A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Phase: PHASE2
Conditions: Alopecia Areata
Sponsor: Eli Lilly and Company

Protocol Addendum: I4V-MC-JAHO (5.1)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive 
Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Severe or 
Very Severe Alopecia Areata 
NCT03570749 
Approval Date: 14-Mar-2024 

CONFIDENTIAL 
I4V-MC-JAHO(5.1) 
1 
Title Page 
Confidential Information 
The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of 
Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical 
investigation of baricitinib (LY3009104) unless such persons are bound by a confidentiality agreement with Eli Lilly and Company 
or its subsidiaries. 
Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information 
exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. 
In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or 
otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries. 
Protocol Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally 
Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of 
Baricitinib in Adult Patients with Severe or Very Severe Alopecia Areata 
BRAVE-AA1 
Protocol Number: I4V-MC-JAHO 
Addendum Number: 5.1 
Addendum Statement: This addendum is to be performed in place of procedures required by 
protocol I4V-MC-JAHO or any subsequent amendments to that protocol. 
Compound: Baricitinib (LY3009104) 
Sponsor Name: Eli Lilly and Company 
Legal Registered Address: Indianapolis, Indiana, USA 46285 
Regulatory Agency Identifier Number: 
IND: 112543 
Approval Date: Revised Protocol Addendum (5.1) Electronically Signed and Approved by Lilly 
on date provided below. 
Document ID: VV-CLIN-074217 
Approved on 14 Mar 2024 GMT

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I4V-MC-JAHO(5.1) 
2 
Protocol Addendum Summary of Changes Table  
DOCUMENT HISTORY 
Document 
Date 
Original Protocol Addendum 
23-Nov-2022 
Overall Rationale for the Revision [5.1] 
The main rationale for the addendum revision is to update the primary objective and the 
statistical considerations to align with the final enrollment of 20 patients. 
Other details are provided in the table below: 
Section # and Name 
Description of Change 
Brief Rationale 
1. Rationale for Addendum 
Added ‘endpoint’ in place of 
‘objective’ in brief rationale for 
Section 2.3. 
Editorial correction 
Updated to percent change for the 
primary endpoint statement in brief 
rationale for Sections 2.3 
To align with the wording used in the 
description of endpoints in the main 
protocol amendment, I4V-MC-
JAHO(e) 
Revised the brief rationale 
statement in the table for Section 
2.4.2. to state that 20 patients were 
enrolled into the addendum. 
To align with the overall rationale. 
Updated to percent change for the 
primary endpoint statement in brief 
rationale for Section 2.9. 
To align with the wording used in the 
description of endpoints in the main 
protocol amendment, I4V-MC-
JAHO(e) 
2.3. Objectives and Endpoints 
Updated the primary objective and 
endpoint.  
To align with the overall rationale. 
Updated Week 36 to Week 52 in 
third bullet for endpoints in the 
table.  
To align with the primary endpoint of 
the study (Week 52). 
2.4.1. Overall design 
Revised the total number of patients 
to 20. 
To align with the overall rationale. 
Removed the addendum version 
number 5 (2 instances) in the first 
paragraph. 
Editorial correction. 
2.4.2. Number of Participants 
Revised the section to state that 20 
patients were enrolled into the 
addendum. 
To align with the overall rationale and 
to indicate that enrollment is 
completed. 
2.6.1. Treatments Administered 
Revised that the patients with renal 
impairment will not receive 4 mg 
QD in the footnote ‘a’ for Table 
JAHO.1. Treatment Regimen. 
Updated for clarification. 
2.6.7.1. Permitted Medications 
and Procedures 
Removed the instances of Week 36 
in the 4th bullet on corticosteroid 
injections  
To align with the primary endpoint of 
the study (Week 52). 
2.6.7.2. Prohibited Medications 
and Procedures 
Revised the period for temporary 
interruption of BCG vaccination 
from Week 36 to Week 52. 
To align with the primary endpoint of 
the study (Week 52). 
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I4V-MC-JAHO(5.1) 
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Section # and Name 
Description of Change 
Brief Rationale 
2.9.1. Sample Size 
Determination 
Revised the sample size estimation 
for approximately 20 patients. 
To align with the overall rationale. 
2.9.3.1.1. Analysis Methods 
The analysis methods were revised 
to descriptive statistics. 
To align with the descriptive nature of 
the study. 
2.9.3.1.2. Missing Data 
Imputation 
Added that no imputation methods 
will be applied and removed 
information on non-responder 
imputation and last observation 
carried forward. 
To substantiate the use of appropriate 
missing data imputation techniques. 
2.9.4.1. Primary Analyses 
The primary analyses were revised 
to descriptive statistics. 
To align with the descriptive nature of 
the study. 
Updated to percent change for the 
primary endpoint description. 
To align with the wording used in the 
description of endpoints in the main 
protocol amendment, I4V-MC-
JAHO(e) 
2.9.4.2. Secondary Analyses 
Removed information on missing 
data imputation in the first 
paragraph. 
To align with the revision made in 
Section 2.9.3.1.2. Missing Data 
Imputation. 
Throughout the addendum 
Minor editorial changes 
For clarification 
 
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I4V-MC-JAHO(5.1) 
4 
Table of Contents  
Protocol Addendum Summary of Changes Table .........................................................................2 
1. 
Rationale for Addendum ......................................................................................................7 
2. 
Protocol Additions ...............................................................................................................14 
2.1. 
Schema for Substudy ......................................................................................................14 
2.2. 
Schedule of Activities .....................................................................................................15 
2.3. 
Objectives and Endpoints ..............................................................................................22 
2.4. 
Study Design....................................................................................................................23 
2.4.1. 
Overall Design ........................................................................................................23 
2.4.1.1. 
Period 1: Screening (-35 to -5 days) ...................................................................24 
2.4.1.2. 
Period 2: Open-Label Treatment (Weeks 0-52) .................................................24 
2.4.1.3. 
Period 3: Posttreatment Follow-Up ....................................................................25 
2.4.2. 
Number of Participants .........................................................................................25 
2.4.3. 
End of Study Definition .........................................................................................25 
2.4.4. 
Scientific Rationale for Study Design ...................................................................25 
2.4.5. 
Justification for Dose .............................................................................................25 
2.5. 
Study Population ............................................................................................................25 
2.5.1. 
Inclusion Criteria ...................................................................................................26 
2.5.2. 
Exclusion Criteria ..................................................................................................28 
2.5.3. 
Lifestyle Restrictions ..............................................................................................34 
2.5.4. 
Screen Failures .......................................................................................................34 
2.6. 
Treatments ......................................................................................................................35 
2.6.1. 
Treatments Administered ......................................................................................35 
2.6.1.1. 
Packaging and Labelling ....................................................................................35 
2.6.2. 
Method of Treatment Assignment ........................................................................35 
2.6.2.1. 
Selection and Timing of Doses ..........................................................................35 
2.6.2.2. 
Dose Adjustment for Renal Impairment ............................................................36 
2.6.3. 
Blinding ...................................................................................................................36 
2.6.4. 
Dosage Modification ..............................................................................................36 
2.6.5. 
Preparation/Handling/Storage/Accountability ...................................................36 
2.6.6. 
Treatment Compliance ..........................................................................................36 
2.6.7. 
Concomitant Therapy ............................................................................................36 
2.6.7.1. 
Permitted Medications and Procedures ..............................................................36 
2.6.7.2. 
Prohibited Medications and Procedures .............................................................37 
2.6.8. 
Treatment after the End of the Study ..................................................................38 
2.6.8.1. 
Continued Access ...............................................................................................38 
2.7. 
Discontinuation Criteria ................................................................................................38 
2.7.1. 
Discontinuation from Study Treatment ...............................................................38 
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I4V-MC-JAHO(5.1) 
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2.7.1.1. 
Permanent Discontinuation from Investigational Product .................................38 
2.7.1.2. 
Temporary Interruption of Investigational Product ...........................................39 
2.7.1.3. 
Discontinuation of Inadvertently Enrolled Patients ...........................................41 
2.7.2. 
Discontinuation from the Study ............................................................................41 
2.7.3. 
Lost to Follow-Up ...................................................................................................42 
2.8. 
Study Assessments and Procedures ..............................................................................42 
2.8.1. 
Efficacy Assessments ..............................................................................................42 
2.8.1.1. 
Primary Efficacy Assessments ...........................................................................42 
2.8.1.1.1. 
Severity of Alopecia Tool Score ..................................................................42 
2.8.1.2. 
Secondary Efficacy Assessments .......................................................................42 
2.8.1.2.1. 
Other Clinician-Reported Outcomes ............................................................42 
2.8.1.2.1.1. 
Eyebrow Hair Loss and Eyelash Hair Loss ............................................42 
2.8.1.2.2. 
Alopecia Areata Patient-Reported Outcomes ..............................................42 
2.8.1.2.2.1. 
Patient-Reported Outcomes for Scalp Hair 
Assessment™ .........................................................................................42 
2.8.1.2.2.2. 
Patient-Reported Outcomes for Appearance of 
Eyebrows, Appearance of Eyelashes......................................................43 
2.8.1.2.2.3. 
Patient-Reported Outcomes for Body Hair ............................................43 
2.8.1.2.2.4. 
Patient-Reported Outcomes for Change .................................................43 
2.8.1.2.2.5. 
Patient-Reported Outcomes for Satisfaction ..........................................43 
2.8.1.3. 
Health Outcomes and Quality-of-Life Measures ...............................................43 
2.8.1.3.1. 
Skindex-16 A for Alopecia Areata ...............................................................43 
2.8.1.3.2. 
Hospital Anxiety and Depression Scale .......................................................43 
2.8.1.4. 
Photography .......................................................................................................44 
2.8.1.5. 
Appropriateness of Assessments ........................................................................44 
2.8.2. 
Adverse Events .......................................................................................................45 
2.8.2.1. 
Serious Adverse Events ......................................................................................45 
2.8.2.1.1. 
Suspected Unexpected Serious Adverse Reactions .....................................46 
2.8.2.2. 
Adverse Events of Special Interest .....................................................................46 
2.8.2.3. 
Complaint Handling ...........................................................................................47 
2.8.3. 
Treatment of Overdose ..........................................................................................47 
2.8.4. 
Safety .......................................................................................................................47 
2.8.5. 
Pharmacogenomics ................................................................................................47 
2.8.5.1. 
Whole Blood Samples for Pharmacogenetic Research ......................................47 
2.8.6. 
Biomarkers .............................................................................................................48 
2.9. 
Statistical Considerations ..............................................................................................48 
2.9.1. 
Sample Size Determination ...................................................................................48 
2.9.2. 
Populations for Analyses .......................................................................................48 
2.9.3. 
Statistical Analyses .................................................................................................49 
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I4V-MC-JAHO(5.1) 
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2.9.3.1. 
General Statistical Considerations .....................................................................49 
2.9.3.1.1. 
Analysis Methods .........................................................................................49 
2.9.3.1.2. 
Missing Data Imputation ..............................................................................49 
2.9.3.1.3. 
Descriptive Population Analyses Patient Disposition ..................................49 
2.9.3.1.4. 
Concomitant Therapy ...................................................................................50 
2.9.3.1.5. 
Treatment Compliance .................................................................................50 
2.9.4. 
Efficacy Analyses ....................................................................................................50 
2.9.4.1. 
Primary Analyses ...............................................................................................50 
2.9.4.2. 
Secondary Analyses ...........................................................................................50 
2.9.4.3. 
Exploratory Analyses .........................................................................................50 
2.9.5. 
Safety Analyses .......................................................................................................50 
2.9.6. 
Other Analyses .......................................................................................................51 
3. 
References ............................................................................................................................52 
4. 
Supporting Documentation .................................................................................................53 
4.1. 
Appendix 1. Abbreviations and Definitions .................................................................53 
4.2. 
Appendix 2. Clinical Laboratory Tests ........................................................................56 
4.3. 
Appendix 3. Study Governance Considerations ..........................................................58 
4.3.1. 
Appendix 3.1. Regulatory and Ethical Considerations, 
Including the Informed Consent Process .................................................................58 
4.3.1.1. 
Appendix 3.1.1. Informed Consent ....................................................................58 
4.3.1.2. 
Appendix 3.1.2. Recruitment .............................................................................58 
4.3.1.3. 
Appendix 3.1.3. Ethical Review .........................................................................58 
4.3.1.4. 
Appendix 3.1.4. Regulatory Considerations ......................................................59 
4.3.1.5. 
Appendix 3.1.5. Investigator Information ..........................................................59 
4.3.1.6. 
Appendix 3.1.6. Protocol Signatures ..................................................................59 
4.3.1.7. 
Appendix 3.1.7. Final Report Signature .............................................................59 
4.3.2. 
Appendix 3.2. Data Quality Assurance ................................................................59 
4.3.2.1. 
Appendix 3.2.1. Data Capture System ...............................................................60 
4.3.3. 
Appendix 3.3. Study and Site Closure ..................................................................60 
4.3.3.1. 
Appendix 3.3.1. Discontinuation of Study Sites ................................................60 
4.3.3.2. 
Appendix 3.3.2. Discontinuation of the Study ...................................................61 
4.3.4. 
Appendix 3.4. Publication Policy ..........................................................................61 
4.4. 
Appendix 4. Hepatic Monitoring Tests for 
Treatment-Emergent Abnormality ...............................................................................62 
4.5. 
Appendix 5. Liver Function Testing and Hepatic Safety 
Monitoring.......................................................................................................................63 
4.6. 
Appendix 6. Provisions for Changes in Study Conduct During 
Exceptional Circumstances............................................................................................64 
 
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I4V-MC-JAHO(5.1) 
7 
1. 
Rationale for Addendum  
This addendum is a 52-week subpopulation study to better characterize the effectiveness of 
baricitinib therapy in Black patients with AA. 
AA is a clinically heterogenous, autoimmune mediated, nonscarring hair loss disorder that varies 
widely in the amount and pattern of hair loss. While AA can affect people of different races and 
sexes, recent epidemiological studies have suggested that Black or African American patients 
may have a greater risk of AA (Thompson et al. 2018; Lee et al. 2020). Furthermore, Black or 
patients of African descent also have a higher prevalence of other comorbid alopecia, including 
both scarring and nonscarring forms, such as central centrifugal cicatricial alopecia and traction 
alopecia, which creates further diagnostic challenges in this population (Olsen et al. 2011; Raffi 
et al. 2019). 
In the BRAVE clinical development program for severe AA, baricitinib therapy was 
demonstrated to be an efficacious therapy compared with placebo. While patients who were 
Black or African American also showed significantly greater response to baricitinib compared 
with placebo, the overall response rate was lower in this subgroup compared to other racial 
subgroups. Potential hypotheses regarding the lower response rate includes the diagnostic 
challenges within a large clinical trial for ascertaining primary AA in the context of other 
comorbid alopecia or potential subgroup differences related to hair follicle, including the rate of 
regrowth (Taylor et al. 2002). Therefore, this knowledge gap indicates a need to study more 
closely the diagnosis and treatment outcomes of Black or African American patients with severe 
AA. The present addendum will allow a closer examination and provide additional descriptive 
outcomes in response to therapy with 4-mg baricitinib in this subpopulation. 
The overall changes to this addendum are provided below. 
Section # and Name 
Description of 
Change 
Brief Rationale 
Section 2.1. Schema for Substudy 
Updated the study 
schema to 52 weeks 
The primary study has 
demonstrated the efficacy of 
baricitinib versus placebo at 
36 weeks. As Black patients 
were observed to have a 
slower rate of response, the 
endpoint for this study was 
extended to 52 weeks. 
Long-term efficacy and 
treatment withdrawal are 
studied in the JAHO(e) 
protocol and are not part of 
the addendum objectives. 
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I4V-MC-JAHO(5.1) 
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Section # and Name 
Description of 
Change 
Brief Rationale 
Section 2.2. Schedule of Activities 
 
Removed visits 
after 52 weeks 
 
 
 
 
Included IWRS 
visit code 
 
 
 
 
Added 
Fitzpatrick scale 
and Hair Curl 
Assessment 
 
 
 
 
Added close-up 
photography 
views of scalp at 
baseline to 
enhance 
diagnostic 
assessment 
 
Added review of 
screening 
photographs by 
external expert to 
increase 
diagnostic 
reliability 
 
 
Deleted 
assessment 
related to nails 
 
 
 
 Visits related to long-
term extension and 
substudy are not needed 
for study objectives 
 
 IWRS visits codes were 
added to reduce 
confusion with main 
protocol visits 
 
 Fitzpatrick scale and 
Hair Curl assessment 
tools added to better 
characterize study 
population 
 
 
 Study procedures were 
modified including 
close-up photographs to 
enhance diagnostic 
reliability with the 
inclusion of an 
independent reviewer 
who is an expert in 
severe AA in Black 
patients. 
 
