A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS
Phase: PHASE2
Conditions: Atopic Dermatitis
Sponsor: Pfizer

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A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, 
PARALLEL GROUP, DOSERANGING STUDY TO ASSESS THE EFFICACY, 
SAFETY, TOLERABILITY AND PHARMACOKINETICSOF PF-06700841 CREAM 
APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH 
MILDOR MODERATE ATOPIC DERMATITIS
Investigational Product Number:
PF-06700841
Investigational Product Name:
Not applicable (N/A)
United States (US) Investigational New 
Drug (IND) Number:
European Clinical Trials Database 
(EudraCT) Number:
2018-003050-24
Protocol Number:
B7931022
Phase:
2b
Short Title:A Phase 2b, multicenter, randomized, double-blind, vehicle controlled, parallel group dose 
ranging study to assess efficacy, safety, tolerabilityand pharmacokinetics of PF-06700841 cream in 
participants with mildor moderate atopic dermatitis
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Protocol Amendment Summary of Changes Table
Document History
Document
Version Date
Summary of Changes and Rationale
Original protocol
31 October 2018
Not applicable (N/A)

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Final Protocol, 31 October 2018
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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................9
LIST OF FIGURES...................................................................................................................9
1. PROTOCOL SUMMARY...................................................................................................10
1.1. Synopsis..................................................................................................................10
1.2. Schema....................................................................................................................13
1.3. Schedule of Activities (SoA)...................................................................................14
2. INTRODUCTION...............................................................................................................19
2.1. Study Rationale.......................................................................................................19
2.2. Background.............................................................................................................19
2.3. Benefit/Risk Assessment.........................................................................................27
3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS...........................................................27
4. STUDY DESIGN.................................................................................................................32
4.1. Overall Design.........................................................................................................32
4.2. Scientific Rationale for Study Design.....................................................................35
4.4. End of Study Definition..........................................................................................38
5. STUDY POPULATION......................................................................................................38
5.1. Inclusion Criteria.....................................................................................................39
5.2. Exclusion Criteria....................................................................................................40
5.3. Lifestyle Considerations..........................................................................................44
5.3.1. Contraception..............................................................................................44
5.3.2. Medications/Treatments Discontinuation, Non-Medicated Emollients 
and Bathing......................................................................................................44
5.3.3. Dietary Supplements...................................................................................45
5.3.4. Vaccine and Exposure to Infection Guidelines..........................................45
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5.3.4.1. Participant Specific Recommendations.....................................45
5.3.4.2. Guidance Regarding Household Contact Vaccine-Related 
Exposure............................................................................................46
5.3.5. Other Requirements....................................................................................46
5.4. Screen Failures ........................................................................................................47
6. STUDY INTERVENTION..................................................................................................47
6.1. Study Intervention Administered ............................................................................48
6.1.1. Administration............................................................................................48
6.1.1.1. Treated Atopic Dermatitis Areas...............................................48
6.1.1.2. General Instructions ..................................................................48
6.2. Preparation/Handling/Storage/Accountability ........................................................50
6.2.1. Preparation and Dispensing........................................................................51
6.2.2. Investigational Product Accountability ......................................................52
6.2.3. Destruction of Investigational Product Supplies ........................................52
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................52
6.3.1. Allocation to Investigational Product .........................................................52
6.3.2. Breaking the Blind......................................................................................53
6.4. Study Intervention Compliance...............................................................................53
6.5. Concomitant Therapy..............................................................................................54
6.5.1. Rescue Medicine.........................................................................................55
6.6. Dose Modification...................................................................................................55
6.7. Intervention after the End of the Study...................................................................55
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................55
7.1. Discontinuation of Study Intervention ....................................................................55
7.1.1. ECG Changes..............................................................................................56
7.1.2. Local Tolerability .......................................................................................56
7.1.3. Adverse Events...........................................................................................56
7.1.3.1. Serious Infections......................................................................57
7.1.3.2. Treated Infections......................................................................57
7.1.4. Potential Cases of Decreased eGFR ...........................................................57
7.1.5. Laboratory Abnormalities...........................................................................58
7.1.6. Pregnancy ...................................................................................................58

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7.1.7. Suicidal Ideation and Behavior...................................................................58
7.1.8. Temporary Discontinuation........................................................................59
7.1.9. Discontinuation/End of Treatment Monitoring for Adverse Events, 
Laboratory, and Vital Signs.............................................................................59
7.2. Participant Discontinuation/Withdrawal from the Study........................................59
7.3. Lost to Follow-up....................................................................................................60
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................61
8.1. Efficacy Assessments..............................................................................................62
8.1.1. Rater Qualifications....................................................................................62
8.1.2. Investigator’s Global Assessment (IGA)....................................................62
8.1.3. Eczema Area and Severity Index (EASI) ...................................................63
8.1.3.1. Lesion Severity by Clinical Signs .............................................63
8.1.3.2. Percent BSA with Atopic Dermatitis (for efficacy)..................64
8.1.3.3. Calculation of EASI Score ........................................................65
8.1.4. Body Surface Area......................................................................................66
8.1.4.1. Body Surface Area for IP need .................................................66
8.1.5. Peak Pruritus Numerical Rating Scale (PP-NRS) ......................................67
8.2. Safety Assessments .................................................................................................67
8.2.1. Assessments at Screening Only..................................................................67
8.2.1.1. Medical History.........................................................................67
8.2.1.2. Tuberculosis Testing .................................................................68
8.2.1.3. Chest Radiograph ......................................................................69
8.2.1.4. Skin Type Assessment ..............................................................69
8.2.2. Assessments during Study..........................................................................69
8.2.2.1. Physical Examinations ..............................................................69
8.2.2.2. Vital Signs.................................................................................70
8.2.2.3. Electrocardiograms....................................................................71
8.2.2.4. Herpetiform Rash ......................................................................72
8.2.2.5. Clinical Safety Laboratory Assessments...................................72
8.2.2.6. Creatinine, Cystatin C, and estimates of Glomerular 
Filtration Rate....................................................................................73
8.2.2.7. Samples for Lipid Analysis.......................................................73
8.2.2.8. Suicidal Ideation and Behavior Risk Monitoring......................74

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8.2.2.9. Local Tolerability......................................................................74
8.2.2.10. Pregnancy Testing...................................................................74
8.3. Adverse Events and Serious Adverse Events..........................................................75
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......75
8.3.1.1. Reporting SAEs to Pfizer Safety...............................................76
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................76
8.3.2. Method of Detecting AEs and SAEs..........................................................76
8.3.3. Follow-up of AEs and SAEs.......................................................................76
8.3.4. Regulatory Reporting Requirements for SAEs...........................................76
8.3.5. Exposure during Pregnancy or Breastfeeding, and Occupational 
Exposure..........................................................................................................77
8.3.5.1. Exposure During Pregnancy......................................................77
8.3.5.2. Exposure During Breastfeeding................................................77
8.3.5.3. Occupational Exposure.............................................................77
8.3.6. Medication Errors.......................................................................................78
8.4. Treatment of Overdose............................................................................................78
8.5. Pharmacokinetics....................................................................................................79
8.7.Genetics...................................................................................................................82
8.7.1. Specified Genetics......................................................................................82
8.8. Biomarkers..............................................................................................................82
8.9. Health Economics...................................................................................................83
8.10. Patient Reported Outcomes...................................................................................84
8.10.1. Patient-Oriented Eczema Measure (POEM).............................................84
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8.10.2. Dermatology Life Quality Index (DLQI) and Children’s 
Dermatology Life Quality Index (CDLQI)......................................................84
8.10.5. Peak Pruritis Numerical Rating Scale (PP-NRS).....................................85
 
 
9. STATISTICAL CONSIDERATIONS................................................................................87
9.1. Estimands and Statistical Hypotheses.....................................................................87
9.2. Sample Size Determination.....................................................................................88
9.3. Populations for Analysis.........................................................................................88
9.4. Statistical Analyses.................................................................................................89
9.4.1. Efficacy Analyses.......................................................................................89
9.4.2. Safety Analyses..........................................................................................90
9.4.2.1. Electrocardiogram Analyses......................................................90
9.5. Interim Analyses.....................................................................................................91
9.5.1. Data Monitoring Committee.......................................................................92
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................93
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............93
10.1.1.Regulatoryand Ethical Considerations....................................................93
10.1.1.1. Reporting of Safety Issuesand Serious Breaches of the 
Protocol or ICH GCP.........................................................................93
10.1.2. Financial Disclosure.................................................................................94
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10.1.3. Informed Consent Process........................................................................94
10.1.4. Data Protection.........................................................................................95
10.1.5. Dissemination of Clinical Study Data......................................................95
10.1.6. Data Quality Assurance............................................................................97
10.1.7. Source Documents....................................................................................98
10.1.8. Study and Site Closure..............................................................................98
10.1.9. Publication Policy.....................................................................................99
10.1.10. Sponsor’s Qualified Medical Personnel.................................................99
10.2.Appendix2: Clinical Laboratory Tests...............................................................100
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting....................................................................102
10.3.1. Definition of AE.....................................................................................102
10.3.2. Definition of SAE...................................................................................103
10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs.....................104
10.3.4. Reporting of SAEs..................................................................................107
10.4. Appendix 4: Contraceptive Guidance and Collection of Pregnancy 
Information..............................................................................................................109
10.4.1. Male Participant Reproductive Inclusion Criteria..................................109
10.4.2. Female Participant Reproductive Inclusion Criteria...............................109
10.4.3. Woman of Childbearing Potential (WOCBP)........................................110
10.4.4. Contraception Methods...........................................................................111
10.5. Appendix 5: Genetics..........................................................................................114
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments 
and Study Intervention Re-challenge Guidelines....................................................115
10.7. Appendix 7: ECG Findings of Potential Clinical Concern.................................117
10.8. Appendix 8: Country-Specific Requirements.....................................................119
10.9. Appendix 9: Diagnosis Criteria for Atopic Dermatitis.......................................120
10.10. Appendix 10: Prohibited Concomitant Medications.........................................121
10.11. Appendix 11: Fitzpatrick Skin Type.................................................................124
10.12. Appendix 12: Patient Reported Outcomes........................................................125
10.12.1. Peak Pruritis Numerical Severity Scale (PP-NRS)...............................125
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10.12.3. Patient-Oriented Eczema Measure (POEM).........................................130
10.12.4. Dermatology Life Quality Index (DLQI)/Children’s DLQI.................131
10.13. Appendix 13: C-SSRS –Columbia Suicide Severity Rating Scale..................135
10.14. Appendix 14: eGFR Calculations.....................................................................139
10.15. Appendix 15: Abbreviations.............................................................................140
11. REFERENCES................................................................................................................145
LIST OF TABLES
Table1.
Schedule of Activities...........................................................................................14
 
Table3.
Treatment Arms....................................................................................................33
Table5.
Investigator’s Global Assessment (IGA) Score....................................................63
Table6.
Clinical Sign Severity Scoring Criteria forthe Eczema Area and Severity 
Index (EASI).........................................................................................................64
Table7.
Determination of Body Region Surface Area.......................................................64
Table8.
Area Score Criteria...............................................................................................65
Table9.
Body Region Weighting.......................................................................................65
Table10. Skin Tolerability Grading System........................................................................74
Table11. Protocol-Required Laboratory Assessments.......................................................100
LIST OF FIGURES
Figure 1. Study Design Schema...........................................................................................13
Figure 2. Study Design Schema...........................................................................................34
Figure 3. Peak Pruritus Numerical Rating Scale (PP-NRS)................................................67
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1. PROTOCOL SUMMARY 
1.1. Synopsis
Short Title:
A Phase 2b, multicenter, randomized, double-blind, vehicle controlled, parallel group dose 
ranging study to assess efficacy, safety, tolerability, and pharmacokinetics (PK) of 
PF-06700841 cream in participants with mild or moderate atopic dermatitis.
Rationale:
This multicenter, randomized, double-blind, vehicle controlled, parallel group, dose ranging 
study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple 
topical formulation concentrations of PF-06700841 topical cream in the treatment of 
mild-to-moderate atopic dermatitis (AD).  This is the first study where a PF-06700841 cream 
formulation is being applied topically to participants with AD.  Additionally, the study is 
intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily 
[BID] application) for the future clinical development of topical PF-06700841. 
Objectives, Endpoints and Estimands:a
Objectives
Endpoints
Estimandsb
Primary Objective 
Primary Endpoint(s)
Primary Estimands
To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle applied QD or 
BID, on percent change from 
baseline in Eczema Area and 
Severity Index (EASI) in 
participants with mild or 
moderate atopic dermatitis (AD).
Percent change from baseline in EASI 
total score at Week 6.
Estimand E1: This estimand is 
intended to provide a 
population level estimate of 
the treatment effect of the
investigational product (IP) on 
a continuous endpoint; without 
the benefit of additional 
prohibited medications during 
treatment and regardless of 
participant compliance with 
the IP dosing.
Secondary Objective(s): 
Secondary Endpoints
Secondary Estimands
To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, using Investigator’s Global 
Assessment (IGA) score 
assessment as endpoint in 
participants with mild or 
moderate AD.
Key Secondary Endpoint:
Proportion of participants achieving 
IGA score of clear (0) or almost clear 
(1) (on a 5 point scale) and a reduction 
from baseline of 2 points at Week 6.
Estimand E2: This estimand is 
intended to provide a 
population level estimate of 
the treatment effect of the IP 
on a binary responder 
endpoint; without the benefit 
of additional prohibited 
medications and regardless of 
a participant compliance with 
the IP dosing.

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To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, on change from baseline in 
EASI in participants with mild 
or moderate AD.
Change from baseline in EASI total 
score at Week 6.
All continuous secondary 
endpoints will be analyzed 
descriptively and using 
estimand E1 described above, 
when appropriate.
All categorical secondary 
endpoints will be analyzed 
descriptively and using 
estimand E2 described above, 
when appropriate.
To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, using measures of patient 
reported outcomes (PRO), in 
participants with mild or 
moderate AD.
Proportion of participants having 
2 grades of reduction in weekly 
averages of Peak Pruritus Numerical 
Rating Scale (PP-NRS) at all site visit 
time points specified in the SoA.
To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, using measures of disease 
affected area, in participants 
with mild or moderate AD.
Percent change from baseline in 
affected Body Surface Area (BSA) at 
Week 6 and at other time points 
specified in the SoA.
To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, using measures of disease 
severity and symptoms as 
endpoints in participants with 
mild or moderate AD.
Proportion of participants achieving 
EASI-75 (75% improvement from 
baseline).
To characterize the safety and 
tolerablility of multiple doses of 
PF-06700841 cream versus 
vehicle applied QD or BID in
participants with mild or 
moderate atopic dermatitis.
a.
Incidence of treatment-emergent 
adverse events (AEs and SAEs), 
significant changes in vital signs, 
clinical laboratory abnormalities, 
and electrocardiogram (ECG).
b.
Incidence of severity grades in skin 
tolerability at times indicated in 
SoA.
There is no defined estimand 
for these endpoints and they 
will be analyzed using Pfizer 
data standards as applicable.
a.
See Section 3 for Tertiary/Exploratory Objectives and Endpoints.
b.
See Section 3 for detailed Estimand description.
Overall Design:
This multicenter, Phase 2b, randomized, double-blind, vehicle-controlled, parallel-group, 
dose-ranging study will assess efficacy, safety, tolerability, and PK of the topical cream 
formulation of PF-06700841 in the treatment of mild-to-moderate atopic dermatitis.  
Participants will be screened within 6 weeks prior to the Day 1 application of investigational 

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product (IP) to confirm they meet the selection criteria for the study.  The treatment period 
will be 6 weeks, followed by follow-up period of 4 weeks. 
Number of Participants: 
The study will explore QD and BID dosing regimen and will enroll approximately 
280 participants (approximately 35 participants per treatment arm) to allow for 
224 completers (28 participants/arm). 
Intervention Groups and Duration:
There will be 8 dosing arms: 

4 arms with increasing doses of active IP in QD dosing regimen ie PF-06700841 
cream in 0.1% (1 mg/g), 0.3% (3 mg/g), 1% (10 mg/g), and 3% (30 mg/g) strengths;

2 arms with increasing doses of active IP in BID dosing regimen ie PF-06700841 
cream in 0.3% (3 mg/g) and 1% (10 mg/g) strengths;

1 vehicle cream arm in QD dosing regimen; 

1 vehicle cream arm in BID dosing regimen.
Participants will be randomized into one of the doses in the QD dosing regimen or BID 
dosing regimen of PF-06700841 or its matching vehicle in equal ratio. 
A study design schematic is presented in Section 1.2.
Data Monitoring Committee: Yes
Statistical Methods
The primary estimand will be estimated population-based average treatment effect on percent 
change from baseline in Eczema and Severity Index (EASI) score relative to vehicle at 
6 weeks for all randomized participants in the absence of prohibited medication without 
regard to compliance. 
The secondary estimand will be the estimated population-based average treatment effect on 
the rates of Investigator’s Global Assessment (IGA) response (percentage of participants 
with a score of 0 or 1 and a 2 point or greater decrease from baseline) at Week 6 relative to 
vehicle (with the same dosing schedule, QD or BID) without regard to compliance with IP in 
the absence of prohibited medication. 
All other secondary continuous clinical endpoints will be analyzed using the primary 
estimand, while all other secondary categorical clinical endpoints will be analyzed using the 
secondary estimand described above. 

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Other estimands may be used for some of the primary and secondary endpoints as a means to 
examine the robustness of the results and to compare to available literature as needed.  
Details of these analyses will be presented in thestatistical analysis plan (SAP).
1.2.Schema
Figure 1. Study Design Schema
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1.3. Schedule of Activities (SoA)
The SoA table provides an overview of the protocol visits and procedures.  Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section of the protocol for detailed information on each procedure and assessment required for compliance with the 
protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the participant.
Table 1.
Schedule of Activities
Visit Identifiera
Screening 
& Washout
Day 1
(Baseline)
Day 8
Week 1
Day 15
Week 2
Day 22
Week 3
Day 29
Week 4
Day 43
Week 6
(EOT)
Follow-up
(EOS)
Early 
Termination 
(ET)
Visit Window
-42 to -1
N/A
81
152
222
292
432
28–35 Days 
post-last 
Dose
Visit Number
1
2
3
4
5
6
7
Enrollment Procedures
Informed Consent
X
Eligibility Assessment
X
X
Demography
X
Medical and Atopic Dermatitis Historyb
X
Medication History
X
Randomization
X
Clinical Assessments
Complete Physical Examc
X
X
X
Targeted Physical Examc
X
X
X
X
X
Vital Signsd
X
X
X
X
Weight
X
X
Height
X
ECGe
X
X
X
X
Chest Radiographf
X
C-SSRSg
X
X
X
X
X
Fitzpatrick Skin Type Assessment
X
Laboratory Assessments
Hematology, Blood Chemistry, and Urinalysis
X
Xh
X
X
X
X
X
X
Lipid Panel (Fasting)i
X
X
Tuberculosis Testj
X

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Visit Identifiera
Screening 
& Washout
Day 1
(Baseline)
Day 8
Week 1
Day 15
Week 2
Day 22
Week 3
Day 29
Week 4
Day 43
Week 6
(EOT)
Follow-up
(EOS)
Early 
Termination 
(ET)
Visit Window
-42 to -1
N/A
81
152
222
292
432
28–35 Days 
post-last 
Dose
Visit Number
1
2
3
4
5
6
7
FollicleStimulating Hormone (FSH) Testk
X
BloodPregnancy testl
X 
X
X
Urine Pregnancy testl
X 
X 
X 
X 
X 
X 
X 
X
Hepatitis Testing
m,n
X
X
HIV Testing
X
VZV IgG Ab (adolescents only, if applicable)
o
X
Pharmacokinetics (PK)
PK sampling (pre-dose)
X 
X 
X 
X 
X 
X
 
 
Investigational Product Related Processes
Dispense dosing diary/PROsand instruct on usage
X
Assess BSA & calculate IP need
X 
X 
X 
X
X
Body Site Checklist
X 
X 
X 
X 
X 
X
Weigh and dispense IP
X 
X 
X
X
IP application and observation(at site)
X 
X
X 
X 
X
Record dose and time of IP application in eDiary 
X
 
 
 

