention.
The study site may deliver the study intervention to participants using an acceptable delivery 
method only if this is consistent with local laws and regulations and the site is able to ship the 
study intervention according to the guidelines provided by the sponsor in a separate 
document.
The amount of study intervention to be shipped should correspond to the amount dispensed 
per the Impala Quick Reference Guide at the specific study visit which is being conducted 
remotely. Dispensing and/or shipment of additional study intervention to extend the visit 
window is not permitted.  
Participants should continue taking the current supply of study intervention until the new 
supply is received (unless temporary withholding of study intervention is required).
Dosing logs should be shipped with the study intervention.
Study sites should follow up with the participant once the study intervention is received by 
the participant to review when to start using the new blister cards or the new bottles, the 
dosing instructions, and completion of the dosing logs.
Participants should be instructed not to re-use or dispose of any blister cards or bottles 
dispensed at a previous visit (with the exception of the Week 2 visit).  
All blister cards, or bottles, and dosing logs must be returned to the study site at the next on-
site visit.
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10.13.5. Home Health Visits
A home health care service may be utilized to facilitate scheduled visits per the Schedule of 
Activities if operationally feasible and will be conducted according to local 
regulations. Home health visits include a healthcare provider conducting an in-person study 
visit at the participant’s location, rather than an in-person study visit at the site. 
If a third-party engaged by Pfizer or Pfizer’s CRO is used for home health visits, written 
consent must be documented in the informed consent document prior to conducting the first 
home health visit.  If a third-party engaged by Pfizer or Pfizer’s CRO is not used for home 
health visits, consent must be verbally obtained (or per local guidelines/regulations) and 
documented in site’s source documents prior to conducting the first home health visit.
The following may be performed during a home health visit:

Review dosing logs and record study intervention(s), including doses taken and any 
interruptions in intake of study intervention (ie, missed doses) since the last contact, and 
calculate compliance.

Review and record any AEs and SAEs since the last contact. Refer to Section 8.3.

Review and record any new concomitant medications or changes in concomitant 
medications since the last contact.

For WOCBP: Review and record contraceptive method and results of pregnancy testing. 
Confirm that the participant is adhering to the contraception method(s) required in the 
protocol Appendix 4, Section 10.4.4. Refer to Section 8.2.11 of the protocol and 
Section 10.13.3.1 of this appendix regarding pregnancy tests.

For premenarchal female participants: Check for initiation of menarche.

Collection of updated audiological history (Part 1 in the Audiometry Study Guide 
Worksheet for Post Day 1 visits) at visits requiring audiological evaluation.

Body temperature and collection method (eg, oral, tympanic, axillary, or temporal), pulse 
rate, and blood pressure.

ECG per Section 8.2.5

Hematology

Serum chemistry 

Lipid panel (for visits on or before Month 36)
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
Urinalysis (for visits after Month 36, urinalysis will be performed only if considered
clinically indicated by the investigator)

Pregnancy testing (for WOCBP)

Day 1 and annual tuberculosis testing

Physical examination
10.13.6. Adverse Events and Serious Adverse Events
If a participant has a confirmed or suspected COVID-19 infection during the study, this 
should be reported as an adverse event (AE) or serious adverse events (SAE) and appropriate 
medical intervention provided. For non-serious COVID-19 infections, temporary 
discontinuation of the study intervention may be medically appropriate until the participant 
has recovered from the COVID-19 infection.  If this is a serious infection (ie, requires 
parenteral antimicrobial therapy or hospitalization for treatment or meeting other criteria that 
require the infection to be classified as a serious adverse event), the participant must be 
permanently discontinued from study intervention per Appendix 8, Section 10.8.2 of the 
protocol.
10.13.7. Efficacy Assessments
Efficacy assessments listed in Section 8.1 are only to be collected during on-site visits.  This 
includes SALT, ELA, EBA, fingernail assessment, CGI-AA, all patient reported outcomes, 
and the BRIEF®2.  In addition, photographs described in Section 8.1.4 will only be collected 
during on-site visits. 
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10.14. Appendix 14: Management of Participants with a Positive Tuberculosis Test 
Result on Day 1 or Annual Tuberculosis Testing
The following evaluation process applies to participants WITHOUT either a positive QFT-G 
(or T-Spot or PPD, if applicable) test result during prior testing (including screening visits in 
Study B7931005, B7981015 or B7981032, as applicable) or a history of previous treatment 
for active or latent TB.  For participants WITH either a positive TB test result during prior 
testing or a history of previous treatment for active or latent TB, refer to Section 8.2.8.1.2.
Per Section 8.2.8.1.2, participants with a positive QFT-G (or T-Spot or PPD, if applicable) 
test result must be evaluated to determine whether the participant has latent or active TB, and 
to determine whether study intervention may be re-started.  NOTE: Repeat QFT-G (or 
T-Spot or PPD, if applicable) testing should not be performed unless specifically requested 
by the specialist (eg, pulmonologist or infectious disease specialist).  The following process 
should be followed:

Perform a chest radiograph or other appropriate diagnostic chest imaging (ie, computed 
tomography or MRI).

Once the chest radiograph results are available, have the participant referred to a 
specialist (eg, infectious disease specialist or pulmonologist).  The results of the recent 
chest radiograph, TB test (ie, QFT-G, T-SPOT, or PPD) and any other relevant 
information should be provided to the specialist.

If the specialist diagnoses active TB, the participant is required to be permanently 
withdrawn from study intervention.

If the specialist diagnoses latent TB:

The specialist should establish a treatment plan for latent TB based on the 
participant’s best interest and local standard of care, taking into account that the 
participant would be receiving an immunosuppressive study intervention in 
B7981032.  The local incidence rates of TB and multi-drug resistant TB should be 
considered.

Once the treatment plan for latent TB is established, the PI should provide to the 
sponsor the English translation of the specialist’s report, the treatment plan 
recommended by the specialist, and local incidence rate of multi-drug resistant 
TB infection.  

Upon review of the relevant documentation, the sponsor’s Medical Monitor may
give approval to re-start study intervention.

Depending on the time off study intervention, the participant may be required 
to complete an on-site visit prior to re-starting study intervention. 
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
Note that the only latent TB treatment that will be considered for concomitant use 
with study intervention is INH.  Participants taking INH concomitantly with study 
intervention should also receive vitamin B6 supplementation for the duration of 
INH treatment (as appropriate per opinion of the treating physician).

If study intervention is permitted to be re-started, at the next annual visit 
(ie, Month 12, 24, 36, 48 or 60), a chest radiograph is required to be performed (a 
QFT-G, T-SPOT, or PPD test need not be obtained).

If the specialist determines that the participant does not have latent or active TB in spite 
of a positive QFT-G (or T-Spot or PPD, if applicable) test result:

The specialist must provide the following:

An unequivocal documented diagnosis that the participant does not have latent 
or active TB. A rationale for this medical opinion, which takes into 
consideration local incidence rates of TB and multi-drug resistant TB, must 
also be provided.

A statement as to whether treatment for latent TB should be instituted. 

A statement as to whether it is safe for the participant to receive the 
immunosuppressive study intervention in B7981032.

The English translation of the specialist’s report must be forwarded to the sponsor 
for review.

If the sponsor’s Medical Monitor grants approval then study intervention may be 
re-started.  

Depending on the time off study intervention, the participant may be required 
to complete an on-site visit prior to re-starting study intervention.