 
 
 
 
 Measure of nail 
assessment were 
removed given the lack 
of sensitivity to change 
in the JAHO study. 
 
 
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I4V-MC-JAHO(5.1) 
9 
Section # and Name 
Description of 
Change 
Brief Rationale 
 
Included Body 
Hair Symptoms 
and Impact, 
Patient Global 
Impression of 
Change, Patient 
Global 
Impression of 
Satisfaction 
 
 
Deleted Alopecia 
Areata-
Investigator 
Global 
Assessment, EQ-
5D-5L, Short 
Form-36 Health 
Survey acute 
version 2, self-
harm 
supplement, and 
self-harm follow-
up form, and 
baricitinib 
plasma 
concentration 
(pharmacokinetic 
sample) 
 
Modified 
footnotes as per 
52-week 
subpopulation 
study 
 
 Measures for other body 
hair areas as well as 
patient satisfaction and 
perception of change 
were included to address 
treatment response in 
other body hair areas 
that were not included in 
the JAHO study. 
 
 Additional measures 
were deleted as these 
secondary objectives 
were identified as not 
relevant to the 
addendum. 
 
 
 
 
 
 
 
 
 SOA table and footnotes 
edited to reflect these 
changes. 
Section 2.3. Objectives and Endpoints 
 
Modified weeks 
to Week 36 and 
Week 52 
 
Updated the 
endpoints to 
 
The primary endpoint 
of this study was 
changed to percent 
change to characterize 
the degree of 
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I4V-MC-JAHO(5.1) 
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Section # and Name 
Description of 
Change 
Brief Rationale 
include 52 
weeks 
 
 
 
 
 
 
Added 
secondary 
objectives 
related to earlier 
time points 
 
Deleted 
secondary 
objectives 
related to long-
term extension 
and substudy 
 
Deleted 
secondary 
objectives for 
measures  
improvement observed 
within the 
subpopulation of Black 
patients and was based 
on Week 52 due to the 
longer regrowth cycle 
of Black hair. 
 
Earlier time points 
included to describe 
early regrowth patterns. 
 
 
Removed objectives 
related to design 
elements and measures 
that are not relevant to 
addendum 
Section 2.4.1. Overall Design 
 
Updated as 
Open-label 
study, 
population to be 
included Black 
participants, and 
the total number 
of participants 
enrolled in the 
study 
 
Included 3 study 
periods 
As baricitinib has been 
demonstrated to be effective, 
there is no comparison to a 
placebo arm and outcomes 
are descriptive in nature 
Section 2.4.2. Number of Participants 
Included total 
number of 
participants to be 
enrolled in this study 
Although the initial target of 
enrollment was 60 patients, 
20 patients were enrolled 
during the enrollment period.  
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I4V-MC-JAHO(5.1) 
11 
Section # and Name 
Description of 
Change 
Brief Rationale 
Section 2.4.5. Scientific Rationale for 
Study Design and Section 2.4.5. 
Justification for Dose 
Modified as per the 
substudy 
Clarification on the objective 
of this addendum 
Section 2.5.1. Inclusion Criteria 
Included Black or 
African American 
race population 
Inclusion to identify the 
patient subpopulation 
Section 2.5.2. Exclusion Criteria 
 
Included 
“central 
centrifugal 
cicatricial 
alopecia” in the 
criterion [8] 
 
Included 
“baricitinib” in 
criterion [10]b 
 
Clarification on 
potential differential 
diagnosis 
 
 
 
 
Clarification on prior 
exposure to JAK 
inhibitor 
Section 2.5.3. Lifestyle Restrictions 
Added additional 
information to clarify 
the use of extensions 
and cosmetics 
Addressed the use of hair 
and cosmetic styling relevant 
to subpopulation to ensure 
scalp assessment  
Section 2.6.1. Treatments 
Administered 
Treatment regimen 4 
mg was updated 
Open-label therapy was 
based on 4 mg to provide the 
dose necessary for patients 
who have nearly complete or 
complete scalp hair loss. 
Section 2.6.2. Method of Treatment 
Assignment and Section 2.6.8.1. 
Continued Access 
Modified as per 52-
week subpopulation 
study  
Updated as per study design 
Section 2.6.7.1. Permitted Medications 
and Procedures 
Included 
nutraceuticals 
Additional clarification on 
permitted medications 
Section 2.7.2. Discontinuation from 
Study 
Deleted that patient 
should remain in the 
study after 
discontinuation of IP 
Not needed as study is not 
for regulatory submission 
Section 2.8.1.2. Secondary Efficacy 
Assessments 
 
Included as 
Other Clinician-
reported 
 
For increased clarity 
 
 
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I4V-MC-JAHO(5.1) 
12 
Section # and Name 
Description of 
Change 
Brief Rationale 
Outcomes under 
Section 
2.8.1.2.1 and 
Alopecia Areata 
Patient-
Reported 
Outcomes under 
Section 
2.8.1.2.2 
 
Removed eye 
irritation and 
nail assessment 
 
 
Added Body 
Hair Symptoms 
and Impact 
Scale 
 
Added Patient 
Global 
Impression of 
Satisfaction 
 
Added close-up 
photographs 
views with 
normal and 
polarized light 
 
 
 
 
 
 
 
 
 
 
Nail and eye irritation 
measures were not 
sensitive to change in 
the JAHO(e) protocol. 
 
Included body hair 
assessment tool and 
patient perception of 
change and satisfaction 
with treatment related 
to secondary objectives 
of the addendum 
 
 
Added additional 
photographs views to 
increase diagnostic 
reliability and detection 
of early regrowth 
Section 2.9. Statistical considerations 
 Revised primary 
objective 
 
 
 Revised 
secondary 
objectives to 
descriptive 
within subject 
changes 
 Percent change of SALT 
score improvement was 
selected as primary 
endpoint to characterize 
the overall regrowth in 
this population. 
 Adjusted analyses as 
needed for secondary 
objectives relevant to 
open-label therapy and 
descriptive statistics 
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I4V-MC-JAHO(5.1) 
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Section # and Name 
Description of 
Change 
Brief Rationale 
Throughout the document 
Updated the 
treatment as 4-mg 
baricitinib 
Changed the word 
for “randomization” 
to “initiation” or 
“enrollment” 
Open-label study design 
without randomization 
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I4V-MC-JAHO(5.1) 
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2. 
Protocol Additions  
2.1. 
Schema for Substudy  
 
 
 
 
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I4V-MC-JAHO(5.1) 
15 
2.2. 
 Schedule of Activities  
 
Screening Period 
Treatment Period 
 
PTFU 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
ET 
801o 
Visit Code in IWRS 
501 
502 
503 
504 
505 
506 
507 
508 
509 
510 
511 
 
801 
Weeks from Initiation 
 
0 
4 
8 
12 
16 
24 
36 
40 
44 
52 
 
 
Visit Tolerance Interval (days) 
-5 to -35 
 
±4 
±4 
±4 
±4 
±7 
±7 
±4 
±4 
±7 
 
28±4 
Inclusion and Exclusion Review 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment Initiation  
 
X 
 
 
 
 
 
 
 
 
 
 
 
Clinical Assessments 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Fitzpatrick Scale 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Preexisting Conditions/Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
MPHL/FPHL History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Substance Use (Alcohol, Tobacco) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Previous and Current AA Treatments 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Chest x-ray (Posterior and Anterior View)a 
X 
 
 
 
 
 
 
 
 
 
 
 
 
TB Testb 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Read PPD if Applicable (48 to 72 hours after V1)c 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Physical Examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
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I4V-MC-JAHO(5.1) 
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Screening Period 
Treatment Period 
 
PTFU 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
ET 
801o 
Visit Code in IWRS 
501 
502 
503 
504 
505 
506 
507 
508 
509 
510 
511 
 
801 
Weeks from Initiation 
 
0 
4 
8 
12 
16 
24 
36 
40 
44 
52 
 
 
Visit Tolerance Interval (days) 
-5 to -35 
 
±4 
±4 
±4 
±4 
±7 
±7 
±4 
±4 
±7 
 
28±4 
12-Lead ECG (Single, Local) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Weight 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
BMI 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Vital Signs (BP and Pulse) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Symptom-Directed Physical Examd 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
MPHL/FPHL Assessmente 
 
 
 
 
 
 
 
X 
 
 
X 
X 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
IWRS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Photography Scalpf 
X 
X 
X 
X 
X 
 
X 
X 
 
 
X 
X 
 
Photography Eyebrows/Eyelashesf 
 
X 
X 
X 
X 
 
X 
X 
 
 
X 
X 
 
Review by Sponsor Designee 
X 
 
 
 
 
 
 
 
 
 
 
 
 
IP Dispensed 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
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CONFIDENTIAL 
I4V-MC-JAHO(5.1) 
17 
 
Screening Period 
Treatment Period 
 
PTFU 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
ET 
801o 
Visit Code in IWRS 
501 
502 
503 
504 
505 
506 
507 
508 
509 
510 
511 
 
801 
Weeks from Initiation 
 
0 
4 
8 
12 
16 
24 
36 
40 
44 
52 
 
 
Visit Tolerance Interval (days) 
-5 to -35 
 
±4 
±4 
±4 
±4 
±7 
±7 
±4 
±4 
±7 
 
28±4 
IP Returned and Compliance Assessed 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Scales/Questionnaires 
 
 
SALT 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hamilton-Norwood Scalee 
X 
 
 
 
 
 
 
X 
 
 
X 
X 
 
ClinRO Measure for Eyebrow Hair Loss™ 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ClinRO Measure for Eyelash Hair Loss™ 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PRO for Scalp Hair Assessment™ 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PRO Measure for Eyebrows™ 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PRO Measure for Eyelashes™ 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Body Hair Symptoms and Impact 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Patient Global Impression of Change 
 
 
 
X 
X 
 
X 
X 
 
 
X 
X 
 
Patient Global Impression of Satisfaction 
 
 
 
 
X 
 
X 
X 
 
 
X 
X 
 
Skindex-16 for AA 
 
X 
 
 
X 
 
X 
X 
 
 
X 
X 
X 
HADS 
 
X 
 
 
X 
 
X 
X 
 
 
X 
X 
X 
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I4V-MC-JAHO(5.1) 
18 
 
Screening Period 
Treatment Period 
 
PTFU 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
ET 
801o 
Visit Code in IWRS 
501 
502 
503 
504 
505 
506 
507 
508 
509 
510 
511 
 
801 
Weeks from Initiation 
 
0 
4 
8 
12 
16 
24 
36 
40 
44 
52 
 
 
Visit Tolerance Interval (days) 
-5 to -35 
 
±4 
±4 
±4 
±4 
±7 
±7 
±4 
±4 
±7 
 
28±4 
C-SSRSg 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hair Curl Assessmenth 
X 
 
 
 
 
 
 
 
 
 
X 
X 
 
Laboratory Assessment 
Lipids (Fasting Visit)i 
 
X 
 
 
X 
 
X 
X 
 
 
X 
X 
X 
Clinical Chemistryj 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hematology 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Serum Pregnancy Testk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
FSHl 
X 
 
 
 
 
 
 
 
 
 
 
 
 
TSH 
X 
 
 
 
 
 
 
 
 
 
 
 
 
HIV 
X 
 
 
 
 
 
 
 
 
 
 
 
 
HCV antibody testingm 
X 
 
 
 
 
 
 
 
 
 
 
 
 
HBV Testingn 
X 
 
 
 
 
 
 
 
 
 
 
 
 
HBV DNAn 
X 
 
 
 
X 
 
X 
X 
 
 
X 
X 
X 
Urinalysis 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
X 
X 
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I4V-MC-JAHO(5.1) 
19 
 
Screening Period 
Treatment Period 
 
PTFU 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
ET 
801o 
Visit Code in IWRS 
501 
502 
503 
504 
505 
506 
507 
508 
509 
510 
511 
 
801 
Weeks from Initiation 
 
0 
4 
8 
12 
16 
24 
36 
40 
44 
52 
 
 
Visit Tolerance Interval (days) 
-5 to -35 
 
±4 
±4 
±4 
±4 
±7 
±7 
±4 
±4 
±7 
 
28±4 
Urine Pregnancy Testk 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Pharmacogenetics Blood 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Serum Immunoglobulin (IgE) 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Exploratory Storage Samples (serum, plasma) 
 
X 
 
 
X 
 
X 
X 
 
 
X 
X 
X 
RNA and Biomarkers: Blood 
 
X 
 
 
X 
 
X 
X 
 
 
X 
X 
X 
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I4V-MC-JAHO(5.1) 
20 
Abbreviations: AA = alopecia areata; AGA = androgenetic alopecia; BMI = body mass index; BP = blood pressure; CKD-EPI = Chronic Kidney Disease 
Epidemiology Collaboration; ClinRO = clinician-reported outcome; C-SSRS = Columbia-Suicide Severity Rating Scale; ECG = electrocardiogram; 
eGFR = estimated glomerular filtration rate; FPHL = female pattern hair loss; FSH = follicle-stimulating hormone; HADS = Hospital Anxiety and Depression 
Scale; HBcAb = hepatitis B core antibody; HBsAb = hepatitis B surface antibody; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human 
immunodeficiency virus; IP = investigational product; IWRS = investigator web-response system; MPHL = male pattern hair loss; PPD = purified protein 
derivative; PRO = patient-reported outcome; PTFU = posttreatment follow-up; SALT = Severity of Alopecia Tool; TSH = thyroid-stimulating hormone; 
TB = tuberculosis. 
a  A posterior-anterior view chest x-ray will be obtained locally at Screening (Visit 1), unless one has been performed in the past 6 months and the x-ray and/or 
the report is available. 
b TB test(s) including PPD, QuantiFERON®-TB Gold, and T SPOT®. See exclusion criterion [28] for description of TB testing. In countries where the 
QuantiFERON-TB Gold test or T-SPOT is available, either test may be used instead of the PPD TB test. It is preferred that the QuantiFERON-TB Gold test 
be performed centrally; the T-SPOT must be performed locally. Note: Patients with a history of active or latent TB who have documented evidence of 
appropriate treatment, have no history of re-exposure since their treatment was completed, and have a screening chest x-ray with no evidence of active TB 
may be enrolled if other entry criteria are met. Such patients would not be required to undergo the protocol-specific TB testing, but must have a chest x-ray at 
screening. 
c If PPD testing was chosen to test for TB, then the patient must return and have the PPD test read 48 to 72 hours after Visit 1 (post-PPD). 
d The symptom-directed physical examination may be repeated at the investigator’s discretion any time a patient presents with physical complaints. 
e Presence of MPHL (AGA) will be assessed at screening using the Hamilton-Norwood Scales for male patients, through examination, and via patient 
interview; these will be re-evaluated at Weeks 36 and 52/ET. The presence of FPHL (AGA) will be assessed at Weeks 36 and 52/ET for female patients 
whose history of AGA is “no history” or unknown at screening. 
f 
All sites/patients will obtain photographs of the scalp at Screening and Baseline. All sites/patients will obtain photographs of the scalp at Weeks 4, 8, 12, 24, 
36, and 52, and at Early Termination. Photographs of the eyelash/eyebrows will be captured at Baseline and repeated at Weeks 4, 8, 12, 24, 36, and 52, and at 
early termination only from patients with AA involvement of those areas (ClinRO ≥1) at Baseline (Visit 2). See Section 2.8.1.4 Photography for details. 
g 
 A “Baseline/Screening” form is used at Visit 1. A “Since Last Visit” form used for all remaining visits. A suicidal ideation and behavior subscales excerpt is 
adapted for the assessment of 11 preferred ideation and behavior categories. 
h 
 Information will be collected from patients who require Spanish once the translation is available. 
i 
Fasting lipid profile: patients should not eat or drink anything except water for 8 hours prior to sample collection. If a patient attends these visits in a 
nonfasting state, this will not be considered a protocol violation. Unscheduled lipid testing can be performed at the discretion of the investigator. For ET 
visits, collect fasting lipids when possible. 
j 
Clinical chemistry will include the following value calculated from serum creatinine: eGFR (calculated using the CKD-EPI creatinine 2009 equation). 
k 
For all women of childbearing potential, a serum pregnancy test (central laboratory) will be performed at Visit 1. Urine pregnancy tests (local laboratory) will 
be performed at Visit 2 and at all subsequent study visits. If required per local regulations and/or institutional guidelines, pregnancy testing can occur at other 
times during the study treatment period. 
l 
For female patients ≥40 and <60 years of age who have had a cessation of menses for at least 12 months, an FSH test will be performed to confirm 
nonchildbearing potential (FSH ≥40 mIU/mL). 
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I4V-MC-JAHO(5.1) 
21 
m For patients who are positive for HCV antibody, a follow-up test for HCV RNA will be performed automatically. Patients who are positive for HCV antibody 
and negative for HCV RNA may be enrolled. 
n 
Patients who are positive for HBcAb and negative for HBV DNA may be enrolled. Any enrolled patient who is HBcAb positive, regardless of HBsAb status 
or level, must undergo HBV DNA testing per the schedule 
o Visit 801 (posttreatment follow-up period) occurs approximately 28 days after the last dose of IP. Patients who have completed Week 52 and will continue on 
marketed product beyond Week 52 do not need to complete V801. 
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I4V-MC-JAHO(5.1) 
22 
2.3. 
Objectives and Endpoints  
Objectives 
Endpoints 
Primary Objective 
To describe the effectiveness of 4-mg baricitinib in 
achieving scalp hair regrowth in patients with severe 
AA 
Percent change from baseline in SALT score at Week 
52  
Key Secondary Objectives (Treatment Period 2) 
To describe the effectiveness of 4-mg baricitinib in 
achieving regrowth as assessed by physician assessed 
signs and symptoms of AA 
 