X
Collect and weigh returned IP tubes for compliance check
X
X 
X 
X
X
Review of dosing Diary/PROs
X 
X
X 
X 
X 
X 
X
Collect dosing Diary/PROs
Xq
X 
X
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Visit Identifiera
Screening 
& Washout
Day 1
(Baseline)
Day 8
Week 1
Day 15
Week 2
Day 22
Week 3
Day 29
Week 4
Day 43
Week 6
(EOT)
Follow-up
(EOS)
Early 
Termination 
(ET)
Visit Window
-42 to -1
N/A
81
152
222
292
432
28–35 Days 
post-last 
Dose
Visit Number
1
2
3
4
5
6
7
AD-Related Clinical Assessments
EASI
X 
X 
X
X 
X 
X 
X 
X 
X
IGA
X 
X 
X
X 
X 
X 
X 
X 
X
BSA
X 
X 
X 
X 
X 
X 
X 
X 
X
Safety Monitoring
Contraception checkr
X 
X 
X
X  
X  
X 
X 
X
Review Concomitant Treatment
X 
X 
X
X  
X  
X 
X 
X 
X
Local Tolerability Assessmentss
X
 
 
 

X 
X 
X
Serious and non-serious adverse event monitoring
X
 
 
 
 
 

X 
X
Patient Reported Outcomes (PRO) Assessmentst
in-clinic completion
POEM
X 
X 
X
X 
X 
X
DLQI/CDLQI
X 
X 
X
X 
X 
X
at-home completion
PP-NRS 
At least 7 
days prior 
to Day 1
X
 
 
 

X 
X 
X
 
Abbreviations: = ongoing/continuous event; BSA = Body Surface Area; 
; C-SSRS = Columbia Suicide Severity Rating Scale; 
DLQI/CDLQI = Dermatology Life Quality Index/Children’s DLQI;EASI = Eczema Assessment Severity Index; ECG=electrocardiogram; EOS = End of Study; EOT = End of 
Treatment; ET = Early termination; hCG = -Human Chorionic Gonadotropin; HDL = High Density Lipoprotein; 
; 
IGA=Investigator’s Global Assessment; IP = Investigational Product;
;LDL = Low Density Lipoprotein;
 
 PCP = Primary Care Physician; PE: Physical Examination;
; 
; POEM = Patient 
oriented eczema measure; PP-NRS = Peak Pruritis Numerical rating Scale;
; 
 
;TB = Tuberculosis;VZV = Varcilla Zoster Virus.
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a. Day relative to start of study treatment (Day1).
b. Atopic Dermatitis Disease History includes collection of details of AD: AD diagnosis, the use of topical treatments, systemic treatments and other treatments for AD taken 
during the 3months/90days prior to Screening/Washout with dose, duration of treatment, and reason for discontinuation.  All other drugs (includingsunscreen, over the 
counter medication, vitamins, and dietary supplements) taken within 28days prior to the Screening/Washout visit should be recorded. 
c. Full Physical Examination(PE): includes, but is not limited to the following organ or body systems-head, ears, eyes, nose, mouth, skin, heart and lung, lymph nodes, 
gastrointestinal, musculoskeletal, abdomen, cardiovascular, and neurological systems.  In addition, an assessment will be made of the condition of all AD involved skin; 
Disease focusedPhysical Examination: includes all skin (treatable and non-treatable areas) and evaluation of any current or reported symptoms for clinically significant 
changes.Skin swabs may be obtained if herpetiform rash is noticed during the PE to rule out VZV infection.
d. Vital Signs: Temperature (Oralortympanic temperature), pulse rate, and blood pressure will be taken in supine position, after the participant has been lying calmly for a 
minimum of 5minutes.  Assessment of vital signs should precede blood draw for clinical laboratory tests.
e. Local read, single ECG (in supineposition) at all time points indicated.  Triplicate ECG will be conducted as appropriate per Section 8.2.2.3.
f. Chest X-ray or other appropriate diagnostic image (ie, CAT or MRI) may be performed up to 12weeks prior to Screening.  Official reading must be located and available in 
the source documentation.  See Section 8.2.1.3for more details. 
g. Site staff is to administer the Columbia Suicide Severity Scale (C-SSRS) to all participants at screening and score immediately.  Participants who have recent or active 
suicidal ideation or behavior or clinically significant depression will be excluded from the study or discontinued from the study per Section 5.2. For participants meeting 
exclusionary results on the C-SSRS, it is recommended the participant’s primary care physician (PCP) should be informed, and the participant referred to a mental health 
professional, either by the PCP or the investigatoraccording to their usual practice.  See Section 8.2.2.8for more details.
h. Blood draw for hematology and serum chemistry on Day1 will be performed before the in-clinic IP application.  If the screening hematologyand serum chemistry are 
performed within 7days prior to Day1, then Day1 hematology and serum chemistry tests will be performed at the discretion of the investigator or his/her designee.  
Laboratory tests with abnormal results (per Section 7.1.5)may be repeated once during the screening period; the last value will be used to determine eligibility. 
i. Participants must be fasting (water only) for 8hours prior to visits when lipid panel is being taken.  Includes total cholesterol, LDL, HDL and triglycerides.
j. A documented TB test performed within 12weeks prior to Screeningis acceptable.  Participants with a history of tuberculosis may not require TB testing as per the protocol 
exclusion criteria in Section 5.2.  In addition to protocol required TB testing, sites should follow their local standards for TB status determination, which may include chest 
X-ray, CAT or MRI (as per local regulation).  See Section 8.2.1.2for additional details.  Official reading must be located in the source document.
k. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or 
hormone replacement therapy (HRT).
l. Serum pregnancy testing at screening is required for women of childbearing potential (WOCBP).  Pregnancy tests may also be repeated more frequently as per request of 
IRBs/ECs or if required by local regulations.  Pregnancy tests will also be done whenever 1menstrual cycle is missed during the active treatment period (or when potential 
pregnancy is otherwise suspected).  Two negative pregnancy tests are required before randomization (one negative serum pregnancy test at screening and one negative urine 
pregnancy test at Day1 visit).  Serum will also be collected at Day 1 to test pregnancy, the results of which may be received after Day1.  If urine pregnancy test is positive
after IP application, serum pregnancy test will be conducted, IP application paused and sponsor clinician and sponsor medical monitor notified immediately. 
m. Includes testing for HepatitisB Surface Antigen (HBsAg) and HepatitisB Core Antibody (HBcAb); HepatitisB Surface Antibody (HBsAb) will be reflex tested if 
participants are positive for HBsAb.  HBsAbwill be tested for all participants if required by country-specific regulations, See country-specific details in Appendix8.  
Hepatitis C Viral RNA (HCV RNA) will be reflex tested if participants are positive for HCVAb.
n. [if required by country-specific regulations] Hepatitis B virus (HBV)deoxyribonucleic acid (DNA)assessments will be reflex tested only if HBsAg and HBcAb are negative 
and HBsAb is positive without documentation of prior HBV vaccination at screening and for participants who had negative HBsAg, positive HBcAb and positive HBsAb 
with documentation of HBV vaccination at screening.
o. VZV IgG antibody testing is required to confirm eligibility in adolescent participants who have not received at least one dose of a varicella vaccine.
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q. Only for participants who do not meet randomization criteria.
r. The contraception check is an opportunity to confirm that contraception, if assigned, is used consistently and correctly.  Also, it is the opportunity to assess changing potential 
to father/bear children and allows for altering contraception if new disease contraindicates a selected method of contraception or if non-childbearing status is achieved. 
s. Local tolerability at the site of IP application will be assessed pre-dose and immediately after post-dose.
t. PP-NRSwill be assessed daily during the screening period (at least 7days immediately prior to Day1) and from Day1 to EOT visit (Week6) and then, at follow-up; 
 
 
 
 
 
  
 
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2. INTRODUCTION
PF-06700841 is a TYK2/JAK1 inhibitor that is currently being investigated for multiple 
therapeutic indications.
2.1. Study Rationale 
The purpose of this study is to assess PF-06700841 efficacy, safety, tolerability and PK of 
multiple topical formulation concentrations of PF-06700841, in mild to moderate AD
population.  In addition, the study is intended to enable selection of a dose and dosing 
regimen (QD vs. BID) for the future clinical development of PF-06700841.  Oral formulation 
of PF-06700841 has been studied in multiple indications, but this is the first study in topical 
formulation to be applied to participants with mild or moderate AD. 
2.2. Background 
Atopic dermatitis (AD), also known as atopic eczema, is a common, chronic, inflammatory 
skin disorder characterized by flaky skin lesions, intense pruritus, and a general deterioration 
in quality of life.  Atopic dermatitis can affect any age group.1  Prevalence estimates suggest 
approximately 10% of adults and 10%-20% of children suffer from AD.  AD usually begins 
in early childhood and continues to intermittently and unpredictably flare in adolescence and 
in adulthood.  Up to 18% of those affected with AD suffer with severe disease.  The burden 
of disease is substantial for children, adolescents, and adults, as well as their family members 
and caregivers.
Progress in the development of topical therapies for AD has not advanced as rapidly as other 
areas in dermatology.  Patients with persistent AD often require long-term intermittent 
treatment, in addition to topical treatments, which can be self-administered at home, remain 
timely and are easily accessible option. 
There are a limited number of treatments available for AD.  Current treatments for AD 
include emollients, topical corticosteroids (eg, betamethasone, clobetasol, fluocinonide), 
topical calcineurin inhibitors (eg, pimecrolimus, tacrolimus), and coal tar preparations.  
Crisaborole was approved as a topical treatment in December 2016 by the US Federal Drug 
Administration (FDA) for use in patients with mild to moderate AD.  Additional treatments 
generally reserved for severe AD include phototherapy (eg, ultraviolet A light [UVA] with or 
without psoralen, ultraviolet B light [UVB] narrowband or broadband) and systemic agents 
(eg, corticosteroids, cyclosporine, recombinant IFN-, mycophenolate mofetil, methotrexate 
[MTX], azathioprine [AZA], intravenous immunoglobulin).2 None of the currently available 
therapies offer a cure; therefore, the main aims of existing treatments are to reduce the 
occurrence of acute flares, increase the time between relapses, reduce pruritus and reduce the 
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For AD patients not responding to topical therapies and phototherapy, off-label use of 
systemic agents, which includes both oral corticosteroids and oral immunosuppressants 
remain the last viable treatment option.  Systemic therapy options are associated with 
potentially severe adverse effects and require careful monitoring.  The risk of toxicity and 
side effects remain a concern when systemic agents are used.  For these reasons the use of 
these agents is limited to short courses or intermittent therapy.
Other systemic agents used to treat AD are under clinical development or recently approved.  
Dupilumab, an injectable human monoclonal antibody targeting interleukin (IL)-4 and -13,
was approved by the FDA in March 2017 and received marketing authorisation in Europe in 
September 2017.  This offers a novel mechanism of action for the treatment of moderate to 
severe AD. However, the approved dosing for dupilumab as an initial dose of 2 x 300 mg 
subcutaneous injections followed by 300 mg every other week injections may limit the 
desirability of this treatment.
Therefore, the prominent unmet medical need in the topical treatment of AD is for an 
effective, safe topical agent without restrictions on long-term or continuous use, and without 
local or systemic side effects, and to be approved for use on all body regions, and will be 
approved for use in adolescents.
Mechanism of Action
The pathophysiology of AD is the product of a complex interaction between various 
susceptibility genes, host environmental factors, infectious agents, defects in skin barrier 
function, and immunologic responses.  The predominant symptom of AD (ie pruritus and the 
resulting scratching) typically sets off an amplification cycle of atopic skin inflammation.  
Activation of T lymphocytes, dendritic cells, macrophages, keratinocytes, mast cells, and 
eosinophils results in a release of numerous pro-inflammatory cytokines and chemokines.  
This amplification cycle sustains the inflammatory responses characteristic of atopic 
dermatitis lesions.  Acute atopic dermatitis lesions have been associated with a 
Th2 phenotype, showing dominance of interleukin (IL)-4, IL-5, IL-13, and IL-31 secretion.  
While IL-4 producing Th2 cells may drive the development of atopic skin lesions, chronic 
lesions show either the coexistence of both IL-4 producing Th2 and IFN-producing 
Th1 cells or Th1 dominance.  This coexistence of Th2 and Th1 responses or Th1 dominance 
is more likely to be the underlying immunopathology in adult participants who have had 
atopic dermatitis chronically or intermittently since childhood.  Recent evidence5 supports 
IL-31 having an important role in pruritus and inflammation in AD.6,7
In the skin, cytokines induced by Janus Kinase (JAK) signaling impact several cellular 
inflammatory functions such as apoptosis of inflammatory T cell infiltrates and promoting 
T helper (Th) cell differentiation.  C-X-C motif chemokine ligand 10 (CXCL10), C-C motif 
chemokine ligand 26 (CCL26) and matrix metalloprotease 12 (MMP12) have been reported 
to be induced by cytokines acting via the JAK class of kinases8-11 and are implicated in 
inflammatory and autoimmune conditions of the skin.12-17 In addition, impairment of the 
skin barrier protein filaggrin has also been implicated in inflammatory and autoimmune 
diseases of the skin,18 and its expression has been reported to increase upon inhibition of JAK

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enzymes.
9 Following topical applicationof the clinical formulation to freshly excised human 
skin, PF-06700841 caused a dose-dependent inhibition of gene expression of 
pro-inflammatory molecules CXCL10, CCL26 and MMP12 (measured by changes in 
messenger ribonucleic acid [mRNA] in the presence and absence of PF-06700841) and a 
dose-dependent stimulation of the skin barrier protein, filaggrin.  Thus PF-06700841 showed 
pharmacology in human skin by the topical application, consistent with the known activity of 
PF-06700841 on JAKclass of kinases.
The Tyrosing Kinase2 (TYK2)activity of PF-06700841 will block IL-23 signaling which is 
important for Th17 and Th22 cell differentiation, bringing about the potential for activity in 
certain subtypes of AD that appear to have greater dependence on Th17 and Th22 pathways, 
including early-onset pediatric AD, intrinsic (non-allergic AD), and AD in Asian and 
African-American participants.
19-22
PF-06700841 is a dual TYK2/JAK1 inhibitor with good selectivity profile over other human 
kinases.  Based on its cytokine inhibition profile, PF-06700841 is expected toprovide
therapeutic benefit in thetreatment of Atopic Dermatitis by targeting the signaling of 
cytokines in Th1, Th2and Th17 lymphocytes.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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2.3.Benefit/Risk Assessment
This is the first study where a PF-06700841 cream formulation is being applied topically to 
participantswith atopic dermatitis.  This is also the first study where PF-06700841 cream 
formulation will be applied to participants from 12-18years of age with AD. 
JAKkinase inhibitors have shown efficacious in AD studies.  In addition, systemic exposures
following topicalapplication of PF-06700841 is expected to be lower than that observed 
following oral administration in alopecia areata (B7931005) and psoriasis (B7931004) 
studies therefore, no change isanticipated in benefit/risk profile. 
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events (AEs) of PF-06700841 may be found in the IB, which is the single 
reference safety document (SRSD) for this study. 
3.OBJECTIVES, ESTIMANDS, AND ENDPOINTS
Objectives
Endpoints
Estimands
Primary Objective: 
Primary Endpoint(s):
Primary Estimands: 
To compare the efficacyof 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, on percent change from 
baseline in Eczema Area and 
Percent change from baseline in 
EASI total score at Week6.
Estimand E1: This estimand is 
intended to provide a population 
level estimate of the treatment 
effect of theIP on a continuous 
endpoint; without the benefit of 
additional prohibited medications 
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Severity Index (EASI) in 
participants with mild or 
moderate atopic dermatitis (AD). 
during treatment and regardless of 
participant compliance with the 
IP dosing.
Population:
Participants with mild or 
moderate AD as defined by the 
inclusion and exclusion criteria; 
without the benefit of receiving 
prohibited medications during 
treatment and regardless of 
compliance.
Inter-current Events: 
a.
Prohibited medication – all 
scores in participants who 
receive prohibited medication 
post randomization will be 
omitted from the analysis and 
treated as missing scores. 
Missing scores will be 
imputed based on the 
assumption that participants 
do not benefit from the IP 
treatment.
b.
Withdrawal and all other 
events leading to missing 
data will be treated similarly 
assuming participants have 
efficacy values similar to 
control participants. 
c.
Inadequate compliance –
participants data will be used 
as recorded.
Population level summary: 
The percent change from baseline 
mean difference between treated 
and vehicle in EASI score.

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Secondary Objective(s): 
Secondary Endpoints:
Secondary Estimands:
To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, using Investigator’s Global 
Assessment (IGA) score 
assessment as endpoint in 
participants with mild or 
moderate AD. 
Key Secondary Endpoint:
Proportion of participants achieving 
IGA score of clear (0) or almost 
clear (1) (on a 5 point scale) and a 
reduction from baseline of 2 points 
at Week 6.
Estimand E2: This estimand is 
intended to provide a population 
level estimate of the treatment 
effect of the IP on a binary 
responder endpoint; without the 
benefit of additional prohibited 
medications and regardless of a 
participant compliance with the 
IP dosing.
Population:
Participants with mild or 
moderate AD as defined by the 
inclusion and exclusion criteria; 
without the benefit of receiving 
prohibited medications during 
treatment and regardless of 
compliance.
Inter-current Events: 
a.
Prohibited medication –
response will be considered 
negative for participants who 
receive prohibited medication 
post-randomization.
b.
Withdrawal and all other 
events leading to missing 
data will be treated similarly 
assuming that participants no 
longer receive benefit from 
the IP and hence will be 
treated as failure for endpoint 
above.
c.
Inadequate compliance –
participants data will be used 
as recorded.
Population level summary: 
The difference in proportions 
between IP treated and vehicle 
response rates.
To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, on change from baseline in 
EASI in participants with mild or 
moderate AD.
Change from baseline in EASI total 
score at Week 6.
All continuous secondary 
endpoints will be analyzed 
descriptively and using estimand 
E1 described above, when 
appropriate.
All categorical secondary 
endpoints will be analyzed 
descriptively and using estimand 

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To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, using measures of patient 
reported outcomes (PRO), in 
participants with mild or 
moderate AD.
Proportion of participants having 
2grades of reduction in weekly 
averages ofPeak Pruritus Numerical 
Rating Scale (PP-NRS) at all site 
visit time points specified in the 
SoA.
E2 described above, when 
appropriate.
To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle, applied QD or 
BID, using measures of disease 
affected area, in participants with 
mild or moderateAD.
Percent change from baseline in 
affected BodySurface Area (BSA) 
at Week6 and at other time points 
specified in the SoA.
To compare the efficacy of 
multiple dose levels of 
PF-06700841 topical cream 
versus vehicle cream, applied QD 
or BID, using measures of disease 
severity and symptoms as 
endpoints in participants with 
mild or moderate AD.
Proportion of participants achieving 
EASI-75 (75% improvement from 
baseline).
To compare safety and 
tolerability of multiple doses of 
PF-06700841 cream versus 
vehicle, applied QD or BID, in 
participants with mild or 
moderate AD.
a.Incidence of treatment-emergent 
adverse events (AEs and SAEs), 
significant changes in vital signs, 
clinical laboratory abnormalities 
and ECG.
b.Change from baselinein clinical 
laboratory values (chemistry and 
hematology, lipids).
c.Change from baseline in ECG 
parameters (heart rate, QT, QTc, 
PR and QRS intervals).
d.Change from baseline in vital 
signs (blood pressure, pulse rate 
and temperature measurements).
e.Incidence of severity grades in 
skin tolerability at times 
indicated in SoA.
There is no defined estimand for 
these endpoints and they will be 
analyzed using Pfizer data 
standards as applicable.
 