If study intervention is permitted to be re-started, QFT-G testing (or T-SPOT or 
PPD, if applicable) will be required at the next visit per the protocol Schedule of 
Activities (ie, Month 12, 24, 36, 48 or 60); in this case the recent test has been 
effectively deemed a ‘false positive’ by the specialist and the participant is 
considered to be WITHOUT a true positive QFT-G (or T-Spot or PPD, if 
applicable) test result at this visit.
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10.15. Appendix 15: Abbreviations
Abbreviation
Term
5-ARI
5α-Reductase inhibitors
AA
Alopecia areata
AA SALT
Severity of Alopecia Tool alopecia areata (used interchangeably 
with SALT AA)
AAPPO
Alopecia areata patient priority outcomes
AARU
Alopecia areata resource utilization
ACWY
groups A, C, W-135 and Y
AE
Adverse event
AESI
adverse event of special interest
AGA
androgenetic alopecia
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
AT
Alopecia totalis
ATP
Adenosine triphosphate
AU
Alopecia universalis
AUC
Area under the concentration-time curve
BAEP
brainstem auditory evoked potentials
BCR
B cell receptor
BMX
Bone marrow tyrosine kinase on chromosome X
BP
Blood pressure
BRI
Behavior Regulation Index
BRIEF®2
Behavior Rating Inventory of Executive Function®, Second 
Edition
BTK
Bruton’s tyrosine kinase
Cavg
Average steady state drug concentration
CD
Cluster of differentiation
CDC
Centers for Disease Control and Prevention
CFB
Change from baseline
CFP-10
Culture filtrate protein 10 kiloDalton
CFR
Code of Federal Regulations
CGI-AA
Clinician Global Impression - Alopecia Areata
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CONSORT
Consolidated Standards of Reporting Trials
COVID-19
Coronavirus disease 2019
CK
Creatine kinase
Cmax
Maximum plasma concentration
CRF
Case report form
CRI
Cognitive Regulation Index
CRO
Contract research organization
CRU
Clinical research unit
CSR
Clinical study report
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Abbreviation
Term
C-SSRS
Columbia Suicide Severity Rating Scale
CT
Clinical Trial
CTA
Clinical trial application
CYP450
Cytochrome P450
CYP3A
Cytochrome P450, family 3, subfamily A
DDI
Drug-drug interaction
DILI
Drug-induced liver injury
DMC
Data monitoring committee
DNA
Deoxyribonucleic acid
DNCB
1-chloro-2,4-dinitrobenzene
DPCP
Diphenylcyclopropenone
EBA
Eyebrow Assessment
EBV
Epstein Barr Virus
EC
Ethics committee
ECG
Electrocardiogram
eCRF
Electronic case report form
E-DMC
External data monitoring committee 
EDP
Exposure during pregnancy
eGFR
Estimated glomerular filtration rate
ELA
Eyelash assessment
ELISA
Enzyme-linked immunosorbent assay
EMA
European Medicines Agency
EOS
End of study
EOT
End of treatment
EQ-5D-5L
EuroQoL 5 dimensions
EQ-5D-Y
EuroQoL 5 Dimensions—Youth
ERI
Emotional Regulation Index
ESAT-6
Early secreted antigenic target of 6 kiloDalton
ET
Early Termination
EU
European Union
EudraCT
European Clinical Trials Database
FACS-TBNK
Fluorescence-activated cell sorting for T-cells, B-cells, and 
natural killer (NK) cells
FAS
Full analysis set
FSH
Follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
Gamma-glutamyl transferase
GMC
geometric mean concentrations
GMT
geometric mean titers
GPSP
Good Post Marketing Surveillance Practices
HADS
Hospital Anxiety and Depression Scale
HBcAb
Hepatitis B core antibody
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Abbreviation
Term
HBsAb
Hepatitis B surface antibody
HBsAg
Hepatitis B surface antigen
HBV
Hepatitis B virus
HBVDNA
Hepatitis B virus deoxyribonucleic acid
HCRU
Healthcare resource utilization
HCVAb
Hepatitis C antibody
HCV RNA
Hepatitis C virus ribonucleic acid
HEENT
Head, eyes, ears, nose, and throat
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human immunodeficiency virus
HRQoL
Health-related quality of life
HRT
Hormone replacement therapy
hSBA
human serum bactericidal activity
HTA
Health technologies assessment
IB
Investigator’s brochure
ICF
Informed consent document
ICH
International Council for Harmonisation
ID
Identification
IEC
Independent Ethics Committee
IFN
Interferon
Ig
Immunoglobulin
IgA
Immunoglobin A antibody
IgG
Immunoglobulin G antibody
IgM
Immunoglobin M antibody
IL
Interleukin
IMP
Investigational medicinal product
IND
Investigational new drug application
INH
isoniazid
INR
International normalized ratio
IP
Investigational product
IP-10
Interferon gamma-induced protein 10
IRB
Institutional review board
IRT
Interactive response technology
ITK
Interleukin 2 inducible T cell kinase
IUD
Intrauterine device
IUS
Intrauterine hormone-releasing system
IVRS
Interactive voice response system
IWRS
Interactive web response system
JAK
Janus kinase
J-NDA
Japan New Drug Application
K2EDTA
Dipotassium ethylenediaminetetraacetic acid
LFT
Liver function test
LOAEL
Lowest observed adverse effect level
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Abbreviation
Term
MHLW, 
Ministry of Health, Labour and Welfare 
MMF
Mycophenolate mofetil
MMR
Measles, mumps, rubella
MMRM
Mixed Model for Repeated Measures
MRI
Magnetic resonance imaging
MTX
Methotrexate
NK
Natural killer
NOAEL
No observed adverse effect level
NRS
Numerical rating scale
ObsRO
observer reported outcomes
PACL
Protocol administrative change letter
PCD
Primary completion date
PD
Pharmacodynamic
PGI-C
Patient’s global impression of change
PHQ-8
Patient health questionnaire – 8 items
PI
Principal investigator
PK
Pharmacokinetic
PPD
Purified protein derivative
PRO
Patient reported outcome
P-Sat
Patient’s Satisfaction with Hair Growth 
PT
Prothrombin time
PUVA
Psoralen ultraviolet A
QD
Once daily
QFT-G
QuantiFERON-TB Gold In–tube test
QoL
Quality of life
QT interval
Time from the beginning of the QRS complex to the end of the 
T wave
QTcF
QT corrected using Fridericia’s correction factor
RA
Rheumatoid Arthritis
RNA
Ribonucleic acid
SADBE
Squaric acid dibutylester
SAE
Serious adverse event
SALT
Severity of Alopecia Tool
SALT ≤10
Response based on achieving absolute Severity of Alopecia 
Tool (SALT) score ≤10, for overall and AA SALT score
SALT ≤20
Response based on achieving absolute SALT score ≤20, for 
overall and AA SALT score
SALT50
50% improvement in SALT score from baseline
SALT75
75% improvement in SALT score from baseline
SALT AA
Severity of Alopecia Tool alopecia areata (used interchangeably 
with AA SALT)
SALT AGA
Severity of Alopecia Tool androgenetic alopecia
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Abbreviation
Term
SAP
statistical analysis plan
SARS-CoV2
severe acute respiratory syndrome coronavirus 2
SAS
Safety analysis set
SBA
serum bactericidal activity
SF-36v2 Acute
36-Item Short Form Health Survey version 2 Acute
SoA
Schedule of Activities
SOP
Standard operating procedure
SRSD
Single reference safety document
STAT
Signal transducer and activator of transcription
SUSAR
suspected unexpected serious adverse reaction
TB
Tuberculosis
TBili
Total bilirubin
TCR
T cell receptor
Td
tetanus and diphtheria toxoids
Tdap
tetanus and diphtheria toxoids and acellular pertussis
TdP
Torsades de Pointes
TEAE
Treatment-emergent adverse event
TEC
Tyrosine kinase expressed in hepatocellular carcinoma
TH1
Type 1 helper
TP1
Treatment Period 1
TP2
Treatment Period 2
T-Spot test
T-SPOT.TB
TYK2
Tyrosine kinase 2
TXK
tyrosine kinase expressed in T cells
UK
United Kingdom
US
United States
USPI
United States Prescribing Information
ULN
Upper limit of normal
UTI
Urinary Tract Infection
UVB
Ultraviolet B
VHP
Voluntary Harmonisation Procedure
VZV
Varicella zoster virus
VZV IgG Ab
Varicella zoster virus immunoglobulin G antibody
WOCBP
Woman of childbearing potential
WPAI:AA
Work productivity and activity impairment: alopecia areata
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10.16. Appendix 16: Protocol Amendment History
The Protocol Amendment Summary of Changes Table for the current amendment is located 
directly before the Table of Contents (TOC).
Amendment 5 (23 April 2021)
Section # and Name
Description of Change
Brief Rationale
Section 1.1: Synopsis, 
Section 1.2: Schema; 
Section 1.3: Schedule of 
Activities; 
Section 4.1: Overall 
Design; Section 4.2; 
Scientific Rationale for 
Study Design; 
Section 4.3: Justification 
for Dose
Study extension for all participants 
(de novo or originating from Study 
B7981015 or B7931005) to continue 
to receive open-label 50 mg 
PF-06651600 QD for 12 additional 
months, through Month 36.
Study extended to 
36 months based on 
regulatory feedback to 
obtain longer-term safety 
and efficacy data from 
adolescent participants with 
alopecia areata (AA) 
receiving PF-06651600 and 
based on sponsor decision 
to also extend the study 
duration for adult 
participants.
Section 1.3.2: Intervention 
Period
Added that the contraception check 
will also be performed monthly 
between study visits at the time of 
the phone contact to check the at-
home pregnancy test results.
This was made for 
consistency with the 
Protocol Deviation Alert 
Letter (dated 12Nov2020).
Section 1.3.2: Intervention 
Period; 
Section 8.2.11: Pregnancy 
Testing
Added clarification that the site 
contact to check pregnancy test 
results between visits will occur via 
telephone contact.
This was made for 
consistency with the 
Protocol Deviation Alert 
Letter (dated 12Nov2020) 
and with the case report 
form (CRF) collection for 
this study.
Section 1.3.2: Intervention 
Period
Added clarification for timing of 
pharmacokinetic (PK) sampling.
Added as PK may be 
skipped at visits under the 
alternative measures during 
public emergencies, 
including the COVID-19 
pandemic, as outlined in 
Appendix 21.
Section 1.3.2: Intervention 
Period; Section 1.3.3: Early 
Termination and 
Follow-up; Section 8.6: 
Pharmacodynamics; and 
Section 10.2, Appendix 2: 
Clinical Laboratory Tests; 
Section 10.8, Appendix 8: 
Guidelines for Participant 
Safety Monitoring and 
Discontinuation.
Clarified timing for collection of 
samples for reflex testing of 
fluorescence activated cell sorting 
(FACS) analysis of samples for 
T cell, B cell, and natural killer cell 
(TBNK) subsets, and that separate 
blood samples will be collected for 
FACS TBNK samples.
These changes were made 
to be consistent with the 
central laboratory manual, 
which requires a separate 
5 mL collection tube for 
FACS TBNK samples.
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Section # and Name
Description of Change
Brief Rationale
Section 1.3.2: Intervention 
Period
Created subsection (Section 1.3.2.2) 
for intervention period for receipt of 
open-label 50 mg PF-06651600 QD 
for 12 additional months, through 
Month 36, to distinguish from 
Schedule of Activities for 
intervention period through 
Month 24. Updated subsection for 
Week 2 to Month 24 
(Section 1.3.2.1) to reference study 
procedures from Month 28 through 
Month 36/EOT.
These changes were made 
to align with the changes 
for participants to continue 
to receive open-label 50 mg 
PF-06651600 QD for 
12 additional months, 
through Month 36.
Section 1.3.2.1: 
Intervention Period: 
Week 2 to Month 24
Removed 12-lead ECG procedure 
for Month 18 visit.
Reduced the frequency of 
ECG assessments to occur 
yearly after the Month 12 
visit, as the sponsor has 
performed an analysis of 
applicable nonclinical and 
clinical data that indicate 
that the risk for 
PF-06651600 to cause 
clinically meaningful QT 
prolongation in humans is 
low.  
Section 1.3.3: Early 
Termination and Follow-Up
Added statements to clarify the 
patient reported outcomes (PROs) 
that will not be reported at the Early 
Termination visit for participants 
who have completed the Month 24 
visit: 36 Item Short Form Health 
Survey version 2 (SF36v2), 
EuroQoL 5 Dimensions
(EQ-5D-5L), EuroQoL 
5 Dimensions Youth (EQ-5D-Y), 
Alopecia Areata Resource 
Utilization (AARU), and WPAI:AA 
(Work Productivity and Activity 
Impairment: Alopecia Areata).
These changes were made 
for consistency with 
Section 1.3.2 in which 
select PROs are not 
collected after Month 24.
Section 1.3.3: Early 
Termination and Follow-
up; Section 7.1: 
Discontinuation of Study 
Intervention
Added statement for study visit 
continuation for participants that 
discontinue study intervention.
Added in order to collect 
data in participants who 
have discontinued study 
intervention.
Section 1.3: Schedule of 
Activities; Section 8.1: 
Efficacy Assessments; 
Section 8.2: Safety 
Assessments; Section 10: 
Removed Section 10 appendices for 
copyrighted instruments (Severity of 
Alopecia Tool [SALT], Columbia 
Suicide Severity Rating Scale 
[C-SSRS], Hospital Anxiety and 
Updated per current 
practice not to include 
copyrighted instruments in 
protocol appendices.
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Section # and Name
Description of Change
Brief Rationale
Supporting Documentation 
and Operational 
Considerations
Depression Scale [HADS], EuroQol 
5 Dimensions [EQ-5D-5L], EuroQol 
5 Dimensions – Youth [EQ-5D-Y], 
Patient Health Questionnaire –
8 Items [PHQ-8], 36-Item Short 
Form Health Survey Version 2 
Acute [SF-36v2 Acute], and Tanner 
Stages of Development) as well as
cross-references to the deleted 
appendices.
Section 3: Objectives, 
Estimands and Endpoints
Added clarification for timing of 
endpoints.
These changes were made 
to provide clarification for 
the timing of each endpoint, 
to account for a potential 
extension of the study 
duration beyond Month 36 
(eg, in the event of a 
regulatory authority 
request).
Section 4.4: End of Study 
Definition
Added definition for primary 
completion date (PCD).
These changes were made 
to align with the changes 
for participants to continue 
to receive open-label 50 mg 
PF-06651600 QD for 
12 additional months, 
through Month 36, and in 
the event the study duration 
is extended beyond 
Month 36 (eg, per a 
regulatory authority 
request).
Section 4.4.1: Expanded 
Study Duration
Language added to provide the 
option for study extension (eg, per a 
regulatory authority request).
This change was made to 
allow for participants to 
continue to receive study 
intervention beyond 
Month 36 (eg, if requested 
by a regulatory authority.)
Section 5.2: Exclusion 
Criteria; Section 
6.5.2: Prohibited 
Concomitant Medications
Removed restrictions for 
medications that cause QT 
prolongation.
Sponsor has performed an 
analysis of applicable 
nonclinical and clinical 
data, which indicate that the 
risk for PF-06651600 to 
cause clinically meaningful 
QT prolongation in humans 
is low.  Prohibition of these 
medications is no longer 
required.
Section 5.3.1: 
Contraception; 
Updated text to clarify the time 
period, including the time after last 
These changes were made 
as some participants may 
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Section # and Name
Description of Change
Brief Rationale
Section 5.3.2: Cosmetic 
Treatments/Applications; 
Section 5.3.5: Elective 
Surgery; 
Section 6.5.2: Prohibited 
Concomitant Medications; 
Section 6.5.3: Vaccinations; 
Section 6.5.4: Surgery
dose, under which the restrictions 
apply.
remain in the study without 
study intervention per 
updates in Section 7.1.
Section 6.5.3: Vaccinations
Added text to clarify that vaccines 
(including COVID-19 vaccines) that 
are not live attenuated are permitted.
Added to provide 
affirmatory clarity given the 
widespread use of 
COVID-19 vaccines in the 
setting of the COVID-19 
pandemic.
Section 8: Study 
Assessments
Updated maximum amount of blood 
to be collected from a participant 
over the duration of the study. 
This change was made to 
align with the changes for 
participants to continue to 
receive open-label 50 mg 
PF-06651600 QD for 
12 additional months, 
through Month 36 and with 
clarifications regarding 
FACS TBNK sample 
collection in Sections 1.3.2, 
1.3.3, 8.6, and 10.2. 
Section 8: Study 
Assessments
Added statement regarding handling 
of participant medical records if 
requested by the sponsor.
This change was made to 
align text for handling of 
participant medical records 
in Section 10.3.3.
Section 8.1.2.1.1: 
Androgenetic Alopecia 
SALT Score; 
Section 8.1.3.5: EQ-5D-5L 
and EQ-5D-Y; 
Section 8.1.3.9: Behavior 
Rating Inventory of 
Executive Function®, 
Second Edition 
(BRIEF®2); 
Section 8.2.11: Pregnancy 
Testing; Section 9.4.1: 
Efficacy Analyses
Updated assessment timing for 
participants that receive open-label 
50 mg PF-06651600 QD through 
Month 36.
These changes were made 
to align with the changes 
for participants to continue 
to receive open-label 50 mg 
PF-06651600 QD for 
12 additional months, 
through Month 36.
Section 8.2.3: Vital Signs; 
Section 10.13.2: Telehealth 
visits; Section 10.13.5: 
Home Health Visits
Respiratory rate has been removed 
from the vital sign measurements.
Respiratory rate is 
considered to have little 
utility for safety monitoring 
or reporting purposes.
Section 8.2.8.1.2; 
Appendix 22, Section 10.22
Added clarification of the process 
(included in Appendix 22) for 
Clarification added, which 
is consistent with updates 
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Section # and Name
Description of Change
Brief Rationale
participants with a positive 
tuberculosis (TB) test result during 
the study.
made in B7981032 Protocol 
Amendment 4.
Section 8.3.5.1: Exposure 
During Pregnancy
Updated language to include 
reporting of pregnancies in female 
partners of male participants and to 
add the routes of exposure to study 
intervention.
To correct an error made in 
Protocol Amendment 4 
when updating for 
consistency with the 
protocol template.
Section 9.3: Populations for 
Analyses; Appendix 22, 
Section 10.22: List of 
Abbreviations
Updated efficacy analysis population 
to define Full Analysis Set (FAS) 
and added the definition of the PK 
population.
FAS definition added for 
consistency with updates 
made in Study B7981015, 
per regulatory agency 
request, and PK population 
definition added for 
consistency with 
Section 9.4.4.
Section 9.4.1: Timing of the 
Analyses
Added specification for PCD 
analysis and potential for 
supplemental analysis in the event of 
study duration extension beyond 