 
Proportion of patients achieving SALT ≤20 
from baseline through Week 52 
 
Proportion of patients achieving a SALT50, 
SALT75, and SALT90 from baseline through 
Week 52 
 
Percent change from baseline in SALT score 
at Week 52 
 
Mean change from baseline in SALT through 
Week 52 
 
Proportion of patients achieving ClinRO 
Measure for EB Hair Loss 0 or 1 with ≥2-
point improvement from Baseline through 
Week 52 (among patients with ClinRO 
Measure for EB Hair Loss ≥2 at Baseline) 
 
Proportion of patients achieving ClinRO 
Measure for EL Hair Loss 0 or 1 with ≥2-
point improvement from Baseline through 
Week 52 (among patients with ClinRO 
Measure for EL Hair Loss ≥2 at Baseline) 
To describe the effectiveness of 4-mg baricitinib 
during open-label treatment as assessed by PRO 
measures 
 
Proportion of patients with PRO for Scalp 
Hair Assessment score of 0 or 1 with ≥2-point 
improvement from Baseline through Week 52 
among patients with a score ≥3 at Baseline 
 
Proportion of patients with PRO for Eyebrow 
Hair Loss score of 0 or 1 with ≥2-point 
improvement from baseline through Week 52 
among patients with a score of ≥2 at Baseline 
 
Proportion of patients with PRO for Eyelash 
Hair Loss score of 0 or 1 with ≥2-point 
improvement from baseline through Week 52 
among patients with a score of ≥2 at baseline 
 
Proportion of patients with ≥1-point 
improvement in body hair areas (nose, beard, 
genital) as measured by the Body Hair 
Symptoms and Impact scale at Week 52 
 
Mean change in bothersome score on each 
area of hair loss (nose, beard, genital) as 
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I4V-MC-JAHO(5.1) 
23 
Objectives 
Endpoints 
measured by the Body Hair Symptoms and 
Impact scale at Week 52 
 
Proportion of patients who rate their AA as 
much improved or very much improved on the 
Patient Global Impression of Change scale at 
Week 52 
To describe the effectiveness of 4-mg baricitinib 
during open-label treatment on emotional symptoms 
and quality of life 
 
Mean change in HADS anxiety and 
depression scale scores from baseline at Week 
36 and Week 52 
 
Mean change in Skindex-16 AA emotions, 
functioning, and symptom scores from 
baseline at Week 36 and Week 52 
To describe treatment satisfaction after therapy with 4-
mg baricitinib for severe AA 
 