 
 
 
 
 
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EASI-90,
 
 
 
, EASI-90
90%
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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4.STUDY DESIGN
4.1.Overall Design
This Phase2b, multi-center, randomized, double-blind, vehicle-controlled, parallel group, 
dose-rangingstudy will assess efficacy, safety, tolerability and PK of a topical formulation of 
PF-06700841, whenapplied once or twice daily, in participants with mildor moderate atopic 
dermatitis.  This is the first study where a PF-06700841 cream formulation is being applied 
to participants with atopic dermatitis. 
Participants will bescreenedwithin 6weeks prior to the Day1 dose of IP to confirm they 
meet the selection criteria for the study.  The treatment will be 6weeks, followed by a 
4weekfollow-up.  The total study duration is approximately 16weeks.
At the start of the study, adult participants 18-75yearsof age (or minimum age based on 
country-specific criteria) with mild or moderate atopic dermatitiswill be enrolled.  Once 
approximately 20% of participants have completed at least 2weeks (Week2 visit) of 
treatment, assessment of safety and tolerability data will be conducted by an independent 
Internal Review Committee(IRC). After confirming acceptable safety and tolerability, the 
minimum age of male participants to be enrolled in this study with mild or moderate atopic
dermatitis will be lowered to 12years. 
Assuming 20% dropout rate, a total of approximately 280participants (approximately 
35participants per treatment arm) will be randomized to ensure completion of approximately 
224participants (28participants/arm). 
Multiple safety, efficacy, PK and pharmacodynamics (PD) related assessments will be 
performed during the treatmentand follow-up period. 
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Participants will be randomizedto 1of 8treatment arms in the ratio of 1:1:1:1:1:1:1:1.  
Investigators, participants, and the sponsor study team will be blinded as to investigational 
product (PF-06700841 cream vs vehicle cream). 
Table3.
Treatment Arms
Treatment 
Arm
Target Number of 
Participants Randomized
Approximate Number of 
Completers
Investigational Product
A
35
28
Vehicle cream QD
B
35
28
PF-06700841 0.1% cream QD
C
35
28
PF-06700841 0.3% cream QD
D
35
28
PF-06700841 1.0% cream QD
E
35
28
PF-06700841 3.0% cream QD
F
35
28
Vehicle cream BID*
G
35
28
PF-06700841 0.3% cream BID*
H
35
28
PF-06700841 1.0% cream BID*
A study design schematic is in Figure 2below.
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Figure 2. Study Design Schema
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4.2.Scientific Rationale for Study Design
This 6-week study is first time a topical PF-06700841cream formulation is being evaluated 
in a mild-to-moderate ADpopulationwith an affected body surface area (BSA) of 2-20%. 
Multiple formulation concentrations are being tested in two dosing regimens(QD vs BID)to 
assess efficacy, safety, tolerabilityand PK.  The duration of the study is appropriate to assess 
theefficacy, safety and tolerabilityprofile of topical PF-06700841.  The current nonclinical 
toxicology package supports the study durations of up to 12weeks.
Primary and key secondary registration endpoints of this study are: percent change from 
baseline in Eczema Areaand Severity Index (EASI), acontinuousendpoint and 
Investigator’s Global Assessment (IGA), a binary endpoint respectively. 
Male Adolescents
Prevalence estimates suggest approximately 10%-20% children suffer from AD.  AD usually 
begins in early childhood and continues to intermittently and unpredictably flare in 
adolescence and in adulthood.  Therefore, inclusion of adolescent population will provide an 
estimate of the efficacy of PF-06700841 in this population and will assist in future 
registration and Phase3 planning.  PF-06700841 has been associated with fetotoxicity in 
animals.  Since the systemic PF-06700841 exposure following topical treatment is unknown, 
only male adolescent participants will be enrolled at this time to avoid any risk of pregnancy 
in adolescent females in an unlikely event of failure to strictly follow contraception 
requirements.
PK Assessments
Since this is a first topical application study of PF-06700841, PK samples will be collected at 
each visit to characterizesystemic PK.  Understanding of systemic exposures will inform the 
potential contribution of systemic exposure to the overall pharmacology in this study.
 
 
 
 
 
 
 
 
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Patient-Reported Outcome Measures
Patient reported outcomes will evaluate changes in AD symptoms and health related quality 
of life.  The 
 
Peak-Pruritis Numerical Rating Scale (PP-NRS)are assessments of the symptoms associated 
with AD, predominantly itching, redness, scaling, burning, stinging, cracking, flaking and 
pain. 
 
The PatientOriented Eczema 
Measure (POEM) is an assessment of the frequency of the most common symptoms of AD, 
which has been assessed for labeling in other AD treatments. The Dermatology Life Quality 
Index (DLQI) assesses dermatology specific impact on quality of life, which has also been 
used for labeling of AD treatments. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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4.4.End of Study Definition
A participant is considered to have completed the study if they have completed all phases of 
the study including the follow-up visit (Visit7), approximately 28-35days post-last dose
application.
The end of the study is defined as the date of the last visit (Visit7)by last participant, across 
all sites.
5.STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled.  The 
following eligibility criteria are designed to select participants for whom participation in the 
study is considered appropriate.  All relevant medical and nonmedical conditions should be 
taken into consideration when deciding whether a particular participant is suitable for this 
protocol. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
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5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. Female participants between the ages of 18 and 75 years, inclusive, at the time of 
informed consent at Screening or male participants between the ages of 12 and 
75 years, inclusive, at the time of informed consent at Screening.

Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female 
(Section 10.4.2) participants.
Note: Female participants who are of child-bearing potential must not be intending to 
become pregnant, currently pregnant, or lactating.
Note: Male participants between the ages of 12 and <18 years (or the minimum 
country-specific age of consent) are eligible to enroll only after safety/tolerability is 
reviewed and deemed acceptable by an IRC review of the data from approximately 
20% of enrolled participants.
Type of Participant and Disease Characteristics:
2. The following atopic dermatitis criteria must be met:
a.
Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at 
least 3 months (Appendix 9); the clinical diagnosis of atopic dermatitis will be 
confirmed according to the criteria of Hanifin and Rajka26 at the Screening Visit.
b. Have an Investigator’s Global Assessment (IGA) score of 2 (mild), or 
3 (moderate) at screening and at Day 1 (prior to first dose of the IP).
c.
Have atopic dermatitis on the head (including face, but excluding hair-bearing 
scalp), neck, trunk (excluding groin and genitals), or limbs, including palms and 
soles, covering at least 2% of total BSA and up to and including 20% of total 
BSA at Screening and at Day 1 (Visit 1).  At least 2% of the total BSA will need 
to be on the head (including face, but excluding hair bearing scalp), neck, trunk 
(excluding groin and genitals), or limbs (excluding palms and soles).
Note: Refer to Section 8.1.4 for methods of calculating %BSA.
d. Have an EASI total score of 3 to 21 at Screening and at Day 1.
Note: Refer to Section 8.1.3 for method of calculating EASI scores.
e.
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3. Participants who are willing and able to comply with all scheduled visits, treatment 
plan, laboratory tests, lifestyle considerations, and other study procedures.
Note: Refer to Section 5.3 for Lifestyle considerations.
Weight:
4. Body weight 40 kg and Body Mass Index (BMI) 17.5 kg/m2 up to 35 kg/m2
(inclusive) at Screening and at Day 1.
Informed Consent:
5. Capable of giving signed informed consent as described in Appendix 1, which 
includes compliance with the requirements and restrictions listed in the informed 
consent document (ICD) and in this protocol.
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. Active forms of dermatitides/eczematous conditions (eg, contact dermatitis, 
seborrhhoeic, discoid, gravitational, asteatotic and dishydrotic eczema) or other 
inflammatory skin diseases, ie, not AD or evidence of skin conditions (eg, psoriasis, 
viral infection, fungal infection, bacterial infection) that would interfere with 
evaluation of atopic dermatitis or response to treatment.
2. Any psychiatric condition including recent or active suicidal ideation or behavior that 
meets any of the following criteria at Screening or Day 1: 
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) (Appendix 13);
b. Previous history of suicidal behaviors in the past 5 years: “Yes” answer (for 
events that occurred in the past 5 years) to any of the suicidal behavior items of 
the C-SSRS;
c.
Any lifetime history of serious or recurrent suicidal behavior;
d. The presence of any current major psychiatric disorder that is not explicitly 
permitted in the inclusion/exclusion criteria;
e.
In the opinion of the investigator or Pfizer (or designee) exclusion is required.
3. Fitzpatrick skin type score >5.

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4. Current or recent history (approximately, within 3 months) of severe, progressive, or 
uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, 
pulmonary, cardiovascular, or neurological disease.
5. A history of any lymphoproliferative disorder (such as Epstein Barr Virus [EBV] –
related lymphoproliferative disorder), history of lymphoma, leukemia, malignancies 
or signs and symptoms suggestive of current lymphatic disease.
Note: Adequately treated or excised non-metastatic basal cell or squamous cell cancer 
of the skin, or cervical carcinoma in situ are allowed.
6. A history (single episode) of disseminated herpes zoster or disseminated herpes 
simplex, or a recurrent (more than one episode of) localized, dermatomal herpes 
zoster.
7. A history of systemic (within approximately 3 months), chronic or acute skin 
infection (within approximately 2 weeks) requiring hospitalization, parenteral 
antimicrobial, antivirals, antiparasitics, antiprotozoals, or antifungals therapy, or as 
otherwise judged clinically significant by the investigator.
8. A known immunodeficiency disorder or a first-degree relative with a hereditary 
immunodeficiency.
9. Undergone significant trauma or major surgery within 1 month prior to screening.
10. A current or past medical history of conditions associated with thrombocytopenia, 
coagulopathy or platelet dysfunction.
11. Other acute or chronic medical or psychiatric condition including recent (within the 
past year) or active suicidal ideation or behavior or laboratory abnormality that may 
increase the risk associated with study participation or investigational product 
administration or may interfere with the interpretation of study results and, in the 
judgment of the investigator, would make the participant inappropriate for entry into 
this study.
Prior/Concomitant Therapy:
12. Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the 
first dose of IP, or is expected to be vaccinated or to have household exposure to 
these vaccines during treatment or up until follow-up visit.
Note: Male participants 12 to <18 years old without documented evidence of having 
received at least one dose of the varicella vaccine in countries where the vaccine is 
approved and standard of care or those who do not have evidence of prior exposure to 
varicella zoster virus (VZV) based on serological testing (ie, varicella zoster virus 
immunoglobulin G antibody [VZV IgG Ab]) at screening are excluded.

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Prior/Concurrent Clinical Study Experience:
13. Previous administration with an investigational drug within 4 weeks (or as 
determined by the local requirement) or 5 half-lives prior to Screening (whichever is 
longer). 
Note: local regulations or other factors may require more than 4 weeks.
Note: Any investigational or experimental therapy taken or procedure performed for 
AD, psoriasis, psoriatic arthritis or rheumatoid arthritis in the previous 1 year should 
be discussed with the Pfizer Medical Monitor (or designee).  Participants cannot 
participate in studies of other investigational or experimental therapies or procedures 
at any time during their participation in this study.
14. Participants who have received prior treatment with any TYK2 and/or JAK inhibitors
within 3 months or 5 half-lives preceding Screening (whichever is longer).
Diagnostic Assessments:
15. A Screening 12-lead ECG that demonstrates clinically significant abnormalities 
requiring treatment (eg, acute myocardial infarction, serious tachy- or 
brady-arrhythmias) or that are indicative of serious underlying heart disease 
(eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, 
Wolff-Parkinson-White syndrome) or criteria associated with Q wave interval 
(QT)/Fridericia-corrected Q wave interval (QTcF) abnormalities including.
16. A marked prolongation of QTcF interval (>450 milliseconds [msec]) on the screening 
ECG:
a.
A history of additional risk factors for Torsade de Pointes (TdP) (eg, heart failure, 
hypokalemia, family history of Long QT Syndrome);
b. Use of concomitant medications that prolong the QT/QTcF interval;
c.
If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 
2 more times and the average of the 3 QTc or QRS values should be used to 
determine the participant’s eligibility.  Computer-interpreted ECGs should be 
overread by a physician experienced in reading ECGs before excluding 
participant.
17. Participants with 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.
Hemoglobin <11 g/dL (<100 g/L) or hematocrit <30%; 
b. White blood cell count <3.0 x 109/L (<3000 mm3); 

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c.
Absolute neutrophil count <1.5 x 109/L (<1500 mm3); 
d. Absolute lymphocyte count of <1.0 x 109/L (<1000/mm3);
e.
Platelet count <100 x 109/L (<100,000/mm3); 
f.
Estimated glomerular filteration rate (eGFR) <60 mL/min/1.73 m2 using 
creatinine or cystatin C based calculations (Section 7.1.4);
g. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values 
2 times the ULN; 
h. Total bilirubin 1.5 times the ULN; participants with a history of Gilbert's 
syndrome may have a direct bilirubin measured and would be eligible for this 
study provided the direct bilirubin is ULN;
i.
Creatinine kinase (CK) >3 times the ULN.
18. In the opinion of the investigator or sponsor, have any uncontrolled clinically 
significant laboratory abnormality that would affect interpretation of study data or the 
participant’s participation in the study.
19. Infected with Mycobacterium tuberculosis (TB) as defined by the following: 
a.
A positive Interferon Gamma Release Assay (IGRA) test or positive
Mantoux/Purified Protein Derivative (PPD) tuberculin skin test;
b. Any chest imaging (chest x-ray, computed tomography (CAT Scan) or Magnetic 
Resonance Imaging (MRI)) taken at screening (or performed and documented 
within 12 weeks prior to Screening) with changes suggestive of active TB 
infection will be excluded;
c.
A participant who has been treated or is currently being treated for active or latent 
TB infection;
d. A history of either untreated or inadequately treated latent or active TB infection.
20. Infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C 
viruses.  (Also see country-specific exclusion criteria in Appendix 8).
Note: For Hepatitis B, all participants will undergo testing for Hepatitis B Surface 
Antigen (HBsAg) and Hepatitis B Core Antibody (HBcAb) during Screening.  
Participants who are HBsAg positive are not eligible for the study.  Participants who 
are HBsAg negative and HBcAb positive will be reflex tested for Hepatitis B Surface 
Antibody (HBsAb) and if HBsAb is positive, may be enrolled in the study; if HBsAb 
is negative, the participant is not eligible for the study. 

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Note: For Hepatitis C, all participants will undergo testing for Hepatitis C antibody (HCV
Ab) during Screening.  Participants who are hepatitis C antibody (HCV Ab) positive require 
further testing with HCV RNA polymerase chain reaction (PCR) and are allowed to enroll if 
HCV RNA PCR negative.
Other Exclusions:
21. 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 
Pfizer employees, including their family members, directly involved in the conduct of 
the study. 
22. A history of alcohol or substance abuse within 6 months prior to Screening that in the
opinion of the investigator will preclude participation in the study.
23. In the opinion of the investigator or Sponsor Clinician or Sponsor Medical Monitor, 
the participant is inappropriate for entry into this study.
5.3. Lifestyle Considerations
5.3.1. Contraception
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected an appropriate method of contraception for the individual 
participant and his or her partner(s) from the permitted list of contraception methods (see 
Appendix 4 and 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 (SoA), the 
investigator or designee will inform the participant of the need to use highly effective 
contraception consistently and correctly and document the conversation and the participant’s 
affirmation 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 or if pregnancy is known or suspected in the participant or partner.
5.3.2. Medications/Treatments Discontinuation, Non-Medicated Emollients and Bathing
Participants are required to discontinue and avoid using certain medications and treatments as 
described in participant selection criteria.  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. 
All medications and treatments that could affect atopic dermatitis must be discontinued for 
the duration of the study.  The only exception is that shampoo containing tar, salicylic acid or 
low or least potent corticosteroid products (Class 6 or 7 corticosteroids, namely 
hydrocortisone 1% and hydrocortisone acetate 1%) is allowed for atopic dermatitis on 
hair-bearing scalp throughout the study.  Due to the potential to affect atopic dermatitis with 
ultraviolet light exposure, participants must also avoid prolonged exposure to the sun and 
avoid the use of tanning booths, sun lamps or other ultraviolet light sources during the study. 

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The non-medicated emollient and sunscreen are the only topical products permitted to be 
used on atopic dermatitis skin during the Washout/Screening period (only exception is the 
use of permitted topical products for atopic dermatitis on hair-bearing scalp).  Participants 
will stop applying non-medicated emollient and sunscreen on atopic dermatitis skin on the 
day before Day 1 (Visit 1).  During the study period, use of non-medicated emollient and 
sunscreen are allowed only on skin that was considered normal or non-lesional at Day 1 
(Visit 1) (ie, never treated with IP).  Any non-medicated emollient used by the participant 
during the study should be documented in study records and the Case Report Form (CRF).
Through and including Week 6 visit, participants are to continue to treat all treatment-eligible 
atopic dermatitis areas identified at Day 1 (Visit 1) once or twice daily in accordance with the 
original dosing regimen assigned, regardless of clearing or improvement of atopic dermatitis.  
Any new atopic dermatitis areas occurring following Day 1 (Visit 1) should also be treated 
with the IP. 
The treatment areas should not be bathed or showered for at least 4 hours after applying the 
IP.  Bathing or showering is permitted pre-dose and the application areas must be dry prior to 
cream application.
5.3.3. Dietary Supplements
For the purposes of this protocol, dietary supplements are defined as vitamins, minerals, 
purified food substances, and herbals with pharmaceutical properties. Vitamins, minerals 
and purified food substances are allowed in amounts not known to be associated with adverse 
effects (such as hypervitaminosis).
Herbals supplements are only allowed on a case by case basis; please contact the Pfizer staff.
Herbals eg, St. John’s Wort that are known to have an effect on drug metabolism must be 
discontinued at least 4 weeks or 5 half-lives (whichever is longer) before Day 1.
Participants should not consume grapefruit or grapefruit juice or citrus fruits eg, Seville 
oranges, pomelos within 7 days prior to Day 1 and until collection of the final PK blood 
sample.
5.3.4. Vaccine and Exposure to Infection Guidelines
5.3.4.1. Participant Specific Recommendations
It is recommended that all participants should be up-to-date with respect to standard of care 
vaccinations (as defined by their country health ministry) or AD guidelines.  Vaccination of 
participants with live components is prohibited within the 6 weeks prior to first dose of 
investigational product.  Adolescent participants without documented evidence of having 
received at least one dose of the varicella vaccine or those who are without evidence of 
previous varicella zoster exposure as confirmed by VZV IgG Ab serological testing are 
excluded. 

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5.3.4.2. Guidance Regarding Household Contact Vaccine-Related Exposure
Current routine household contact with children and others who have been vaccinated with 
live vaccine components may pose a risk during treatment and for 6 weeks following 
completion of the study.  Some of these vaccines include varicella (“chickenpox”) vaccine, 
oral polio vaccine, and the inhaled flu vaccine.  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.  Participants are suggested that exposure (through routine 
contact) should be avoided following vaccination (of others) with these vaccines for the 
stated time period:
1. Varicella or attenuated typhoid fever vaccination for 4 weeks following vaccination.
2. Oral polio vaccination for 6 weeks following vaccination.
3. Attenuated rotavirus vaccine for 10 days following vaccination.
4. FluMist(inhaled flu vaccine) for 1 week following vaccination.
Participants should avoid exposure to vaccinated or infected persons and contact the 
investigator promptly should they develop signs or symptoms of infections.
5.3.5. Other Requirements
1. Agree to avoid strenuous exercise during the study, especially within one week prior 
to the scheduled study visits and maintain adequate hydration, if possible.
2. On study visit days, do not smoke or ingest caffeine (eg, tea, coffee, some soft 
drinks/colas/energy drinks and power bars) during the 30 minutes prior to blood
pressure and pulse (heart) rate measurements.
3. On study visit days, showering or bathing is permitted prior to attending the study 
visit, but do not moisturize.
4. On study visit days, take prescribed permitted concomitant medication, as needed, 
prior to the study visit, if it can be administered with water only.
5. Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or 
other ultraviolet light sources during the study.
6. Contact the study site investigator if there are any changes or additions to 
concomitant medications.
7. Avoid having major elective surgery.
8. The participant should continue all non-pharmacological therapies, such as physical 
therapy, as indicated.  However, the participant should avoid changing the type or 
intensity of therapy or initiating new therapy until after Week 6 visit. 

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9. When applying the IP, the participant will not be required to wear gloves.  However, 
participants should be instructed to wash their hands with mild soap and water before 
and after each application. 
10. If study participants needs someone else to assist with applying investigational 
product on hard to reach areas (eg back), this person must wear gloves to avoid 
accidental exposure to the IP.  In order to limit the potential risk associated with 
accidental exposure, this individual should not be a pregnant or breastfeeding female.
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently randomly assigned to investigational product in the study.  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).
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
re-screened once if they fail the screening evaluation for reasons related to incidental 
transitory conditions, unless the reason for the screen failure is the disease severity inclusion 
criteria. 
All screening assessments must be repeated during re-screening, with the exception of chest 
radiograph, HIV, Hepatitis and TB testing.  These assessments do not have to be repeated if 
re-screening is done within 3 months of the initial screening visit and these assessments were 
performed during the initial screening visit.
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.
For the purposes of this protocol, the term investigational product may be used 
synonymously with study intervention.
Study intervention cream will be packaged in tubes containing 54 or 57 grams of either 
vehicle or PF-06700841 for topical application.  Treatment assignment will be blinded.  The 
tubes will be provided in cartons and both will be labelled in a blinded fashion according to 
local regulatory requirements. 

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6.1. Study Intervention Administered
For this study, investigational products are the following:

PF-06700841 cream, in 0.1%, 0.3%, 1%, and 3% strengths; may also be referred to as 
1 mg/g, 3 mg/g, 10 mg/g, and 30 mg/g, respectively.