Month 36 (eg, due to regulatory 
authority request).
These changes were made 
to align with the changes 
for participants to continue 
to receive open-label 50 mg 
PF-06651600 QD for 
12 additional months, 
through Month 36, and to 
include a supplemental 
analysis if participants 
continue to receive study 
intervention beyond 
Month 36 (eg, upon request 
by a regulatory authority).
Appendix 1, 
Section 10.1.5.2: 
Adjudication/Review 
Committee Submission
Added language for sponsor review 
of source documents to support 
event adjudication by the 
Adjudication/Review Committee.
This change was made for 
consistency with language 
in the March 2021 protocol 
template, Section 4.2.3 
Adjudication Committee.
Appendix 4, Section 10.4.3: 
Women of Childbearing 
Potential
Added language regarding use of 
contraception if a participant’s 
childbearing potential or risk of 
pregnancy changes after the start of 
the study.
This change was made for 
consistency with 
Sections 5.3.1 and 8.2.12.
Appendix 10, 
Section 10.10: Summary
Updated timing for which 
participants from the main 
B7981032 study can participate in 
the vaccine sub-study.
This change was made to 
align with the changes for 
participants to continue to 
receive open-label 50 mg 
PF-06651600 QD for 
12 additional months, 
through Month 36.
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Section # and Name
Description of Change
Brief Rationale
Appendix 10, 
Section 10.10: Summary; 
Schedule of Activities; 
Study Design, Participant 
Selection; Study 
Intervention
Updated vaccine sub-study to allow 
participants to either receive both 
meningococcal ACWY and Tdap 
vaccines or just one of the two 
vaccines, and to match age 
requirements in Tdap label for 
participants who receive only Tdap 
vaccine.
Increased flexibility of 
vaccine sub-study vaccine 
requirement to allow 
enrollment of participants 
eligible to receive only one 
of the vaccines.
Appendix 10, 
Section 10.10: Introduction, 
References for Vaccine 
Sub-Study
Updated information for the Tdap 
and meningococcal ACWY vaccines 
to reference the US prescribing 
information (USPI).  References to 
single reference source documents 
(SRSD) for the vaccines in the 
sub-study were also removed as 
these are non-IMP.  
These updates were made 
for clarification and 
consistency with the change 
made in the Study 
Intervention section of the 
sub-study, which specifies 
these as non-IMP.
Appendix 10, 
Section 10.10: Study 
Objectives and Endpoints
Updated primary endpoint to only 
include immune response to Tdap 
vaccination; immune response to 
meningococcal ACWY vaccination 
moved to a secondary endpoint.
These updates were made 
due to the expectation that 
only a smaller number of 
participants is likely to be 
eligible for receiving the 
meningococcal ACWY 
vaccine.
Appendix 10, 
Section 10.10: Study 
Intervention
Updated table for study intervention 
supplies to include a row that 
specifies whether each study 
intervention (vaccine) is an 
investigational medicinal product 
(IMP) or non-IMP.
Added clarification that the 
Tdap and meningococcal 
ACWY vaccines are 
considered non-IMPs in the 
United States, Canada, and 
Australia, where the 
vaccine sub-study is 
planned to be conducted.
Appendix 10, 
Section 10.10: Statistical 
Considerations
Updated vaccine sub-study sample 
size to be based on the number of 
participants who receive the Tdap 
vaccine (with or without 
meningococcal ACWY vaccine).
These changes were made 
to align with the changes to 
allow vaccine sub-study 
participants to either 
receive both meningococcal 
ACWY and Tdap vaccines 
or just one of the two 
vaccines, and due to the 
expectation that more 
participants are likely to be 
eligible for Tdap vaccine 
than for meningococcal 
ACWY vaccine.
Appendix 10, 
Section 10.10: Statistical 
Considerations
Defined vaccine sub-study Full 
Analysis Sets (FAS) and Safety 
Analysis Set (SAS).
These changes were made 
to align with the changes to 
allow vaccine sub-study 
participants to either 
receive both meningococcal 
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Section # and Name
Description of Change
Brief Rationale
ACWY and Tdap vaccines 
or just one of the two 
vaccines, and due to the 
expectation that more 
participants are likely to be 
eligible for Tdap vaccine 
than for meningococcal 
ACWY vaccine.
Appendix 10, 
Section 10.10: Summary, 
Participant Selection
Added Australia as a country 
location for the vaccine sub-study.
Updated to clarify that the
vaccine sub-study will also 
be conducted at site(s) in 
Australia.
Appendix 13, 
Section 10.13.3.1
Specified windows for remote visits 
and laboratory sample collections for 
participants that receive open-label 
50 mg PF-06651600 QD through 
Month 36.
These changes were made 
to align with the changes 
for participants to continue 
to receive open-label 50 mg 
PF-06651600 QD for 
12 additional months, 
through Month 36.
Appendix 16, 
Section 10.16: Protocol 
Amendment History
Moved table for Amendment 4 
descriptions of changes and brief 
rationales to this appendix.
Following Pfizer’s standard 
procedure for the common 
protocol template.
Throughout document.
Other relatively minor 
administrative/typo/formatting 
updates.
Updated for grammatical 
correctness, clarity, 
consistency with Pfizer 
Global Style Guide and 
protocol template.
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Amendment 4 (31 August 2020)
Section # and Name
Description of Change
Brief Rationale
Section 1.1: Synopsis
Updates were made to the 
Objectives and Endpoints 
table.
These changes were made to 
align with changes made to the 
Objectives and Endpoints table 
in Section 3.
Section 1.1: Synopsis; Section 
4.1: Study Design, Overall 
Design; Section 4.2: Scientific 
Rationale for Study Design; 
Section 9.2: Sample Size 
Determination
The number of de novo 
participants was updated, 
with a corresponding update 
to the total sample size, and 
reference to the number of 
participants from the index 
studies B7931005 and 
B7981015 was removed. In 
addition, the number of sites 
was updated.
Updated the total sample size 
to more accurately reflect the 
actual number of participants 
expected to be enrolled.  
Reference to number of 
participants from Study 
B7931005 and B7981015 was 
removed considering the 
uncertainty regarding the 
number of participants willing 
and eligible to be enrolled in 
Study B7981032 from each of 
the index studies.  The number 
of sites was updated to more 
accurately reflect the actual 
number of sites expected to 
participate in this study.
Section 1.3: Schedule of 
Activities, table footnotes; 
Section 8.1.3.3: Patient’s 
Satisfaction with Hair Growth 
(P-Sat); Appendix 22: 
Abbreviations
For Patient’s Satisfaction with 
Hair Growth (P-Sat), 
“(3-items)” was removed 
from the title of the 
instrument.
Updated for consistency with 
the title of the instrument, 
which does not include a 
description of the number of 
items.
Section 1.3: Schedule of 
Activities; Section 4.1: Study 
Design, Overall Design  
Reference to Appendix 21, 
Alternative Measures During 
Public Emergencies, was 
added.
This change has been made to 
clarify alternative measures to 
accommodate study 
procedures during the public 
emergencies, including the 
COVID-19 pandemic.  This 
change is consistent with the 
protocol administrative change 
letter dated 05 June 2020.
Section 1.3.1: Schedule of 
Activities, Screening and Day 1
Under the Laboratory 
Section, Serum FSH, added a 
reference to Section 10.4.3 
and clarifying text.
This change was added to 
provide clarity regarding FSH 
testing in postmenopausal 
women and to instruct that this 
testing will not be performed 
in WOCBP.
Section 1.3.1: Schedule of 
Activities, Screening and Day 1
Under Patient Reported 
Outcomes section, AARU, 
second paragraph in the Notes 
This update was made to 
clarify which visit was referred 
to for this PRO.
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Section # and Name
Description of Change
Brief Rationale
column: “first visit” was 
updated to “Day 1 visit”
Section 1.3.2: Schedule of 
Activities, Intervention Period
Under Clinical Assessments 
section, Photography: in the 
Notes column, Section 8.1.3.9 
was changed to Section 8.1.4.
This change was made to 
update the Section header to its 
correct number.
Section 1.3.2: Schedule of 
Activities, Intervention Period
Under Observer Reported 
Outcomes Section, 
BRIEF®2: the shading in 
columns for Months 1 and 3 
was removed.
Updated for clarification as 
BRIEF®2 is not administered 
at these timepoints.
Section 1.3.2, Schedule of 
Activities, Intervention Period
Under Other Section: Added 
a row titled, “Check for study 
intervention continuation 
criteria for adolescents” and 
timepoints at Months 3 and 6.
A Section reference and notes 
were added to the Notes 
column.
This addition was made to 
align with updates made in 
Appendix 10.8.2.
Section 2.2.2: Nonclinical and 
Phase 1 Efficacy and Safety 
Data
The text related to exposure 
margins was updated.
These changes have been made 
to provide updated information 
to sites.
Section 2.2.3: Clinical 
Experience; Section 2.2.3.1: 
Phase 2a Study in Alopecia 
Information was updated to 
include new ongoing studies 
with PF-06651600. In 
addition, a statement was 
added to indicate that the final 
results of the Phase 2a study 
in participants with alopecia 
areata (B7931005) are now 
available in the Investigator’s 
Brochure.
The header title of Section 
2.2.3.1 was updated to Phase 
2a Study in Alopecia Areata.
These changes have been made 
to provide updated information 
now available in the January 
2020 Investigator’s Brochure.
The header title was updated to 
include the full name of the 
study intervention indication.
Section 3: Objectives, 
Estimands and Endpoints
The following secondary 
endpoints were moved to 
tertiary endpoints:
-Absolute SALT scores at all 
time points collected, for 
overall and AA SALT score
-Response based on achieving 
at least 50% improvement in 
SALT (SALT50) from 
baseline at all time points 
These changes were made to 
align with regulatory feedback 
for the B7981015 protocol to 
reduce the number of 
secondary endpoints.
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collected, for overall and AA 
SALT score
- Change from baseline in 
36-Item Short Form Health 
Survey version 2 Acute 
(SF36v2 Acute) at all time 
points collected
Section 3: Objectives, 
Estimands and Endpoints
The following secondary 
endpoint was removed:
- Absolute score of Patient’s 
Global Impression of Change 
(PGI-C) at all time points 
collected;
The definition for the 
secondary endpoint of PGI-C 
response was updated to the 
following:
- PGI-C response defined as a 
PGI-C score of “moderately 
improved or greatly 
improved” at all timepoints 
collected.
The following tertiary 
endpoint was added:
- Improvement on PGI-C 
defined as “slightly 
improved”, moderately 
improved”, or “greatly 
improved” at all time points 
collected
These changes have been made 
to align with regulatory agency 
feedback for the B7981015 
protocol to report on multiple 
aspects of this patient reported 
outcome.
Section 3: Objectives, 
Estimands and Endpoints
The tertiary endpoint for the 
P-Sat was revised from a 
continuous score to a 
categorical assessment to 
accurately indicate a 
participants categorical 
improvement at the item 
level.
These changes have been made 
because the scaling and 
scoring for this patient 
reported outcome is still in the 
process of being established.
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Section 3: Objectives, 
Estimands and Endpoints
Reference to the specific 
domain scores were removed 
from the secondary endpoint 
evaluating a change from 
baseline in the AAPPO. The 
scales are now described in 
section 8.1.3.1.
These changes have been made 
because the validation for this 
patient reported outcome has 
now been completed to reflect 
the correct domains.
Section 3: Objectives, 
Estimands and Endpoints
The secondary endpoint 
evaluating a change from 
baseline in the HADS was 
split into two separate 
endpoints to clarify that the 
depression and anxiety 
subscales will be analyzed 
separately.  
In addition, the secondary 
endpoint assessing 
participants with baseline 
HADS subscale scores 
indicative of depression or 
anxiety were revised and split 
into 2 separate endpoints.  
These changes have been made 
to align with feedback from 
the developer’s scoring manual 
and clinical experts in AA to 
analyze depression and anxiety 
separately and to measure a 
change in individual subscales.
Section 4.1: Overall Design
The text describing de novo 
participant characteristics was 
updated.
Update made for consistency 
with revisions to inclusion #1 
in Section 5.1.1.
Section 4.3: Justification for 
Dose
Minor revisions were made to 
this section and data were 
updated in Table 1.
Revisions were made to 
provide updated study 
information.
Section 5: Study Population
The text regarding 
participants originating from 
Study B7981015 with ≤30 
days between the first visit of 
Study B7981032 and the last 
dose of the index study was 
updated.
Updated for consistency with 
revisions made in Exclusion 
Criterion #1.
Section 5.1.1: Inclusion Criteria 
for De Novo Participants and 
Those Originating From 
B7931005 or B7981015 with ≥ 
30 Days Between the Index 
Study and Study B7981032
Inclusion Criterion #1 was 
updated to require ≥50% 
terminal scalp hair loss 
(previously ≥25%) for de 
novo participants ≥12 to <18 
years of age at the time of 
signing informed 
consent/assent.
To address regulatory agency 
feedback, Pfizer modified the 
Study B7981032 inclusion 
criteria to require that de novo 
adolescent participants at the 
time of the B7981032 Day 1 
visit have ≥50% (changed 
from ≥25%) terminal scalp 
hair loss due to AA (including
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Brief Rationale
AT and AU) at both the 
screening and Day 1 visits.
Section 5.1.3: Inclusion Criteria 
for All Participants
The following text was added 
to Inclusion Criterion #4:
“Within  the UK, participants 
must be 18 years of age or 
older.”
Added per request of MHRA 
(Medicines and Healthcare 
Products Regulatory Agency) 
to clarify that within the UK, 
participants below the age of 
18 years are not permitted.
Section 5.1.3: Inclusion Criteria 
for All Participants
References to sections in 
Appendix 4 were added.
Appendix 4 was updated to 
align with the latest version of 
the Pfizer protocol template.
Section 5.2.1: Exclusion Criteria 
for Participants Originating from 
B7981015 with ≤30 Days 
between Studies
Exclusion Criterion #1 was 
updated to:
“During Study B7981015 or 
in the period between the 
index study and Study 
B7981032, presence of safety 
events meeting 
discontinuation criteria in  
Appendix 8, Section 10.8.2 
(eg, serious infections, 
laboratory results, ECG 
results)”
For clarity, the VHP country 
specific Discontinuation 
Criteria for Worsening of AA 
was moved from Appendix 8, 
Section 10.8.2 to the separate 
Appendix 19. Consequently, 
the section reference was 
updated to refer specifically to 
Section 10.8.2.  As such, 
reference to the 
discontinuation criteria for 
worsening AA was removed 
from this criterion as it is not 
applicable in the context of 
Exclusion criterion #1.
Section 5.2.2: Exclusion Criteria 
for De Novo Participants and 
Those Originating From 
B7931005 or B7981015 with 
>30 Days between the Index 
Study and Study B7981032
In Criterion #11, “Exclusion 
Criterion 21” was updated to 
“Exclusion Criterion 19”. 
Update was made because the 
numbering for this criterion 
had changed.  The content of 
the criterion did not change.
Section  5.2.3: Exclusion 
Criteria for all Participants
The following text was added 
to Exclusion Criterion #16:
“This criterion is not 
applicable to sites where 
enrollment of adolescent 
participants is not permitted 
(see Inclusion #4).”
Added for clarification
Section 5.2.3: Exclusion Criteria 
for all Participants
Exclusion Criterion #25, item 
d, was updated to refer to 
immunosuppressants instead 
of immune suppressants.   
Updated for consistency with 
Section 6.5.2.
Section 5.2.3: Exclusion Criteria 
for all Participants
Exclusion Criterion #25, item 
i, was updated to state that 
psychiatric drugs and 
antihypertensives are 
prohibited unless allowed by 
Updated for clarification
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Brief Rationale
the sponsor (changed from 
“may be acceptable if 
approved” to “prohibited 
unless approved”   
Section 5.3.1: Contraception
The text in this section was 
updated.
This change was made to align 
with the current version of the 
Pfizer protocol template.
Section 5.3.1: Contraception
The following text was 
deleted: 
“Participants who are 
WOCBP must agree to use 
one highly effective method 
of contraception (as specified 
in Appendix 4), as 
applicable.”
Text was added to include 
consultation with the 
participant’s parent/legal 
guardian (if required for 
adolescent participants).  
This change was made to align 
with the current version of the 
Pfizer protocol template.
This text was added to account 
for adolescent participants in 
the study.
Section 6.5.2: Prohibited 
Concomitant Medications
Text was updated to state that 
psychiatric drugs and 
antihypertensives are 
prohibited unless allowed by 
the sponsor (changed from 
“may be acceptable if 
approved” to “prohibited 
unless approved”  
This change was made to align 
to changes made to Exclusion 
Criterion #25 in Section 5.2.3: 
Exclusion Criteria for All 
Participants.
Section 7: Discontinuation of 
Study Intervention and 
Participant Discontinuation/ 
Withdrawal
References added to 
Appendix 8, Appendix 19, 
and Appendix 20.
Updated based on changes 
made in Appendix 8 and the 
addition of Appendix 19 and 
Appendix 20.
Section 8: Study Assessments 
and Procedures
Text regarding the following 
was added:

Completion of screening 
evaluations

Completion of protocol-
required tests and 
procedures

Information regarding 
provision of instructions 
for samples being 
collected and shipped.
These changes were made to 
align with the current version 
of the Pfizer protocol template.
Section 8: Study Assessments 
and Procedures
Added that all Day 1 
evaluations must be 
This text was added for 
clarification.
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Description of Change
Brief Rationale
completed and reviewed to 
confirm that potential de novo 
participants and participants 
originating from B7931005 or 
B7981015 with >30 days 
between the first visit of 
Study B7981032 and the last 
dose in Study B7931005 or 
B7981015 meet all eligibility 
criteria prior to randomizing 
the participant in Impala.
Section 8: Study Assessments 
and Procedures
References to the following 
appendices were added:
Appendix 19, Discontinuation 
criteria for Worsening AA in 
VHP countries in the EU.
Appendix 20, Study 
Intervention Continuation 
Criteria for adolescents.
Appendix 21, Alternative 
Measures During Public 
Emergencies,
These criteria were moved 
from Appendix 8 as they are 
not safety discontinuation 
criteria.
This change has been made to 
address regulatory agency 
feedback regarding 
discontinuation criteria for 
adolescents without adequate 
clinical response to limit their 
total exposure to chronic study 
treatment. Based on this, Pfizer 
modified the B7981032 
protocol in order to minimize 
the time that non-responder 
adolescent participants are 
exposed to PF-06651600 
treatment in Study B7981032.
This change has been made to 
clarify alternative measures to 
accommodate study 
procedures during the public 
emergencies, including the 
COVID-19 pandemic.  This 
change was previously 
communicated to sites in the 
protocol administrative change 
letter dated 05 June 2020.
Section 8.1.3.1: Alopecia Areata 
Patient Priority Outcomes 
(AAPPO)
Language was added to this 
section providing information 
on the anchor-based 
methodology to be used for 
This change has been made for 
clarification.
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Brief Rationale
the interpretation of the 
AAPPO.
Section 8.1.3.4: Hospital 
Anxiety and Depression Scale 
(HADS)
Language was updated to 
correct the description of the 
subscales for the HADS.
This change has been to limit 
any observer bias at sites.
Section 8.2: Safety Assessments
Text regarding unscheduled 
clinical laboratory 
assessments was added.
This change was made to align 
with the current version of the 
Pfizer protocol template.
Section 8.2.3: Vital Signs
Language was updated to 
allow for the use of temporal 
artery temperature 
measurements.
This change has been made to 
reflect current clinical practice 
for temperature measurement.
Section 8.2.7.2.2: Drug-Related 
Rash
Header title updated to 
Potential Drug-Related Rash 
and Unexplained Rash.
This update was made for 
clarity.
Section 8.2.8: Clinical Safety 
Laboratory Assessments
Text regarding protocol-
required laboratory 
assessments and a reference 
to Appendix 6 for DILI were 
added.
These changes were made to 
align with the current version 
of the Pfizer protocol template.
Section 8.2.8.1.2: Day 1 and 
Annual Tuberculosis Testing

Text was added 
regarding withholding of 
study intervention for 
participants with a positive 
TB result or a chest 
radiograph indicative of 
active TB.
Minor edits were also made to 
this section to align with the 
above additions.
This text was added to provide 
clarification for study 
intervention administration for 
participants with positive TB 
test results.
Section 8.3: Adverse Events and 
Serious Adverse Events
Text was added regarding the 
questioning about the 
occurrence of AEs.
This change was made to align 
with the current version of the 
Pfizer protocol template. 
Section 8.3.4: Regulatory 
Reporting Requirements for 
SAEs
Minor edits were made to this 
section.
These changes were made to 
align with the current version 
of the Pfizer protocol template.
Section 8.3.5.1: Exposure 
During Pregnancy
The original text was deleted 
and replaced with alternate 
text.
This change was made to align 
with the current version of the 
Pfizer protocol template.
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Brief Rationale
Section 8.3.5.2: Exposure 
During Breastfeeding
The original text was deleted 
and replaced with alternate 
text.
This change was made to align 
with the current version of the 
Pfizer protocol template.
Section 8.3.5.3: Occupational 
Exposure
Minor edits were made to this 
section.
These changes were made to 
align with the current version 
of the Pfizer protocol template.
Section Headers 8.3.6 -8.3.9
Headers were added.
Text was added to Section 
8.3.8: “Refer to Section 
8.2.7”.
Header for Section 8.3.8.1. 
Lack of Efficacy (Not 
Applicable) was added with 
accompanying text.
Added headers to align with 
the current version of the 
Pfizer protocol template.
Reference was added for 
clarity.
Updated to align with the 
current version of the Pfizer 
protocol template.
Section 8.3.6: Medication 
ErrorsHeader re-numbered to 
8.3.10Header was re-numbered 
since additional headers were 
added.Sections 8.3.10: 
Medication Errors, and Section 
8.4, Treatment of Overdose 
Updated text to clarify that in 
the event of a medication 
dosing error, the sponsor 
should be notified within 24 
hours.
Updated to align with the 
current version of the Pfizer 
protocol template.
Section 8.4: Treatment of 
Overdose
Updated the instruction 
regarding monitoring of 
events of overdose.
This change was made to align 
with the current version of the 
Pfizer protocol template.
Section 8.5: Pharmacokinetics, 
and Section 8.6, 
Pharmacodynamics
The following text was 
added: “These additional 
exploratory analyses will not 
be performed on samples 
collected from participants at 
sites in China; refer to Section 
10.7.2.”
Updated text to:
“Samples will be analyzed 
using fit for purpose or 
validated analytical methods 
in compliance with applicable 
Pfizer standard operating 
procedures.”  
This text was added to provide
reference to the new Section 
10.7.2.
Updated to correct a typo.
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Section # and Name
Description of Change
Brief Rationale
Section 9.2: Sample Size 
Determination
Text was updated to align 
with changes made in Section 
4.1: Overall Design.
Refer to rationale for changes 
made in Section 4.1: Overall 
Design.
Appendix 1, Section 10.1.3: 
Informed Consent Process
Text was added regarding 
giving participants sufficient 
time to ask questions before 
deciding to participate in the 
trial.
Text was added regarding 
informed consent procedures 
for minor participants.
In addition, text was added to 
include consultation with the 
participant’s parent/legal 
guardian. 
This revision was made to 
align with the current version 
of the Pfizer protocol template.
These additions were added 
from the template pediatric 
library to address informed 
consent for adolescent 
participants in the study.
This text was added to account 
for adolescent participants in 
the study.
Appendix 1, Section 10.1.3: 
Informed Consent Process

Text regarding the 
use of remaining mandatory 
samples for optional 
exploratory research was 
deleted. 
This change is in accordance 
with the PACL dated 21 Feb 
2020 to correct an error in the 
protocol as banked 
biospecimen samples will not 
be collected for this study.
Appendix 1, Section 10.1.5.2: 
Adjudication/Review 
Committee Submission