Distribution of scores on the Patient Global 
Impression of Satisfaction at Week 52 
Exploratory Objectives may include evaluating the response to baricitinib treatment on clinical measures and 
patient-reported outcomes. These endpoints may include dichotomous endpoints or change from baseline for the 
following measures: SALT, ClinROs for Eyebrows, and/or Eyelash Hair Loss™, PROs for Scalp Hair 
Assessment, Eyebrows, and Eyelashes™, Body Hair Symptoms and Impact, Skindex-16 AA, PGI-Change, 
HADS, and PGI - Satisfaction, and baseline Hair Curl Assessment. 
Abbreviations: AA = alopecia areata; ClinRO = clinician-reported outcome; EB = eyebrow; EL = eyelash; 
HADS = Hospital Anxiety and Depression Scale; PGI = Patient Global Impression; PRO = patient-reported 
outcome; SALT = Severity of Alopecia Tool; Skindex-16 AA = Skindex-16 for Alopecia Areata. 
2.4. 
Study Design  
2.4.1. 
Overall Design  
Study I4V-MC-JAHO (JAHO) addendum is an open-label therapy in a subpopulation of Black 
patients with severe AA. Approximately 20 adult patients will be enrolled into Study JAHO 
addendum. 
Patients must self-identify as Black or African American for race. Patients must have a current 
AA episode of more than 6 months’ duration prior to screening (Visit 1), with at least 50% scalp 
involvement at screening AND Baseline (Visits 1 and 2) with no spontaneous improvement (no 
more than a 10-point reduction in SALT) over the past 6 months. Patients with a current episode 
of severe or very severe AA of more than 8 years will not be eligible for inclusion in the study 
unless episodes of regrowth, spontaneous or under treatment, have been observed on the affected 
areas of the scalp over the past 8 years. Photographs at screening must be submitted to Sponsor’s 
designee for the confirmation of severe AA prior to enrollment. 
All procedures to be conducted during the study, including the timing of all procedures, are 
indicated in the SOA (Section 2.2). Section 9.4.4 of the JAHO(e) protocol describes the 
collection of laboratory samples; Appendix 2, Appendix 4, and Appendix 5 list the specific 
laboratory tests that will be performed for this study. Study governance considerations are 
described in detail in Appendix 3. 
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I4V-MC-JAHO(5.1) 
24 
2.4.1.1. 
Period 1: Screening (-35 to -5 days)  
The duration of the Screening Period is between 5 and 35 days prior to Visit 2 (Week 0). 
Therapies that must be washed out or discontinued before initiation of therapy (Visit 2) are listed 
in exclusion criterion [10]. Patients who receive a PPD skin test at Visit 1 will return 48 to 72 
hours later to read the skin test. Patients who are eligible for herpes zoster vaccine (per local 
guidelines) and have not previously received the vaccine will be encouraged to do so prior to 
initiation. Vaccination with the live herpes zoster vaccination (single injection) must occur at 
least 28 days (4 weeks) prior to enrollment. Vaccination with the nonlive herpes zoster vaccine 
requires 2 injections administered at least 8 weeks apart. It is recommended that patients who 
have initiated vaccination with the non-live herpes zoster vaccine receive the second dose at least 
4 weeks prior to enrollment. For both vaccines, completion of the vaccination may require 
rescreening the patients to comply with the maximum allowed duration of the screening period. 
In addition, investigators should review the vaccination status of their patients and follow the 
local guidelines for vaccination of those ≥18 years of age with nonlive vaccines intended to 
prevent infectious disease prior to entering patients into the study. 
At Screening (Visit 1), photographs of the scalp will be obtained from all patients. Views will 
include the right lateral, frontal, left lateral, forward tilt, and posterior. Up to 4 additional close-
up views will be taken with and without cross-polarization lens of the left and right temporal 
area, the crown, and a representative patch selected by the physician, when applicable. Medical 
history and photographic data obtained at screening will be sent to the Sponsor’s designee who 
will confirm the diagnosis of AA prior to initiation of therapy at Visit 2. Patients who meet all of 
the inclusion criteria (Section 2.5.1) and none of the exclusion criteria (Section 2.5.2) will 
continue to Visit 2. 
2.4.1.2. 
Period 2: Open-Label Treatment (Weeks 0-52)  
At Visit 2 (Week 0, Baseline), study eligibility for each patient will be reviewed on the basis of 
all inclusion (Section 2.5.1) and exclusion (Section 2.5.2) criteria and laboratory test results. 
Patients who meet all eligibility criteria will proceed to initiation of therapy and begin the 52 
weeks open-label treatment (Study Period 2). 
At Visit 2, after laboratory samples are collected and all assessments are completed, patients will 
take the first dose of IP in the clinic. 
During Study Period 2, procedures and medications will be prohibited as listed in Section 2.6.7.2 
At Baseline (Visit 2), photographs of the scalp and eyebrows/eyelashes will be obtained from all 
patients. Additional close-up views of the left and right temporal area, the crown, and the same 
representative patch selected at screening by the physician will be taken. Close-up photographs 
will be taken with and without a cross-polarization lens. After baseline, photographs of the scalp 
and close-up photographs will be repeated at Week 4, 8, 12, 24, 36, 44, 52 visits and in case of 
ET visit. Photographs of the eyebrows/eyelashes will be captured at these visits only from 
patients who have AA involvement (ClinRO ≥1) of those areas at Baseline, as assessed by 
investigator (see SOA [Section 2.2] and Section 2.8.1.4). Missed photographs after screening 
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I4V-MC-JAHO(5.1) 
25 
will not be considered a protocol violation. Detailed requirements for photography are located in 
the Photography Manual. 
The primary efficacy endpoint will be at Week 52 (Visit 11). 
2.4.1.3. 
Period 3: Posttreatment Follow-Up  
Patients who complete the study through Visit 11 (Week 52) will have a posttreatment follow-up 
visit (Visit 801) approximately 28 days after the last dose of IP. Patients who have completed 
Week 52 and who will continue on marketed product beyond Week 52 do not need to complete 
Period 3 (Visit 801). 
Patients who have received at least 1 dose of IP and discontinue early from the study must have 
an ET and return for the posttreatment safety follow-up visit (Visit 801) approximately 28 days 
after the last dose of IP. 
Patients who have discontinued IP product but remain in the study for more than 28 days without 
IP will have an ET if they choose to discontinue early. However, a separate follow-up visit 
(V801) is not required. 
2.4.2. 
Number of Participants  
Twenty patients were enrolled into the addendum. 
2.4.3. 
End of Study Definition  
End of study is the date of the last visit or last scheduled procedure shown in the SOA (Section 
2.2) for the last patient. 
2.4.4. 
Scientific Rationale for Study Design  
Baricitinib has been evaluated in the JAHO and JAIR studies and shown to be efficacious in the 
treatment of severe AA. Therefore, the subpopulation addendum does not require a comparator 
arm. 
2.4.5. 
Justification for Dose  
Based on the JAHO study primary outcomes, 4-mg baricitinib resulted in a greater proportion of 
patients achieving a SALT≤20 compared with 2-mg baricitinib. Therefore, 4-mg baricitinib dose 
was selected as the treatment for this addendum. 
2.5. 
Study Population  
Prospective approval of protocol deviations to recruitment and enrollment criteria (also known as 
protocol waiver or exemption) is not permitted. 
Study investigator(s) will review patient history and screening test results at Visit 1 and Visit 2 to 
determine if the patient meets all inclusion criteria and none of the exclusion criteria to qualify 
for initiation in the study. All screening activities must be completed and reviewed before the 
patient is enrolled. Photographs taken at Screening must be submitted to the Sponsor or designee 
for the verification of SALT score ≥50 and hair loss due to AA. Subjects must not be enrolled 
until verification has been confirmed. 
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I4V-MC-JAHO(5.1) 
26 
2.5.1. 
Inclusion Criteria  
Patients are eligible to be included in the study only if they meet all of the following criteria at 
screening: 
Informed Consent 
[1] Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the 
time of informed consent. 
Note: Use local requirements to provide consent if the age of adulthood is defined as 
>18 years. Different upper age limits have been included for male and female patients 
based on difference in the prevalence of concomitant androgenetic alopecia. 
[2] Self-identify as Black or African American race. 
[3] Are able to read, understand, and give documented (electronic or paper signature) 
informed consent. 
Type of Patient and Disease Characteristics 
[4] Have severe or very severe AA, as determined by all of the following: 
a. Current AA episode of more than 6 months’ duration and hair loss encompassing 
≥50% of the scalp as measured by SALT at Visit 1 AND Visit 2. 
b. No spontaneous improvement (that is, no more than 10-point spontaneous 
reduction in SALT) over the past 6 months. 
c. Current episode of severe or very severe AA of less than 8 years. 
Note: patients who have severe or very severe AA for ≥8 years may be enrolled if 
episodes of regrowth, spontaneous or under treatment, have been observed on the 
affected areas of the scalp over the past 8 years. 
[5] Agree not to use any AA treatments during the study, including, but not limited to 
a. systemic therapies (for example, methotrexate, cyclosporine, corticosteroids, JAK 
inhibitors, apremilast, dimethyl fumarate derivatives, hydroxychloroquine, 
mycophenolate-mofetil, IFNγ, azathioprine) and biologics (for example, 
monoclonal antibodies) 
b. intralesional corticosteroid injections 
c. topical therapies, including irritants and immunotherapies (for example, 
diphenylcyclopropenone) 
d. phototherapy, including lasers 
e. platelet-rich plasma injection 
f. HMG-CoA reductase inhibitors or “Statins” (for example, simvastatin, 
simvastatin + ezetimibe) for treatment of AA, and 
g. Cryotherapy. 
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I4V-MC-JAHO(5.1) 
27 
Note: Treatment with bimatoprost ophthalmic solution for eyelashes may be continued if the 
patient has been on a stable dose for 8 weeks prior to enrollment. Treatment with finasteride (or 
other 5 alpha reductase inhibitors) or oral or topical minoxidil may be continued if the patient has 
been on a stable dose for 12 months and is anticipated to continue on a stable dose up until Week 
36. 
[6] Are male or nonpregnant, nonbreastfeeding female patients 
a. Male patients will either remain abstinent (if this is their preferred and usual 
lifestyle) or agree to use 2 forms of birth control (1 must be highly effective, see 
below) while engaging in sexual intercourse with female partners of childbearing 
potential and agree to not father a child while enrolled in the study and for at least 
4 weeks after the last dose of IP. Men who are in exclusively same-sex 
relationships (when it is their preferred and usual lifestyle) are not required to use 
contraception. 
b. Female patients of child-bearing potential who are abstinent (if this is complete 
abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as 
part of their preferred and usual lifestyle) must agree to either remain abstinent or 
stay in a same-sex relationship without sexual relationships with males. Periodic 
abstinence (for example, calendar, ovulation, symptothermal, postovulation 
methods), declaration of abstinence just for the duration of a trial, and vaginal 
withdrawal are not acceptable methods of contraception. 
Otherwise, female patients of childbearing potential must agree to use 2 forms of 
birth control, when engaging in sexual intercourse with male partners while 
enrolled in the study and for at least 4 weeks after the last dose of IP. 
The following birth control methods are considered acceptable (the patient should 
choose 2 to be used with their male partners, and 1 must be highly effective): 
 Highly effective birth control methods: oral, injectable, or implanted hormonal 
contraceptives (combined estrogen/progesterone or progesterone only, 
associated with inhibition of ovulation); intrauterine device or intrauterine 
system (for example, progestin-releasing coil); or vasectomized male (with 
appropriate postvasectomy documentation of the absence of sperm in the 
ejaculate). 
 Effective birth control methods: condom with a spermicidal foam, gel, film, 
cream, or suppository; occlusive cap (diaphragm or cervical/vault caps) with a 
spermicidal foam, gel, film, cream, or suppository; or oral hormonal 
contraceptives that do not inhibit ovulation. 
Note: When local guidelines concerning highly effective or effective methods of 
birth control differ from the above, the local guidelines must be followed. 
c. Females of nonchildbearing potential are not required to use birth control. They 
are defined as: 
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I4V-MC-JAHO(5.1) 
28 
 women ≥60 years of age or women who are congenitally sterile, or 
 women ≥40 and <60 years of age who have had a cessation of menses for 
≥12 months and a follicle-stimulating hormone test confirming nonchildbearing 
potential (≥40 mIU/mL or ≥40 IU/L), or women who are surgically sterile (that 
is, have had a hysterectomy or bilateral oophorectomy or tubal ligation). 
2.5.2. 
Exclusion Criteria  
Patients will be excluded from study enrollment if they meet any of the following criteria: 
Medical Conditions Related to AA 
[7] primarily “diffuse” type of AA (characterized by diffuse hair shedding) 
[8] are currently experiencing other forms of alopecia, including but not limited to: 
androgenetic alopecia (male pattern Grade IV or greater using Hamilton-Norwood 
classification, or female pattern), central centrifugal cicatricial alopecia traction, 
trichotillomania, telogen effluvium, chemotherapy-induced hair loss or any other 
concomitant conditions (for example, tinea capitis, psoriasis, lupus erythematosus, or 
secondary syphilis) that would interfere with evaluations of the effect of study 
medication on AA. 
[9] Patients who, in the opinion of the investigator, are currently experiencing or have a 
history of unstable concomitant disease that requires frequent hospitalizations and/or 
frequent use of systemic immunosuppressants that may interfere with participation in 
the study. 
[10] Have been treated with the following therapies: 
a. 
Corticosteroids 
i. Topical corticosteroids applied to the scalp or eyebrows within 1 week prior to 
enrollment. 
ii. Systemic corticosteroids within 8 weeks prior to enrollment. 
iii. Intralesional corticosteroid injections for treatment of AA within 8 weeks 
prior to enrollment. 
iv. Have had an intraarticular corticosteroid injection within 8 weeks prior to 
enrollment. 
Note: Intranasal, ophthalmic, or inhaled steroid use is allowed during screening and 
throughout the study. 
b. 
JAK inhibitors 
i. Topical JAK inhibitor applied to the scalp (for example, tofacitinib, 
ruxolitinib) within 4 weeks prior to enrollment. 
ii. Oral JAK inhibitor within 8 weeks prior to enrollment. 
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iii. Previously treated with an oral JAK inhibitor (for example, baricitinib, 
tofacitinib, ruxolitinib) and had an inadequate response (for example, absence 
of significant terminal hair growth after at least 12 weeks of treatment). 
c. 
Other topical therapies (for example, anthralin, diphenylcyclopropenone, or other 
topical immunotherapies) for the treatment of AA within 4 weeks prior to 
enrollment. 
d. 
Monoclonal antibody (for example, ustekinumab, secukinumab, adalimumab, 
dupilumab) less than 5 half-lives prior to enrollment. 
e. 
Probenecid at the time of the enrollment (Visit 2) that cannot be discontinued for 
the duration of the study (probenecid may increase baricitinib exposures). 
f. 
Platelet-rich plasma within 8 weeks prior to enrollment. 
g. 
Phototherapy (Ultra Violet therapy and laser on scalp lesions) within 4 weeks 
prior to enrollment. 
h. 
HMG-CoA reductase inhibitors or “statins” (for example, simvastatin, simvastatin 
+ ezetimibe) for treatment of AA within 4 weeks prior to enrollment. 
i. Cryotherapy for treatment of AA within 4 weeks prior to enrollment. 
j. Finasteride (or other 5 alpha reductase inhibitors) or minoxidil (topical or oral) 
within 8 weeks prior to enrollment, unless the subject has been on a stable dose for 
at least 12 months AND is anticipated to continue on a stable dose up until Week 
36 
k. Immunosuppressants (for example, methotrexate, cyclosporine, dimethyl fumarate 
derivatives, mycophenolate-mofetil, IFNγ, azathioprine) within 8 weeks of 
enrollment. 
l. Apremilast or hydroxychloroquine within 4 weeks prior to enrollment. 
Medical Conditions in General 
[11] Are largely or wholly incapacitated, permitting little or no self-care, such as being 
bedridden. 
[12] Have uncontrolled arterial hypertension characterized by a repeated systolic blood 
pressure >160 mm Hg or diastolic blood pressure >100 mm Hg in a seated position. 
[13] Have had any major surgery within 8 weeks prior to screening or will require major 
surgery during the study that, in the opinion of the investigator (in consultation with 
Lilly or its designee), would pose an unacceptable risk to the patient if participating in 
the trial. 
[14] Are immunocompromised and, in the opinion of the investigator, at an unacceptable 
risk for participating in the study. 
[15] Have experienced any of the following within 12 weeks of screening: myocardial 
infarction, unstable ischemic heart disease, stroke, or New York Heart Association 
Stage III/IV heart failure. 
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[16] Have a history of VTE, or are considered at high risk for VTE, as deemed by the 
investigator, or have 2 or more of the following risk factors for VTE: 
a) Aged >65 years 
b) body mass index >35 kg/m2 
c) Oral contraceptive use and current smoker status 
[17] Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, 
endocrine, hematological, neurological, or neuropsychiatric disorders or any other 
serious and/or unstable illness that, in the opinion of the investigator, could constitute 
an unacceptable risk when taking IP or interfere with the interpretation of data. 
[18] Have a history of lymphoproliferative disease; or have signs or symptoms suggestive 
of possible lymphoproliferative disease, including lymphadenopathy or 
splenomegaly; or have active primary or recurrent malignant disease; or have been in 
remission from clinically significant malignancy for <5 years. 
a. Patients with cervical carcinoma in situ that has been successfully treated with no 
evidence of recurrence or metastatic disease for at least 3 years may participate in 
the study. 
b. Patients with basal cell or squamous cell skin cancers that have been successfully 
treated with no evidence of recurrence for at least 3 years may participate in the 
study. 
[19] Have a current or recent and/or serious viral, bacterial, fungal, or parasitic infection, 
including but not limited to the following: 
a. Symptomatic herpes zoster infection within 12 weeks prior to screening. 
b. A history of disseminated/complicated herpes zoster (for example, 
multidermatomal involvement, ophthalmic zoster, central nervous system 
involvement, or postherpetic neuralgia). 
c. Symptomatic herpes simplex at the time of enrollment. 
d. Active or chronic viral infection from HBV, HCV, or HIV. 
e. Household contact with a person with active TB and did not receive appropriate 
and documented prophylaxis for TB. 
f. Evidence of active TB or have previously had evidence of active TB and did not 
receive appropriate and documented treatment. 
g. Clinically serious infection, or received intravenous antibiotics for an infection, 
within 4 weeks prior to enrollment. 
h. Any other active or recent infection within 4 weeks of enrollment that, in the 
opinion of the investigator, would pose an unacceptable risk to the patient if 
participating in the study. 
Note: A recent viral upper respiratory tract infection or uncomplicated urinary tract 
infection should not be considered clinically serious. 
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[20] A history of eczema herpeticum within 12 months prior to screening. 
[21] A history of 2 or more episodes of eczema herpeticum in the past. 
[22] Have any serious concomitant illness that is anticipated to require the use of systemic 
corticosteroids or otherwise interfere with study participation or require active 
frequent monitoring (for example, atopic dermatitis, unstable chronic asthma). 
[23] Have been exposed to a live vaccine within 12 weeks prior to enrollment or are 
expected to need/receive a live vaccine during the course of the study (with the 
exception of herpes zoster vaccination). 
Note: Patients eligible for herpes zoster vaccine, who have not received it prior to 
screening will be encouraged (per local guidelines) to do so prior to enrollment; 
vaccination with the live herpes zoster vaccine can occur during the screening period 
but must take place >4 weeks prior to enrollment and start of IP. Vaccination with the 
nonlive herpes zoster vaccine requires at least 2 injections administered 8 weeks 
apart. It is recommended that patients who have initiated vaccination with the nonlive 
herpes zoster vaccine receive the second dose at least 4 weeks prior to enrollment. 
For both vaccines, completion of the vaccination may require rescreening the patients 
to comply with the maximum allowed duration of the screening period. Patients will 
be excluded if they were exposed to herpes zoster vaccination within 4 weeks of 
planned enrollment. 
[24] Have a history of chronic alcohol abuse, intravenous drug abuse, or other illicit drug 
abuse within the 2 years prior to screening. 
[25] Presence of significant uncontrolled neuropsychiatric disorder, are clinically judged 
by the investigator to be at risk for suicide, or have a “yes” answer to any of the 
following: 
a. Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific 
Plan) on the “Suicidal Ideation” portion of the C-SSRS; or 
b. Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the 
“Suicidal Ideation” portion of the C-SSRS; or 
c. Any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted 
attempt, preparatory act or behavior) on the “Suicidal Behavior” portion of the 
C-SSRS; 
and the ideation or behavior occurred within 2 months of Visit 1. 
Note: A patient does not necessarily have to be excluded if they have self-injurious 
behavior that would be classified as nonsuicidal self-injurious behavior. If this 
situation arises, the patient should be referred to a psychiatrist or appropriately trained 
professional, as indicated. 
[26] Have donated more than a single unit of blood within 4 weeks prior to screening or 