Vehicle cream; may also be referred to as vehicle and/or placebo.
PF-06700841 creams will be supplied in four different strengths: 0.1%, 0.3%, 1% and 
3% (w/w), light mineral oil, white petrolatum, oleyl alcohol, emulsifying wax, diethylene 
glycol monoethyl ether, polyethylene glycol 400, 2-phenoxyethanol, and purified water.
Vehicle cream (no active drug in the formulation) contains light mineral oil, white 
petrolatum, oleyl alcohol, emulsifying wax, diethylene glycol monoethyl ether, polyethylene 
glycol 400, 2-phenoxyethanol, and purified water.
All active and vehicle creams will be packaged in laminate tubes containing 54 grams or 
57 grams of either vehicle cream or PF-06700841 cream for topical application.  All tubes 
will be provided in cartons and labelled in a blinded fashion according to local regulatory 
requirements.
6.1.1. Administration
6.1.1.1. Treated Atopic Dermatitis Areas
Atopic Dermatitis treatment areas will be all areas affected by AD, except hair-bearing 
scalp
Before the Day 1 initial IP application is performed, the designated areas for treatment will 
be identified at the Day 1 Visit and documented in the participant’s source document study 
records (body-site check list).  The participant and/or caregiver will be provided with 
documentation of the designated treatment areas.  Treated AD area identified on Day 1 
should be continued to be treated even if substantial improvement or clearing of AD occurs.  
If new AD areas emerge during the study, IP should be applied to these new areas after 
consultation with the Investigator.
6.1.1.2. General Instructions
On study Day 1 until the final dose at Week 6 visit, the IP should be applied once or twice
daily (around same time of the day), to all treatable AD involved areas (excluding the scalp) 
identified at Day 1.
All participants will be supplied with instructions on application and dose frequency 
commensurate to assigned treatment arm.  Those participants having difficulty reaching 
treatment-eligible atopic dermatitis areas (eg, back) may be assisted by another person who 
will need to apply the IP to the participant according to the investigational product 
application instructions.  The person assisting with the application must wear gloves to avoid 
any exposure to the IP. If a participant misses applying a dose, the participant should apply 

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this dose provided this dose should have been applied within the last 6 hours.  For longer 
intervals, the dose should be skipped.  The missed dose should be recorded in the dosing 
diary.  The next dose should be applied according to the regular dosing regimen.
Day 1 (Baseline Visit )
Participants and/or caregivers will be encouraged to observe and participate in the initial IP 
application on Day 1.  All subsequent doses, including the second dose on Day 1 (if 
applicable), will be applied at home.  The participant and/or caregiver will be instructed to 
complete the Dosing Diary starting with the first dose applied in the clinic on Day 1 through 
Week 6 (each time IP is applied) for all IP doses applied.
A thin layer of IP cream will be applied at a target application rate of approximately 
2 mg/cm2.
In order for participant or caregiver to keep track of the treatable BSA cleared, a paper 
version of the body check list may be provided on Day 1. 
Post Day 1 Visits
Post Day 1 (Baseline/Visit 1), any new atopic dermatitis on treatment-eligible areas 
identified by the participant or caregiver(s) should also be treated with the IP.  Decision to 
apply the IP to new eligible areas should be made following assessment by the Investigator 
or his/her designee.  Body site check-list will be updated and IP need will be re-assessed at 
every site visit during the treatment period.  If the total, treatable BSA exceeds 
20% (inclusion criteria requirement) during the six-week treatment period, the participant 
will still remain eligible for the study, given, that the total, treatable BSA does not exceed 
22%.  If the total, treatable BSA reaches 22%, the Sponsor may decide to discontinue the 
participant.
The reason for maintaining IP treatment areas the same as identified at Day 1
(Baseline/Visit 1) is to understand the efficacy, systemic safety, and local tolerability of 
PF-06700841 cream when applied to BSA of 2-20% for 6 weeks in participants with mild or 
moderate atopic dermatitis. 
Participants and/or caregivers will be instructed not to wipe investigational product off the 
skin, avoid applying an occlusive dressing to the treated areas, and refrain from swimming or 
bathing/washing the treated areas within 4 hours after application.
Use of any topical product (eg, sunscreens, moisturizers or non-medicated emollients) is 
prohibited on AD skin from Day 1 (Baseline/Visit 1) to the end of treatment period 
(Week 6), except for permitted products on scalp. 
Under no circumstances will the investigational drug application regimen be modified 
(eg, frequency of application increased or reduced, not stopped, or the application rate [target 
2 mg/cm2] increased or reduced) during the study.  Temporary discontinuation of 
investigational drug may be appropriate under some circumstances (eg, surgery, non-serious 

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infections) and should be discussed with the Medical Monitor (or designee) preferably prior 
to temporary discontinuation of investigational drug.
6.2. Preparation/Handling/Storage/Accountability
1. The investigator or designee must confirm appropriate temperature conditions have 
been maintained during transit for all study interventions received and any 
discrepancies are reported and resolved before use of the study intervention, as 
applicable for temperature-monitored shipments.
2. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention.  All study 
interventions must be stored in a secure, environmentally controlled, and monitored 
(manual or automated recording) area in accordance with the labeled storage 
conditions with access limited to the investigator and authorized site staff.  At a 
minimum, daily minimum and maximum temperatures for all site storage locations 
must be documented and available upon request.  Data for nonworking days must 
indicate the minimum and maximum temperature since previously documented for all 
site storage locations upon return to business.
3. 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).  All study 
interventions will be accounted for using an investigational product accountability 
form/record.
4. Further guidance and information for the final disposition of unused study 
interventions are provided in the investigational product manual (IP manual).
5. Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the product label. 
6. Study interventions should be stored in their original containers and in accordance 
with the labels. 
7. Site staff will instruct participants on the proper storage requirements for take-home 
study intervention. 
8. Any excursions from the study intervention label storage conditions should be 
reported to Pfizer upon discovery along with any actions taken.  The site should 
actively pursue options for returning the study intervention to the storage conditions 
described in the labeling, as soon as possible.  Once an excursion is identified, the 
study intervention must be quarantined and not used until Pfizer provides permission 
to use the study intervention.  It will not be considered a protocol deviation if Pfizer 
approves the use of the study intervention after the temperature excursion.  Use of the 
study intervention prior to Pfizer approval will be considered a protocol deviation.  

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Specific details regarding the definition of an excursion and information the site 
should report for each excursion will be provided to the site in the IP manual.
9. The sponsor or designee will provide guidance on the destruction of unused study 
intervention (eg, at the site).  If destruction is authorized to take place at the 
investigator site, the investigator must ensure that the materials are destroyed in 
compliance with applicable environmental regulations, institutional policy, and any 
special instructions provided by Pfizer, and all destruction must be adequately 
documented.
Additional details about accountability, storage, destruction, and excursion reporting can be 
found in the IP manual.
6.2.1. Preparation and Dispensing
Within this protocol, preparation refers to the investigator site activities performed to make 
the IP ready for application or dispensing to the participant/caregiver by qualified staff.  
Dispensing is defined as the provision of IP, concomitant treatments, and accompanying 
information by qualified staff member(s) to a healthcare provider, participant, or caregiver in 
accordance with this protocol.  Local health authority regulations or investigator site 
guidelines may use alternative terms for these activities.
The IP will be dispensed in a blinded fashion using an interactive response technology (IRT)
system at Day 1/Baseline, Week 1 (Visit 2), Week 2 (Visit 3), and Week 4 (Visit 5) visits.  A 
qualified staff member will dispense the IP via unique container numbers on the cartons 
provided, in quantities appropriate for the study visit schedule and the treatable % BSA.
For doses to be applied at home, the participant or caregiver should be instructed to maintain 
the product in its original package provided throughout the course of dosing and return the 
product and its original package (including empty, partial used and unused tubes) to the site 
at the next study visit.  All previously dispensed IP tubes will be retained by the site.  For 
each participant, IP tubes with caps will be weighed individually or collectively by the study 
site before dispensing and after return and the weights will be recorded.  The sponsor will use 
the recorded weights to estimate usage (eg, mg/cm2/application) for each participant.  Note 
that the weight recorded on the IP label is a nominal weight and not an exact weight of the IP 
and tube. 
Investigational product will be assigned to participants at the Day 1 (Baseline/Visit 1) visit 
once the participant is successfully randomized through the IRT system.  The investigator, 
appropriate delegate or site personnel will access the IRT system at screening and all 
subsequent IP dispensing visits to enter information including, but not limited to, the 
participants height, weight and % affected BSA to receive correct tube numbers to be 
dispensed to the participant.  Alternatively, the tool to standardize the IP need calculation 
across participants and study sites may be provided by the sponsor. 
The calculation of % BSA is described in Section 8.1.4.

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All tubes of investigational product dispensed or returned will be recorded and documented.
6.2.2. Investigational Product Accountability 
The investigator site must maintain adequate records documenting the receipt, use, loss, or 
other disposition of the IP supplies.  All investigational products will be accounted for using 
a drug accountability form/record.  All tubes of the IP must be returned to the investigator by 
the participant at every visit and at the end of the trial.
The participant will be asked to bring all dispensed IP (including empty, partially used and 
unused tubes) at every ‘compliance check’ visit; participants will be asked to bring dosing 
diary to the clinic at every clinic visit.  Detailed drug accountability records, including tube 
weights measured in the clinic, will be maintained by study staff for each participant.
The original IP accountability log, or equivalent document, must be accurately completed, 
signed by the Investigator, and retained at the study site (with a copy supplied to the 
Sponsor) when the study is complete.
6.2.3. Destruction of Investigational Product Supplies 
For all IP returned to the investigator by the participant, the investigator will maintain the 
returned supply until destruction is authorized. 
The sponsor or designee will provide guidance on the destruction of unused investigational 
product (eg, at the site).  If destruction is authorized to take place at the investigator site, the 
investigator must ensure that the materials are destroyed in compliance with applicable 
environmental regulations, institutional policy, and any special instructions provided by 
Pfizer, and all destruction must be adequately documented.
Further guidance and information for the final disposition of unused study interventions are 
provided in the IP manual.
6.3. Measures to Minimize Bias: Randomization and Blinding
Allocation to treatment will occur via an Interactive Response Technology (IRT) system.  
The system will be programmed with blind-breaking instructions.  Refer to Section 6.3.2 for 
further details. 
6.3.1. Allocation to Investigational Product
For this study, the IP is PF-06700841 (or its matching vehicle) topical cream.  Participants
will be randomized into one of the doses in QD dosing regimen or BID dosing regimen of 
PF-06700841 cream or its matching vehicle cream. 
At the Day 1 (Baseline/Visit 1) visit, provided all inclusion/exclusion criteria have been met, 
the participant will be randomized to trial medication.  The investigative site will contact an 
interactive response technology (IRT) system (or interactive Web-based response [IWR]).  
Allocation of participants to treatment arms will proceed through IRT.  The site personnel 
(study coordinator or specified designee) will be required to enter or select information 

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including but not limited to the user’s identification (ID) and password, the protocol number, 
the participant number.  The site personnel will then be provided with a treatment 
assignment, randomization number, and dispensable unit (DU) or container number.  The 
IRT system will provide a confirmation report containing the participant number, 
randomization number, and DU or container number assigned.  The confirmation report must 
be stored in the site’s files. 
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.
Investigational product will be dispensed at the study visits summarized in the SoA. 
Returned IP must not be re-dispensed to the participants.
6.3.2. Breaking the Blind
At the initiation of the study, the study site will be instructed on the method for blind 
breaking.  The method will be an electronic process and will use IRT system.  The IRT will 
be programmed with blind-breaking instructions.  Blinding codes should be broken only in 
exceptional circumstances when knowledge of the actual treatment code is absolutely 
essential for further management of the participant.  In case of an emergency, the investigator 
has the sole responsibility for determining if un-blinding of a participant’s treatment 
assignment is warranted.  Participant safety must always be the first consideration in making 
such a determination.  If the investigator decides that un-blinding is warranted, the 
investigator should make every effort to contact the sponsor prior to un-blinding a 
participant’s treatment assignment unless this could delay further management of the 
participant.  If a participant’s treatment assignment is unblinded, the sponsor must be notified 
within 24 hours after breaking the blind.  The date and reason that the blind was broken must 
be recorded in the source documentation and case report form (CRF). 
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.
Participants whose code is broken will be discontinued from treatment and the entire 
procedures equivalent to end of treatment will be performed where possible.
The participant’s data will be included in any full analyses.  Any broken blinds will be 
documented in the study report.
6.4. Study Intervention Compliance
The participant and/or a caregiver will apply IP at home and during in-clinic visits as
specified in Schedule of Activities (SoA). The participant and/or caregiver will be instructed 
to complete the Dosing Diary starting with the first dose applied in the clinic on Day 1
through Week 6 (each time IP is applied) for the IP doses applied at home.  In addition, 
participants will be instructed to bring to the clinic all used, partially used and empty IP tubes 
in their original containers for weighing, at each visit. 

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Participant compliance with IP will be assessed on visits identified in Schedule of Activities 
(SoA).  Compliance will be assessed by review of the participant/caregiver completed 
Dosing Diary and by weighing of the returned IP tubes. The difference in weight(s) of the
returned IP tubes will be used to estimate the doses applied.  Source documents will be 
placed in the participant’s study file.  Deviation(s) from the prescribed dosage regimen 
should be recorded in the CRF.
From Day 1 (Visit 1) through and including Week 6 visit (Visit 6), non-compliance is 
defined as less than 80% or more than 120% of IP applications.  If non-compliance is 
identified, or even if a few dose applications are missed or over-applied, then, participants 
will be re-trained on the importance and the process of proper IP application.  If 
non-compliance persists, the investigator, in consultation with the Sponsor, may withdraw 
any participant from the study for reasons of non-compliance with the dosing regimen.  
Investigators should indicate on the appropriate CRF page noncompliance with study 
intervention and provide an explanation. 
Inventory control of all IPs must be rigorously maintained throughout the duration of the 
study until all medication has been accounted for and/or returned to the sponsor.  Any 
discrepancies noted between drug dispensing records and the drug inventory must be 
reported to Pfizer.
6.5. Concomitant Therapy
Medications that are taken in the Screening period (after informed consent is obtained and 
before the first dose of IP) will be documented as prior medications.  Medications taken after 
the first dose of IP has been administered will be documented as concomitant medications.  
All concomitant medications taken during the study must be recorded in study records with 
indication, daily dose, and start and stop dates of application.  Participants will be queried 
about concomitant medication (including topical medications and treatments, 
over-the-counter and prescription medications and treatments, and vaccinations) at each 
study visit.  Any new concomitant medications or dose changes to current concomitant 
medications should be evaluated for potential new or worsening adverse events.
See Appendix 10 on prohibited medications and procedures.
In addition, the following concomitant medications are allowed, unless excluded in 
Prohibited Medications list (Appendix 10):
1. Antihistamines.
2. Acetaminophen/paracetamol and Ibuprofen.
3. Medications for regulation of thyroid function.
4. Selective leukotriene receptor antagonists (eg, montelukast sodium, zafirlukast), mast 
cell stabilizers (eg, cromolyn sodium or nedocromil sodium).

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5. Corticosteroid inhalers and intranasal sprays provided participants are on stable dose 
for at least 1 week before Day 1 and/or during treatment period.
6. Ophthalmic corticosteroids, provided participants are on stable dose for at least 
1 week before Day 1 and/or during treatment period.
7. Hormone replacement therapy (HRT) and hormonal contraceptives that meet the 
requirements of this study are allowed to be used in participants who are women of 
childbearing potential (WOCBP) (see Appendix 4). 
8. Medications for chronic stable medical conditions (eg, hypertension) provided these 
are not expected to affect the study assessments and participant is on a stable dosage.  
If prescribed, change in medication for hypertension is allowed.
9. Topical treatments applied to areas not treated with IP unless prohibited in 
Appendix 10.
10. Sunscreen and regular moisturizers applied to areas not treated with IP.  Site staff 
must verify that these are not emollients.
Any other concomitant medication will be considered on a case by case basis by the 
investigator in consultation with the Sponsor Medical Monitor.
6.5.1. Rescue Medicine
There is no rescue therapy to reverse the adverse events (AEs) observed with PF-06700841; 
standard medical supportive care must be provided to manage the AEs. 
6.6. Dose Modification 
Not applicable.
6.7. Intervention after the End of the Study
No intervention will be provided to study participants at the end of the study.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
In rare instances, it may be necessary for a participant to permanently discontinue IP.  Per the 
study estimands, if IP is permanently discontinued, the participant will proceed to early 
termination and follow-up visit per Schedule of Activities (SoA).  The site will inform 
Sponsor Medical Monitor or Sponsor clinician if the below criteria for permanent 
discontinuation of the IP are triggered.
Note that discontinuation of investigational product does not represent withdrawal from the 
study.

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7.1.1. ECG Changes
A participant who meets either of the bulleted criteria based on the average of triplicate ECG 
readings (also see Section 8.2.2.3) will be withdrawn from the study. 

QTcF >500 msec.

Change from baseline: QTc >60 msec.
If a clinically significant finding is identified (including, but not limited to, changes from 
baseline in QTcF after enrollment), the investigator or qualified designee will determine if 
the participant can continue in the study and if any change in participant management is 
needed.  This review of the ECG printed at the time of collection must be documented.  Any 
new clinically relevant finding should be reported as an AE.
7.1.2. Local Tolerability 
All participant-reported and observed application site adverse events (AEs) should be 
recorded along with the body region location, severity, duration and outcome as indicated on 
the CRF. 

If a participant experiences severity Grade 3 (severe) or 4 (very severe) on the local 
tolerability assessment (Section 8.2.2.9), study treatment will be discontinued 
permanently and participant will proceed to early termination (ET) visit and 
follow-up as described in Schedule of Activities (SoA). 

If a participant experiences application site reaction of Grade 2 (moderate) on the 
local tolerability assessment, investigator may temporarily discontinue application of 
IP for up to 48 hours without consulting the Sponsor.  If in the clinical judgment of 
the investigator IP interruption beyond 48 hours is advisable, the investigator must 
obtain agreement from the Pfizer medical monitor to continue withholding IP.  If 
temporary IP interruption for more than 5 consecutive days is needed, then the 
participant should be permanently withdrawn from treatment and should follow-up 
with the site until complete or near complete resolution of the AE.  This dosing gap 
may occur only once for the same participant.
7.1.3. Adverse Events
All treated infections occurring during the study, including, but not limited to, respiratory 
infections, cutaneous infections, urinary tract infections and episodes of suspicious or febrile 
diarrhea, should be cultured and any identified organisms noted in the Case Report Form.  
Infections should be classified as either serious infections or treated infections, as defined 
below.

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7.1.3.1. Serious Infections
A serious infection is any infection that requires hospitalization for treatment or requires 
parenteral antimicrobial therapy or meets other criteria that require it to be classified as a 
serious adverse event.  A participant who experiences a serious infection should be 
discontinued from the study and the serious adverse event should be listed as the reason for 
discontinuation in the Case Report Form.  Appropriate laboratory investigations, including 
but not limited to cultures should be performed to establish the etiology of any serious 
infection.  All adverse events, including serious adverse events, should be reported as 
described in Appendix 3 on Adverse Event Reporting.
7.1.3.2. Treated Infections
A treated infection is any infection that requires antimicrobial therapy by any route of 
administration or any surgical intervention (eg, incision and drainage).  Participants who 
experience infections that require treatment can have their blinded IP temporarily 
discontinued during antimicrobial therapy in consultation with the sponsor.  This information 
should be noted in the Case Report Form.
7.1.4. Potential Cases of Decreased eGFR
All participants will have serum creatinine based and serum cystatin-C based eGFR 
calculated at all time points.
Abnormal values in serum creatinine concurrent with absence of increase in blood urea
nitrogen (BUN) that meet the below criteria, in the absence of other causes of kidney injury,
are considered potential cases of acute kidney injury and should be considered important 
medical events.
If an individual participant demonstrates CONCOMITANT serum creatinine-based AND 
serum Cystatin C-based eGFR decline of 30% (See Section 8.2.2.6) compared to the 
participant’s baseline eGFR (pre-dose, Day 1), then the participant should not be further 
dosed and adequate, immediate, supportive measures including immediate evaluation by a 
nephrologist (preferably within 24 hours) with appropriate management and treatment as 
clinically indicated. Results should be repeated as indicated by the nephrologist or weekly at 
a minimum until the eGFR returns to baseline 15%, or the renal parameters are deemed to 
be stable by the nephrologist and/or Principal Investigator (PI).
If the participant cannot be seen by a nephrologist within 24 hours (as described above), then 
the participant should be sent to a local emergency room for evaluation and treatment as 
clinically indicated.
Participants should return to the investigational site and be evaluated as soon as possible,
preferably within 24-48 hours from awareness of the abnormal eGFR result 
(CONCOMITANT serum creatinine based AND serum cystatin C based eGFR decline of 
30% compared to the participant’s baseline eGFR) for a safety follow-up visit.  Follow-up 
evaluations should include laboratory tests, detailed history, and physical assessment.  In 
addition to repeating serum creatinine and serum cystatin C, laboratory tests should also 

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include: serum BUN, serum CK, serum electrolytes (including at a minimum potassium, 
sodium, phosphate/phosphorus, calcium), in addition to urine dipstick, urine microscopic 
examination, and urinary indices.  All cases confirmed on repeat testing as meeting the 
laboratory criteria for acute kidney injury, with no other cause(s) of laboratory abnormalities 
identified should be considered as potential cases of drug-induced kidney injury irrespective 
of availability of all the results of the investigations performed to determine etiology of the 
abnormal serum creatinine.
All relevant test results will be forwarded to Pfizer for review immediately upon receipt by 
the PI.
7.1.5. Laboratory Abnormalities
All the following laboratory abnormalities require discontinuation if they are confirmed.  
Confirmation through re-testing should occur within 2-5 days:
Laboratory Variable
Laboratory Value
Hematology
Absolute Neutrophil Count
<1000/mm3; <1.0 x109/L
Hemoglobin
<10.0 g/dL; <6.2 mmol/L; <100 g/L
Platelet count
<75,000/mm3; <75.0x109/L
Lymphocytes
<500/mm3; <0.5x109/L
Chemistry
ASTa
>2.5x ULN
ALT
>2.5x ULN
Total bilirubinb
>1.5x ULN
a. Additional investigations, such as review of ethanol, recreational drug and dietary supplement 
consumption should be done; testing for acute hepatitis A, B or C infection and biliary tract imaging 
should be promptly discussed with the Pfizer Medical Monitor or designee.
b. Participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be 
eligible to remain in the provided the direct bilirubin is ULN.
7.1.6. Pregnancy
Pregnancy confirmed by serum beta-human beta-human chorionic gonadotropin (-hCG)
testing.  Sponsor Clinician or Medical Monitor should be notified immediately.
7.1.7. Suicidal Ideation and Behavior
Participants triggering criteria for suicidal ideation and behavior as described in 
Section 8.2.2.8.