The following 
statement was added:
“Additional types of events 
for review and adjudication 
may be identified by Pfizer.”  
This statement was added to 
allow for additional types of 
events to be requested for 
review and adjudication.
Appendix 1, Section 10.1.6: 
Dissemination of Clinical Study 
DataMinor revisions were made 
to this section.These revisions 
were made to align with the 
current version of the Pfizer 
protocol template.
Appendix 1, Section 10.1.9: 
Study and Site Closure
Text regarding premature 
termination or suspension of 
the study was added.
This revision was made to 
align with the current version 
of the Pfizer protocol template.  
Appendix 2 (Section 10.2): 
Clinical Laboratory Tests
Footnotes #2, #6, and #13 in 
Table 2 were updated.
Footnote #2 was updated to fix 
a typo.
Footnote #6 was updated and a 
reference to Section 10.4.3 was 
added for clarity.
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Section # and Name
Description of Change
Brief Rationale
Footnote #13 was corrected to 
add hyphens for the QFT-G 
and T-Spot tests. 
Appendix 3 (Adverse Events: 
Definitions and Procedures for 
Recording, Evaluating, Follow-
up, and Reporting)
Minor edits were made to this 
appendix overall.
The revisions were made to 
align with the current version 
of the Pfizer protocol template.
Appendix 3, Section 10.3.1: 
Definition of AE (Events 
Meeting the AE Definition)
Text regarding abnormal 
laboratory test results was 
added. 
These revisions were made to 
align with the current version 
of the Pfizer protocol template.
Appendix 3, Section 10.3.1: 
Definition of AE (Events 
Meeting the AE Definition)
Text regarding lack of 
efficacy was deleted.
The deleted text does not 
pertain to this study.
Appendix 3, Section 10.3.2: 
Definition of SAE (f. Other 
situations)
A bullet was added regarding 
SAE reporting for suspected 
transmission of an infectious 
agent via a Pfizer Product.
The revision was made to align 
with the current version of the 
Pfizer protocol template.
Appendix 3, Section 10.3.3: 
Recording/Reporting and 
Follow-Up of AE and/or SAE
Updated table to provide 
additional clarity.
The revisions were made to 
align with the current version 
of the Pfizer protocol template.
Appendix 4: Contraceptive 
Guidance and Collection of 
Pregnancy Information
This section was retitled, 
updated with third-level 
headers, and updated with 
template text.
These changes were made to 
align this Appendix with the 
current version of the protocol 
template.
No changes to contraceptive 
requirements were made.
Appendix 7, Section 10.7.2: 
China Specific Language For 
Section 8.5 Pharmacokinetics 
and Section 8.6 
Pharmacodynamics
This section was added to the 
protocol.
The following text was also 
added: “Section 8.5 
Pharmacokinetics and Section 
8.6 Pharmacodynamics are 
updated to remove 
exploratory analyses 
performed on 
pharmacokinetic and 
pharmacodynamic blood 
samples collected from 
participants at sites in China.”
The section added is in 
accordance with the PACL 
dated 06 Apr 2020 in order to 
document that exploratory 
analyses will not be performed 
on these samples collected 
from participants at sites in 
China.
The additional text was added 
for clarification.
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Section # and Name
Description of Change
Brief Rationale
Appendix 8, Section 10.8.1: 
Monitoring
Text regarding withholding of 
study intervention in 
participants with a positive 
TB result was added. 
A footnote was added to the 
table in this section.
This text was added to provide 
clarification for study 
intervention administration for 
participants with positive TB 
test results, in alignment with 
updates made to Section 
8.2.8.1.2.The footnote was 
added to the table to provide 
clarification regarding the 
timelines for re-testing of 
laboratory values.
Appendix 8, Section 10.8.2: 
Discontinuation
Under Laboratory 
Abnormalities, text was 
added to indicate that test 
abnormalities require 
discontinuation if they are 
confirmed by retest, and a 
reference to Section 10.8.1 
was added for laboratory 
abnormalities re-testing 
timeframes.
The VHP country specific 
Discontinuation Criteria for 
Worsening of AA was moved 
from Appendix 8: Guidelines 
for Participant Safety 
Monitoring and 
Discontinuation, Section 
10.8.2. Discontinuation to the 
separate Appendix 19. 
This text and section reference 
were added to provide 
clarification concerning re-
testing regarding laboratory 
abnormalities.
These criteria were moved as 
they are not safety 
discontinuation criteria.
Appendix 18: Vaccine Sub-
Study
A day was added to the Study 
Day for the sub-study Month 
1 visit in the Schedule of 
Activities.  
In addition, the timeframe for 
the vaccine sub-study 
endpoints was updated in the 
Study Objectives and 
Endpoints table and the 
Statistical Considerations 
sections of the sub-study 
appendix.
The update to the Study Day 
was made to correct a 
typographic error.
The timeframe for the vaccine 
sub-study endpoints was 
updated for consistency with 
the visit name in the Schedule 
of Activities
Appendix 18: Vaccine Sub-
Study
Inclusion Criterion #3 was 
updated with the additional 
Inclusion criterion #3 of the 
sub-study is being clarified so 
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Section # and Name
Description of Change
Brief Rationale
text: “In addition, participant 
should not miss any dose of 
PF-06651600 for at least 
seven consecutive days just 
prior to Day 1 of this sub-
study.”
In the section titled 
Administration, the following 
text was added: “The 
participant should be 
observed for at least 30 
minutes after vaccine 
administration to assess any 
acute reactions.”
The following text was added 
to the Summary and Sub-
Study Inclusion Criteria 
Sections: “The vaccine sub-
study will be performed at 
sites in the US and Canada.” 
that the baseline antibody 
levels are evaluated during 
uninterrupted PF-06651600 
treatment and to ensure that 
the response to vaccination 
reflects uninterrupted exposure 
to study intervention.  This 
change was made according to 
the PACL dated 13-May-2020.
The text to the Administration 
section was added in 
accordance with the PACL 
dated 13-May-2020 in order to 
add observations of 
participants to assess any acute 
reactions following 
administration of vaccines.
The additional text was added 
to the Summary and Sub-Study 
Inclusion Criteria sections for 
clarity.
Appendix 19: Discontinuation 
Criteria for Worsening of 
Alopecia Areata
The VHP country specific 
Discontinuation Criteria for 
Worsening of AA was moved 
from Appendix 8: Guidelines 
for Participant Safety 
Monitoring and 
Discontinuation, Section 
10.8.2. Discontinuation to the 
separate Appendix 19.
These criteria were moved as 
they are not safety 
discontinuation criteria.
Appendix 20: Study Intervention 
Continuation Criteria for 
Adolescents
New text and table were 
added under the heading 
“Study Intervention 
Continuation Criteria for 
Adolescents.”
This change has been made to 
address regulatory agency 
feedback regarding 
discontinuation criteria for 
adolescents without adequate 
clinical response to limit their 
total exposure to chronic study 
treatment. Based on this, Pfizer 
modified the B7981032 
protocol in order to minimize 
the time that non-responder 
adolescent participants are 
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Section # and Name
Description of Change
Brief Rationale
exposed to PF-06651600 
treatment in Study B7981032.
Appendix 21: Alternative 
Measures During Public 
Emergencies
This appendix was added.
These changes have been made 
to clarify alternative measures 
to accommodate study 
procedures during public 
emergencies, including the 
COVID-19 pandemic.  These 
changes were previously 
communicated to sites in the 
protocol administrative change 
letter dated 05 June 2020.
Appendix 22: Abbreviations
This appendix was 
renumbered to Appendix 22 
from Appendix 19 after the 
addition of 3 new 
Appendices. 
Additional definitions were 
added as needed to align with 
added text.
This is a change resulting from 
an additional 3 appendices 
being added.  Additional text 
resulted in additional 
abbreviations; those 
abbreviations and definitions 
were added to this section.
Appendix 23: Protocol 
Amendment History
This appendix was 
renumbered to Appendix 23 
from Appendix 20 after the 
addition of 3 new 
Appendices.
The information for Protocol 
Amendment 3 was moved 
from the beginning of the 
document to this section.
This is a change resulting from 
an additional 3 appendices 
being added.
Protocol amendment 3 
information was moved to this 
section since only the current 
amendment information 
(protocol amendment 4) 
should be placed at the 
beginning of the document.
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Amendment 3 (28 April 2020)
Overall Rationale for the Amendment:
Section # and Name
Description of Change
Brief Rationale
Appendix 18: Vaccine Sub-
Study
The following was added to the 
Summary and Inclusion 
Criteria sections of the 
appendix describing the 
vaccine sub-study:
The vaccine sub-study will not 
be conducted at sites within the 
VHP countries in the EU (ie, 
Czech Republic, Germany, 
Hungary, Poland, and Spain).  
Added per VHP request to 
clarify that sites in VHP 
countries will not participate in 
the sub-study.
Appendix 20: Protocol 
Amendment History
Moved table for Amendment 2 
descriptions of changes and 
brief rationales to this 
appendix.
Following Pfizer’s standard 
procedure for the common 
protocol template.
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Amendment 2 (05 February 2020)
Overall Rationale for the Amendment:
Section # and Name
Description of Change
Brief Rationale
Section 1.1 Synopsis; Section 
1.3 Schedule of Activities; 
Section 2 Introduction; Section 
2.1 Study Rationale; Section 
2.3 Benefit/Risk Assessment; 
Section 3 Study Objectives and 
Endpoints; Section 4.1 Overall 
Design; Section 5 Study 
Population; Section 6 Study 
Intervention; Section 9 
Statistical Considerations
Added references to the 
vaccine sub-study in Appendix 
18.
Updated to reflect sections for 
which corresponding 
information for the vaccine 
sub-study can be found in 
Appendix 18.
Section 1.3.1 Schedule of 
Activities, Screening and 
Day 1
Removed the Hamilton-
Norwood Scale
Updated for consistency with 
revisions to Inclusion #1, in 
which the requirement 
regarding degree of 
androgenetic alopecia in male 
participants was removed.
Section 1.3.1 Schedule of 
Activities, Screening and 
Day 1; Section 1.3.2 Schedule 
of Activities, Intervention 
Period; Section 1.3.3 Schedule 
of Activities, Early 
Termination and Follow-up; 
Section 3 Study Objectives and 
Endpoints; Section 8.1.3.9 
BRIEF®2
Added BRIEF®2 to the 
Schedule of Activities.
Added BRIEF®2 endpoint to 
Section 3.
Added BRIEF®2 information 
to Section 8.
Added questionnaire to assess 
neuropsychological 
development and executive 
functioning in adolescents.
Section 1.3.1 Schedule of 
Activities, Screening and 
Day 1
The following was updated for 
the notes for the AARU:
“For participants originating 
from Study B7981015 with <3 
months between the Day 1 
visit of Study B7981032 and 
the last visit at which the 
AARU was performed in 
Study B7981015, the AARU 
will not be collected until the 
Month 3 visit (ie, the AARU 
will not be collected at the 
Day 1 visit for this group).”
This was updated as Day 1 is 
the first visit at which the 
AARU is collected in Study 
B7981032.
Section 1.3.1 Schedule of 
Activities, Screening and 
Language regarding varicella 
zoster virus immunoglobulin G 
Updates made based on 
revisions to Exclusion #16
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Section # and Name
Description of Change
Brief Rationale
Day 1; Section 8.2.8.3. 
Varicella Zoster Virus 
Immunoglobulin G Antibody 
(VZV IgG Ab) Testing; 
Section 10.2. Appendix 2: 
Clinical Laboratory Tests, 
Table 1 footnote12
antibody (VZV IgG Ab) 
testing was updated to the 
following:
“Serological testing must be 
performed for VZV IgG Ab 
only in the absence of 
documented evidence of 
having received varicella 
vaccination (2 doses) per 
Exclusion #16.”
Section 1.3.1 Schedule of 
Activities, Screening and 
Day 1; Section 8.2.8.3. 
Varicella Zoster Virus 
Immunoglobulin G Antibody 
(VZV IgG Ab) Testing; 
Section 10.2. Appendix 2: 
Clinical Laboratory Tests, 
Table 1 footnote 12
Language regarding varicella 
zoster virus immunoglobulin G 
antibody (VZV IgG Ab) 
testing was updated to the 
following:
“Serological testing must be 
performed for VZV IgG Ab 
only in the absence of 
documented evidence of 
having received varicella 
vaccination (2 doses) per 
Exclusion #16.”
Updates made based on 
revisions to Exclusion #16
Section 1.3.2 Schedule of 
Activities, Intervention Period; 
Schedule 1.3.3 Schedule of 
Activities, Early Termination 
and Follow up; Section 8.2.2 
Tanner Stages of Development
The following statement was 
added:
“For participants with AU (ie, 
total loss of hair on the scalp, 
face and body) at the Day 1 
visit and for whom the stage 
for pubic hair cannot be 
reliably assessed, the Tanner
stages will be collected at 
visit(s) after the Day 1 visit 
only until the participant has 
reached a score of 5 on the 
remaining applicable domain 
(ie, breasts for females and 
genitalia for males).” 
This clarification was added as 
the Tanner stage for pubic hair 
will not be able to be reliably 
assessed in participants with 
AU.
Section 2.2
The definition for AU was 
updated to include total hair 
loss on the face. 
Updated for clarification.
Section 2.2.2 Nonclinical and 
Phase 1 Efficacy and Safety 
Data
The following statement was 
added:
“The potential for 
PF-06651600 to be involved in 
drug-drug interactions (DDI) is 
Updated for clarification 
regarding the process for 
removing excluded prior or 
concomitant medications from 
the protocol based on 
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Section # and Name
Description of Change
Brief Rationale
being investigated.  If results 
exclude a clinically meaningful 
DDI (eg, relative to AUC) 
between PF-65551600 and a 
perpetrator or victim drug then 
that perpetrator or victim drug 
will no longer be prohibited as 
a prior or concomitant 
medication based on DDI; this 
information will be 
communicated via an 
administrative letter. Refer to 
Exclusion Criterion 25, Section 
6.5.2, and Section 10.9.1 for 
medications prohibited to be 
used prior to and during the 
study.”
PF-06651600 drug-drug 
interaction (DDI) studies.
Section 1. Protocol Summary; 
Section 3. Objectives, 
Estimands and Endpoints
The following secondary 
endpoints were added:

“Response based on 
achieving absolute SALT 
score ≤20 at all time points 
collected, for overall and 
AA SALT score;

Change from baseline in 
SALT score at all 
timepoints collected, for 
overall and AA SALT 
score;

PGI-C response defined as 
PGI-C score of moderately 
or greatly improved;

Shift from baseline (among 
participants with abnormal 
scores at baseline) in the 
category for each of the 
depression and anxiety 
sub-scales of the Hospital 
Anxiety and Depression 
Scale (HADS) at all time 
points collected.”
The following secondary 
endpoint was removed:

“Response based on 
achieving at least 90% 
improvement in SALT 
These changes have been 
made to align with scientific 
advice interactions with 
regulatory agencies and from 
clinical experts in alopecia 
areata.
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Section # and Name
Description of Change
Brief Rationale
(SALT90) from baseline at 
all time points collected, 
for overall and AA SALT 
score”
The following secondary 
endpoint was revised:

“Change from baseline of 
the total score for each of 
the depression and anxiety 
sub-scales of the Hospital 
Anxiety and Depression 
Scale (HADS) at all time 
points collected”
The following endpoint was 
moved from tertiary to 
secondary: 

“Absolute score of Patient’s 
Global Impression of 
Change (PGI-C) at all time 
points collected”
The following tertiary endpoint 
was removed:

“Response based on 
improvement status in 
PGI-C at all timepoints 
collected”
Section 4.1 Overall Design
The following sentence was 
removed from the 4th 
paragraph:
“For these participants, scalp 
photographs will be taken at 
the screening visit to verify 
eligibility.”
Updated for consistency with 
revisions to Inclusion #1, in 
which the requirement for 
central photography review to 
verify study entry criteria was 
removed.
Section 5.1.1 Inclusion Criteria 
for De Novo Participants and 
Those Originating from 
B7931005 or B7981015 with 
>30 Days between the Index 
Study and Study B7981032
Inclusion #1 was updated to 
the following:
“Participants must meet the 
following AA criteria;

Have a clinical diagnosis of 
AA with no other etiology 
of hair loss (including, but 
not limited to traction and 
scarring alopecia, telogen 
effluvium).  Androgenetic 
alopecia coexistent with 
Updated to remove 
requirements regarding the 
degree of hair loss due to 
androgenetic alopecia in male 
participants and for central 
photography review to verify 
study entry criteria.
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Section # and Name
Description of Change
Brief Rationale
AA is allowed provided 
that the following criteria 
are met;

≥25% terminal scalp hair 
loss due to AA (including 
AT and AU), as measured 
by SALT, at both the 
screening and Day 1 visits 
which, in the opinion of 
the investigator, is 
appropriate for systemic 
therapy;

Hair loss must be 
carefully reviewed to 
verify that ≥25% 
terminal scalp hair loss 
is due to AA (ie, SALT 
(AA) score is ≥25%).  
If, in cases of 
concomitant AA and 
androgenetic alopecia, 
it cannot be verified 
that SALT (AA) score 
is ≥25%, then the 
participant must be 
excluded from the 
study.