intend to donate blood during the course of the study. 
Diagnostic Assessments 
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[27] Have screening electrocardiogram abnormalities that, in the opinion of the 
investigator, are clinically significant and indicate an unacceptable risk for the 
patient’s participation in the study. 
[28] Have evidence of active TB or latent TB 
a. Have evidence of active TB, defined in this study as the following: 
i. 
Documented by a positive PPD test (≥5 mm of induration between 
approximately 48 and 72 hours after application, regardless of vaccination 
history), medical history, clinical features, and abnormal chest x-ray at 
screening. 
ii. 
The QuantiFERON®-TB Gold test or T SPOT.®TB test (as available and if 
compliant with local TB guidelines) may be used instead of the PPD test. 
Patients are excluded from the study if the test is not negative and there is 
clinical evidence of active TB. 
Exception: Patients with a history of active TB who have documented evidence of 
appropriate treatment, have no history of re-exposure since their treatment was 
completed, and have a screening chest x-ray with no evidence of active TB may be 
enrolled if other entry criteria are met. Such patients would not be required to 
undergo the protocol specific TB testing for PPD, QuantiFERON-TB Gold test, or 
T SPOT.TB test but must have a chest x-ray at screening. 
b. Have evidence of untreated/inadequately or inappropriately treated latent TB, 
defined in this study as the following: 
i. 
Documented to have a positive PPD test (≥5 mm of induration between 
approximately 48 and 72 hours after application, regardless of vaccination 
history), no clinical features consistent with active TB, and a chest x-ray with 
no evidence of active TB at screening; or 
ii. 
PPD test is positive and the patient has no medical history or chest x-ray 
findings consistent with active TB, the patient may have a QuantiFERON-TB 
Gold test or T SPOT.TB test (as available and if compliant with local TB 
guidelines). If the test results are not negative, the patient will be considered 
to have latent TB (for purposes of this study); or 
iii. 
QuantiFERON-TB Gold test or T SPOT.TB test (as available and if compliant 
with local TB guidelines) may be used instead of the PPD test. If the test 
results are positive, the patient will be considered to have latent TB. If the test 
is indeterminate, the test may be repeated once within approximately 2 weeks 
of the initial value. If the repeat test results are again not negative, the patient 
will be considered to have latent TB (for purposes of this study). 
Exception: Patients who have evidence of latent TB may be enrolled if they complete 
at least 4 weeks of appropriate treatment prior to enrollment and agree to complete 
the remainder of treatment while in the trial. 
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Exception: Patients with a history of latent TB who have documented evidence of 
appropriate treatment, have no history of re-exposure since their treatment was 
completed, and have a screening chest x-ray with no evidence of active TB may be 
enrolled if other entry criteria are met. Such patients would not be required to 
undergo the protocol-specific TB testing for PPD, QuantiFERON-TB Gold test, or T 
SPOT.TB test but must have a chest x-ray at screening. 
[29] Have a positive test for HBV infection defined as: 
a. 
Positive for hepatitis B surface antigen, or 
b. 
Positive for HBcAb and positive HBV DNA. 
Note: Patients who are HBcAb-positive and HBV DNA-negative may be enrolled 
in the study. Patients who meet these criteria at screening will be identified by the 
central laboratory and will need to be monitored during the study. 
[30] Have HCV infection (positive for anti-hepatitis C antibody with confirmed presence 
of HCV RNA 
Note: Patients who have documented anti HCV treatment for a past HCV 
infection AND are HCV RNA negative may be enrolled in the study. 
[31] Have evidence of HIV infection and/or positive HIV antibodies. 
[32] Have screening laboratory test values, including TSH, outside the reference range for 
the population or investigative site that, in the opinion of the investigator, pose an 
unacceptable risk for the patient’s participation in the study. 
Note: Patients who are receiving thyroxine as replacement therapy may 
participate in the study, provided stable therapy has been administered for 
≥12 weeks and TSH is within the laboratory’s reference range. Patients who are 
receiving stable thyroxine replacement therapy who have TSH marginally outside 
the laboratory’s normal reference range may participate if the treating physician 
has documented that the thyroxine replacement therapy is adequate for the patient. 
[33] Have any of the following specific abnormalities on screening laboratory tests: 
a. 
AST or ALT ≥2 × ULN 
b. 
ALP ≥2 × ULN 
c. 
TBL ≥1.5 × ULN 
d. 
Hemoglobin <10.0 g/dL (100.0 g/L) 
e. 
Total white blood cell count <2500 cells/µL (<2.50 × 103/µL or <2.50 GI/L) 
f. 
Neutropenia (absolute neutrophil count <1200 cells/µL) (<1.20 × 103/µL or 
<1.20 GI/L) 
g. 
Lymphopenia (lymphocyte count <750 cells/µL) (<0.75 × 103/µL or 
<0.75 GI/L) 
h. 
Thrombocytopenia (platelets <100,000/µL) (<100 × 103/µL or <100 GI/L) 
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i. 
eGFR <40 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology 
Collaboration equation creatinine 2009 equation). 
Note: For cases with any of the aforementioned laboratory abnormalities 
(exclusion criteria [32] and [33]), the tests may be repeated during screening, and 
values resulting from repeat testing may be accepted for enrollment eligibility if 
they meet the eligibility criterion. 
Other Exclusion Criteria 
[34] Are unable or unwilling to make themselves available for the duration of the study 
and/or are unwilling to follow study restrictions/procedures. 
[35] Are currently enrolled in any other clinical study involving an IP or any other type of 
medical research judged not to be scientifically or medically compatible with this 
study. 
[36] Have participated within the last 30 days in a clinical study involving an IP. If the 
previous IP has a long half-life (2 weeks or longer), at least 3 months or 5 half-lives 
(whichever is longer) should have passed. 
[37] Have previously been randomized in this study or any other study investigating 
baricitinib. 
[38] Are investigator site personnel directly affiliated with this study and/or their 
immediate families. Immediate family is defined as a spouse, parent, child, or sibling, 
whether biological or legally adopted. 
[39] Are Lilly or Incyte employees or their designee. 
2.5.3. 
Lifestyle Restrictions  
Study participants should be instructed not to donate blood or blood products during the study. 
It is highly recommended that patients remain consistent with hairstyle and hair coloring during 
the study to facilitate scalp hair assessments. Patients who prefer to shave their scalp must refrain 
from shaving the scalp within 2 weeks prior to a study visit. For patients who prefer to wear a 
wig, it is recommended that the wig should not be taped at more than 2 places on the periphery 
of the scalp to avoid pulling the hair. Patients with hair extensions are allowed to be enrolled in 
the trial as long as the entire scalp (and regrowth when applicable) can be assessed at every visit. 
Hair styling gel or other hair products must not be used on the day of scheduled visits. 
Patients with eyebrows and/or eyelashes extensions, and/or tattoos are allowed to be enrolled in 
the trial as long as the degree of eyebrows and eyelashes involvement (and regrowth when 
applicable) can be assessed at every visit. 
2.5.4. 
Screen Failures  
Patients who are entered into the study but do not meet the enrollment criteria for participation in 
this study (screen failure) may be rescreened a maximum of 2 times. The interval between screen 
failure and rescreenings should be at least 4 weeks. At the time of rescreening, the individual 
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must sign a new ICF, repeat all necessary screening procedures, and will be assigned a new 
identification number. 
If a patient undergoes rescreening, scalp photographs and radiographic images acquired as part 
of initial screening and within 6 months of enrollment may be used. 
2.6. 
Treatments  
2.6.1. 
Treatments Administered  
Patients will receive 4-mg baricitinib dispensed as study drug. Table JAHO.1 shows the 
treatment regimen and the IP supplied. The investigator or his/her designee is responsible for the 
following: 
 explaining the correct use of the investigational agent(s) to the patient 
 verifying that instructions are followed properly 
 maintaining accurate records of IP dispensing and collection, and 
 at the end of the study, returning all unused medication to Lilly or its designee, 
unless the Sponsor and sites have agreed all unused medication is to be destroyed 
by the site, as allowed by local law. 
Table JAHO.1. 
Treatment Regimen 
Treatment Regimen 
Investigational Product Supplied 
Dose 
4-mg Baricitinib QDa 
4-mg Baricitinib tablets 
1 tablet per day 
Abbreviation: QD = once daily; eGFR = estimated glomerular filtration rate. 
aThe baricitinib dose for patients who have renal impairment (defined as eGFR <60 mL/min/1.73 m2) will be 2-mg 
QD. 
2.6.1.1. 
Packaging and Labelling  
The sponsor (or its designee) will provide the following IPs: tablets containing 4-mg of 
baricitinib. Storage and handling instructions are provided in the IP packaging. 
2.6.2. 
Method of Treatment Assignment  
The interactive web-response system will be used to assign bottles, each containing 4-mg 
baricitinib IP tablets (2-mg IP tablets for patients with eGFR <60 mL/min/1.73 m2), to each 
patient, starting at Visit 2 (Week 0), and at each visit up to and including Visit 10 (Week 44). 
Site personnel will confirm that they have located the correct bottles by entering a confirmation 
number found on the bottle into the interactive web-response system. 
2.6.2.1. 
Selection and Timing of Doses  
The IP should be taken QD without regard to food and, if possible, at approximately the same 
time every day, usually at the start of the patient’s day, to aid patient compliance. All patients 
will take 1 tablet QD. 
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2.6.2.2. 
Dose Adjustment for Renal Impairment  
Based on pharmacokinetic simulations of baricitinib exposures for the mild and moderate 
categories of renal function (stratified as eGFR 60 to <90 mL/min/1.73 m2 and eGFR 30 to 
<60 mL/min/1.73 m2, respectively), dose adjustment is not required for patients with eGFR 
≥60 mL/min/1.73 m2. Patients with eGFR <60 mL/min/1.73 m2 will receive a dose of 2-mg QD, 
which will ensure that exposures do not exceed those of the 4 mg QD dose in patients with eGFR 
≥60 mL/min/1.73 m2. 
2.6.3. 
Blinding  
Not applicable 
2.6.4. 
Dosage Modification  
No other dose adjustments will be made other than for renal impairment as described in Section 
2.6.2.2 
2.6.5. 
Preparation/Handling/Storage/Accountability  
All IP (used and partially used) will be returned to the Sponsor or destroyed at site level with the 
Sponsor’s written approval. In some cases, sites may destroy the material if, during the 
investigative site selection, the evaluator has verified and documented that the site has 
appropriate facilities and written procedures to dispose of clinical trial materials. 
Follow storage and handling instructions on the IP packaging. 
2.6.6. 
Treatment Compliance  
Patient compliance with study medication will be assessed at each visit during the treatment 
period (Visit 3 through Visit 11) by counting returned tablets. A patient will be considered 
significantly noncompliant if he/she misses more than 20% of the prescribed doses of IP during 
the study unless the patient’s IP is withheld by the investigator for safety reasons. Similarly, a 
patient will be considered significantly noncompliant if he/she is judged by the investigator to 
have intentionally or repeatedly taken 20% more than the prescribed amount of medication 
during the study. 
2.6.7. 
Concomitant Therapy  
All concomitant medication, whether prescription or over-the-counter, used at Baseline and/or 
during the course of the study, must be recorded on the Concomitant Medication eCRF. Patients 
will be instructed to consult the investigator or other appropriate study personnel at the site 
before taking any new medications or supplements during the study. For AA therapies permitted, 
see Section 2.6.7.1. 
2.6.7.1. 
Permitted Medications and Procedures  
The following medications are permitted during the study: 
 Topical corticosteroids except on the scalp, eyebrows, and eyelids. 
 Topical calcineurin inhibitors except on the scalp, eyebrows and eyelids. 
 Intranasal, ophthalmic, or inhaled steroid use. 
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 A maximum of 2 intra-articular or soft tissue (bursa, tendon, and/or ligament) 
corticosteroid injections are allowed. 
 Nonlive vaccinations such as seasonal vaccination, nonlive herpes zoster (for subjects 
who become eligible during the trial), and/or all emergency vaccinations, such as rabies 
or tetanus vaccinations. 
 Bimatoprost ophthalmic solution (if on stable dose for 8 weeks prior to enrollment). 
 Finasteride (or other 5 alpha reductase inhibitors) or oral or topical minoxidil, if on a 
stable dose for 12 months prior to enrollment. 
 HMG-CoA reductase inhibitors or “statins” (for example, simvastatin, simvastatin + 
ezetimibe) for treatment of hypercholesterolemia and the prevention of cardiovascular 
disease. 
Nutraceuticals (for example, Viviscal, Nutrafol) and other over-the-counter hair products may be 
used if patients are currently using them at baseline. They should be encouraged to continue with 
the same amount and frequency during the study. Oil on the scalp should be avoided at 
scheduled visits to reduce potential glare for photographs. 
Treatment with concomitant therapies for other medical conditions, such as diabetes and 
hypertension, is permitted during the study. 
2.6.7.2. 
Prohibited Medications and Procedures  
Any investigational or commercial topical, intralesional or systemic therapies (except those listed 
in Section 2.6.7.1) or phototherapy to treat AA are not allowed during the trial. 
In addition, the following medications and procedures are prohibited during the study: 
Prohibited Medications and Procedures Requiring Temporary Interruption of 
Investigational Product 
The following therapies will not be allowed during the course of the study and, if taken by or 
administered to the patient, temporary interruption of IP is required: 
 Live vaccines, including BCG or herpes zoster, (see exclusion criterion [23]). 
o For BCG vaccination, IP should be temporarily interrupted for 12 weeks. If BCG 
vaccine is given prior to Week 52, IP should be permanently discontinued. 
o For live herpes zoster vaccination, IP should be temporarily interrupted for 
4 weeks after the injection. 
 Probenecid: If a patient is inadvertently started on probenecid, IP should be temporarily 
interrupted, and can be resumed after patient has discontinued probenecid. If a patient is 
not able to discontinue probenecid, then IP should be permanently discontinued. 
 Systemic corticosteroids may be used for the treatment of an AE (for example, worsening 
of an existing condition, such as an asthma flare). IP may be restarted if systemic 
corticosteroids were used for a short duration (<30 days). If used for ≥30 days, Sponsor 
approval to restart IP is required. 
 Phototherapy: Full body Ultra Violet therapy. 
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Prohibited Medications Requiring Permanent Discontinuation of Investigational 
Product 
 Corticosteroids (systemic, intralesional, or topical on the scalp, eyebrows, and/or eyelids) 
for the treatment of AA. 
 Topical JAK inhibitors applied to the scalp, eyebrows, and eyelids. 
 Other oral JAK inhibitors (for example, tofacitinib and ruxolitinib). 
 Any systemic treatment with an immunosuppressive/immunomodulating substance, 
including, but not limited to, cyclosporine, mycophenolate-mofetil, IFNγ, azathioprine, 
methotrexate, dimethyl fumarate derivatives, hydroxychloroquine, or biologics (for 
example, monoclonal antibodies). 
 Any other AA treatment which has been inadvertently initiated and cannot be 
discontinued will lead to permanent discontinuation of IP. 
2.6.8. 
Treatment after the End of the Study  
2.6.8.1. 
Continued Access  
After the conclusion of the study, continued access to baricitinib will not be provided. Patients 
will be referred to their local treatment centers for AA therapy, as clinically indicated. 
2.7. 
Discontinuation Criteria  
2.7.1. 
Discontinuation from Study Treatment  
2.7.1.1. 
Permanent Discontinuation from Investigational Product  
IP should be permanently discontinued if the patient or the patient’s designee requests to 
discontinue IP. 
Discontinuation of the IP for abnormal liver tests should be considered by the investigator when 
a patient meets 1 of the following conditions after consultation with the Lilly-designated medical 
monitor: 
 ALT or AST >8 × ULN 
 ALT or AST >5 × ULN for more than 2 weeks 
 ALT or AST >3 × ULN and TBL >2 × ULN or international normalized ratio >1.5 
 ALT or AST >3 × ULN with the appearance of fatigue, nausea, vomiting, right 
upper-quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%) 
 ALP >3 × ULN 
 ALP >2.5 × ULN and TBL >2 × ULN 
 ALP >2.5 × ULN with the appearance of fatigue, nausea, vomiting, right quadrant 
pain or tenderness, fever, rash, and/or eosinophilia (>5%) 
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NOTE: Patients who are discontinued from IP due to a hepatic event or liver test 
abnormality should have additional hepatic safety data collected via the hepatic safety 
eCRF. 
IP should be permanently discontinued if any of the following are observed: 
 white blood cell count <1000 cells/µL (1.00 × 103/µL or 1.00 GI/L) 
 absolute neutrophil count <500 cells/µL (0.50 × 103/µL or 0.50 GI/L) 
 lymphocyte count <200 cells/µL (0.20 × 103/µL or 0.20 GI/L), and 
 hemoglobin <6.5 g/dL (<65.0 g/L). 
NOTE: Temporary interruption rules (see Section 2.7.1.2) must be followed, where 
applicable. For laboratory values that meet permanent discontinuation thresholds, IP should 
be discontinued. However, if, in the opinion of the investigator, the laboratory abnormality is 
due to intercurrent illness, such as cholelithiasis or another identified factor, laboratory tests 
may be repeated. Only when the laboratory value meets resumption thresholds (Table 
JAHO.2) following the resolution of the intercurrent illness or other identified factor, may 
the investigator restart IP, after consultation with the Lilly-designated medical monitor. 
In addition, patients will be discontinued from IP in the following circumstances: 
 pregnancy 
 malignancy (except for successfully treated basal or squamous cell skin carcinoma) 
 HBV DNA is detected with a value above limit of quantitation (see Section 9.4.8 
of the JAHO(e) protocol). 
 certain prohibited medications are taken per Section 2.6.7.2 (Prohibited 
Medications and Procedures) 
 development of a VTE 
Note: Patients who develop a VTE may have additional follow-up and testing 
recommended (see Section 9.4.9 and Appendix 7 of JAHO(e)). 
If a patient develops multiple risk factors for a VTE during the conduct of the study, as described 
in exclusion criterion [16], the investigator may consider study discontinuation if he/she believes 
the risk outweighs the benefits of continuing therapy. It is recommended that the investigator 
consult with Lilly (or its designee) before discontinuing therapy for this reason. 
Patients discontinuing from the IP prematurely for any reason should complete AE and other 
follow-up procedures per Section 2.2 (SOA), Section 2.8.2 (Adverse Events) of this addendum, 
and Section 9.4 (Safety) of the JAHO(e) protocol. 
2.7.1.2. 
Temporary Interruption of Investigational Product  
In some circumstances, it may be necessary to temporarily interrupt treatment as a result of AEs 
or abnormal laboratory values that may have an unclear relationship to IP. For example, IP 
should be temporarily interrupted if the patient experiences a cardiovascular AE considered to be 
related to study treatment, is graded as moderate (Grade 2 according to Common Terminology 
Criteria for Adverse Events Version 3.0), and that does not resolve promptly with supportive 
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care. Except in cases of emergency, it is recommended that the investigator consult with Lilly (or 
its designee) before temporarily interrupting therapy for reasons other than those defined in 
Table JAHO.2. 
For the abnormal laboratory findings and clinical events (regardless of relatedness) listed in 
Table JAHO.2, specific guidance is provided for temporarily interrupting treatment and when 
treatment may be restarted. Retest frequency and timing of follow-up laboratory tests to monitor 
the abnormal finding are at the discretion of the investigator. IP that was temporarily interrupted 
because of an AE or abnormal laboratory value not specifically covered in Table JAHO.2 may be 
restarted at the discretion of the investigator. 
Table JAHO.2. 
Criteria for Temporary Interruption of Investigational Product 
Hold Investigational Product if the Following 
Laboratory Test Results or Clinical Events Occur: 
Investigational Product May Be Resumed 
When: 
WBC count <2000 cells/µL 
(<2.00 × 103/µL or <2.00 GI/L) 
WBC count 2500 cells/µL 
(≥2.50 × 103/µL or ≥2.50 GI/L) 
ANC <1000 cells/L 
(<1.00 × 103/µL or <1.00 GI/L) 
ANC ≥1200 cells/µL 
(≥1.20 × 103/µL or ≥1.20 GI/L) 
Lymphocyte count <500 cells/µL 
(<0.50 × 103/µL or <0.50 GI/L) 
Lymphocyte count 750 cells/µL 
(≥0.75 × 103/µL or ≥0.75 GI/L) 
Platelet count <75,000/µL 
(<75 × 103/µL or <75 GI/L) 
Platelet count 100,000/µL 
(≥100 × 103/µL or ≥100 GI/L) 
eGFR <40 mL/min/1.73 m2 (from serum creatinine) for 
patients with screening eGFR ≥60 mL/min/1.73 m2 
eGFR 50 mL/min/1.73 m2 
eGFR <30 mL/min/1.73 m2 (from serum creatinine) for 
patients with screening eGFR ≥40 to <60 mL/min/1.73 m2 
eGFR 40 mL/min/1.73 m2 
ALT or AST >5 × ULN 
ALT and AST return to <2 × ULN, and IP is not 
considered to be the cause of enzyme elevation 
Hemoglobin <8 g/dL (<80.0 g/L) 
Hemoglobin 10 g/dL (≥100.0 g/L) 
Symptomatic herpes zoster 
All skin lesions have crusted and are resolving 
Infection that, in the opinion of the investigator, merits the 
IP being interrupted 
Resolution of infection 
Clinical features of VTE (such as deep vein thrombosis or 
pulmonary embolism) are presenta 
VTE ruled out 
Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate 
aminotransferase; eGFR = estimated glomerular filtration rate; IP = investigational product; ULN = upper limit 
of normal; VTE = venous thromboembolic event; WBC = white blood cell. 
a 
Evaluate promptly and institute appropriate treatment. If upon evaluation, VTE is ruled out and no other 
temporary or permanent discontinuation criteria are met, then IP may be resumed. 