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7.1.8. Temporary Discontinuation 
Temporary discontinuations of IP

will occur in cases of positive urine pregnancy test which if confirmed by serum 
pregnancy test will lead to permanent discontinuation (Section 7.1.6). 

may apply in some cases application site reaction during local tolerability 
assessments (Section 8.2.2.9). 

additional instances of temporary discontinuation may be appropriate (eg, surgery, 
infection, etc). 
All temporary discontinuations should be discussed with Sponsor Clinician or Sponsor 
Medical Monitor to determine if participant may continue in the study.  If possible, site will 
consult sponsor prior to temporary discontinuation. 
7.1.9. Discontinuation/End of Treatment Monitoring for Adverse Events, Laboratory, 
and Vital Signs
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 (instead of 
two weeks described in Schedule of Activities (SoA) and continue visits per Investigator’s 
discretion until the event has returned to normal or baseline levels or is deemed clinically 
stable.  The procedures scheduled for Week 6 (end of treatment) visit will be performed on 
the last day the participant takes the investigational product 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.
See the SoA for data to be collected at the time of intervention discontinuation and follow-up 
and for any further evaluations that need to be completed.
7.2. Participant Discontinuation/Withdrawal from the Study 
A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, 
or administrative reasons.
At the time of discontinuing from the study, if possible, an early discontinuation visit should 
be conducted.  See the SoA for assessments to be collected at the time of study 
discontinuation and follow-up and for any further evaluations that need to be completed. 

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The early discontinuation visit applies only to participants who are randomized and then are 
prematurely withdrawn from the study.  Participants should be questioned regarding their 
reason for withdrawal.  The participant will be permanently discontinued both from the study 
intervention and from the study at that time.
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples, but data already generated from the samples will continue to be available, and may 
be used to protect the integrity of existing analyses.  The investigator must document any 
such requests in the site study records.
If the participant withdraws from the study and also withdraws consent (see below) 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.
When a participant withdraws from the study because of an SAE, the SAE must be recorded 
on the CRF and reported on the Clinical Trial (CT) SAE Report.
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.
Withdrawal of Consent: 
Participants who request to discontinue receipt of study treatment will proceed to ET visit as 
soon as possible.  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 IP 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;

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
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. 
Discontinuation of specific sites or of the study as a whole is handled as part of Appendix 1.
8. STUDY ASSESSMENTS AND PROCEDURES
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures. 
Study procedures and their timing are summarized in the SoA.  Protocol waivers or 
exemptions are not allowed.
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.
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct.
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 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
Procedures conducted as part of the participant’s routine clinical management (eg, blood 
count) and obtained before signing of the ICD 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.
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.

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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 total blood sampling volume for individual participants during treatment period is 
approximately 195 mL.  The actual collection times of blood sampling may change.  
Additional blood samples may be taken for safety assessments at times specified by Pfizer, 
provided the total volume taken during the study does not exceed 550 mL during any period 
of 60 consecutive days.
8.1. Efficacy Assessments
All efficacy assessments will be based on areas treated with IP, but excluding scalp, 
palms and soles.
8.1.1. Rater Qualifications
For specific rating assessments, only qualified raters will be allowed to evaluate and/or rate 
participants in this study.  The minimum qualifications a rater must meet for each study 
rating assessment will be outlined in the Rater Assessment Manual provided to each 
participating site.  The level of experience with the target population (or equivalent), specific 
scale experience (or equivalent), and certification required (if applicable) will be listed and 
used to determine whether a rater is approved for a given assessment.  Proposed raters who 
do not meet specific criteria but who may be qualified based on unique circumstances may be 
individually reviewed by the study clinical team to determine whether or not a waiver may be 
issued.  The rater must become certified to perform selected study assessments before he or 
she can participate in the conduct of the study.  For specifically defined assessments, rater 
training and standardization exercises may be conducted, and written and signed 
documentation will be provided by the site for each rater’s certification.  In return, each site 
will be provided written and signed documentation outlining each rater’s certification for 
specific study assessments.  Recertification may be required at periodic intervals during the 
study.  The raters who administer specific study assessments will be documented in a 
centralized location and all site staff who administer ratings will be verified in the site study 
documentation during the conduct of the study.
8.1.2. Investigator’s Global Assessment (IGA)
The Investigator’s Global Assessment of atopic dermatitis is scored on a 5-point scale (0-4), 
reflecting a global consideration of the erythema, induration and scaling.  The clinical 
evaluator of atopic dermatitis will perform an assessment of the overall severity of atopic 
dermatitis and assign an IGA score and category as described below. 
The assessment will be a static evaluation without regard to the score at a previous visit. 

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Table 5.
Investigator’s Global Assessment (IGA) Score
Score
Category
Description
0
Clear
Atopic dermatitis is cleared, except for any residual discoloration 
(post-inflammatory hyperpigmentation and/or hypopigmentation).
1
Almost Clear
Overall, the atopic dermatitis is not entirely cleared and remaining lesions are 
light pink (not including post inflammatory hyperpigmentation) and/or; have 
barely palpable hard thickened skin and/or papules and/or; have barely 
perceptible lichenification; excoriation and oozing/crusting are absent.
2
Mild
Overall, the atopic dermatitis consists of lesions that are light red; with slight, 
but definite hard thickened skin and/or papules; with slight, but definite linear 
or picked scratch marks or penetrating surface injury; with slight, but definite 
thickened skin, fine skin markings, and lichenoid scale; oozing/crusting is 
absent.
3
Moderate
Overall, the atopic dermatitis consists of lesions that are red; with easily 
palpable moderate hard thickened skin and/or papules; with moderate linear or 
picked scratch marks or penetrating surface injury; with moderate thickened 
skin, coarse skin markings, and coarse lichenoid scale; with slight 
oozing/crusting.
4
Severe
Overall, the atopic dermatitis consists of lesions that are deep, dark red; with 
severe hard thickened skin and/or papules; with severe linear or picked scratch 
marks or penetrating surface injury; with severe thickened skin with very coarse 
skin markings and lichenoid scale; with moderate to severe oozing/crusting.
The IGA will exclude scalp, palms, and soles from the assessment/scoring.
8.1.3. Eczema Area and Severity Index (EASI)
The EASI quantifies the severity of a participant’s atopic dermatitis based on both severity of 
lesion by clinical signs and the percent of BSA affected.  EASI is a composite scoring by the 
atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, 
excoriation, and lichenification (each scored separately) for each of four body regions, with 
adjustment for the percent of BSA involved for each body region and for the proportion of 
the body region to the whole body.
8.1.3.1. Lesion Severity by Clinical Signs 
The basic characteristics of atopic dermatitis lesions-erythema, induration/papulation, 
excoriation, and lichenification-provide a means for assessing the severity of lesions.  
Assessment of these four main clinical signs is performed separately for four body regions: 
head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including 
buttocks).  Average erythema, induration/papulation, excoriation, and lichenification are 
scored for each body region according to a 4 point scale: 0 = absent; 1 = mild; 2 = moderate; 
3 = severe.  Morphologic descriptors for each clinical sign severity score are shown below.

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Table 6.
Clinical Sign Severity Scoring Criteria for the Eczema Area and Severity 
Index (EASI)
Score
Description*
Erythema (E)
0
Absent
None; may have residual discoloration (post-inflammatory hyperpigmentation 
and/or hypopigmentation)
1
Mild
Light pink to light red
2
Moderate
Red
3
Severe
Deep, dark red
Induration/Papulation (I)
0
Absent
None
1
Mild
Barely palpable to slight, but definite hard thickened skin and/or papules
2
Moderate
Easily palpable moderate hard thickened skin and/or papules
3
Severe
Severe hard thickened skin and/or papules
Excoriation (Ex)
0
Absent
None
1
Mild
Slight, but definite linear or picked scratch marks or penetrating surface injury
2
Moderate
Moderate linear or picked scratch marks or penetrating surface injury
3
Severe
Severe linear or picked scratch marks or penetrating surface injury
Lichenification (L)
0
Absent
None
1
Mild
Barely perceptible to slight, but definite thickened skin, fine skin markings, 
and lichenoid scale
2
Moderate
Moderate thickened skin, coarse skin markings, and coarse lichenoid scale
3
Severe
Severe thickened skin with very coarse skin markings and lichenoid scale
The EASI will exclude scalp, palms, and soles from the assessment/scoring.
8.1.3.2. Percent BSA with Atopic Dermatitis (for efficacy)
Percent BSA affected by AD should be calculated in each of the four body regions ie head
and neck (h), upper extremities (u), trunk (t), and lower extremities (l).  The area within each 
body region with the key signs of the disease is estimated using handprint as a measure, 
where the full palmar hand of the participant (ie, the participant’s fully extended palm, 
fingers and thumb together) represents approximately 1% of the total BSA.
Each region is typically assigned proportionate body surface areas of 10 (h), 20 (u), 30 (t), 
and 40 (l) handprints respectively.  Refer to Table 7 to identify the surface area equivalent of 
1 handprint in each respective body region. 
Table 7.
Determination of Body Region Surface Area
Body Region
Total Number of 
Handprints in Body 
Region
Surface Area of Body 
Region Equivalent of 
One Handprint
Head and Neck
10
10%
Upper Limbs
20
5%
Trunk (including axillae and groin)
30
3.33%
Lower Limbs (including buttocks)
40
2.5%

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Area Score
The extent (%) to which each of the four body regions is involved with AD (by using Table 7
above) is categorized using a non-linear scaling method to a numerical area score according 
to the following BSA scoring criteria (Table 8).
Table 8.
Area Score Criteria
Percent BSA with Atopic 
Dermatitis in a Body Region
Area Score
0%
0
>0-<10%
1
10-<30%
2
30-<50%
3
50-<70%
4
70-<90%
5
90-100%
6
Body Region Weighting: Each body region is weighted according to its approximate 
percentage of the whole body (Table 9). 
Table 9.
Body Region Weighting
Body Region
Body Region Weighting
Head and Neck
0.1
Upper Limbs
0.2
Trunk (including axillae and groin)
0.3
Lower Limbs (including buttocks)
0.4
8.1.3.3. Calculation of EASI Score 
In each body region, the sum of the Clinical Signs Severity Scores for erythema, 
induration/papulation, excoriation, and lichenification is multiplied by the Area Score and by 
the Body Region Weighting to provide a body region value, which is then summed across all 
four body regions resulting in an EASI score as described in Equation.
Equation: EASI = 0.1Ah(Eh+Ih+Exh+Lh) + 0.2Au(Eu+Iu+Exu+Lu) + 0.3At(Et+It+Ext+Lt) + 
0.4Al(El+Il+Exl+Ll)
A = Area Score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; 
h = head and neck; u = upper limbs; t = trunk; l = lower limbs.
The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores 
representing greater severity of atopic dermatitis.  Since the scalp, palms and soles (even if 
hairless scalp, palms and soles are being treated with the IP) will be excluded from the EASI 
assessment in this study, the maximum possible score will be less than 72.0.
Calculation will be done centrally by Sponsor programmers.

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8.1.4. Body Surface Area
The BSA affected (%) is calculated by adding the %BSA affected in each body region area.  
The extent to which each of the four areas of the body is affected (% BSA) is obtained by 
multiplying the % obtained from Table 7 with a weighting factor as shown in Table 9.  The 
% BSA is captured on the CRF (to 2 decimal places, as necessary). 
The sum of the weighted percent involvement obtained for each of the four body areas is the 
grand total BSA with AD, as described in the following equation:
BSA (%) =
0.1Sh + 0.2Su + 0.3St + 0.4Sl
where S = body region surface area with AD; h = head; u = upper limbs; t = trunk; l = lower limbs.
Symptoms (eg, pruritus), along with secondary signs (eg, xerosis, scaling) are excluded from 
the area assessments.
8.1.4.1. Body Surface Area for IP need 
Evaluation of BSA for IP need is the total BSA across all body locations being treated with 
the IP.  BSA for IP need evaluation method will be the same as the BSA Efficacy evaluation 
(Section 8.1.4), except that the BSA for IP need will include AD on all IP treated body 
locations, some of which may be excluded from the BSA Efficacy evaluation.  If a 
participant has atopic dermatitis on palms, and/or soles, these body locations will be included 
in the BSA for IP need estimation.
Participants with atopic dermatitis on the groin or genitals at Day 1 (Visit 1) are not eligible 
for the study.  If new atopic dermatitis occurs on the groin and/or genitals following Day 1 
(Visit 1), the groin and/or genitals may be treated with IP, but the groin and genitals will be 
excluded from the clinical evaluation of atopic dermatitis for efficacy. New atopic dermatitis 
occurring on the groin and/or genitals following Day 1 (Visit 1) will be included in the 
clinical evaluation of atopic dermatitis BSA for IP need to ensure the participant has an 
adequate supply of IP.
Investigational product should be applied to the BSA determined at Day 1 (Visit 1)
throughout the treatment period regardless of clearing or improvement of atopic dermatitis.  
Any new atopic dermatitis on treatment-eligible locations occurring following Day 1 
(Visit 1) should also be treated with the IP.  Therefore, the BSA for IP need at subsequent 
visits should be equal to or greater than the value at Day 1.
A checklist of body site areas currently affected by AD will be completed at the Day 1 visit.  
Location of skin lesions will be selected from a prepopulated listing of body locations.
The body site checklist will be reviewed at every visit to the site to update for any new, 
treatable areas, if needed.

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8.1.5. Peak Pruritus Numerical Rating Scale (PP-NRS) 
The intensity of pruritus will be assessed by a numerical rating scale (NRS), an 11-category 
numeric rating scale from 0 to 10, which is patient reported (see Appendix 12).  The PP-NRS 
will be completed by participant.  The PP-NRS will be completed once daily at least 7 days 
prior to Day 1, and completed once daily every day from Day 1 to Week 6 before IP morning 
dose is applied preferably at the same time of each day if applicable, as noted in the Schedule 
of Activities (SoA). 
Pruritus will be evaluated by asking participants to assign a numerical score representing the 
worst imaginable itch over the last 24 hours on a scale from 0 to 10, with 0 indicating no 
symptoms and 10 indicating the worst imaginable symptoms.  The PP-NRS is presented in
Figure 3.  This item will be administered to all participants. 
Figure 3.
Peak Pruritus Numerical Rating Scale (PP-NRS)
8.2. Safety Assessments
Planned time points for all safety assessments are provided in the Schedule of Activities 
(SoA).  Unscheduled clinical laboratory measurements may be obtained at any time during 
the study to assess any perceived safety concerns.
8.2.1. Assessments at Screening Only
8.2.1.1. Medical History
Investigators should make all reasonable efforts to obtain an accurate and complete medical 
history and history of prior medication use when evaluating whether a participant is eligible 
for the study.  The following will be collected at Screening: complete medical history, AD 
disease history (including disease duration and prior treatments) and alcohol and tobacco use 
history. 

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Complete AD disease history includes collection of details of AD at Screening: AD 
diagnosis, the use of topical treatments, systemic treatments and other treatments for AD 
taken during the 3 months/90 days prior to Screening/Washout with dose, duration of 
treatment, and reason for discontinuation.  All other drugs (including sunscreen, over the 
counter medication, vitamins, and dietary supplements) taken within 28 days prior to the 
Screening/Washout visit should be recorded.
Medical history in addition to AD history including disease duration will be collected at 
screening.  Medical history also includes history of alcohol and tobacco use.  Smoking status 
and average weekly alcohol consumption (units/week) will be collected, where a unit 
contains 12 g of pure alcohol, an amount equivalent to that contained in 5 oz/150 mL (a 
glass) of wine, 12 oz/360 mL of beer, or 1.5 oz/45 mL of 90 proof of spirits. 
If the status of a participant’s medical history is in doubt or information pertaining to a 
critical variable is conflicting, every reasonable step to secure proper documentation of 
correct medical status should be attempted.  Documentation of the medical and medication 
histories over the protocol defined time periods should be available for sponsor review 
during the source data verification process.  Questions about prior medications or eligibility 
should be directed to the Sponsor Clinician or Sponsor Medical Monitor.
8.2.1.2. Tuberculosis Testing
At the time of screening, all participants will undergo tuberculosis (TB) testing unless 
performed within 12 weeks of Screening (with available documentation) using one of the 
tests below. 
8.2.1.2.1. Interferon Gamma Release Assay (IGRA) Tuberculin Test
Participants may be screened for TB using an IGRA per local guidelines.  Interferon gamma 
release assay will be tested during screening or within 12 weeks prior to Day 1.  The 
following are acceptable IGRA assays: QuantiFERON-TB Gold test (QFT-G), 
QuantiFERON-TB Gold In-Tube test (QFT-GIT) and T-SPOTTB test.  Site personnel 
should follow the processing and analyses steps based on the assay chosen.  Ensure 
incubation steps are followed as appropriate.
An IGRA is preferred for participants with a prior bacille Calmette-Guerin (BCG)
vaccination, but may be used for any participant.  Documentation of IGRA product used and 
the test result must be in the participants’ source documentation.
If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result 
is obtained, enrollment may proceed.  A positive test on repeat is exclusionary. 
Participants with repeat indeterminate IGRA results may be enrolled after consultation with 
pulmonary or infectious disease specialist that determines low risk of infection 
(ie, participant would be acceptable for immunosuppressant (eg, anti-tumor necrosis factor 
[TNF]) treatment without additional action).

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Participants who test positive for IGRA test (including borderline T-SPOT result), but in the 
opinion of the PI are at low risk of TB infection may be referred to pulmonary or infectious 
disease specialist for consultation and potential IGRA test repeated once.  Participants will be 
eligible if the repeat test is negative before the randomization.
Refer to lab manual for any additional processing information and shipping instructions.
8.2.1.2.2. Mantoux/Purified Protein Derivative (PPD) Tuberculin Skin Test
Participants can be TB screened using the Mantoux/PPD Tuberculin Skin Test.  
Mantoux/PPD testing can also be performed if there are indeterminate QFT-G test results.  
Participants must have a Mantoux/PPD tuberculin skin test administered and then evaluated 
by a health care professional 48 to 72 hours later.  A positive Mantoux/PPD tuberculin skin 
test is exclusionary.
8.2.1.3. Chest Radiograph
Participants must have chest radiograph (posterior-anterior and lateral views are 
recommended however local guidelines should be followed) or other appropriate diagnostic 
image of the chest/thorax (ie, computerized axial tomography [CAT] or magnetic resonance 
imaging [MRI]) taken at Screening and read by a qualified radiologist.  Documentation of 
official reading must be available in source documentation.  Chest imaging may be 
performed to aid in TB status determination for all adults, and recommended for adolescents
according to local guidelines and standard of care and/or in countries with a high incidence 
rate of TB.
If chest radiograph had been taken within 12 weeks prior to Screening and read by a qualified 
radiologist as normal, the test does not have to be repeated at screening, provided 
documentation is available. 
Participants with evidence of currently active TB, general infections, heart failure or 
malignancy will be excluded.  Participants with changes suggestive of untreated latent or 
active TB infection may be enrolled after consultation with a pulmonary or infectious disease 
specialist who determines low risk of infection.
8.2.1.4. Skin Type Assessment
As part of screening, a skin type assessment will be done using the Fitzpatrick Skin Type 
assessment (Refer to Appendix 11).  This is used to classify a person’s skin type by their 
response to sun exposure (ie, burning or tanning).
8.2.2. Assessments during Study
8.2.2.1. Physical Examinations
Physical examinations, including height, and weight will be performed at times specified in 
the Schedules of Activities section of this protocol.