No evidence of terminal 
scalp hair regrowth in 
areas affected by AA 
within 6 months of both 
the screening and Day 1 
visits (for de novo 
participants only);

Current episode of terminal 
scalp hair loss due to AA 
≤10 years (for de novo 
participants only).”
Section 5.1.1 Inclusion Criteria 
for De Novo Participants and 
Those Originating from 
B7931005 or B7981015 with 
>30 Days between the Index 
Study and Study B7981032
Inclusion #1 was updated to 
include the following 
description of current episode 
of hair loss:
“When determining the 
duration of “current episode of 
terminal scalp hair loss”, the 
initiation of the current episode 
Update made for clarification.
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Section # and Name
Description of Change
Brief Rationale
should be the last time when 
the patient had substantial 
scalp hair (regardless of 
whether that hair growth 
occurred spontaneously or was 
the result of interventional 
treatment).”
Section 5.1.1 Inclusion Criteria 
for De Novo Participants and 
Those Originating from 
B7931005 or B7981015 with 
>30 Days between the Index 
Study and Study B7981032; 
Section 4.1 Overall Design; 
Section 4.2 Scientific Rationale 
for Study Design
Inclusion 1 was updated to 
include reference to terminal 
scalp hair loss.
Section 4.1 and 4.2 updated to 
reference terminal scalp hair 
loss due to change in 
Inclusion 1.
This clarification was added to 
differentiate between terminal 
hair versus indeterminate or 
vellus hair.
Section 5.2.1 Exclusion 
Criteria for Participants 
Originating from B7981015 
with ≤30 Days between Studies
Exclusion #1 was updated to 
the following: “During Study 
B7981015 or in the period 
between the index study and 
Study B7981032, presence of 
events meeting criteria in the 
Discontinuation section of 
Appendix 8 (eg, serious 
infections, laboratory results, 
ECG results) other than 
discontinuation criteria for 
worsening of AA.”
Updated to clarify that the 
criterion regarding worsening 
of AA is not exclusionary for 
participants continuing from 
Study B7981015.
Section 5.2.2 Exclusion 
Criteria for De Novo 
Participants and Those 
Originating from B7931005 or 
B7981015 with >30 Days 
between the Index Study and 
B7981032.
Exclusion #16 was updated to 
the following:
“Adolescent participants 12 to 
<18 years of age without one 
of the following:
Documented evidence of 
having received the varicella 
vaccine (2 doses); or
Evidence of prior exposure
to varicella zoster virus 
(VZV) based on serological 
testing (ie, a positive VZV
immunoglobulin G antibody 
[VZV IgG Ab] result) at 
screening.
Note: Serological testing must 
be performed for VZV IgG Ab 
only in the absence of 
Updated to allow adolescent 
participants with documented 
evidence of varicella vaccine 
(2 doses) to participate 
regardless of results of 
serological VZV testing.
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Section # and Name
Description of Change
Brief Rationale
documented evidence of 
having received varicella 
vaccination (2 doses).  If 
serological testing is 
performed in the presence of 
documented evidence of 
having received varicella 
vaccination (2 doses), 
participants are eligible to 
enter the study regardless of 
the result of serological 
testing.”
Section 5.2.2 Exclusion 
Criteria for De Novo 
Participants and Those 
Originating from B7931005 or 
B7981015 with >30 Days 
between the Index Study and 
B7981032.
Exclusion #17 was updated to 
the following:
“Active acute or chronic 
infection requiring treatment 
with oral antibiotics, antivirals, 
antiparasitics, antiprotozoals, 
or antifungals within 4 weeks 
prior to Day 1 or any active 
infection not meeting other 
exclusion criteria within 
1 week prior to Day 1.  NOTE: 
participants may be rescreened 
after the infection resolves.”
Updated to include any active 
infection, not only skin 
infections.
Section 5.2.2 Exclusion 
Criteria for De Novo 
Participants and Those 
Originating from B7931005 or  
B7981015 with >30 Days 
between the Index Study and 
B7981032.
Corrected Exclusion #21c to 
reference Exclusion #25i 
instead of Exclusion #27h.
Corrected a typographical 
error in the number and 
updated to reflect correct 
letter.
Section 5.2.2 Exclusion 
Criteria for De Novo 
Participants and Those 
Originating from B7931005 or 
B7981015 with >30 Days 
between the Index Study and 
B7981032.
Exclusion #21b: Added 
abbreviation for first use of 
Torsades de Pointes (TdP).
For document consistency.
Section 5.2.3 Exclusion 
Criteria for All Participants
Added Exclusion #25a: “At 
any time: previous use of any 
non-B-cell selective 
lymphocyte-depleting agent 
(eg, alefacept, alemtuzumab).”  
Subsequent exclusion criterion 
numbers were also updated.
Added for consistency with the 
B7981015 protocol, which 
also specifically excludes any 
previous use of B-cell 
selective lymphocyte-depleting 
agents.
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Section # and Name
Description of Change
Brief Rationale
Section 5.2.3 Exclusion 
Criteria for All Participants
Added everolimus and 
ibritunib to the second bullet of 
Exclusion #25d:
“Within 8 weeks of first dose 
of study intervention or within 
5 half-lives (if known), 
whichever is longer:
Other systemic treatments 
that could affect AA 
including:
Immune suppressants (eg, 
cyclosporine A, azathioprine, 
methotrexate [MTX], 
sulfasalazine, mycophenolate 
mofetil [MMF], everolimus, 
ibrutinib).”
Updated to clarify that while 
everolimus and ibritunib are 
no longer prohibited CYP3A 
substrates, they are still 
prohibited as they are immune 
suppressants.
Section 5.2.3 Exclusion 
Criteria for All Participants; 
Section 6.5.2 Prohibited 
Medications
Added clarification to 
Exclusion #25i and in the 
corresponding bullet in Section 
6.5.2 regarding medications 
that prolong the QT interval.
Updated for clarification.
Section 5.2.3 Exclusion 
Criteria for All Participants
Removed the following bullet 
from Exclusion #25j: 
“Prohibited CYP3A inhibitors 
as described in Appendix 9 
(within 7 days or 5 half lives, 
whichever is longer).”
Changes to restrictions 
regarding prior and 
concomitant CYP3A inhibitors 
were made based on the results 
of the PF-06651600 drug-drug 
interaction (DDI) studies.
Section 5.4 Screen Failures
The last paragraph was 
updated to the following:
“De novo participants and 
participants originating from 
B7931005 or B7981015 with 
>30 days prior to enrolling in 
Study B7981032 who do not 
meet the criteria for 
participation in this study 
(screen failure) may be 
rescreened (with a new 
screening number) following 
an agreement with the 
sponsor.”
The restriction for re-screening 
participants only once was 
removed.  However, sponsor 
agreement is still required 
before a participant can be re-
screened.
Section 6.5.1 Permitted 
Concomitant Medications
The following statement was 
added after the second 
paragraph:
Changes to restrictions 
regarding prior and 
concomitant CYP3A inhibitors 
and sensitive and moderate 
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Section # and Name
Description of Change
Brief Rationale
“With the exception of those 
medications prohibited for use 
in Section 6.5.2, CYP3A 
inhibitors are permitted to be 
used during the study.  
Sensitive and moderate 
sensitive CYP3A substrates 
permitted to be used during the 
study are listed in Section 
10.9.2.”
sensitive CYP3A substrates 
were made based on the results 
of the PF-06651600 drug-drug 
interaction (DDI) studies.
Section 6.5.2 Prohibited 
Concomitant Medications
Under ‘Medications that could 
affect AA’, the 2nd bullet was 
updated to the following:
“• Immunosuppressants (eg, 
cyclosporine A, azathioprine, 
methotrexate [MTX], 
sulfasalazine, mycophenolate 
mofetil [MMF], everolimus, 
ibrutinib).”
Under ‘Medications with 
potential drug-drug 
interactions or potential safety 
concerns’, the 5th and 6th
bullets were updated to the 
following:
“• Moderate to potent CYP3A 
inducers (See Appendix 9.1).
•
Specific sensitive to 
moderate sensitive CYP3A 
substrates as listed in 
Appendix 9.1.”
Changes to restrictions 
regarding prior and 
concomitant CYP3A inhibitors 
and sensitive and moderate 
sensitive CYP3A substrates 
were made based on the results 
of the PF-06651600 drug-drug 
interaction (DDI) studies.
Section 7 Discontinuation of 
Study Intervention and 
Participant Withdrawal; 
Section 7.1.1 Temporary 
Discontinuation; Section 7.2 
Participant 
Discontinuation/Withdrawal 
From Study, Section 7.2.1 
Withdrawal of Consent; 
Updated sections to be 
consistent with new mandatory 
template language (05 Dec 
2019 version).
Updated sections to be 
consistent with new mandatory 
template language (05 Dec 
2019 version).
Section 8 Study Assessments 
and Procedures 
The 8th bullet was updated to 
remove reference to 
verification of screening SALT 
scores.
Updated for consistency with 
revisions to Inclusion #1, in 
which the requirement for 
central photography review to 
verify study entry criteria was 
removed.
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Section # and Name
Description of Change
Brief Rationale
Section 8 Study Assessments 
and Procedures
Added reference to observer 
reported outcomes to the 11th
bullet.
Updated due to the addition of 
the BRIEF®2.
Section 8.1.1 Rater 
Qualifications
Removed reference to rater 
qualifications for the 
Hamilton-Norwood scale.
Updated for consistency with 
revisions to Inclusion #1, in 
which the requirement 
regarding degree of 
androgenetic alopecia in male 
participants was removed.
Section 8.1.2.2 
Hamilton-Norwood Scale for 
Androgenetic Alopecia in 
Males
This section was removed.
Updated for consistency with 
revisions to Inclusion #1, in 
which the requirement 
regarding degree of 
androgenetic alopecia in male 
participants was removed.
Section 8.1.3 Patient Reported 
Outcomes
Updated title to include 
observer reported outcomes.
Added information on observer 
reported outcomes.
Updated due to the addition of 
the BRIEF®2.
Section 8.1.4 Photography
Removed 2nd paragraph 
regarding central review of 
screening photographs.
Updated for consistency with 
revisions to Inclusion #1, in 
which the requirement for 
central photography review to 
verify study entry criteria was 
removed.
Section 8.2.1 Medical History, 
Physical Examinations, Height, 
and Weight
The description of information 
on substance use collected for 
medical history was revised 
from “Smoking status and 
average weekly alcohol 
consumption (units/week) 
will…” to “Smoking status and 
alcohol consumption will…”.
This change has been made to 
correct an inconsistency 
between the protocol and the 
case report forms (CRFs).
Section 8.2.6 Audiological 
Evaluation
Added “All procedures must 
be performed according to the 
Audiological Evaluation Study 
Guide”.
Added for clarity.
Section 8.2.9.1 Columbia 
Suicide Severity Rating Scale 
(C-SSRS)
The 3rd paragraph was updated 
to the following:
“For de novo participants and 
participants originating from 
Study B7931005 or B7981015 
with >30 days between the first 
visit of Study B7981032 and 
This was updated to include 
instructions regarding which 
version of the C-SSRS should 
be used and to refer to the 
specific exclusion criterion 
related to the C-SSRS. 
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Description of Change
Brief Rationale
the last dose in Study 
B7931005 or B7981015: At 
the screening or Day 1 visits, 
the C-SSRS for screening and 
Day 1 visits will be used and 
the results must be evaluated 
against Exclusion criterion 5.”
Section 9.4.1 Efficacy 
Analyses
The table for Endpoints and 
Statistical Analysis Methods 
was updated to indicate that 
there are no primary efficacy 
endpoints.
Updated for consistency with 
the endpoints listed in Section 
3.
Section 9.4.1 Efficacy 
Analyses
The Statistical Analysis 
Methods for the Secondary 
Endpoint was updated to the 
following:
“Efficacy analyses are 
descriptive in nature (such as 
number and percent, mean, 
standard deviation) at each 
visit where measured…”
Analysis by quartiles was 
removed for consistency with 
the statistical analysis plan. 
Section 9.4.1 Efficacy 
Analyses
The Statistical Analysis 
Methods for the Exploratory 
Endpoint was updated to the 
following:
“Will be described in the 
statistical analysis plan.”
As this is a long-term open-
label study, the statement 
regarding the statistical 
analysis plan has been updated 
for consistency with 
Section 9.5, which states that 
interim analyses may be 
performed for internal decision 
making, due to regulatory 
requests, or to support 
regulatory submissions. 
Section 9.4.2 Safety Analyses
The Statistical Analysis 
Methods for the Primary 
Endpoint was updated to the 
following:
“The primary endpoints of 
incidence of TEAEs, SAEs, 
and AEs leading to 
discontinuation, clinically 
significant abnormalities in 
vital signs, and clinically 
significant abnormalities in 
laboratory values will be 
summarized using descriptive 
This clarification was added 
for consistency with the 
endpoints listed in Section 3.
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Section # and Name
Description of Change
Brief Rationale
measures such as numbers and 
percentages.”
Section 9.4.2 Safety Analyses
The table for Endpoints and 
Statistical Analysis Methods 
was updated to indicate that 
there are no secondary or 
exploratory safety endpoints.
Updated for consistency with 
the endpoints listed in Section 
3.
Section 9.4.3 Other Analyses
The following was added to 
this section:
“Analyses of 
pharmacodynamic and 
disease-related biomarkers will 
be described in the statistical 
analysis plan.”
Added for consistency with the 
endpoints listed in Section 3.
Appendix 2: Clinical 
Laboratory Tests; Appendix 8: 
Guidelines for Participant 
Safety Monitoring and 
Discontinuation
Updated from creatinine kinase 
to creatine kinase
Updated for consistency 
throughout the protocol.
Appendix 4: Contraceptive 
Guidance and Collection of 
Pregnancy information
Added bilateral tubal ligation 
to the list of highly effective 
contraceptive measures.
This clarification was added as 
the term “bilateral tubal 
occlusion” was intended to 
encompass the procedures for 
both bilateral tubal occlusion 
and bilateral tubal ligation 
since both of these prevent ova 
from moving through the 
fallopian tubes, thereby 
preventing contact with sperm.
Appendix 6: Hepatitis 
B Testing Algorithm and Full 
Eligibility Criteria
The reference for the testing 
algorithm was updated to the 
following:
“The Polaris Observatory 
Collaborators.  Global 
prevalence, treatment, and 
prevention of hepatitis B virus 
infection in 2016: a modelling 
study.  Lancet Gastroenterol 
Hepatol. 2018;3(6):383-403.”
Updated to provide the 
complete reference
Appendix 8: Guidelines for 
Participant Safety Monitoring 
and Discontinuation, Section 
10.8.2. Discontinuation
Revised the 2nd bullet under 
ECG findings to the following:
“Confirmed increase from 
baseline in QTcF of >60 
milliseconds.”
Updated for clarification 
regarding discontinuation 
criteria for ECG findings.
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Section # and Name
Description of Change
Brief Rationale
Appendix 9: Prohibited 
Concomitant Medications
The following changes were 
made to this section:
- The title of this Appendix 
was updated to the following:
“Appendix 9 Prohibited and 
Permitted Concomitant 
CYP3A Inducers and 
Substrates.”
- The instructional paragraphs 
were updated to the following:
“Please note that this list 
addresses only CYP3A 
inducers and CYP3A 
substrates.  Other prohibited 
medications for this trial are 
listed in Section 6.5.2.  Refer 
to Section 6.5.1 for additional 
information regarding 
permitted medications for this 
trial, including CYP3A 
inhibitors.
This is not an all-inclusive list.  
Study personnel should stay 
current and consult with their 
pharmacy to exclude all 
concomitant medications that 
are moderate to potent CYP3A 
inducers or sensitive or  
moderate sensitive CYP3A 
substrates.  If a medication is a 
sensitive or moderate sensitive 
CYP3A substrate and is not 
listed below as prohibited or 
permitted, consultation with 
the sponsor is required.
The list of prohibited 
concomitant CYP3A 
inhibitors, inducers and 
substrates was revised to 
include only the updated list of 
prohibited concomitant 
CYP3A inducers and 
substrates and a separate 
section for permitted 
concomitant CYP3A substrates 
was added.
Changes to restrictions 
regarding prior and 
concomitant CYP3A inhibitors 
and sensitive and moderate 
sensitive CYP3A substrates 
were made based on the results 
of the PF-06651600 drug-drug 
interaction (DDI) studies.
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Section # and Name
Description of Change
Brief Rationale
Appendix 17: Hamilton-
Norwood Scale for 
Androgenetic Alopecia Males
This appendix was removed.
Updated for consistency with 
revisions to Inclusion #1, in 
which the requirement 
regarding degree of 
androgenetic alopecia in male 
participants was removed.
Appendix 18: Vaccine Sub-
Study
This appendix was added to 
provide details for the newly 
added vaccine sub-study.
The vaccine substudy was 
added to assess 
immunogenicity to tetanus 
booster vaccination and 
meningococcal primary 
vaccination in adult 
participants with AA 
undergoing treatment with 
PF-06651600 in Study 
B7981032.
Appendix 19: Abbreviations
The following abbreviations 
were added:
BRI, BRIEF®2, CDC, CI, 
CRI, ERI, GMC, GMT, hSBA, 
IgG, ObsRO, SAP, SBA, Td, 
TdP, Tdap, USPI. 
Updated to ensure 
abbreviations are in 
alphabetical order.
Updated to include new 
abbreviations and to list 
abbreviations alphabetically.
Appendix 21: Protocol 
Amendment History
Added appendix and moved 
table for Amendment 1 
descriptions of changes and 
brief rationales to this 
appendix.
Following standard procedure 
for the common protocol 
template.
Section 11 References
Added 2 references for the 
BRIEF®2.
Updated due to the addition of 
the BRIEF®2.
Section 11 References
Added references for the 