Although temporary interruption of IP is not a requirement at times of increased potential risk for 
VTE (for example, surgery, significant air travel, or other situations involving prolonged 
immobilization), it is recommended that the investigator follow appropriate VTE prophylaxis 
guidelines to help manage the VTE risk under these circumstances. 
For specific guidance on temporary interruption of IP after the use of a prohibited medication, 
please refer to Section 2.6.7.2 (Prohibited Medications and Procedures). 
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Lastly, IP should be temporarily interrupted for suicidal ideation or any suicide-related behaviors, 
as assessed by the following patient responses on the C-SSRS: 
 A “yes” answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without 
Specific Plan); or 
 A “yes” answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on 
the “Suicidal Ideation” portion of the C-SSRS; or 
 A “yes” answer to any of the suicide-related behaviors (actual attempt, interrupted 
attempt, aborted attempt, preparatory act or behavior) on the “Suicidal Behavior” portion 
of the C-SSRS. 
NOTE: Prior to resumption of IP, it is recommended that a patient be assessed by a 
psychiatrist or appropriately trained professional to assist in deciding whether the subject 
should remain on IP and, ultimately, continue participation in the study. A patient does not 
necessarily have to have IP interrupted if he/she has self-injurious behavior that would be 
classified as non-suicidal self-injurious behavior. 
2.7.1.3. 
Discontinuation of Inadvertently Enrolled Patients  
If the Sponsor or investigator identify a patient who did not meet enrollment criteria and was 
inadvertently enrolled, then the patient should be discontinued from study treatment unless there 
are extenuating circumstances that make it medically necessary for the patient to continue on 
study treatment. If the investigator and the Sponsor CRP agree it is medically appropriate to 
continue, the investigator must obtain documented approval from the Sponsor CRP to allow the 
inadvertently enrolled patient to continue in the study with or without treatment with IP. Safety 
follow-up is as outlined in Section 2.2 (SOA), Section 2.8.2 (Adverse Events) of this addendum, 
and Section 9.4 (Safety) of the JAHO(e) protocol. 
2.7.2. 
Discontinuation from the Study  
Patients will be discontinued in the following circumstances: 
 enrollment in any other clinical study involving an investigational medicinal product or 
enrollment in any other type of medical research judged not to be scientifically or 
medically compatible with this study 
 participation in the study needs to be stopped for medical, safety, regulatory, or other 
reasons consistent with applicable laws, regulations, and GCP 
 investigator decision 
o the investigator decides that the patient should be discontinued from the study 
o if the patient, for any reason, requires treatment with another therapeutic agent for 
AA (not allowed per protocol [Section 2.6.7.2]) that has been demonstrated to be 
effective for treatment of the study indication, discontinuation from the study 
occurs prior to introduction of the new agent 
 subject decision 
o the patient or the patient’s designee (for example, parents or legal guardian) 
requests the patient to be withdrawn from the study 
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Patients discontinuing from the study prematurely for any reason should complete AE and other 
safety follow-up per Section 2.2 (SOA), Section 2.8.2 (Adverse Events) of this addendum, and 
Section 9.4 (Safety) of the JAHO(e) protocol. 
2.7.3. 
Lost to Follow-Up  
A patient will be considered lost to follow-up if he/she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site. Site personnel are expected to make diligent 
attempts to contact patients who fail to return for a scheduled visit or were, otherwise, unable to 
be followed up by the site. 
2.8. 
Study Assessments and Procedures  
Section 2.2 lists the SOA, with the study procedures and their timing (including tolerance limits 
for timing). 
Appendix 2 lists the laboratory tests that will be performed for this study. 
Unless, otherwise, stated in the subsections below, all samples collected for specified laboratory 
tests will be destroyed within 60 days of receipt of confirmed test results. Certain samples may 
be retained for a longer period, if necessary, to comply with applicable laws, regulations, or 
laboratory certification standards. 
2.8.1. 
Efficacy Assessments  
2.8.1.1. 
Primary Efficacy Assessments  
2.8.1.1.1. 
Severity of Alopecia Tool Score  
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top 
constituting 40% of total surface, the posterior/back 24%, right side and left side of scalp 18% 
each. The percentage of hair loss in each area is determined and is multiplied by the percentage 
of scalp covered by that area. The total sum of the 4 products of each area will give the SALT 
score, as developed by the National Alopecia Areata Foundation Working Committee 
(Oslen et al. 2004). Only terminal hair is included in the SALT; vellus hair or any fine downy 
hair is not taken into account in the SALT scoring process (Oslen et al. 1999, 2004). 
2.8.1.2. 
Secondary Efficacy Assessments  
2.8.1.2.1. 
Other Clinician-Reported Outcomes  
2.8.1.2.1.1. 
Eyebrow Hair Loss and Eyelash Hair Loss  
Lilly has developed 2 single-item ClinRO assessments: ClinRO Measure for Eyebrow Hair 
Loss™ and ClinRO Measure for Eyelash Hair Loss™. Each of these ClinRO assessments uses a 
4-point response scale, ranging from 0 = no hair loss to 3 = severe hair loss (Wyrwich et al. 
2020a. 
2.8.1.2.2. 
Alopecia Areata Patient-Reported Outcomes  
2.8.1.2.2.1. 
Patient-Reported Outcomes for Scalp Hair Assessment™  
Lilly has developed a novel single-item PRO assessment of the patient’s current extent of scalp 
involvement. It is comprised of 5 category response options: 0 = no missing hair (0% of my 
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scalp is missing hair; I have a full head of hair); 1 = a limited area (1% to 20% of my scalp is 
missing hair); 2 = a moderate area (21% to 49% of my scalp is missing hair); 3 = a large area 
(50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is 
missing hair) (Wyrwich et al. 2020b). 
2.8.1.2.2.2. 
Patient-Reported Outcomes for Appearance of Eyebrows, Appearance of 
Eyelashes  
Lilly has developed single-item PRO assessments measuring AA signs and symptoms. The PRO 
Measure for Eyebrows™ and PRO Measure for Eyelashes™ are single-item instruments which 
use a 4-point response scale, ranging from 0 = no problem to 3 = severe problem (Wyrwich et al. 
2020a). 
2.8.1.2.2.3. 
Patient-Reported Outcomes for Body Hair  
The Body Hair Symptoms and Impact Questionnaire asks patients about current nasal, beard 
(male only), and genital hair loss. For each of these areas, patients are asked to assess the amount 
of hair loss using the categories of “no missing hair,” “a limited amount of hair loss,” “a large 
amount of hair loss,” or “complete or nearly complete hair loss.” Patients are also asked to rate 
how bothered they are by the hair loss using a 11-point Numeric Rating Scale of 0 to 10 where 0 
is “not at all bothered” and 10 is “worst imaginable for being bothered.” 
2.8.1.2.2.4. 
Patient-Reported Outcomes for Change  
Patients will assess their overall impression of change (PGI-C) during the course of therapy. This 
single-item question assesses their perception of change relative to their baseline status using a 7 
Likert-point scale where 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 
5 = a little worse, 6 = much worse, and 7 = very much worse. 
2.8.1.2.2.5. 
Patient-Reported Outcomes for Satisfaction  
Treatment satisfaction will be assessed using the single item Patient Global Impression of 
Satisfaction (PGI-Satisfaction in which they assess their current satisfaction with the treatment 
outcome using a 7-point Likert scale where 1 = completely satisfied, 2 = mostly satisfied, 3 = 
somewhat satisfied, 4 = neither satisfied or dissatisfied, 5 = dissatisfied, 6 = mostly dissatisfied, 
and 7 = completely dissatisfied. 
2.8.1.3. 
Health Outcomes and Quality-of-Life Measures  
The following patient self-reported questionnaires will be administered via an electronic tablet. 
2.8.1.3.1. 
Skindex-16 A for Alopecia Areata  
The Skindex-16 has been used to assess the health-related quality of life in patients with skin 
diseases. The Skindex-16 items’ wordings were adapted for use among adults with AA. It is 
composed of 16 items grouped under 3 domains: Symptoms (4 items), Emotions (7 items), and 
Functioning (5 items). 
2.8.1.3.2. 
Hospital Anxiety and Depression Scale  
The Hospital Anxiety and Depression Scale is a 14-item self-assessment scale that determines 
the levels of anxiety (7 items) and depression (7 items) that a patient is experiencing over the 
past week. The Hospital Anxiety and Depression Scale utilizes a 4-point Likert response scale 
(for example, 0 to 3) for each item, and is intended for ages 12 to 65 years (Zigmond and Snaith 
1983; White et al. 1999). Scores for each domain (anxiety and depression) can range from 0 to 
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21, with higher scores indicating greater anxiety or depression (Zigmond and Snaith 1983; Snaith 
2003). 
2.8.1.4. 
Photography  
At Screening (Visit 1), photographs of the scalp will be obtained from all patients. Views will 
include the right lateral, frontal, left lateral, forward tilt, and posterior. Up to 4 additional close-
up views will be taken with and without cross-polarization lens of the left and right temporal 
area, the crown, and a representative patch (when applicable) selected by the physician. At 
Baseline (Visit 2), photographs of the scalp will be repeated as at the screening visit. All patients 
will also have photograph of the eyebrows/eyelashes. After baseline, photographs of the scalp 
and close-up will be repeated as per the SOA. After Baseline, photographs of the eyebrows/ 
eyelashes will be captured only from patients who have AA involvement (ClinRO ≥1) of those 
areas at Baseline, as assessed by investigator (see SOA [Section 2.2] and Section 2.8.1.4). 
Missed photographs after screening will not be considered a protocol violation. Detailed 
requirements for photography are located in the Photography Manual. 
Camera equipment, necessary ancillary materials, and a study-specific photography manual will 
be provided to all sites by the Sponsor or designee. The photographs will be obtained by trained 
site personnel under similar lighting conditions and magnifications, and per instructions provided 
during training and as outlined in the photographic procedure manual. 
Photographs are commonly obtained in research investigations of AA and are effective in 
demonstrating disease presentation at Baseline and clinical response after treatment with 
baricitinib. 
The photographs may be included in the CSR, a regulatory submission package, scientific 
publications, or in other public dissemination of clinical data to demonstrate disease presentation 
at Baseline and clinical response after treatment with baricitinib. 
Photographs from consenting patients may also be used in advertising and promotional activities 
including, but not limited to, communication with healthcare professionals/payers, as well as in 
patient education, speaker programs, and digital/print media messaging. 
Patient anonymity will be protected in photographs included in patient education, speaker 
programs, print media, or any form available to the public. To protect the patient’s anonymity, 
identifiable characteristics of the skin, such as facial birthmarks, or tattoos will be redacted from 
the final photographs and will not appear in any published version of the photograph. No formal 
analyses of photographs are planned. 
2.8.1.5. 
Appropriateness of Assessments  
The primary clinical and safety assessments in this study are standard, widely used, and 
generally recognized as reliable, accurate, and relevant. 
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2.8.2. 
Adverse Events  
Investigators are responsible for monitoring the safety of patients who have entered this study 
and for alerting Lilly or its designee to any event that seems unusual, even if this event may be 
considered an unanticipated benefit to the patient. 
The Investigator is responsible for the appropriate medical care of patients during the study. 
Investigators must document their review of each laboratory safety report. 
The Investigator will record all relevant AE/SAE information in the CRF. The Investigator 
remains responsible for following, through an appropriate health care option, AEs that are: 
serious or, otherwise, medically important; considered related to the IP or the study; or that 
caused the patient to discontinue the IP before completing the study. The patient should be 
followed until the event resolves, stabilizes with appropriate diagnostic evaluation, or is 
reasonably explained. The frequency of follow-up evaluations of the AE is left to the discretion 
of the investigator. 
Lack of drug effect is not an AE in clinical studies because the purpose of the clinical study is to 
establish treatment effect. 
After the ICF is signed, study site personnel will record, via eCRF, the occurrence and nature of 
each patient’s preexisting conditions, including clinically significant signs and symptoms of the 
disease under treatment in the study. In addition, site personnel will record any change in the 
condition(s) and any new conditions as AEs. Investigators should record their assessment of the 
potential relatedness of each AE to IP, via eCRF. 
The investigator will interpret and document whether an AE has a reasonable possibility of being 
related to study treatment, to a study device, or to a study procedure, taking into account the 
disease, concomitant treatment, or pathologies. A “reasonable possibility” means that there is a 
cause-and-effect relationship between the IP, study device, and/or study procedure and the AE. 
The investigator answers yes/no when making this assessment. 
Planned surgeries and nonsurgical interventions should not be reported as AEs unless the 
underlying medical condition has worsened during the course of the study. 
If a patient’s IP is discontinued as a result of an AE, study site personnel must report this to Lilly 
or its designee via eCRF, clarifying, if possible, the circumstances leading to any dosage 
modifications or discontinuations of treatment. 
2.8.2.1. 
Serious Adverse Events  
An SAE is any AE from this study that results in one of the following outcomes: 
 death 
 initial or prolonged inpatient hospitalization 
 a life-threatening experience (that is, immediate risk of dying) 
 persistent or significant disability/incapacity 
 congenital anomaly/birth defect 
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 important medical events that may not be immediately life-threatening or result in death 
or hospitalization, but may jeopardize the patient or may require intervention to prevent 
one of the other outcomes listed in the definition above. Examples of such medical events 
include: allergic bronchospasm requiring intensive treatment in an emergency room or at 
home; blood dyscrasias or convulsions that do not result in inpatient hospitalization; or 
the development of drug dependency or drug abuse. 
All AEs occurring after signing the ICF are recorded in the eCRF and assessed for seriousness 
criteria. The SAE reporting to the Sponsor begins after the patient has signed the ICF and has 
received IP. However, if an SAE occurs after signing the ICF, but prior to receiving IP, the SAE 
should be reported to the Sponsor, as per SAE-reporting requirements and timelines (see 
Section 2.8.2) if it is considered reasonably possibly related to study procedure. 
Study site personnel must alert Lilly or its designee of any SAE within 24 hours of investigator 
awareness of the event via a Sponsor-approved method. If alerts are issued via telephone, they 
are to be immediately followed with official notification on study-specific SAE forms. This 
24-hour notification requirement refers to the initial SAE information and all follow-up SAE 
information. Patients with a serious hepatic AE should have additional data collected using the 
eCRF. 
Pregnancy (during maternal or paternal exposure to IP) does not meet the definition of an AE. 
However, to fulfill regulatory requirements, any pregnancy should be reported after the SAE 
process to collect data on the outcome for both the mother and the fetus. 
Investigators are not obligated to actively seek AEs or SAEs in subjects once they have 
discontinued and/or completed the study (the patient disposition eCRF has been completed). 
However, if the investigator learns of any SAE, including a death, at any time after a subject has 
been discharged from the study, and he/she considers the event reasonably possibly related to the 
study treatment or study participation, the investigator must promptly notify Lilly. 
2.8.2.1.1. 
Suspected Unexpected Serious Adverse Reactions  
SUSARs are serious events that are not listed in the IB and that the investigator identifies as 
related to IP or procedure. United States 21 CFR 312.32 and European Union Clinical Trial 
Directive 2001/20/EC and the associated detailed guidance or national regulatory requirements 
in participating countries require the reporting of SUSARs. Lilly has procedures that will be 
followed for the identification, recording, and expedited reporting of SUSARs that are consistent 
with global regulations and the associated detailed guidance. 
2.8.2.2. 
Adverse Events of Special Interest  
Adverse events of special interest will include the following: 
 infections (including TB, herpes zoster, or opportunistic infections) 
 malignancies 
 hepatic events (see Section 9.4.10.1 of the JAHO(e) protocol) 
 major adverse cardiovascular events (see Section 9.4.10 of the JAHO(e) protocol), and 
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 thrombotic events (such as deep vein thrombosis and pulmonary embolism and arterial 
thrombotic event (see Section 9.4.9 of the JAHO(e) protocol). 
Sites will provide details on these AEs, as instructed on the eCRF, and may be asked for 
additional description by Lilly. 
2.8.2.3. 
Complaint Handling  
Lilly collects product complaints on IPs and drug delivery systems used in clinical studies in 
order to ensure the safety of study participants, to monitor quality, and to facilitate process and 
product improvements. 
Patients will be instructed to contact the investigator as soon as possible if they have a complaint 
or problem with the IP so that the situation can be assessed. 
2.8.3. 
Treatment of Overdose  
Refer to the IB. 
2.8.4. 
Safety  
Refer to JAHO(e) protocol for electrocardiogram, vital signs, physical examination, laboratory 
tests, C-SSRS, chest x-ray and TB testing, HBV DNA monitoring, venous thromboembolism 
assessment, and safety monitoring. 
2.8.5. 
Pharmacogenomics  
2.8.5.1. 
Whole Blood Samples for Pharmacogenetic Research  
A whole blood sample will be collected for pharmacogenetic analysis, as specified in the SOA 
(Section 2.2), where local regulations allow. 
Samples will not be used to conduct unspecified disease or population genetic research, either 
now or in the future. Samples will be used to investigate variable response baricitinib and to 
investigate genetic variants thought to play a role in AA. Assessment of variable response may 
include evaluation of AEs or differences in efficacy. 
All samples will be coded with the patient number. These samples and any data generated can be 
linked back to the patient only by the investigator site personnel. 
Samples will be retained at a facility selected by Lilly for a maximum of 15 years after the last 
patient visit for the study, or for a shorter period if local regulations and/or ERBs/investigational 
review boards impose shorter time limits. This retention period enables the use of new 
technologies, response to regulatory questions, and investigation of variable response that may 
not be observed until later in the development of baricitinib or after baricitinib becomes 
commercially available. 
Molecular technologies are expected to improve during the 15-year storage period and, therefore, 
cannot be specifically named. However, existing approaches include whole genome or exome 
sequencing, genome-wide association studies, and candidate gene studies. Regardless of 
technology utilized for genotyping, data generated will be used only for the specific research 
scope described in this section. 
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2.8.6. 
Biomarkers  
Biomarker research is performed to address questions of relevance to drug disposition, target 
engagement, pharmacodynamics, mechanism of action, variability of patient response (including 
safety), and clinical outcome. Sample collection is incorporated into clinical studies to enable 
examination of these questions through measurement of biomolecules including DNA, RNA, 
proteins, lipids, and other cellular elements. 
Blood samples for biomarker research will be collected at the times specified in the SOA 
(Section 2.2), where local regulations allow. 
Samples will be used for research on the drug target, disease process, variable response to 
baricitinib, pathways associated with AA, mechanism of action of baricitinib, and/or research 
method or in validating diagnostic tools or assay(s) related to AA. 
All samples will be coded with the patient number. These samples, and any data generated, can 
be linked back to the patient only by the investigator site personnel. 
Samples will be retained at a facility selected by Lilly for a maximum 15 years after the last 
patient visit for the study, or for a shorter period if local regulations and ERBs impose shorter 
time limits. This retention period enables the use of new technologies, response to regulatory 
questions, and investigation of variable response that may not be observed until later in the 
development of baricitinib or after baricitinib becomes commercially available. 
2.9. 
Statistical Considerations  
2.9.1. 
Sample Size Determination  
Study JAHO addendum initially intended to screen approximately 80 patients to enroll 60 
patients, as a sample size considered sufficient for subject improvement in hair growth. 
Subsequent enrollment resulted in a sample size of 20 patients. The sample size of approximately 
20 patients is sufficient to provide descriptive information on subject improvement in hair 
regrowth. As the addendum objectives were designed as descriptive in nature, it did not rely on 
power calculations and therefore, a sample size of approximately 20 patients is sufficient for 
further description of treatment outcomes with this population.  
2.9.2. 
Populations for Analyses  
For the purpose of analyses, the following populations are defined: 
Population 
Description 
Full Analysis Set (FAS)  
All patients enrolled will be included in the FAS.  
 