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Physical examinations may be conducted by a physician, trained physician's assistant, or 
nurse practitioner as acceptable according to local regulation.
Full Physical Examination: includes, but is not limited to the following organ or body 
systems-head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, 
gastrointestinal, musculoskeletal, abdomen, cardiovascular, and neurological systems.  In 
addition, an assessment will be made of the condition of all AD involved skin (skin 
assessments should be completed by PI or Sub-I). 
A full physical examination will be performed at Screening, Day 1, and at Week 6 visit. 
Disease focused Physical Examination: includes all AD involved skin (in treatable and 
non-treatable areas) and evaluation of any current or reported symptoms for clinically 
significant changes. A disease-focused physical examination will be performed at Week 1, 
Week 2, Week 4, follow-up and at early termination (ET) visits.
Any clinically significant changes from the most recent physical examination should be 
recorded as adverse events (AEs).  Lack of efficacy is generally not considered an AE.
Any treatment-emergent finding of other forms of dermatitides/eczematous conditions, 
(eg, contact dermatitis, seborrhoeic, discoid, gravitational, asteatotic) should be recorded as 
an AE.
Investigators should pay special attention to clinical signs related to previous serious 
illnesses. 
8.2.2.1.1. Weight and Height
It is recommended that weight be measured in kilograms (kg) to the nearest 0.1 kg and that 
height be measured in centimeters (cm) with shoes removed. 
For measuring weight, a scale with appropriate range and resolution is used and must be 
placed on a stable, flat surface.  Participants must remove shoes, bulky layers of clothing, and 
jackets so that only light clothing remains.  They must also remove the contents of their 
pockets and remain still during measurement of weight.
8.2.2.2. Vital Signs
Vital signs will be measured with the participant in supine position after 5 minutes of rest as 
indicated in the Schedule of Activities (SoA) and will include temperature, systolic and 
diastolic blood pressure, and pulse rate (PR).  On study day visits when clinical laboratory 
tests are performed, assessment of vital signs should precede blood draw.
Body temperature will be collected using the tympanic or oral methods and the same method 
should be used consistently throughout the study. 

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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 following method should be used to record the blood pressure:

Participants should be seated 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) and in same position (sitting or supine) as their baseline visit.

Participants should refrain from smoking or ingesting caffeine during the 30 minutes 
preceding the measurements.  Measurements should begin after at least 5 minutes of 
rest without distractions.  When the timing of BP and pulse (heart) rate measurements 
coincides with a blood collection or other study procedure, BP and pulse (heart) rate 
should be obtained first.

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.

BP should be recorded to the nearest mmHg value.
Pulse rate should be measured at approximately the same time as BP for a minimum of 
30 seconds. 
8.2.2.3. Electrocardiograms
A single 12-Lead ECGs should be collected at times specified in the Schedule of Activities
(SoA) section of this protocol using an ECG machine that automatically calculates the heart 
rate and measures PR, QT, and QTc intervals and QRS complex.  Additional ECG may be 
performed upon request by the Sponsor Clinician or the Sponsor Medical Monitor. 
All scheduled ECGs should be performed after the participant has rested quietly for at least 
10 minutes in supine position.  When the timing of these measurements coincides with a 
blood collection, the ECG should be obtained prior to the nominal time of the blood
collection, BP, and pulse rate.
ECGs will be read and interpreted locally.  To ensure safety of the participants, a qualified 
individual (eg, sub-investigator) at the investigator site will make comparisons to baseline 
measurements taken at Day 1.  ECG parameters (PR, QT, QTc and QRS intervals) should be 
recorded on the CRF.  A copy of the ECG should be available as source document for review.
During screening, if participants have initial screening value QTcF >450 milliseconds (ms), 
ECG should be repeated two more times and the average of the three QTcF should be used to 
determine the participant eligibility.

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If at any subsequent time QTcF 500 msec or change from baseline QTc 60 msec, ECG 
should be repeated two more times and average of these values should be used to determine 
withdrawal from IP (see Section 7.1.1).  If average is above these thresholds, participants 
should be monitored hourly with triple ECGs. 
If a postdose QTc interval remains 30 msec from the baseline and is >450 msec; or b) an 
absolute QTc value is 500 msec for any scheduled ECG for greater than 4 hours (or sooner,
at the discretion of the investigator), or QTc intervals get progressively longer, the participant
should undergo continuous ECG monitoring.  A cardiologist should be consulted if QTc 
intervals do not return to less than the criterion listed above after 8 hours of monitoring (or 
sooner, at the discretion of the investigator). 
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality.  It is important that leads be placed in the 
same positions each time in order to achieve precise ECG recordings.  If a machine-read QTc 
value is prolonged, as defined above, repeat measurements may not be necessary if a 
qualified medical provider’s interpretation determines that the QTc values are in the 
acceptable range.
ECG values of potential clinical concern are listed in Appendix 7.
8.2.2.4. Herpetiform Rash
For any occurrence of a suspected herpetiform rash (eg, herpes zoster and herpes simplex), 
specimens for viral deoxyribonucleic acid (DNA) analysis will be obtained: A swab of the 
affected area will be collected for confirmation; a blood sample for viral surveillance will be 
collected for the analysis of viral load. Details for these collections will be provided in the 
laboratory manual.
8.2.2.5. Clinical Safety Laboratory Assessments
See Appendix 2 for the list of clinical safety laboratory tests to be performed and the SoA for 
the timing and frequency.
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF.  
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 or within 28 days after the last dose of study intervention 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.

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All protocol-required laboratory assessments, as defined in Appendix 2, must be conducted 
in accordance with the laboratory manual and the SoA.
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.
If the screening serum chemistry and hematology tests are performed within 7 days prior to 
Day 1, whether the Day 1 serum chemistry and hematology tests are to be performed will be 
at the discretion of the investigator or his/her designee.
At the discretion of the investigator or his/her designee, a lidocaine-based topical anesthetic 
(eg, lidocaine 4% cream) may be used prior to clinical laboratory sample collection to 
decrease potential discomfort to the participant provided the anesthetic does not contain 
propylene glycol (PG).  However, the skin must be thoroughly cleansed prior to blood 
sample collection.
The Investigator will review all clinical laboratory test results for safety evaluation upon 
receipt.  After reviewing the laboratory reports and evaluating the results for clinical 
significance, the investigator or his/her designee must sign and date the laboratory report.  
Clinically significant laboratory abnormalities are defined as abnormal values that have 
clinical manifestations or require medical intervention.  Clinically significant laboratory 
abnormalities noted from the Screening Visit will be recorded in the medical history. 
A clinically significant laboratory abnormality detected after the Screening Visit may reflect 
the development of an AE.  Whenever possible, Investigators should report the clinical 
diagnosis suggested by the laboratory abnormality rather than listing individual abnormal test 
results as AEs.  If no diagnosis has been found to explain the abnormal laboratory result, the 
clinically significant lab result should be recorded as an AE.
8.2.2.6. Creatinine, Cystatin C, and estimates of Glomerular Filtration Rate
Serum creatinine will be measured as part of serum chemistry at times specified in the 
Schedule of Activities (SoA) section of the protocol.  Creatinine elevations above the upper 
limit of normal (ULN) will be followed until resolution or baseline.  Serum creatinine based 
eGFR will be calculated.  Serum cystatin C will be measured and cystatin C based eGFR will 
be calculated at corresponding times per Schedule of Activities (SoA). 
The eGFR will be calculated using the 2 sets of equations developed by the Chronic Kidney 
Disease Epidemiology Collaboration (CKD-EPI), which utilize serum creatinine (SCr) and 
serum cystatin C (S Cystatin C) respectively (Appendix 14).
8.2.2.7. Samples for Lipid Analysis
Blood samples (3.5 mL) to provide approximately 1.2 mL serum for the analysis of lipids 
will be collected as per Schedule of Activities (SoA).

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8.2.2.8. Suicidal Ideation and Behavior Risk Monitoring
Participants meeting exclusionary results as described in Section 5.2 on the C-SSRS should 
be excluded from participation; it is recommended the participant’s primary care physician 
(PCP) should be informed, and the participant referred to a mental health professional, either 
by the PCP or the investigator according to their usual practice.
8.2.2.8.1. Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale is a validated tool for investigative staff to use 
to evaluate suicidal ideation and behavior (Appendix 13).  At the screening visit, if there are
“yes” answers on items 4 or 5 in the past year or on any question in the suicidal behavior 
section of the C-SSRS in the past 5 years, the participant will not be included in the study.  
Trained site staff is to administer the C-SSRS to all participants at screening and assess the 
participant’s eligibility based on the answers.
At any of the visits in Schedule of Activities (SoA) when C-SSRS will be administered, 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 IP and referred to a mental health 
professional for appropriate evaluation and treatment.  If the participant cannot be seen by a 
mental health professional within 24 hours, then the participant should be sent to a local 
emergency room for psychiatric assessment.
8.2.2.9. Local Tolerability
The investigator or designee will assess tolerability at the site of IP application (pre-dose and 
immediately post-dose).  This assessment will focus on the treated non-lesional skin using 
scale in Table 10.27  See Section 7.1.2 for permanent and temporary discontinuation criteria 
based on local tolerability assessment. 
Table 10.
Skin Tolerability Grading System
Grade
Severity
Description
0
None
No evidence of local intolerance
1
Mild
Minimal erythema and/or oedema, slight glazed appearance
2
Moderate
Definite erythema and/or oedema with peeling and/or cracking but 
needs no adaptation of posology
3
Severe (to be 
reported as an AE)
Erythema, oedema glazing with fissures, few vesicles or papules: 
consider removing topical agent (if still in place)
4
Very severe (to be 
reported as an AE)
Strong reaction spreading beyond the treated area, bullous 
reaction, erosions: removal of topical agent (if still in place)
8.2.2.10. Pregnancy Testing
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least 
25 mIU/mL.  Pregnancy tests will be performed in WOCBP at the times listed in the SoA.  
Following a negative pregnancy test result at screening, appropriate contraception must be 
commenced and a second negative pregnancy test result will be required at the baseline visit 
prior the participant’s receiving the investigational product.  Pregnancy tests will also be 
done whenever 1 menstrual cycle is missed during the active treatment period (or when 

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potential pregnancy is otherwise suspected) and at the end of the study.  Pregnancy tests may 
also be repeated if requested by institutional review boards (IRBs)/ethics committees (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.
8.3. Adverse Events and Serious Adverse Events
The definitions of an AE and an SAE can be found in Appendix 3.
AEs 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 it 
meets the criteria for classification as an SAE or that caused the participant to discontinue the 
study intervention (see Section 7). 
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 investigational product), through and including 
a minimum of 28 calendar days, except as indicated below, after the last administration of the 
investigational product.
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 event or its sequelae resolve or stabilize at a level acceptable to the investigator, and 
Pfizer concurs with that assessment.
Investigators are not obligated to actively seek AEs or SAEs after conclusion of the study 
participation.  However, if the investigator learns of any SAE, including a death, at any time 
after a participant has been discharged from the study, and he/she considers the event to be 
reasonably related to the study intervention or study participation, the investigator must 
promptly notify the sponsor.

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8.3.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period are reported to Pfizer 
Safety on the CT SAE Report Form immediately 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.
SAEs occurring in a participant after the active collection period has ended are reported to 
Pfizer Safety if the investigator becomes aware of them; at a minimum, all SAEs that the 
investigator believes have at least a reasonable possibility of being related to investigational 
product must be reported to Pfizer Safety.
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF
During the active collection period, both nonserious AEs and SAEs are recorded on the CRF.
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 
nonleading 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 an 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.

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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 (IRBs)/ethics committees 
(ECs), 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 an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the sponsor will review 
and then file it along with the investigator’s brochure and will notify the IRB/EC, if 
appropriate according to local requirements.
8.3.5. Exposure during Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the investigational product 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
Details of all pregnancies in female participants and, if indicated, female partners of male 
participants will be collected after the start of study intervention and until 28 days after the 
last dose.
If a pregnancy is reported, the investigator should inform the sponsor within 24 hours of 
learning of the pregnancy and should follow the procedures outlined in Appendix 4.
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs.
8.3.5.2. Exposure During Breastfeeding
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of 
an associated SAE, to Pfizer Safety within 24 hours of the investigator’s awareness, using the 
CT SAE Report Form.  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’s administration, the SAE is reported together with the exposure during breastfeeding.
8.3.5.3. Occupational Exposure
An occupational exposure occurs when, during the performance of job duties, a person 
(whether a healthcare professional or otherwise) gets in unplanned direct contact with the 
product, which may or may not lead to the occurrence of an AE.

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An occupational exposure is reported to Pfizer Safety within 24 hours of the investigator’s 
awareness, using the CT SAE Report Form, regardless of whether there is an associated 
SAE.  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. Medication Errors
Medication errors may result from the administration or consumption of the investigational 
product by the wrong participant, or at the wrong time, or at the wrong dosage strength. 
Exposures to the investigational product under study may occur in clinical trial settings, such 
as medication errors.
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 investigational product;

Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant.
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 immediately.
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 nonserious, 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 investigational product greater than BID dosing within a 24-hour 
time period will be considered an overdose.
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In the event of an overdose, the investigator should:
1. Contact the medical monitor immediately.
2. Closely monitor the participant for any AEs/SAEs and laboratory abnormalities until 
investigational product can no longer be detected systemically (at least 7 days).
3. Obtain a blood sample for PK analysis within 1 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 an 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 
Blood samples of approximately 3 mL, to provide a minimum of 1.5 mL plasma will be 
collected into appropriately labeled tubes containing dipotassium ethylenediaminetetraacetic 
acid (K2EDTA) for measurement of plasma concentrations of PF-06700841 as specified in 
the Schedule of Activities (SoA).  Instructions for the collection and handling of biological 
samples will be provided in the laboratory manual or by the sponsor.  The actual date and 
time (24-hour clock time) of each sample will be recorded.  The actual times may change, but 
the number of samples will remain the same. 
All efforts will be made to obtain the samples at the exact nominal time relative to dosing.  
The exact time of the collection should be noted on the source document and data collection 
tool (eg, CRF).
Samples collected for analyses of PF-06700841 concentration may also be used to evaluate 
safety or efficacy aspects related to concerns arising during or after the study, for metabolite 
identification and/or evaluation of the bioanalytical method, or for other internal exploratory 
purposes.
Genetic analyses will not be performed on these plasma samples.  Participant confidentiality 
will be maintained.
Samples collected for measurement of plasma concentrations of PF-06700841 will be 
analyzed using a validated analytical method in compliance with applicable standard 
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The PK samples must be processed and shipped as indicated in the instructions provided to 
the investigator site to maintain sample integrity.  Any deviations from the PK 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.
Drug concentration information that may un-blind the study will not be reported to 
investigator sites or blinded personnel.
Any changes in the timing or addition of time points for any planned study assessments must 
be documented and approved by the relevant study team member and then archived in the 
sponsor and site study files, but will not constitute a protocol amendment.  The IRB/EC will 
be informed of any safety issues that require alteration of the safety monitoring scheme or 
amendment of the ICD.
 
 
 
  
 
 
 
 
 
 
 
 
 
 
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8.7.Genetics
8.7.1.Specified Genetics
Genetics (specified analysis) are not evaluatedin this study.
 
 
 
 
 
 
 
 
 
8.8.Biomarkers
Biospecimens collected for biomarker assessments may include peripheral bloodand skin 
tissue and may be used to analyze DNA, RNA, proteins, or metabolic biomarkers, for 
achieving planned biomarker objectives.  Refer to the Schedule of Activities (SoA)for 
sample collection time points and the laboratory manual for sample processing and shipping. 
 
 
 
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8.9.Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluatedin this study.
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8.10.Patient Reported Outcomes
Every effort should be made for the participant to complete all patient reported outcome 
(PRO) questionnairesbefore any other evaluations.  The amount of time required for 
participants to complete the PRO questionnaires is approximately 10-30minutes(depending 
on the visit and associated PROs).  The PROs should be checked for completeness by the 
study site staffat every in-clinic visit.
Once participants have met all inclusion/exclusion criteria, they will be provided a handheld 
device (providedby the Sponsor) for dosing diary andpatient-reported-outcomes (ePROs)or 
paper versions of the above to be completed at home as per the time points defined in
Schedule of Activities (SoA).  The clinic sites may use paper versions of PROs.
The following PROs will be completed only on study visit daysidentified in Schedule of 
Activities (SoA), starting on Day1: POEM, DLQI/Childrens DLQI(CDLQI), and 
  
  Other protocol-specified PROs 
ie,PP-NRS, 
 and 
 will be used by participants for daily completion of PROs at 
home, starting from 7days prior to the dosing/randomization day (Day1)and as defined in 
the Schedule of Activities (SoA).
All participants will completePROs at follow-up visit in clinic.
Delegated site staff will monitor completion of PROs for adherenceand will review 
adherence with participantsat each visit and counsel as appropriate.  If a participant has 
repeated non adherence, the participant should be retrained on use of the deviceor filling out 
paper versions.  If a participant is unable to complete ePROs due to documented technical 
issue or disability or other limitation, the participant will be permitted to enter or remain in 
the study providing that a valid alternate source of daily data entry is completed and 
reviewed by investigational site staff.  No protocol deviations will be recorded in regard to 
PRO completion adherence.  In the event of electronic malfunctionof an ePRO or 
misplacement of paper versions of the PROs, a replacement device or paper PROs will be 
shipped to the site.  Examples of the validated paper versions of Patient Reported Outcomes 
instruments are included in the Appendices of this protocol.  The electronic version may 
differ slightly in format or wording compared with the paper version to facilitate electronic 
implementation.
8.10.1.Patient-Oriented Eczema Measure (POEM)
The POEM is a validated 7-item PRO measure used to assess the impact of AD recalled over 
the past week (Appendix12).  The POEM should be completed in clinic as per Schedule of 
Activities (SoA).
8.10.2.Dermatology Life Quality Index (DLQI) and Children’s Dermatology Life 
Quality Index (CDLQI)
The DLQI is a validated general dermatology questionnaire that consists of 10items to assess 
participant-reportedhealth-related quality of life (daily activities, personal relationships, 
symptoms and feelings, leisure, work and school, and treatment) (Appendix12).  It has been 
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extensively used in clinical trials for AD.  The DLQI is a psychometrically valid and reliable 
instrument that has been translated into several languages, and the DLQI total scores have 
been shown to be responsive to change.  The minimally important difference for the DLQI 
has been estimated as a 3 to 5point change from baseline.  A version of the instrument 
specifically developed and validated for use by adolescents from age 12 to 17is called the 
CDLQI (Appendix12). 
The DLQI/CDLQI should be completed in clinic as per Schedule of Activities (SoA).
 
 
 
 
 
 
8.10.5.Peak Pruritis Numerical Rating Scale (PP-NRS)
See Section 8.1.5for details.
 