HADS.
Updated based on addition of 
categorical HADS endpoints.
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Amendment 1 (15 October 2019)
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) 
of Directive 2001/20/EC of the European Parliament and the Council of the European Union.
Overall Rationale for the Amendment:
Section # and 
Name
Description of Change
Brief Rationale
Section 1.2: 
Schema 
Day 14 updated to Week 2
This clarification was made for 
consistency with showing monthly visits 
as opposed to the specific study days after 
Day 1 in the Schema.
Section 1.2: 
Schema; 
Section 1.3. SoA; 
Section 1.31.: 
Screening and 
Day 1; Section 
1.32.: 
Intervention 
Period; 
Section 1.33.: 
Early 
Termination and 
Follow-up; 
Section 5: Study 
Population; 
Section 5.2.1: 
Exclusion 
Criteria for 
Participants 
Originating from 
B7931005 or 
B7981015 with ≤ 
30 Days between 
Studies; 
Section 8.2: 
Safety 
Assessments; 
Section 8.2.8.1.2: 
Day 1 and 
Annual 
Tuberculosis 
Testing 
Section 8.2.8.5: 
Hepatitis B DNA 
Testing; 
Section 8.2.9.1: 
For groups with 30 days between 
the first visit of Study B7981032 
and the last dose in the index 
study, reference to study 
B7931005 was removed.
This clarification was made as the last 
dose in Study B7931005 was achieved on 
13 April 2019.  Based on the projected 
first study visit for Study B7981032, all 
participants enrolling from Study 
B7981005 will have >30 days between 
the first visit of Study B7981032 and the 
last dose in Study B7931005.
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Section # and 
Name
Description of Change
Brief Rationale
Columbia 
Suicide Severity 
Rating Scale; 
Appendix 8: 
Guidelines for 
Participant 
Safety 
Monitoring and 
Discontinuation
Section 1.3.1: 
SoA, Screening 
and Day 1 
(Hamilton-
Norwood Scale);
Section 5.1.1. 
Inclusion Criteria 
for De Novo 
Participants and 
Those 
Originating from 
B7931005 or 
B7981015 with 
>30 Days 
between the 
Index Study and 
Study B7981032, 
Inclusion #1; 
Section 8.1.1: 
Rater 
Qualifications; 
Section 8.1.2.2: 
Hamilton 
Norwood Scale 
for Androgenetic 
Alopecia; 
Appendix 17: 
Hamilton 
Norwood Scale 
for Androgenetic 
Alopecia
Updates were made to add the 
word “Male or Males” when 
referring to the Hamilton-
Norwood Scale for Androgenetic 
Alopecia
This clarification was made to align with 
the literature references for the 
assessment to indicate that the Hamilton-
Norwood Scale for Androgenetic 
Alopecia should be used for males and 
not for females and was previously 
communicated in the protocol 
administrative change letter dated 11-
Sep-2019.
Section 1.3.1: 
SoA, Screening 
and Day 1 
(Audiological 
Evaluation)
In the SoA, Evaluation at Day 1 
for Group E and the note 
“Participants originating from 
Study B7931005 with ≤30 days 
between the first visit of Study 
B7981032 and the last dose in 
This clarification was made as the last 
dose in Study B7931005 was achieved on 
13 April 2019.  Based on the projected 
first study visit for Study B7981032, all 
participants enrolling from Study 
B7981005 will have >30 days between 
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Section # and 
Name
Description of Change
Brief Rationale
Study B7931005 must have a full 
audiological evaluation performed 
at the Day 1 visit and results 
available at the Month 1 visit (but 
preferably at the Week 2 visit, if 
possible)” were removed.
the first visit of Study B7981032 and the 
last dose in Study B7931005.  Therefore, 
all participants from Study B7931005 will 
have the evaluation performed at the 
Screening visit.
Section 1.3.1: 
SoA, Screening 
and Day 1 
(SALT); 
Section 1.3.2: 
SoA, 
Intervention 
Period; 
Section 8.1.2.1.1: 
Androgenetic 
Alopecia SALT 
Score
For participants with known 
androgenetic alopecia, a separate 
assessment of scalp hair loss due 
to androgenetic alopecia (ie, 
androgenetic alopecia SALT 
score) was removed from the 
Screening, Day 1, and all 
Intervention Period visits with the 
exception of the Month 24 and 
Early Termination visits.
Per updates to Section 9.4.1, the final (ie, 
Month 24 or Early Termination) 
androgenetic alopecia SALT score will be 
used to derive the SALT AA score at all 
study visits, as appropriate.  Therefore, 
androgenetic alopecia SALT score was 
removed from the other visits.  
Section 1.3.2: 
SoA, 
Intervention 
Period. 
A day was added to each of the 
Study Days in the Schedule of 
Activities for Week 2 through 
Month 24/EOT. For example, Day 
14 was updated to Day 15, Day 30 
was updated to Day 31, etc.
This clarification was made to correct a 
typographic error and was previously 
communicated in the protocol 
administrative change letter dated 22-
May-2019.
Sections 1.3.2: 
SoA, 
Intervention 
Period; 
Section 8.2.11. 
Pregnancy 
Testing; 
Section 8.2.12: 
Check for 
Initiation of 
Menarche 
Monthly pregnancy testing was 
changed to start after the Month 1 
visit. 
This change was made to align with a 
request from the Voluntary 
Harmonisation Procedure (VHP) for 
Study B7981015 to include more frequent 
pregnancy testing for females of 
childbearing potential in the VHP 
countries in the EU.  In study B7981032, 
monthly pregnancy testing between the 
Month 1 and Month 3 visits was added as 
a global update as monthly pregnancy 
testing after Month 3 was included in the 
original protocol.
Sections 1.3.2: 
SoA, 
Intervention 
Period; 
Section 8.2.11: 
Pregnancy 
Testing
The following statement was 
added: “The pregnancy testing 
between visits may occur outside 
of the study site”.
This clarification was made to indicate 
that pregnancy testing between visits is 
not required to be performed at the study 
site.
Section 1.3.3: 
Early 
Early Termination and Follow-up 
visit timeframe was clarified.
This update was made to clarify the Early 
Termination and Follow-up visit timing.
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Section # and 
Name
Description of Change
Brief Rationale
Termination and 
Follow-up
Section 4.1 
Overall Design
The second sentence in the third 
paragraph of this section was 
updated to the following: “In 
addition, participants enrolling 
from Study B7931005 must have 
taken their last dose of PF 
06700841 (a TYK2/JAK1 
inhibitor) in Study B7931005 >12 
weeks prior to the B7981032 Day 
1 visit.”  
This change was made for alignment with 
the update to Inclusion #2 in Section 5.1.2 
noted below.
Section 5: Study 
Population
The following statement was 
added: “NOTE: There are certain 
eligibility requirements specific to 
subjects within Voluntary 
Harmonisation Procedure (VHP) 
countries in the EU.  The VHP 
countries participating in this 
study are: Czech Republic, 
Germany, Hungary, Poland, and 
Spain.”
This change was made to align with the 
update for age in Section 5.1.3 and to 
include the list of participating VHP 
countries.
Section 5.1.1: 
Inclusion Criteria 
for De Novo 
Participants and 
Those 
Originating from 
B7931005 or 
B7981015 with 
>30 Days 
between the 
Index Study and 
Study B7981032 
Inclusion #1 was updated to the 
following: “No evidence of
terminal scalp hair regrowth in 
areas affected by AA within 6 
months of both the screening and 
Day 1 visits (for de novo 
participants only).”
This clarification was made to indicate 
more explicitly that evidence of terminal 
hair regrowth is prohibited at both the 
Screening and Day 1 visits.  In addition, 
this was updated to clarify that this only 
refers to regrowth of hair affected by AA 
and was previously communicated in the 
protocol administrative change letter 
dated 11-Sep-2019.
Section 5.1.1: 
Inclusion Criteria 
for De Novo 
Participants and 
Those 
Originating from 
B7931005 or 
B7981015 with 
>30 Days 
between the 
Inclusion #1 was updated to the 
following: “Current episode of 
hair loss due to AA ≤10 years (for 
de novo participants only)”
This clarification was made to indicate 
that the current episode of hair loss only 
refers to loss of hair due to AA and was 
previously communicated in the protocol 
administrative change letter dated 11-
Sep-2019.
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Section # and 
Name
Description of Change
Brief Rationale
Index Study and 
Study B7981032
Section 5.1.2: 
Inclusion Criteria 
for All 
Participants 
Originating from 
B7931005 or 
B7981015
Inclusion #2 was updated to the 
following: “Taken the last dose of 
PF 06700841 (a TYK2/JAK1 
inhibitor) in Study B7931005 >12 
weeks prior to the Study 
B7981032 Day 1 visit.”
This update was made for consistency 
with exclusion #25b and was previously 
communicated in the protocol 
administrative change letter dated 11-
Sep-2019. 
Section 5.1.3: 
Inclusion Criteria 
for All 
Participants
The following was added to 
Inclusion #4: “Within the VHP 
countries in the EU, de novo 
participants must be aged 18 
through 74 years at the time of 
informed consent (see Section 5 
for a list of VHP countries 
participating in this study).” 
This change was made to align with a 
request from the VHP for Study 
B7981015 to exclude participants age 75 
years and older in VHP countries in the 
EU.
Section 5.2.1: 
Exclusion 
Criteria for 
Participants 
Originating from 
B7981015 with 
≤30 Days 
between Studies
Exclusion #2 was updated to the 
following: “Discontinuation from 
Study B7981015 for safety related 
events.  Participants discontinued 
from Study B7981015 due to 
issues other than safety-related 
events must be discussed with the 
sponsor prior to enrollment in 
Study B7981032.”
This change was made to indicate that all 
discontinuations from the index studies 
other than for safety-related events must 
be discussed with the sponsor prior to 
enrollment in Study B7981032.
Section 5.2.2. 
Exclusion 
Criteria for De 
Novo 
Participants and 
Those 
Originating from 
B7931005 or 
B7981015 with 
>30 Days 
between the 
Index Study and 
Study B7981032
Exclusion #23 was updated to: 
“Discontinuation from Study 
B7931005 or B7981015 for 
safety-related events.  Participants 
discontinued from Study 
B7931005 or B7981015 due to 
issues other than safety-related 
events must be discussed with the 
sponsor prior to enrollment in 
Study B7981032”.
This was added for consistency with 
Exclusion #2 in Section 5.2.1.
Section 5.2.3: 
Exclusion 
Criteria for All 
Participants
Exclusion #25g was updated to 
remove the following from the 
end of the criteria: “that could 
affect AA unless used for 
androgenetic alopecia”
This update was made for consistency 
with exclusion #26 and Section 6.5.1 
Permitted Concomitant Medications and 
was previously communicated in the 
protocol administrative change letter 
dated 11-Sep-2019 
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Section # and 
Name
Description of Change
Brief Rationale
Section 5.2.3: 
Exclusion 
Criteria for All 
Participants 
Exclusion #25 h was updated to 
add a reference for the website 
www.CredibleMeds.org.  
Subsequent references were 
renumbered as appropriate.
This clarification was made to correct a 
typographic error and was previously 
communicated in the protocol 
administrative change letter dated 22-
May-2019.
Section 8.2.6: 
Audiological 
Evaluation
The following statement was 
removed: “Participants originating 
from Study B7931005 with ≤30 
days between the first visit of 
Study B7981032 and the last dose 
in Study B7931005 must have a 
full audiological evaluation 
performed at the Day 1 visit and 
results available at the Month 1 
visit (but preferably at the Week 2 
visit, if possible).  Audiological 
testing is not required at the Day 1 
visit for participants originating 
from Study B7981015 with ≤30 
days between the first visit of 
Study B7981032 and the last dose 
in Study B7981015”.
This was updated for consistency with 
changes in Section 1.3.1. SoA, Screening 
and Day 1; Audiological Evaluation.
Section 8.2.8.2: 
Purified Protein 
Derivative (PPD) 
Test
A typographic error in paragraph 
2 was corrected to reflect that the 
test should be performed and 
interpreted as “negative” (not 
“positive”) according to local 
standards.
This clarification was made to correct a 
typographic error and was previously 
communicated in the protocol 
administrative change letter dated 22-
May-2019
Section 8.2.12: 
Check for 
Initiation of 
Menarche (for
Premenarchal 
Females Only)
The language was updated to 
indicate that pregnancy tests 
should be performed “according 
to the Schedule of Activities” 
instead of “at every visit”.
This change was made to ensure 
consistency with the Schedule of 
Activities.
Section 8.5:  
Pharmacokinetics
The first paragraph was updated 
to the following: “During all study 
periods, blood samples (~2 mL) to 
provide plasma for PK analysis 
will be collected into 
appropriately labeled tubes 
containing dipotassium 
ethylenediaminetetraacetic acid 
(K2EDTA) anticoagulant at times 
specified in the (Schedule of 
This update was made for consistency 
with the final required blood volumes 
from the central laboratory for this 
sample and was previously 
communicated in the protocol 
administrative change letter dated 11-
Sep-2019.
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Section # and 
Name
Description of Change
Brief Rationale
Activities) section of the 
protocol.”
Section 9.3: 
Populations for 
Analysis
The “Description” in the table for 
the safety and efficacy 
populations was updated to the 
following: “All participants who 
take at least 1 dose of study 
intervention.”
This change was made to remove the 
requirement that participants must be 
assigned study intervention in order to be 
included in the analysis population as the 
sponsor’s intent is to analyze all 
participants who take at least 1 dose of 
study intervention.  Wording regarding 
how the population would be analyzed 
was also removed as this is not 
appropriate to be included in this section.  
Section 9.4.1. 
Efficacy 
Analyses
The Statistical Analysis Methods 
in the table for the primary 
endpoint was updated to the 
following: “Efficacy analyses are 
descriptive in nature; such as 
number and percent, mean, 
standard deviation and quartiles at 
each visit where measured; there 
will be no formal hypothesis 
testing, though 95% two-sided 
confidence intervals will be 
reported. Displays using by 
stratification by roll-over and de-
novo participants (ie, those who 
did not receive study intervention 
in either Study B7931005 or 
B7981015) and participants 
originating from Study B7931005 
or B7981015 (ie, those who 
received study intervention in 
either Study B7931005 or 
B7981015) will also be included.”
This change was made to clarify the 
descriptions of de novo participants and 
participants originating from Study 
B7931005 or B7981015. 
Section 9.4.1. 
Efficacy
Analyses
The following was added: 
The secondary endpoints for 
SALT include both the SALT 
overall and SALT AA scores. The 
SALT overall score includes hair 
loss regardless of etiology (eg, 
including scalp hair loss due to 
both androgenetic alopecia and 
AA). The SALT androgenetic 
alopecia (SALT AGA) score only 
takes into account scalp hair loss 
due to androgenetic alopecia and 
This change was made to define how the 
SALT AA endpoint will be derived.
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Section # and 
Name
Description of Change
Brief Rationale
is required to be assessed only at 
the Month 24 or Early 
Termination visit (as appropriate). 
The SALT AA score at each visit 
will be calculated as follows using 
the SALT AGA score collected at 
the Month 24 or Early 
Termination visit (as appropriate):
SALT AA score = SALT overall 
score – SALT AGA score.   
Section 9.4.2: 
Safety Analyses
The first paragraph was updated 
to read as follows: “All safety 
analyses will be performed on the 
Safety Population. For the 
purpose of analysis of safety 
measures for the participants with 
≤30 days between the first visit of 
Study B7981032 and the last dose 
of study intervention in the index 
studies, the baseline values are 
defined as the Day 1 values from 
Study B7981015 or B7931005.”
This typographical error was corrected for 
consistency with the baseline definitions 
in Section 8.2 Safety Assessments and 
was previously communicated in the 
protocol administrative change letter 
dated 11-Sep-2019.
Section 9.4.2: 
Safety Analyses
The Statistical Analysis Methods 
in the table for the primary 
endpoint was updated to the 
following: “The primary 
endpoints of incidence of TEAEs, 
SAEs, and AEs leading to 
discontinuation, clinically 
significant abnormalities in vital 
signs, and abnormalities in 
laboratory values will be 
summarized using descriptive 
measures such as numbers and 
percentages.  The safety 
summaries will be reported for all 
participants, as well as by de novo 
participants (ie, those who did not 
receive study intervention in 
either Study B7931005 or 
B7981015) and participants 
originating from Study B7931005 
or B7981015 (ie, those who 
received study intervention in 
either Study B7931005 or 
B7981015).  
This change was made for consistency 
with the Primary Endpoints in Section 3 
and to align with a request from the VHP 
to provide additional details regarding the 
safety analysis methods, including 
analysis by de novo participants and those 
originating from Study B7931005 or 
B7981015.
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Section # and 
Name
Description of Change
Brief Rationale
No formal statistical hypotheses 
will be tested.
Further details will be specified in 
the Statistical Analysis Plan.”
Appendix 2: 
Table 1, 
Protocol-
Required Safety 
Laboratory 
Assessments
A typographic error in the 
laboratory assessment for 
%Reticulocytes was corrected to 
remove “%”.
This clarification was made to correct a 
typographic error to indicate that both % 
and absolute reticulocytes will be 
assessed and is consistent with the update 
previously communicated the protocol 
administrative change letter dated 22-
May-2019.
Appendix 4: 
Contraceptive 
Guidance and 
Collection of 
Pregnancy 
Information:
Bullet 3 (Postmenopausal female) 
was updated to the following: 