 
Safety Population 
 
 
The safety population is defined as all enrolled patients who receive at least 1 
dose of IP and who did not discontinue from the study for the reason ‘Lost to 
Follow-up’ at the first postbaseline visit. 
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Abbreviations: AGA = androgenetic alopecia; IP = investigational product. 
a Some male patients with Grade IV AGA and female patients with patterned baldness may only be identified after 
hair regrowth on the scalp. 
 
Any additional analysis populations may be defined in the SAP. 
2.9.3. 
Statistical Analyses  
2.9.3.1. 
General Statistical Considerations  
Statistical analysis of this study will be the responsibility of Lilly. 
The efficacy analysis of the primary and key secondary endpoints will be conducted in the full 
analysis set population. All other efficacy analyses will be conducted in the full analysis set 
population or other populations described in the SAP. Safety analyses will be conducted using 
the safety population. 
Any change to the data analysis methods described in this addendum will require an amendment 
ONLY if it changes a principal feature of the addendum. Any other change to the data analysis 
methods described in this addendum (and the justification for making the change) will be 
described in the CSR. Additional exploratory analyses of the data will be conducted, as deemed 
appropriate. Complete details of the planned analyses will be documented in the SAP. 
2.9.3.1.1. 
Analysis Methods  
The primary and secondary efficacy objective/endpoints for the study are descriptive in nature 
and will be analyzed in a descriptive way using observed data, unless otherwise stated. 
For all discrete efficacy outcome variables, frequency and counts with percentages and 100(1-
alpha) % CI of the percentages using the Wilson method, without continuity correction method 
will be reported. Continuous safety outcome variables vital signs, body weight, and other 
continuous safety variables, including laboratory variables, will be descriptively summarized in 
terms of number of patients, mean, standard deviation, median, minimum, and maximum. Shift 
tables for categorical safety analyses (for example, “high” or “low” laboratory results) will also 
be produced, as appropriate. 
2.9.3.1.2. 
Missing Data Imputation  
No imputation methods will be applied. Data will be analyzed as observed case analysis. If 
deemed necessary imputation method for handling of missing data will be included in the SAP as 
appropriate. 
2.9.3.1.3. 
Descriptive Population Analyses Patient Disposition  
A detailed description of patient disposition will be summarized with reasons for 
discontinuation. Frequency counts and percentages will be presented for, all patients who 
discontinue from the study or the study treatment will be identified, along with their reason for 
discontinuation. Patient Characteristics Demographic and Baseline characteristics will be 
summarized descriptively. Descriptive statistics including number of patients, mean, standard 
deviation, median, minimum, and maximum will be provided for continuous measures, and 
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frequency counts and percentages will be tabulated for categorical measures. A complete list of 
patient characteristics and Baseline clinical measures will be provided in the SAP. 
2.9.3.1.4. 
Concomitant Therapy  
Concomitant medications will be descriptively summarized in terms of frequencies and 
percentages using the safety population. Additional summaries may be produced by prior 
treatment received. 
2.9.3.1.5. 
Treatment Compliance  
Treatment compliance with the study medication will be evaluated at every clinic visit through 
the counts of returned IP tablets. A patient will be considered significantly noncompliant if 
he/she misses more than 20% of the prescribed doses during the study, unless the patient’s IP is 
withheld by the investigator for safety reasons (that is, compliance <80%). Similarly, a patient 
will be considered significantly noncompliant if he/she is judged by the investigator to have 
intentionally or repeatedly taken more than the prescribed amount of medication (that is, 
compliance ≥120%). 
2.9.4. 
Efficacy Analyses  
2.9.4.1. 
Primary Analyses  
The primary efficacy measure is the continuous endpoint defined as the percent change in SALT 
Score from baseline at Week 52. The mean percent change from baseline, standard error, and 
95% confidence interval (CI) for mean percent change will be reported with all other descriptive 
statistics such as number of patients, standard deviation, median, minimum, and maximum. 
Additional analysis of the primary efficacy outcome may be conducted and include analyzing all 
available data up to the permanent treatment discontinuation.  
2.9.4.2. 
Secondary Analyses  
Proportion of patients achieving a binary response and 100(1-alpha) % CI of the percentages 
using Wilson method, without continuity correction method will be reported. 
Additional analysis of the secondary efficacy outcome may be conducted and include analyzing 
all available data up to the permanent treatment discontinuation. 
2.9.4.3. 
Exploratory Analyses  
Analyses will be conducted for the other exploratory objectives defined in Section 2.3. Specific 
details of analyses will be specified in the SAP. 
2.9.5. 
Safety Analyses  
All safety data will be descriptively summarized and analyzed using the safety population unless, 
otherwise, stated. 
Treatment-emergent adverse events are defined as AEs that first occurred or worsened in 
severity after the first dose of study treatment. The number of TEAEs, as well as the number and 
percentage of patients who experienced at least 1 TEAE, will be summarized using the Medical 
Dictionary for Regulatory Activities for each system organ class (or a body system) and each 
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preferred term. Serious adverse events and AEs that lead to discontinuation of IP will also be 
summarized. 
All clinical laboratory results will be descriptively summarized. Individual results that are 
outside of normal reference ranges will be flagged in data listings. Quantitative clinical 
hematology, chemistry, and urinalysis variables obtained at the Baseline to postbaseline visits 
will be summarized as changes from Baseline Categorical variables, including the incidence of 
abnormal values and incidence of AEs of special interest, will be summarized by frequency and 
percentage of patients in corresponding categories. Shift tables will be presented for selected 
measures. 
Observed values and changes from Baseline for vital signs and physical characteristics will be 
descriptively summarized by timepoint. Change from Baseline in vital signs and body weight 
will be descriptively summarized. 
Summary tables or listings for the C-SSRS will be produced, as needed. 
The incidence and average duration of IP interruptions will be summarized descriptively (if 
necessary). Further analyses may be performed and will be planned in the SAP. 
Full details of the safety analyses and any derivations of AEs of special interest will be 
documented in the program safety analysis plan and study SAP, if needed. 
2.9.6. 
Other Analyses  
Additional subgroup analyses may be conducted to characterize the treatment response. These 
subgroup characteristics may include gender (male vs female), baseline severity (SALT score 
50-94 vs SALT score 95-100), and duration of current episode (<4 years vs ≥4 years) and disease 
(<10 years vs ≥10 years). All subgroup analyses will be descriptive in nature, as appropriate. 
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3. 
References  
Lee H, Jung SJ, Patel AB, et al. Racial characteristics of alopecia areata in the United States. J 
Am Acad Dermatol. 2020;83(4):1064-1070. https://doi.org/10.1016/j.jaad.2019.06.1300 
Olsen EA, Callender V, McMichael A, et al. Central hair loss in African American women: 
incidence and potential risk factors. J Am Acad Dermatol. 2011;64(2):245-252. 
https://doi.org/10.1016/j.jaad.2009.11.693 
Oslen EA, Bettencourt MS, Cote NL. The presence of loose anagen hairs obtained by hair pull in 
the normal population. J Investig Dermatol Symp Proc. 1999;4(3);258-260. 
https://doi.org/10.1038/sj.jidsp.5640225 
Oslen EA, Hprdinsky MK, Price VH, et al. Alopecia areata investigational assessment guidelines 
– Part II. National Alopecia Areata Foundation. J Am Acad Dermatol. 2004;51(3);440-447. 
https://doi.org/10.1016/j.jaad.2003.09.032 
Raffi J, Suresh R, Agbai O. Clinical recognition and management of alopecia in women of color. 
Int J Womens Dermatol. 2019;5(5):314-319. https://doi.org/10.1016/j.ijwd.2019.08.005 
Snaith RP. The Hospital Anxiety and Depression Scale. Health Qual Life Outcomes. 2003;1:29. 
https://doi.org/10.1186/1477-7525-1-29 
Taylor SC. Skin of color: biology, structure, function, and implications for dermatologic disease. 
J Am Acad Dermatol. 2002;46(2 Suppl Understanding):S41-S62. 
https://doi.org/10.1067/mjd.2002.120790 
Thompson JM, Park MK, Qureshi AA, Cho E. Race and Alopecia Areata amongst US Women. J 
Investig Dermatol Symp Proc. 2018;19(1):S47-S50. https://doi.org/10.1016/j.jisp.2017.10.007 
White D, Leach C, Sims R, et al. Validation of the Hospital Anxiety and Depression Scale for 
use with adolescents. Br J Psychiatry. 1999;175:452-454. 
https://doi.org/10.1192/bjp.175.5.452 
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr 
Scand.1983;67(6):361-370. https://doi.org/10.1111/j.1600-0447.1983.tb09716.x 
Wyrwich KW, Kitchen H, Knight S, et al. Development of clinician-reported outcome (ClinRO) 
and patient-reported outcome (PRO) measures for eyebrow, eyelash and nail assessment in 
Alopecia Areata. Am J Clin Dermatol. 2020a;21(5):725-732. https://doi.org/10.1007/s40257-
020-00545-9 
Wyrwich KW, Kitchen H, Knight S, et al. The Alopecia Areata Investigator Global Assessment 
scale: a measure for evaluating clinically meaningful success in clinical trials. Br J Dermatol. 
2020b;183(4):702-709. https://doi.org/10.1111/bjd.18883 
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4. 
Supporting Documentation  
4.1. 
Appendix 1. Abbreviations and Definitions  
Term 
Definition 
AA 
alopecia areata 
AE 
adverse event: any untoward medical occurrence in a patient or clinical investigation 
subject administered a pharmaceutical product that does not necessarily have a causal 
relationship with this treatment. An adverse event can, therefore, be any unfavorable 
and unintended sign (including an abnormal laboratory finding), symptom, or disease 
temporally associated with the use of a medicinal (investigational) product, whether or 
not related to the medicinal (investigational) product. 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
BCG 
Bacillus Calmette-Guérin vaccine 
CI 
confidence interval 
ClinRO 
clinician-reported outcome 
CRF 
case report form 
CRP 
clinical research physician 
CSR 
clinical study report 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
eCOA 
electronic clinical outcome assessment 
eCRF 
electronic case report form 
eGFR 
estimated glomerular filtration rate 
ePRO 
electronic patient-reported outcome 
ERB 
ethical review board 
ET 
early termination  
GCP 
good clinical practice 
HADS 
Hospital Anxiety and Depression Scale 
HBcAb 
hepatitis B core antibody 
HBV 
hepatitis B virus 
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Term 
Definition 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HMG-CoA 
3-hydroxy-3-methylglutaryl coenzyme A 
IAS 
interim analysis set 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IFNγ 
interferon gamma 
IP 
investigational product: a pharmaceutical form of an active ingredient or placebo being 
tested or used as a reference in a clinical trial, including products already on the market 
when used or assembled (formulated or packaged) in a way different from the 
authorized form, or marketed products used for an unauthorized indication, or marketed 
products used to gain further information about the authorized form. 
JAK 
Janus kinase 
NRI 
nonresponder imputation 
PPD 
purified protein derivative 
PRO 
patient-reported outcome 
QD 
once daily administration 
SAE 
serious adverse event 
SALT 
Severity of Alopecia Tool 
SAP 
statistical analysis plan 
SOA 
Schedule of Activities 
SUSAR 
suspected unexpected serious adverse reaction 
TB 
tuberculosis 
TBL 
total bilirubin level 
TEAE 
treatment-emergent adverse event: an untoward medical occurrence that emerges during 
a defined treatment period, having been absent pretreatment, or worsens relative to the 
pretreatment state, which does not necessarily have to have a causal relationship with 
this treatment. 
TSH 
thyroid-stimulating hormone 
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Term 
Definition 
ULN 
upper limit of normal 
VTE 
venous thromboembolic event 
 
 
 
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4.2. 
Appendix 2. Clinical Laboratory Tests  
Hematologya,b 
Clinical Chemistrya,b 
Hemoglobin 
Serum Concentrations of: 
Hematocrit 
Sodium 
Erythrocyte count (RBC) 
Potassium 
Absolute Reticulocyte Count 
Total bilirubin 
Mean cell volume 
Direct bilirubin 
Mean cell hemoglobin 
Alkaline phosphatase 
Mean cell hemoglobin concentration 
Alanine aminotransferase (ALT) 
Leukocytes (WBC) 
Aspartate aminotransferase (AST) 
Platelets 
Blood urea nitrogen (BUN) 
Absolute counts of: 
Creatinine 
Neutrophils, segmented 
Cystatin C 
Neutrophils, juvenile (bands) 
Uric acid 
Lymphocytes 
Calcium 
Monocytes 
Glucose 
Eosinophils 
Albumin 
Basophils 
Total protein 
 
Estimated glomerular filtration rate (eGFR)e 
 
Creatine phosphokinase (CPK) 
Urinalysisa,b,d 
 
Color 
Other Testsa 
Specific gravity 
Hepatitis B Surface antigen (HBsAg)f 
pH 
Anti-Hepatitis B Core antibody (HBcAb)f 
Protein 
Hepatitis B virus (HBV) DNAl
Glucose 
Anti-Hepatitis B Surface antibody (HBsAb)f 
Ketones 
Human immunodeficiency virus (HIV)f 
Bilirubin 
Hepatitis C antibodyf,g 
Urobilinogen 
Thyroid-stimulating hormone (TSH)f 
Blood 
Exploratory storage samples (serum, plasma and 
mRNA) 
Leukocyte esterase 
Pregnancy Testh 
Nitrite 
Follicle-stimulating hormonef,i 
 
QuantiFERON-TB Goldj (central testing preferred) or 
T-SPOT.TB k (local testing) 
Lipidsa,c 
PPD (local testing/reading) 
Total cholesterol 
Serum immunoglobulin (IgE) 
Low-density lipoprotein 
 
High-density lipoprotein 
 
Triglycerides 
 
Abbreviations: mRNA = messenger ribonucleic acid; FSH = follicle-stimulating hormone; HBV = hepatitis B virus; 
IgE = immunoglobulin E; PPD = purified protein derivative; RBC = red blood cell; TB = tuberculosis; WBC = 
white blood cell. 
a Assayed by Sponsor-designated laboratory. 
b Unscheduled or repeat blood chemistry, hematology, and urinalysis panels may be performed at the discretion of 
the investigator, as needed. 
c Fasting lipid profile. Patients should not eat or drink anything except water for 8 hours prior to test. If a patient 
attends these visits in a nonfasting state, this will not be considered a protocol violation. 
d Microscopic examination of sediment performed only if abnormalities are noted on the routine urinalysis. 
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e Estimated glomerular filtration rate for serum creatinine calculated by the central laboratory using the Chronic 
Kidney Disease Epidemiology Collaboration creatinine 2009 equation. 
f Test required at Visit 1 only to determine eligibility of patient for the study. 
g A positive hepatitis C antibody result will be confirmed with an alternate hepatitis C method. 
h For all women of childbearing potential, a serum pregnancy test will be performed at Visit 1 and a local urine 
pregnancy test will be performed at Visit 2 and at all subsequent study visits. If required per local regulations 
and/or institutional guidelines, pregnancy testing can occur at other times during the study treatment period. 
i 
To confirm postmenopausal status for women ≥40 and <60 years of age who have had a cessation of menses, an 
FSH test will be performed. Nonchildbearing potential is defined as an FSH ≥40 mIU/mL and a cessation of 
menses for at least 12 months. 
j 
The QuantiFERON-TB Gold test (central testing) is the preferred alternative to the PPD test for the evaluation of 
TB infection, and it may be used instead of the PPD test or T-SPOT.TB test. If the QuantiFERON-TB Gold test 
is indeterminate, 1 retest is allowed. 
k T-SPOT.TB must be read locally. 
l 
HBV DNA testing will be done in those patients who are HBcAb+ at screening, regardless of hepatitis B surface 
antibody status. 
 