  
 
 
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9.STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in a statistical analysis plan (SAP), whichwill be 
maintainedby the sponsor.  The SAP may modify what is outlined in the protocol where 
appropriate; however, any major modifications of the primary endpoint definitions or their 
analyses will also be reflected in a protocol amendment.
9.1.Estimands andStatistical Hypotheses
The primary estimand will be the populationaverage treatment effect on percent change from 
baseline in EASI score relative to vehicle (with the same dosing schedule, QD or BID) at 
6weeks in the absence of prohibited medication without regard to compliance. All 
observations after the initiation of prohibited medication will be set to missing.  Missing data 
from all causes, includingpost-prohibited medication use will be imputed in the 
PF-06700841 arms using a jump to control method using the distribution of the vehicle group 
with matching BID or QD regimen (ie missing data in 1% QD regimen will be imputed from 
the distribution of participants on QD vehicle).  Participants with inadequate compliance will 
have their recorded EASI scores used as-is in the analysis.  The population based treatment 
effect will be the differences in the mean change from baseline in each treatment arm 
compared to the corresponding vehicle. 
The secondary estimand will be the estimated populationaverage treatment effect on the 
rates of IGA response (participants with a score of 0 or 1 and a 2point or greater decrease 
from baseline) at Week6 relative to vehicle (with the same dosing schedule, QD or BID) 
without regard to compliance with IPin the absence of prohibited medication.  This is a 
composite estimand where success is defined as achievement of an IGA response as defined 
above while remaining on study, providing data and not taking prohibited medication; lack of 
compliance or adverse events will not be counted as a failure.  The population based 
treatment effect will be the differences in the proportions of success in each treatment arm 
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compared to the corresponding vehicle.  EASI-75 and other EASI scores will be treated in a 
similar manner.
All other secondary continuous clinical endpoints will be analyzed using the primary 
estimand, while all other secondary categorical clinical endpoints will be analyzed using the 
secondary estimand described above.  Tertiary and Exploratory analyses may or may not be 
analyzed using these estimands and may be analyzed in a descriptive manner without 
reference to an estimand.  Other estimands may be used for some of the primary and 
secondary endpoints as a means to examine the robustness of the results and to compare to 
available literature as needed.  Details of these analyses will be presented in the statistical 
analysis plan (SAP).
9.2. Sample Size Determination
The sample size calculation is based on the primary endpoint (percentage change from 
baseline in EASI score at Week 6) and the key secondary endpoint (IGA response rate of 
clear or almost clear and 2 points improvement at Week 6).  A total of 280 randomized 
participants in 6 treatments groups and two vehicle groups (35/arm) will provide 
approximately 90% power to detect a difference of 50 in percentage change from baseline 
with a common standard deviation 48% between PF-06700841 and a vehicle arm, controlling 
the one-sided family wise error rate a 0.05 with a Bonferroni correction (alpha=0.008 after 
Bonferroni adjustment for 6 comparisons).  These calculations allow for a 20% dropout rate 
leaving 224 evaluable participants (28/arm).
For the key secondary endpoint, IGA response rate of clear or almost clear and 2 points 
improvement at Week 6, assuming 20% rate for vehicle and 60% rate for the treatment, this 
sample size also ensures the 80% power.
9.3. Populations for Analysis
For purposes of analysis, the following populations are defined:
Population
Description
Safety Analysis Set
All participants randomly assigned to IP and who apply at 
least 1 dose of IP.  Participants will be analyzed according to 
the product they actually received.
Defined Population for 
Analysis
Description
Modified Intention to 
Treat (mITT)
All participants randomly assigned to IP and who apply at 
least 1 dose of IP.  
PK concentration set
All enrolled participants who applied at least one dose of 
PF-06700481 and in whom at least once concentration value 
is reported.

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9.4.Statistical Analyses
The SAP will be developed and finalized before databaselock and will describe the 
participant populations to be included in the analyses, and procedures for accounting for 
missing, unused, and spurious data.  This section is a summary of the planned statistical 
analyses of the primary and secondary endpoints.
9.4.1.Efficacy Analyses
Endpoint
Statistical Analysis Methods
Primary
A landmark analysis using analysis of covariance of percent change from 
baseline in EASI, adjusting for thebaseline EASI score, to estimate the 
effect of the initially randomized treatment in the absence of prohibited 
medication regardless of treatment compliance.  The analysis will use the 
mITT analysis set.  Missing data due to any cause including censoring due 
to initiation of prohibited medication will be imputed using the 
corresponding vehicle arm, missing data in a vehicle arm will be imputed 
using data from the vehicle arm assuming data are missing at random 
(MAR).  The analysis will combine the results from the multiple 
imputations using Rubin’s rule’s as implemented in SAS PROC 
MIANALYZE.  The overall family wise Type I error rate will be controlled 
at the one-sided 0.05 level using the Hochberg step up procedure.
Secondary
A landmark analysis of the composite endpoint; achieving IGA without 
prohibited medication,while remaining on study and providing data.  The 
analysis will use the mITT analysis set.  Based on the definition of the 
composite endpoint all participants in the mITT set will have a response for 
all visits (ie, there is no missing data).  The proportions responding and the 
corresponding risk difference comparing active treatment armto vehicle 
group will be analyzed using the unconditional exact method; the risk 
differences and the corresponding 2-sided unconditional exact 90% 
confidence intervals will be computed using Chan and Zhang28(1999) 
method.  No adjustments for multiplicity will be made.
 
Other continuous secondary endpoints at time points specified in the Schedule of Activities 
(SoA)including change from baseline EASI, will be analyzed as described for the primary 
estimand along with descriptive statistics and possibly graphical displays.  No adjustments 
for multiplicity will be made for these endpoints.
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 EASI-90,
, IGA of clear or almost clearwill be 
analyzed as described for the secondary estimand along with descriptive statistics and 
possibly graphical displays.  No adjustments for multiplicity will be made for these 
endpoints.
 
9.4.2.Safety Analyses
All safety analyses will be performedon the safety population.
Endpoint
Statistical Analysis Methods
Primary
The safety data will be summarized in accordance with Pfizer Data 
Standards.  All participants who receive IP (safety population) will be 
included in the safetyanalyses.  All safety data will be summarized 
descriptively through appropriate datatabulations, descriptive statistics, 
categorical summaries, and graphical presentations.  Safetyendpoints for the 
study include:
Treatment-emergent AEs and SAEs;
WithdrawalsfromactivetreatmentduetoAEs;
Seriousinfections,definedasanyinfection(viral,bacterial,andfungal)
requiringhospitalization or parenteral antimicrobials;
Safetylaboratorytests(eg,hematology [including coagulation panel], 
chemistry andlipid profiles);
Vitalsigns.
Change from baseline on laboratory data and vital signs will be additionally 
summarized.  Participantlistings will also be produced for these safety 
endpoints.
9.4.2.1.Electrocardiogram Analyses
Changes from baseline for the ECG parameters QT interval, heart rate, QTc interval, PR 
interval, and QRS complex will be summarized by treatment and time.
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The number (%) of participants with maximum postdose QTc values and maximum increases 
from baseline in the following categories will be tabulated by treatment: 
Safety QTc Assessment
Degree of Prolongation
Mild (msec)
Moderate (msec)
Severe (msec)
Absolute value
>450-480
>480-500
>500
Increase from baseline
30-60
>60
In addition, the number of participants with uncorrected QT values >500msecwill be 
summarized.
 
 
 
 
 
 
 
 
 
9.5.Interim Analyses
An interim analysis will be performed once approximately 20% of enrolledparticipants
(18years of age) complete at least Week2 (Day15) visit.  The objective of this analysis is 
to evaluate the safety and tolerability of PF-06700841 cream, as compared to vehicle cream.  
If available, systemic exposure (PK) data will also be reviewed during this interim analysis.
The interim analysis will provide safety/tolerability data to commence enrollment of male
population of 12-18years of age in the study. 
Interim analysis results may also be used for internal business decisions regarding future 
study planning.  In that case, before any interim analysis is instigated, the details of the 
objectives, decision criteria, dissemination plan, and method of maintaining the study blind 
as per Pfizer’s SOPs will be documented and approved in an internal review committee 
(IRC) charter.  The resultswill only be distributed to a select list of individuals involved in 
the internal decision-makingprocess in order to protect the integrity of the study.  This list of 
individuals will be providedin the interim analysis plan.  The results of the interim analysis 
will not enable individualsdirectly involved in running the study (such as investigators) to 
identify treatmentassignments for individual participants still in the study.  There are no
prospective plans to stopthe study early for success as a result of the interim analyses.
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Since the analysis approach will be identical between the primary analysis conducted on the 
data based on the snap shot of the database and specified final analysis approaches, there will 
be no separate statistical analysis plan (SAP).
9.5.1.Data Monitoring Committee 
This study will use an internal review committee (IRC).  The IRC will be responsible for 
ongoing monitoring of safety of participants in the study according to the charter.  Members 
of the IRC will be qualified and experienced in reviewing and interpreting clinical study data.  
They will be external to and independent of the study team, and unblinded to treatment.  The 
recommendations made by the IRC to alter the conduct of the study will be forwarded to 
Pfizer for final decision.  This will not include the members of the study team.  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.  
Pfizer may perform an interim analysis which may include safety and efficacy.  If an interim 
analysis is performed, the same IRC will be used.  Details of the IRC are described in the 
IRC charter.
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
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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:

Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines;

Applicable International Council for Harmonisation (ICH) Good Clinical Practice 
(GCP) guidelines;

Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, investigator’s brochure (IB), and other relevant 
documents (eg, advertisements) must be reviewed and approved by the sponsor and 
submitted to an IRB/EC by the investigator and reviewed and approved by the IRB/EC 
before the study is initiated.
Any amendments to the protocol will require IRB/EC 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:

Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC;

Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures;

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/EC, 
European regulation 536/2014 for clinical studies (if applicable), and all other 
applicable local regulations.
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
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 investigational 
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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.
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 or his/her legally authorized representative and answer all questions regarding the 
study.
Participants must be informed that their participation is voluntary.  Participants or their 
legally authorized representative defined as parent or legal guardian will be required to sign a 
statement of informed consent 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/EC 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/EC 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.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was obtained.  
The authorized person obtaining the informed consent must also sign the ICD.
Participants must be reconsented to the most current version of the ICD(s) during their 
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A copy of the ICD(s) must be provided to the participant or the participant’s legally 
authorized representative.
Participants who are rescreened are required to sign a new ICD.
The ICD will contain a separate section that addresses the use of remaining mandatory 
samples for optional exploratory research.  The investigator or authorized designee will 
explain to each participant the objectives of the exploratory research.  Participants will be 
told that they are free to refuse to participate and may withdraw their consent at any time and 
for any reason during the storage period.  A separate signature will be required to document a 
participant's agreement to allow any remaining specimens to be used for exploratory 
research.  Participants who decline to participate in this optional research will not provide 
this separate signature.
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 has 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 data sets 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 confidentiality of participants’ personal data consistent 
with the clinical study agreement and applicable privacy laws.
10.1.5. 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 European Clinical Trials 
Database (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 standard operating procedures (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 
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www.clinicaltrials.gov
Pfizer posts clinical trial US Basic 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.  US Basic 
Results are generally submitted for posting within 1 year of the primary completion date 
(PCD) for studies in adult populations or within 6 months of the PCD for studies in pediatric 
populations.
PCD is defined as the date that the final participant was examined or received an intervention 
for the purposes of final collection of data for the primary outcome, whether the clinical 
study concluded according to the prespecified protocol or was terminated.
EudraCT
Pfizer posts European Union (EU) Basic Results on EudraCT for all Pfizer-sponsored 
interventional studies that are in scope of EU requirements.  EU Basic Results are submitted 
for posting within 1 year of the PCD for studies in adult populations or within 6 months of 
the PCD for studies in pediatric populations.
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 US Basic Results document is 
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 European Medicines Agency (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 
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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.
10.1.6. 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.
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/EC 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.
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 ICDs, 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 as long as they are 
maintained.

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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 the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study.  Furthermore, the investigator will cooperate 
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the 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 the sponsor or its agent.  Before response 
submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings.
10.1.7. 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 site.
Data reported on the CRF or entered in the electronic CRF (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 study completion guidelines.
10.1.8. 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 the contract 
research organization (CRO) if requested to do so by the responsible IRB/EC 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/EC or local health authorities, the sponsor's procedures, or GCP guidelines;

Inadequate recruitment of participants by the investigator;

Discontinuation of further study intervention development.
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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10.1.9. 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 1 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 submits 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 for 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.
10.1.10. 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 study team on demand (SToD) 
system.  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 investigational product identifiers, participant 
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 
advice on medical questions or problems that may arise during the study.  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.Appendix2: Clinical Laboratory Tests
The following safety laboratory tests will be performed at times defined in the Schedule of
Activities (SoA)section of this protocol.  Additional laboratory results may be reported on 
these samples as a result of the method of analysis or the type of analyzer used by the clinical 
laboratory; or as derivedfrom calculated values.  These additional tests would not require 
additional collection of blood.  Unscheduled clinical laboratory measurements may be 
obtained at any time during the study to assess any perceived safety concerns.
Table11.Protocol-Required Laboratory Assessments
Hematologya
Chemistry
a
Urinalysisa
Other
Hemoglobin
Hematocrit
RBC count and indices 
(MCH, MCHC, MCV, RBC 
Morphology)
Reticulocyte count
Platelet count
WBC count with differential
Total neutrophils (%, Abs)
Eosinophils (%, Abs)
Monocytes (%, Abs)
Basophils (%, Abs)
Lymphocytes (%, Abs)
BUN/urea & Creatinine
Cystatin C
Glucose (fasting)
Calcium
Sodium
Potassium
Chloride
Total CO2(bicarbonate)
AST, ALT
GGT
Total, Indirect & Direct 
Bilirubin
Alkaline phosphatase
Lactate Dehydrogenase
Uric acid
Albumin
Total protein
Creatinine Kinasef
pH
Glucose (qual)
Protein (qual)
Blood (qual)
Ketones
Nitrites
Leukocyte esterase
Urobilinogen
Urine bilirubin
Microscopyd
At screening only:
FSHb
HIV
HBsAg
HBcAb
HbsAbc
HBV DNA test(reflex tested in 
countries where required by 
local regulations)
HCV Ab
HCV RNAe
IGRA or PPD (if pplicable)
VZV IgG Ab
Coagulation Panel (as part of 
Hematology)
-aPTT
-PT/INR
At visits in SoA:
Pregnancy test (-hCG)g
Skin swabs for herpetiform rash
h
Lipid Paneli
-Total Cholesterol
-LDL
-HDL
-Triglycerides
Abbreviations: Ab = antibody; Abs = absolute; ALT = alanine aminotransferase; AST = aspartate aminotransferase;
aPTT = activated partial thromboplastin time; -hCG = beta-human chorionic gonadotropin; BUN = blood urea 
nitrogen; Chemokine (C-C motif) ligand 17; CO2 = carbon dioxide;
 IgG = immunoglobulin 
G; FSH= follicle-stimulating hormone; GGT = Gamma Glutamyl Transferase; HBcAb = Hepatitis B Core Antibody; 
HBsAb = Hepatitis B Surface Antibody; HBsAg = Hepatitis B Surface Antigen; HCVAb = Hepatitis C Virus 
Antibody; HCV RNA = Hepatitis C Virus Ribonucleic Acid; HDL = high density lipoprotein; HIV = Human 
Immunodeficiency Virus;
; IGRA = Interferon Gamma Release Assay; 
INR= International Normalized Ratio; 
 LDL = low density lipoprotein; 
MCH = mean corpuscular hemoglobin; MCHC = mean corpuscular hemoglobin concentration; MCV = mean 
corpuscular volume; PPD = purifiedprotein derivative; qual = qualitative; RBC=red blood cell;
 
; VZV = Varcilla Zoster Virus; WBC = white blood cell.
CCI
CCI
CCI
CCI
CCI

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a.
Safety labs include hematology, chemistry and urinalysis.
b.
A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a 
postmenopausal state in women not using hormonal contraception or hormone replacement therapy (HRT).
c.
Hepatitis B Surface Antibody (HBsAb) will be reflex tested if participants are positive for HBsAb.  HBsAB will 
also be tested for all participants when required by country-specific local regulations.  See country-specific details in 
Appendix 8.
d.
Only if urine dipstick is positive for blood, protein, nitrites, or leukocyte esterase.
e.
Hepatitis C Viral RNA (HCV RNA) will be reflex tested if participants are positive for HCVAb.
f.
Fractionation only if CK is elevated >3 x ULN.
g.
Serum pregnancy testing at screening is required for women of childbearing potential (WOCBP). Serum will also 
be collected at Day 1 to test pregnancy, the results of which may be received after Day 1. Pregnancy tests may also 
be repeated more frequently as per request of IRBs/ECs or if required by local regulations women of child-bearing 
potential. Urine pregnancy tests will be used at Day 1 and at other visits. 
h.
In cases of suspected herpetiform rash (eg, suspected herpes zoster and herpes simplex).
i.
Lipid Profile Panel requires at least an 8 hour fast.
Investigators must document their review of each laboratory safety report.
Laboratory results that could un-blind the study will not be reported to investigator sites or 
other blinded personnel until the study has been unblinded.

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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 sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator (ie, not related to progression of 
underlying disease).

Exacerbation of a chronic or intermittent preexisting 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.

“Lack of efficacy” or “failure of expected pharmacological action” per se will not 
be reported as an AE or SAE.  Such instances will be captured in the efficacy 
assessments.  However, the signs, symptoms, and/or clinical sequelae resulting 
from lack of efficacy will be reported as an AE or SAE if they fulfill the definition 
of an AE or SAE.

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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 preexisting 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).
An 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 preexisting condition that did not worsen from 

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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.

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.
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) nonserious adverse events (AEs); and (3) exposure to the 
investigational product 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
Nonserious AE
All
None
Exposure to the investigational 
product under study during 
pregnancy or breastfeeding, and 
occupational exposure
None
All (and exposure during 
pregnancy [EDP] supplemental 
form for EDP)  

When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostic 
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, will 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.

Severe: An event that prevents normal everyday activities.  An AE that is assessed 
as severe should not be confused with an 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 

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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 an 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 investigational product caused 
the event, then the event will be handled as “related to investigational product” for 
reporting purposes, as defined by the sponsor.  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 healthcare professionals.

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 
postmortem 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 an Electronic Data Collection Tool

The primary mechanism for reporting an SAE to Pfizer Safety will be the electronic 
data collection tool.

If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to report the event within 24 hours.

The site will enter the SAE data into the electronic system as soon as the data 
become available.

After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the entry of new data or changes to existing data.

If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form (see 
next section) or to Pfizer Safety by telephone.

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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 pages within the designated reporting 
time frames.

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10.4. Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information
10.4.1. Male Participant Reproductive Inclusion Criteria
Male participants are eligible to participate if they agree to the following requirements 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 study intervention(s): 

Refrain from donating sperm.
PLUS either:

Be abstinent from heterosexual intercourse with a female of childbearing potential as 
their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and 
agree to remain abstinent. 
OR

Must agree to use a male condom when engaging in any activity that allows for 
passage of ejaculate to another person.
In addition to male condom use, a highly effective method of contraception may be 
considered in WOCBP partners of male participants (refer to the list of highly effective 
methods below in Section 10.4.4).
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 that is highly effective (with a failure 
rate of <1% per year), with low user dependency, 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 study intervention(s).  The 
investigator should evaluate the effectiveness of the contraceptive method in 
relationship to the first dose of study intervention. 
OR

Is a WOCBP and using a contraceptive method that is highly effective (with a failure 
rate of <1% per year), with high user dependency, 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 study intervention(s).  In 
addition, a second effective method of contraception, as described below, must be 

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used.  The investigator should evaluate the effectiveness of the contraceptive method 
in relationship to the first dose of study intervention. 
OR 

Is a WOCBP and is abstinent 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 be the preferred and 
usual lifestyle of the participant.
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. Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP:
1. Premenopausal female with 1 of the following:

Documented hysterectomy;

Documented bilateral salpingectomy;

Documented bilateral oophorectomy.
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
Note: Documentation for any of the above categories 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.
2. Postmenopausal female:

A postmenopausal state is defined as age 60 years or older or no menses for 
12 months without an alternative medical cause. 

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
A high follicle-stimulating hormone (FSH) level in the postmenopausal range 
may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormone replacement therapy (HRT). 

Females on HRT and whose menopausal status is in doubt will be required to use 
one of the nonestrogen 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.
10.4.4. Contraception Methods
Highly Effective Methods That Have Low User Dependency 
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device (IUD).
3. Intrauterine hormone-releasing system (IUS).
4. Bilateral tubal occlusion.
5. 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.
Highly Effective Methods That Are User Dependent (must be used in combination with 
another effective method; see below)
1. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:

oral;

intravaginal;

transdermal;

injectable.
2. Progestogen-only hormone contraception associated with inhibition of ovulation:

oral;

injectable.

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Effective Methods
1. Male or female condom with or without spermicide.
2. Cervical cap, diaphragm, or sponge with spermicide.
3. A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods).
Collection of Pregnancy Information
For both unapproved/unlicensed products and for marketed products, an exposure during 
pregnancy (EDP) occurs if:

A female becomes, or is found to be, pregnant either while receiving or having been 
exposed (eg, because of treatment or environmental exposure) to the investigational 
product; or the female becomes or is found to be pregnant after discontinuing and/or 
being exposed to the investigational product;

An example of environmental exposure would be a case involving direct contact 
with a Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant 
and has been exposed to chemotherapeutic products).

A male has been exposed (eg, because of treatment or environmental exposure) to the 
investigational product prior to or around the time of conception and/or is exposed 
during his partner’s pregnancy.
If a participant or participant’s partner becomes or is found to be pregnant during the 
participant’s treatment with the investigational product, 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.  In addition, the investigator must submit 
information regarding environmental exposure to a Pfizer product in a pregnant woman (eg, a 
participant reports that she is pregnant and has been exposed to a cytotoxic product by 
inhalation or spillage) to Pfizer Safety using the EDP supplemental form.  This must be done 
irrespective of whether an AE has occurred and within 24 hours of awareness of the 
exposure.  The information submitted should include the anticipated date of delivery (see 
below for information related to termination of pregnancy).
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 
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).

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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 includes 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 investigational product. 
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.