“A postmenopausal state is 
defined as no menses for 12 
months without an alternative 
medical cause. In addition, a 
high follicle stimulating 
hormone (FSH) level in the 
postmenopausal range must 
also be used to confirm a 
postmenopausal state in 
women under 60 years old and 
not using hormonal 
contraception or hormone 
replacement therapy (HRT).”  
The requirement for follicle 
stimulating hormone (FSH) 
testing has not changed.
This change was made to align with a 
request from the VHP for Study 
B7981015 to update the definition of 
“postmenopausal state”.
Appendix 8: 
Guidelines for 
Subject Safety 
Monitoring and 
Discontinuation
A typographic error in the 
monitoring criteria for 
hemoglobin was corrected to 
reflect that a decrease greater than 
or equal to 2.0 g/dL (not just a 
decrease of 2.0 g/dL) requires 
additional monitoring activities.
This clarification was made to correct a 
typographic error and was previously 
communicated in the protocol 
administrative change letter dated 
22-May-2019.
Appendix 8: 
Guidelines for 
Subject Safety 
Monitoring and 
Discontinuation
Discontinuation criteria for 
worsening alopecia areata were 
added for the VHP countries.
This change was made to align with a 
request from the VHP to add 
discontinuation criteria for worsening 
alopecia areata.
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Section # and 
Name
Description of Change
Brief Rationale
Appendix 10: 
Severity of 
Alopecia Tool 
(SALT) 
Typographic errors were corrected 
in the calculations shown for the 
first example.
This clarification was made to correct a 
typographic error and was previously 
communicated in the protocol 
administrative change letter dated 
22-May-2019.
Appendix 19: 
Abbreviations
AGA: Androgenetic alopecia 
VHP: Voluntary Harmonisation 
Procedure abbreviations added.
This was updated to add new 
abbreviations.
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Xing L, Dai Z, Jabbari A, et al. Alopecia areata is driven by cytotoxic T lymphocytes 
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Ito T, Ito N, Saatoff M, et al. Maintenance of hair follicle immune privilege is linked 
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Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med. 2012;366(16):1515-25.
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Guttman-Yassky E, Ungar B, Noda S, et al. Extensive alopecia areata is reversed by 
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