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10.5.Appendix 5: Genetics
Use/Analysis of DNA
Genetic variation may impact a participant’s response to study intervention, 
susceptibility to, and severity and progression of disease.  Therefore, where local 
regulations and IRBs/ECs allow, a blood sample will be collected for DNA analysis.
Genetic research may consist of the analysis of 1 or more candidate genes or the 
analysis of genetic markers throughout the genome or analysis of the entire genome 
(as appropriate).
The samplesmay be analyzed as part of a multistudy assessment of genetic factors 
involved in the response to PF-06700841or study interventions of this class to 
understand treatments for the disease(s) under study or the disease(s) themselves.
The results of geneticanalyses may be reported in the clinical study report (CSR) or 
in a separate study summary, or may be used for internal decision making without 
being included in a study report.
The sponsor will store the DNA samples in a secure storage space with adequate 
measures to protect confidentiality. 
 
 
 
 
 
C
C
I

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10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-up Assessments and 
Study Intervention Re-challenge Guidelines
Potential Cases of Drug-Induced Liver Injury
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 laboratory 
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.  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:

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).

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).

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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 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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10.7. Appendix 7: ECG Findings of Potential Clinical Concern
ECG Findings That May Qualify as Adverse Events (AEs)

Marked sinus bradycardia (rate <40 bpm) lasting minutes.

New PR interval prolongation >280 msec.

New prolongation of QTcF to >480 msec (absolute) or by 60 msec from baseline.

New-onset atrial flutter or fibrillation, with controlled ventricular response rate: ie, 
rate <120 bpm.

New-onset type I second-degree (Wenckebach) AV block of >30 seconds’ 
duration.

Frequent premature ventricular complexes (PVCs), triplets, or short intervals 
(<30 seconds) of consecutive ventricular complexes.
ECG Findings That May Qualify as Serious Adverse Events (SAEs)

QTcF prolongation >500 msec.

New ST-T changes suggestive of myocardial ischemia.

New-onset left bundle branch block (QRS >120 msec).

New-onset right bundle branch block (QRS >120 msec).

Symptomatic bradycardia. 

Asystole:

In awake, symptom-free patients in sinus rhythm, with documented periods of 
asystole 3.0 seconds or any escape rate <40 bpm, or with an escape rhythm 
that is below the AV node; 

In awake, symptom-free patients with atrial fibrillation and bradycardia with 
1 or more pauses of at least 5 seconds or longer; 

Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate 
>120 bpm.

Sustained supraventricular tachycardia (rate >120 bpm) (“sustained” = short 
duration with relevant symptoms or lasting >1 minute).

Ventricular rhythms >30 seconds’ duration, including idioventricular rhythm (rate 
<40 bpm), accelerated idioventricular rhythm (40< x <100), and 

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monomorphic/polymorphic ventricular tachycardia >100 bpm (such as torsades de 
pointes).

Type II second-degree (Mobitz II) AV block.

Complete (third-degree) heart block.
ECG Findings That Qualify as Serious Adverse Events

Change in pattern suggestive of new myocardial infarction. 

Sustained ventricular tachyarrhythmias (>30 seconds’ duration).

Second- or third-degree AV block requiring pacemaker placement.

Asystolic pauses requiring pacemaker placement.

Atrial flutter or fibrillation with rapid ventricular response requiring cardioversion.

Ventricular fibrillation/flutter.

At the discretion of the investigator, any arrhythmia classified as an adverse 
experience.
The enumerated list of major events of potential clinical concern are recommended as 
“alerts” or notifications from the core ECG laboratory to the investigator and Pfizer study 
team, and not to be considered as all inclusive of what to be reported as AEs/SAEs.

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10.8. Appendix 8: Country-Specific Requirements
Exclusion Criteria #20
In countries where required, all participants may undergo testing for Hepatitis B Virus 
(HBV) surface antigen (HBsAg), HBV core antibody (HBcAb), and HBV surface antibody 
(HBsAb).  The testing will be performed in Clinical Laboratory Improvement Amendments 
(CLIA) certified Laboratory or similar. 
Participants who are negative for all three serology tests may be eligible. 
Participants who are HBsAg positive will be excluded. 
Participants who have negative HBsAg, positive HBcAb, and negative HBsAb will be 
excluded. 
Participants who have negative HBsAg, negative HBcAb and positive HBsAb and provide a 
documentation of prior HBV vaccination, may be eligible for the study and will not require 
HBV DNA monitoring during the study. 
Participants who have negative HBsAg, negative HBcAb and positive HBsAb without 
documentation of prior HBV vaccination, and participants who have negative HBsAg, 
positive HBcAb and positive HBsAb are required to undergo HBV DNA testing

If detectable HBV DNA, participants will be excluded; and 

If not detectable HBV DNA, participants may be eligible.  If enrolled, HBV DNA 
will be assessed at Week 6 also. 

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10.9. Appendix 9: Diagnosis Criteria for Atopic Dermatitis
Per Inclusion Criterion #2, a participant is to have a clinical diagnosis of atopic dermatitis 
according to the criteria of Hanifin and Rajka.26
Hanifin and Rajka’s Diagnostic Criteria for Atopic Dermatitis
Must have three or more basic features described below:
Pruritus
Typical morphology and distribution:
Flexural lichenification in adults
Facial and extensor eruptions in infants and children
Chronic or chronically-relapsing dermatitis
Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis)
Must have three or more following minor features:
Xerosis
Ichthyosis/palmar hyperlinearity, keratosis pilaris
Immediate (type 1) skin test reaction
Elevated serum IgE
Early age of onset
Tendency toward cutaneous infections (esp. staph. aureus and herpes simplex), impaired cell-mediated 
immunity
Tendency toward non-specific hand or foot dermatitis
Nipple eczema
Cheilitis
Recurrent conjunctivitis
Dennie-Morgan infraorbital fold
Keratoconus
Anterior subcapsular cataracts
Orbital darkening
Facial pallor, facial erythema
Pityriasis alba
Anterior neck folds
Itch when sweating
Intolerance to wool and lipid solvents
Periofollicular accentuation
Food intolerance
Course influenced by environmental and emotional factors
White dermographism, delayed blanch

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10.10. Appendix 10: Prohibited Concomitant Medications
The following medications & procedures are prohibited until the last Follow-up visit, unless 
stated otherwise.  If a participant receives prohibited medication or procedure, the 
investigator should either 1) ask the participant to stop IP immediately and schedule ET visit 
as soon as possible with follow-up visits per Schedule of Activities or 2) contact Sponsor 
Clinician or Sponsor Medical monitor to determine if participant may stay in the study.  This 
will be based on the Table below.  Medications listed below are prohibited even if used for a 
different indication than noted below.
Drug Classes and/or Drugs and/or Procedures 
Timeframe of Restriction 
Prior to Screening Visit
If taken, then
Stop IP, 
Proceed to 
ET and 
F/UP
Contact 
Sponsor 
Light therapy
Narrow-band Ultraviolet B light (UVB) 
Broadband phototherapy 
Ultraviolet A light (UVA) 
Excimer laser (308 nm)  
1 month
X
Any cell-depleting agents, including but not 
limited to
Rituximab
Alemtuzumab [CamPath]
Alkylating agents [eg, cyclophosphamide or 
chlorambucil]
Total lymphoid irradiation, etc
6 months or 5 half-lives, 
whichever is longer OR 
until lymphocyte count 
returns to normal, 
whichever is longer
X
Anti-AD or psoriasis biologics 
Efalizumab (Raptiva)
Certolizumab pegol (Cimzia)
Alefacept (Amevive®)
Duplimab
Infliximab (Remicade) and biosimilar
Adalimumab (Humira) and biosimilar
2 months 
X
Ustekinumab (Stelara)
Secukinumab (Cosentyx) 
Ixekizumab (Taltz)
Brodalumab (Siliq)
Guselkumab (Tremfya)
Tildrakizumab
Risankizumab
3 months
X
Etanercept (Enbrel) and biosimilar
1 month
X
Systemic treatments other than biologics that 
could affect AD, including but not limited to:
oral or injectable (eg, intraarticular, 
intramuscular, or intravenous) corticosteroids
retinoids
methotrexate
cyclosporine
fumaric acid derivatives
sulfasalazine
hydroxycarbamide (hydroxyurea)
2 weeks
X

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Drug Classes and/or Drugs and/or Procedures 
Timeframe of Restriction 
Prior to Screening Visit
If taken, then
Stop IP, 
Proceed to 
ET and 
F/UP
Contact 
Sponsor 
azathioprine
intramuscular gold
Otezla (Apremilast)
Any herbal medicine
Other systemic treatments known to possibly 
worsen AD unless on a stable dose for 
>12 weeks (eg lithium, -blockers, 
angiotensin-converting enzyme inhibitors, 
synthetic anti-malarials, anticonvulsants, 
antidepressants, cyclosporine, 
testosterone/estrogens, imiquimod, calcium 
channel blockers, etc)
Tofacitinib
Any other oral JAK inhibitors
1 month or 5 half–live 
whichever is longer
X
Topical treatments applied on AD areas treated 
with IP and which could affect AD.  If applied 
to other areas not treated with IP, this is 
allowed.
Including but not limited to:
Corticosteroids
Tars
Keratolytics
Anthralin
vitamin D analogues
retinoids
2 weeks
X
sunscreens, moisturizers or non-medicated 
emollients
2 weeks
X
Topical AD medication (eg Eucrisa)
1 month or 5 half–live 
whichever is longer
X
Any topical JAK inhibitors
1 month or 5 half–live 
whichever is longer
X
CYP3A4, 5, 7 Inhibitors
HIV antivirals:
delavirdine (Rescriptor)
indinavir (Crixivan)
nelfinavir (Viracept)
ritonavir (Kaletra, Norvir)
saquinavir (Fortovase)
cimetidine (Tagamet)
ciprofloxacin (Cipro)
clarithromycin (Biaxin, Prevpac)
diethyl-dithiocarbamate
diltiazem (Cardizem, Tiazac)
fluconazole (Diflucan)
fluvoxamine (Luvox)
gestodene (Femodene, Melodene, Minulette,
1 month or 5 half-lives, 
whichever is longer
X

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Drug Classes and/or Drugs and/or Procedures 
Timeframe of Restriction 
Prior to Screening Visit
If taken, then
Stop IP, 
Proceed to 
ET and 
F/UP
Contact 
Sponsor 
Mirelle, Triodene ED)
grapefruit juice and marmalade
itraconazole (Sporanox)
ketoconazole (Nizoral)
Itraconazole
Erythromycin
protease inhibitors
verapamil 
diltiazem
Amiodarone
10 months
X
CYP3A Inducers
barbiturates
efavirenz (Sustiva)
nevirapine (Viramune)
barbiturates
carbamazepine (Carbatrol, Tegretol)
modafinil (Provigil)
phenobarbital
Phenytoin (Dilantin, Phenytek)
rifampin (Rifadin, Rifamate, Rifater)
St. John’s wort
troglitazone (Rezulin)
pioglitazone (Actos)
rifabutin (Mycobutin)
1 month or 5 half-lives, 
whichever is longer
X
Strong P-gp inhibitors
Quinidine
1 month or 5 half-lives, 
whichever is longer
X
Substrates of MDR1
Digoxin
1 month or 5 half-lives, 
whichever is longer
X
Substrates of OCT2/MATE
Dofetilide
1 month or 5 half-lives, 
whichever is longer
X
Vaccination with live or attenuated live vaccine
(See Section 5.3.4)
6 weeks
X

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10.11. Appendix 11: Fitzpatrick Skin Type

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10.12. Appendix 12: Patient Reported Outcomes
10.12.1. Peak Pruritis Numerical Severity Scale (PP-NRS)
On a scale of 0 to 10, with 0 being “no itch” and 10 being “worst itch imaginable”, how 
would you rate your itch at the worst moment during the previous 24 hours?
1
9
8
7
6
5
4
3
2
1
0
1
9
8
7
6
5
4
3
2
1
0
N
itch
Worst 
itch 
imaginable

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CCI

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CCI

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CCI

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CCI
CCI

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10.12.3. Patient-Oriented Eczema Measure (POEM)

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10.12.4. Dermatology Life Quality Index (DLQI)/Children’s DLQI
DERMATOLOGY LIFE QUALITY INDEX
The aim of this questionnaire is to measure how much your skin problem has affected 
your life OVER THE LAST WEEK.  Please tick one box for each question.
1.
Over the last week, how itchy, sore, painful or stinging has your 
skin been?
Very much 
A lot
A little 
Not at all
2.
Over the last week, how embarrassed or self conscious have you been 
because of your skin?
Very much 
A lot
A little 
Not at all
3.
Over the last week, how much has your skin interfered with you going
shopping or looking after your home or garden?
Very much 
A lot
A little 
Not at all
Not relevant 4.
Over the last week, how much has your skin influenced the clothes
you wear?
Very much 
A lot
A little 
Not at all
Not relevant 5.
Over the last week, how much has your skin affected any social or
leisure activities?
Very much 
A lot
A little 
Not at all
Not relevant 6.
Over the last week, how much has your skin made it difficult for you to 
do any sport?
Very much 
A lot
A little 
Not at all
Not relevant 7.
Over the last week, has your skin prevented you from working or
studying?
yes 
no
Not relevant If "No", over the last week how much has your skin been a problem at
work or studying?
A lot 
A 
little
Not at all
8.
Over the last week, how much has your skin created problems with your
partner or any of your close friends or relatives?
Very much 
A lot
A little 
Not at all
Not relevant 9.
Over the last week, how much has your skin caused any 
sexual difficulties?
Very much 
A lot
A little 
Not at all
Not relevant 10. Over the last week, how much of a problem has the treatment for your 
skin been, for example by making your home messy, or by taking up 
time?
Very much 
A lot
A little 
Not at all
Not relevant 

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CCI

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CCI

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10.13. Appendix 13: C-SSRS – Columbia Suicide Severity Rating Scale
C-SSRS for Screening and Baseline Visits:

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C-SSRS for post-baseline visits

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10.14. Appendix 14: eGFR Calculations
The estimated GFR (eGFR) will be calculated using the 2 sets of equations developed by the 
Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), which utilize serum 
creatinine (SCr) and serum Cystatin C (S Cystatin C) respectively.
CKD-EPI2009Scr
If female and SCr is 0.7 mg/dL:

GFR (mL/min/1.73 m2) = 144 x (Scr/0.7) – 0.329 x 0.993age (x 1.159, if black).
If female and SCr is >0.7 mg/dL:

GFR (mL/min/1.73 m2) = 144 x (Scr/0.7) – 1.209 x 0.993age (x 1.159, if black).
If male and SCr is 0.9 mg/dL:

GFR (mL/min/1.73 m2) = 141 x (Scr/0.9) – 0.411 x 0.993age (x 1.159, if black).
If male and SCr is >0.9 mg/dL:

GFR (mL/min/1.73 m2) = 141 x (Scr/0.9) – 1.209 x 0.993age (x 1.159, if black).
CKD-EPI2012cys
If female and Scys is 0.8 mg/L:

GFR (mL/min/1.73 m2) = 133 x (Scys /0.8) –0.499 x 0.996age x 0.932.
If female and Scys is >0.8 mg/L:

GFR (mL/min/1.73 m2) = 133 x (Scys /0.8) –1.328 x 0.996age x 0.932.
If male and Scys is 0.8 mg/L:

GFR (mL/min/1.73 m2) = 133 x (Scys /0.8) –0.499 x 0.996age.
If male and Scys is >0.8 mg/L:

GFR (mL/min/1.73 m2) = 133 x (Scys /0.8) –1.328 x 0.996age.

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10.15.Appendix 15: Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
AA
alopecia areata
Ab
antibody
Abs
absolute
AD
atopic dermatitis
AE
adverse event
ALT
alanine aminotransferase
AST
aspartate aminotransferase
AUC
area under the curve
AUC24
area under the concentration-time curve from time 0 to 24 hours 
after dose
AUCinf
area under the concentration-time curve from time 0 to infinity 
AUCtau
area under the concentration-time curve during any dosing interval 
at steady state
AZA
azathioprine
BCG
bacille Calmette-Guerin
-hCG
beta-humanchorionic gonadotropin
BID
twice daily
BMI
body mass index
BP
blood pressure
BSA
body surface area
BUN
blood urea nitrogen
CAT
computerized axial tomography
Cav
average concentrations
CD
Crohn’s disease
CFR
Code of Federal Regulations
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CKD-EPI
Chronic Kidney Disease Epidemiology Collaboration
CL
clearance
CLIA
Clinical Laboratory Improvement Amendments
Cmax
maximum observed concentration
CMV
Cytomegalovirus
CO2
carbon dioxide (bicarbonate)
CONSORT
Consolidated Standards of Reporting Trials
CRF
case report form
CRO
contract research organization
CSR
clinical study report
C-SSRS
Columbia suicide severity rating scale
CT
clinical trial
CCI

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Abbreviation
Term
DILI
drug-induced liver injury
DLQI
Dermatology Life Quality Index
DNA
deoxyribonucleic acid
DU
dispensable unit
EASI
Eczema Area and Severity Index
EBV
Epstein Barr virus
EC50
Half-maximal effective concentration
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
EMA
European Medicines Agency
EOS
end of study
EOT
end of treatment
ePRO
electronic patient reported outcome
ET
early termination
EU
European Union
EudraCT
European Clinical Trials Database
F
bioavailibility
FDA
Federal Drug Administration
FSH
follicle-stimulating hormone
Fu
fraction unbound
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
HBcAb
hepatitis B core antibody
HBsAb 
hepatitis B surface antibody
HBsAg 
hepatitis B surface antigen
HBV
hepatitis B visrus
HCVAb
hepatitis C virus antibody
HIPAA
Health Insurance Portability and Accountability Act
HIV
human immunodeficiency virus
HRT
hormone replacement therapy
 
IB
investigator’s brochure
IC
50
half-maximal inhibitory concentration 
ICD
informed consent document
ICH
International Council for Harmonisation
ID
identification
IFN-α
Interferon alpha
IGA
Investigator’s Global Assessment 
CCI
CCI

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Abbreviation
Term
IgG
immunoglobulin G
IGRA
Interferon Gamma Release Assay
IL-
interleukin
IND
investigational new drug application
INR
international normalized ratio
IP
investigational product
IP manual
investigational product manual
IRB
institutional review board
IRC
internal review committee
IRT
interactive response technology
IUD
intrauterine device
IUS
intrauterine hormone-releasing system
IV
intravenous 
IWR
interactive Web-based response
LFT
liver function test
LLOQ
lower limit of quantification
JAK
Janus Kinase
LDL
low density lipoprotein 
MAD
multiple ascending dose
MCH
mean corpuscular hemoglobin
MCHC
mean corpuscular hemoglobin concentration
MCV
mean corpuscular volume
Mg
milligram
MMP12
Matrix metalloproteinase 12
mRNA
messenger ribonucleic acid
MRI
magnetic resonance imaging
Msec
millisecond
MTX
methotrexate
N/A
not applicable
NOAEL
no-observed-adverse-effect level
NRS
Numerical Rating Scale
PASI
Psoriasis area and severity index
PCD
primary completion date
PCP
primary care physician
PCR
polymerase chain reaction 
PD
pharmacodynamic(s)
PG
polypropyle glycol
PI
principal investigator
PK
pharmacokinetic(s)
CCI
CCI
CCI
CCI

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Abbreviation
Term
POEM
Patient Oriented Eczema Measure
PPD
Purified Protein Derivative
PP-NRS
Peak Pruritus Numerical Rating Scale
PR
pulse rate
PRO
Patient reported outcomes
PT
prothrombin time
PVC
premature ventricular contraction/complex
QD
once daily
QFT-G
QuantiFERON-TB Gold Test
QFT-GIT
QuantiFERON-TB Gold In-tube Test
QT
Q wave interval
QTc
corrected QT
QTcF
corrected QT (Fridericia method)
Qual
qualitative
QW
once a week
RBC
red blood cell
RNA
ribonucleic acid
SAD
single ascending dose
SAE
serious adverse event
SAP
statistical analysis plan
SCr
serum creatinine
S Cystatin C
serum Cystatin C
SoA
schedule of activities
SOP
standard operating procedure
SRSD
single reference safety document
SSID
subject study identification n
SToD
study team on demand
SUSAR
suspected unexpected serious adverse reaction
t1/2
half-life
TB
tuberculosis
TBili
total bilirubin
TdP
Torsade de Pointes
TEAE
treatment emergent adverse events
Tmax
time taken to reach the maximum concentration
TNF
tumor necrosis factor
TYK2
Tyrosine Kinase 2
UC
ulcerative colitis
ULN
upper limit of normal
US
United States
UVA
ultraviolet A light 
Vss
volume of distribution
CCI
CCI

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Abbreviation
Term
UVB
ultraviolet B light
VZV
varicella zoster virus
WBC
white blood cell
WOCBP
woman of childbearing potential

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11. REFERENCES
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CCI

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