 
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4.3. 
Appendix 3. Study Governance Considerations  
4.3.1. 
Appendix 3.1. 
Regulatory and Ethical Considerations, Including the 
Informed Consent Process  
4.3.1.1. 
Appendix 3.1.1. 
Informed Consent  
The investigator is responsible for: 
 ensuring that the patient understands the nature of the study, the potential risks and 
benefits of participating in the study, and that their participation is voluntary. 
 ensuring that informed consent is given by each patient or legal representative. This 
includes obtaining the appropriate signatures and dates on the ICF prior to the 
performance of any protocol procedures and prior to the administration of investigational 
product. 
 answering any questions the patient may have throughout the study and sharing in a 
timely manner any new information that may be relevant to the patient’s willingness to 
continue his/her participation in the study. 
 ensuring that a copy of the ICF is provided to the participant or the participant’s legal 
representative and is kept on file. 
 ensuring that the medical record includes 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 
ICF. 
4.3.1.2. 
Appendix 3.1.2. 
Recruitment  
Lilly is responsible for the central recruitment strategy for patients. Individual investigators may 
have additional local requirements or processes. 
4.3.1.3. 
Appendix 3.1.3. 
Ethical Review  
The investigator must give assurance that the ERB was properly constituted and convened, as 
required by ICH guidelines and other applicable laws and regulations. 
Documentation of ERB approval of the protocol and the ICF must be provided to Lilly before the 
study may begin at the investigative site(s). Lilly or its representatives must approve the ICF, 
including any changes made by the ERBs, before it is used at the investigative site(s). All ICFs 
must be compliant with the ICH guideline on GCP. 
The study site’s ERB(s) should be provided with the following: 
 the protocol and related amendments and addenda, current IB and updates during the 
course of the study 
 informed consent form 
 other relevant documents (for example, curricula vitae, advertisements) 
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4.3.1.4. 
Appendix 3.1.4. 
Regulatory Considerations  
This study will be conducted in accordance with the protocol and with the: 
 consensus ethics principles derived from international ethics guidelines, including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
International Ethical Guidelines 
 applicable ICH GCP Guidelines 
 applicable laws and regulations 
Some of the obligations of the Sponsor will be assigned to a third party. 
4.3.1.5. 
Appendix 3.1.5. 
Investigator Information  
Physicians with expertise in the diagnosis and treatment of alopecia areata will participate as 
investigators in this clinical trial. 
4.3.1.6. 
Appendix 3.1.6. 
Protocol Signatures  
The Sponsor’s responsible medical officer will approve the protocol, confirming that, to the best 
of his/her knowledge, the protocol accurately describes the planned design and conduct of the 
study. 
After reading the protocol, each principal investigator will sign the protocol signature page and 
send a copy of the signed page to a Lilly representative. 
4.3.1.7. 
Appendix 3.1.7. 
Final Report Signature  
Lilly will select a qualified investigator(s) from among investigators participating in the design, 
conduct, and/or analysis of the study to serve as the CSR coordinating investigator. If this 
investigator is unable to fulfill this function, another investigator will be chosen by Lilly to serve 
as the CSR coordinating investigator. 
The CSR coordinating investigator will sign the final CSR for this study, indicating agreement 
that, to the best of his/her knowledge, the report accurately describes the conduct and results of 
the study. 
The Sponsor’s responsible medical officer and statistician will approve the final CSR for this 
study, confirming that, to the best of his/her knowledge, the report accurately describes the 
conduct and results of the study. 
4.3.2. 
Appendix 3.2. 
Data Quality Assurance  
To ensure accurate, complete, and reliable data, Lilly or its representatives will do the following: 
 provide instructional material to the study sites, as appropriate. 
 sponsor start-up training to instruct the investigators and study coordinators. This 
training will give instruction on the protocol, the completion of the CRFs, and study 
procedures. 
 make periodic visits to the study site. 
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 be available for consultation and stay in contact with the study site personnel by mail, 
telephone, and/or fax. 
 review and evaluate CRF data and use standard computer edits to detect errors in data 
collection. 
 conduct a quality review of the database. 
In addition, Lilly or its representatives will periodically check a sample of the patient data 
recorded against source documents at the study site. The study may be audited by Lilly or its 
representatives, and/or regulatory agencies at any time. Investigators will be given notice before 
an audit occurs. 
The investigator will keep records of all original source data. This might include laboratory tests, 
medical records, and clinical notes. If requested, the investigator will provide the Sponsor, 
applicable regulatory agencies, and applicable ERBs with direct access to original source 
documents. 
4.3.2.1. 
Appendix 3.2.1. 
Data Capture System  
An electronic data capture system will be used in this study. The site maintains a separate source 
for the data entered by the site into the Sponsor-provided electronic data capture system. 
ePRO measures (for example, a rating scale) and eCOAs are entered into an ePRO/eCOA 
instrument at the time that the information is obtained. In those instances where there is no prior 
written or electronic source data at the site, the ePRO/eCOA instrument record will serve as the 
source. 
If ePRO/eCOA records are stored at a third-party site, investigator sites will have continuous 
access to the source documents during the study and will receive an archival copy at the end of 
the study for retention. 
Any data for which the ePRO/eCOA instrument record will serve to collect source data will be 
identified and documented by each site in that site’s study file. 
CRF data will be encoded and stored in the electronic data capture system. 
Data managed by a central vendor, such as laboratory test data, will be stored electronically in 
the central vendor’s database system. Data will subsequently be transferred from the central 
vendor to the Lilly data warehouse. 
Data from complaint forms submitted to Lilly will be encoded and stored in the global product 
complaint management system. 
4.3.3. 
Appendix 3.3. 
Study and Site Closure  
4.3.3.1. 
Appendix 3.3.1. 
Discontinuation of Study Sites  
Study site participation may be discontinued if Lilly, the investigator, or the ERB of the study 
site judges it necessary for medical, safety, regulatory, or other reasons consistent with 
applicable laws, regulations, and GCP. 
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4.3.3.2. 
Appendix 3.3.2. 
Discontinuation of the Study  
The study will be discontinued if Lilly judges it necessary for medical, safety, regulatory, or 
other reasons consistent with applicable laws, regulations, and GCP. Study termination may 
occur in a specific country or region when baricitinib is approved for the treatment of AA and 
becomes reimbursed or commercially available in that country or region, or a negative regulatory 
action or opinion is received in that country or region. 
4.3.4. 
Appendix 3.4. 
Publication Policy  
The publication policy for Study JAHO is described in the Clinical Trial Agreement. 
 
 
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4.4. 
Appendix 4. Hepatic Monitoring Tests for Treatment-Emergent 
Abnormality  
Selected tests may be obtained in the event of a treatment-emergent hepatic abnormality and may 
be required in follow-up with patients in consultation with the Lilly, its designee, or the CRP. 
Hepatic Monitoring Tests 
Hepatic Hematologya 
Haptoglobina 
Hemoglobin 
 
Hematocrit 
Hepatic Coagulationa 
Erythrocyte count (RBC) 
Prothrombin Time 
Leukocytes (WBC) 
Prothrombin Time, INR 
Neutrophils, segmented 
 
Lymphocytes 
Hepatic Serologiesa,b 
Monocytes 
Hepatitis A antibody, total 
Eosinophils 
Hepatitis A antibody, IgM 
Basophils 
Hepatitis B surface antigen 
Platelets 
Hepatitis B surface antibody 
 
Hepatitis B Core antibody 
Hepatic Chemistrya 
Hepatitis C antibody 
Total bilirubin 
Hepatitis E antibody, IgG 
Direct bilirubin 
Hepatitis E antibody, IgM 
Alkaline phosphatase 
 
ALT 
Anti-nuclear antibodya 
AST 
 
GGT 
Alkaline Phosphatase Isoenzymesa 
CPK 
 
 
 
Anti-smooth muscle antibody (or anti-actin 
antibody)a 
Abbreviations: ALT = alanine aminotransferase; AST = aspirate aminotransferase; CPK = creatinine phosphokinase; 
GGT = gamma-glutamyl transferase; Ig = immunoglobulin; INR = international normalized ratio; RBC = red 
blood cell; WBC = white blood cell. 
a Assayed by Lilly-designated or local laboratory. 
b Reflex/confirmation dependent on regulatory requirements and/or testing availability. 
 
 
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4.5. 
Appendix 5. Liver Function Testing and Hepatic Safety Monitoring  
Liver Function Testing and Hepatic Safety Monitoring 
Analyte 
Exclusion 
Criteria 
Additional 
Hepatic 
Testing 
Hepatic eCRF 
Reporting 
Temporary 
Interruption 
of IP 
Permanent 
Discontinuation of IP after 
Consultation with the 
Lilly-Designated Medical 
Monitor 
Protocol 
Section 
Section 6.2 
Section 9.4.10.1 
Section 9.4.10.1 
Section 8.1.1 
Section 8.1.1 
ALT/AST 
≥2 × ULN 
As per protocol 
only ALT 
>3 × ULN 
As per protocol 
only ALT 
≥5 × ULN on 
≥2 consecutive 
tests 
≥5 × ULN 
 
>8 × ULN 
 
>5 × ULN for >2 
weeks 
 
>3 × ULN AND TBL 
>2 × ULN or INR >1.5 
 
>3 × ULN with 
symptomsa 
ALP 
≥2 × ULN 
≥2 × ULN 
≥2 × ULN on 
≥2 consecutive 
tests 
No applicable 
criteria 
 
>3 × ULN 
 
>2.5 × ULN AND TBL 
>2 × ULN 
 
>2.5 × ULN with 
symptomsa 
TBL 
≥1.5 × ULN ≥2 × ULN 
≥2 × ULN 
(excluding 
Gilbert’s 
syndrome) 
No applicable 
criteria 
 
ALT or AST (as per 
protocol) >3 × ULN 
AND TBL >2 × ULN 
 
ALP >2.5 × ULN AND 
TBL >2 × ULN 
Abbreviations: ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; 
eCRF = electronic case report form; INR = international normalized ratio; IP = investigational product; 
TBL = total bilirubin level; ULN = upper level of normal. 
a Fatigue, nausea, vomiting, right upper-quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%). 
 
 
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4.6. 
Appendix 6. Provisions for Changes in Study Conduct During 
Exceptional Circumstances  
Implementation of this appendix 
The changes to procedures described in this appendix are temporary measures intended to be 
used only during specific time periods as directed by the sponsor in partnership with the 
investigator. 
Exceptional circumstances 
Exceptional circumstances are rare events that may cause disruptions to the conduct of the study. 
Examples include pandemics or natural disasters. These disruptions may limit the ability of the 
investigators, participants, or both to attend on-site visits or to conduct planned study procedures. 
Implementing changes under exceptional circumstances 
In an exceptional circumstance, after receiving the sponsor’s written approval, sites may 
implement changes if permitted by local regulations. 
After approval by local ERBs, regulatory bodies and any other relevant local authorities, the 
implementation of these exceptional circumstances changes will not typically require additional 
notification to these groups, unless they have specific conditions in which notification is 
required. To protect the safety of study participants, urgent changes may be implemented before 
approval but need to be reported as soon as possible. All approvals must be retained in the study 
records. 
In the event written approval is granted by the sponsor for changes in study conduct, additional 
written guidance, if needed, will be provided by the sponsor. 
Considerations for making a change 
The prevailing consideration for making a change is ensuring the safety of study participants. 
Additional important considerations for making a change are compliance with Good Clinical 
Practice, enabling participants to continue safely in the study and maintaining the integrity of the 
study. 
Informed Consent 
The site should document the participant’s verbal consent for having remote visits and remote 
dispensing of IP, ancillaries, prior to the implementation of these activities. 
Additional consent from the participant will be obtained, if required, for: 
 participation in remote visits, as defined in Section “Remote Visits” 
 a change in the method, location, or both, of study intervention administration 
 dispensation of additional study intervention during an extended treatment period 
 alternate delivery of study intervention and ancillary supplies, and 
 provision of their personal or medical information required prior to implementation of 
these activities. 
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Changes in Study Conduct During Exceptional circumstances 
Changes in study conduct not described in this appendix, or not consistent with applicable local 
regulations, are not allowed. 
The following changes in study conduct will not be considered protocol deviations. 
1. Remote visits 
Visit 11 (Week 52) requires a live clinical assessment because it is the primary outcome 
visit. To facilitate an onsite visit, the visit window may be extended (see below in 
Adjustment to Visit Windows of this appendix). 
All other visits may be conducted remotely if the visit could not otherwise be conducted 
due to local or national restrictions. 
In source documents and the CRF, the study site should capture the visit location and method, 
with a specific explanation for any data missing because of missed in-person site visits. 
Telemedicine: Live, onsite clinical efficacy assessments are preferred for ALL visits. However, 
if a remote visit is the only option, telephone or technology-assisted virtual visits, or both, are 
acceptable to complete appropriate assessments (with the exception of Visit 11). Assessments to 
be completed in this manner include: 
 PRO Scalp, SALT Score, and ClinROs for Eyebrows/Eyelashes if Visual 
Assessment by telemedicine is possible. If NO visual assessment AND ONLY 
verbal assessment by phone is possible. SALT, ClinROs for Eyelash/Eyelash 
should not be assessed. 
 AEs and product complaints 
 concomitant medications 
 C-SSRS (Since Last Visit Version) 
 Photos should be captured at next onsite visit after a remote V8 or V11/ET 
Regardless of the type of remote visits implemented, the protocol requirements regarding the 
reporting of AEs, SAEs, and product complaints remain unchanged. Furthermore, every effort 
should be made to enable participants to return to on-site visits as soon as reasonably possible, 
while ensuring the safety of both the participants and the site staff. 
2. Local laboratory testing option 
Local laboratory testing may be conducted in lieu of central laboratory testing. The local 
laboratory must be qualified in accordance with applicable local regulations. 
 Obtain local labs for safety (hematology, chemistry) and urine pregnancy when 
applicable, as per the study protocol schedule of activities. 
 A urine pregnancy test should be sent to female patients of child bearing potential. 
The patient should conduct the test and provide the verification of results to the site 
per a method agreed to between the patient and the site. Investigational product must 
be temporarily held until site can review photo of pregnancy test results. 
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 All labs will be reviewed by the investigators. Lilly Medical should be informed of 
any labs that meet criteria for temporary or permanent study drug discontinuation. 
 Sign and date review of local labs per normal process and follow-up with the patient 
as needed. Results will not be recorded in the eCRF. 
 Safety labs should be obtained at a minimum of every 12 weeks and IP should not be 
dispensed until these can be collected and reviewed. 
3. Study intervention and ancillary supplies 
When a participant is unable to go to the site to receive study supplies during normal on-site 
visits, the site should work with the sponsor to determine appropriate actions. These actions 
may include: 
 asking the participant to go to the site and receive study supplies from site staff 
without completion of a full study visit 
 asking the participant’s designee to go to the site and receive study supplies on a 
participant’s behalf, and 
 arranging delivery of study supplies. 
These requirements must be met before action is taken: 
 Sponsor approves the alternative method of delivery, taking local regulatory 
requirements into consideration. 
 Participant consents verbally to alternate method of delivery. 
 Site confirms the participant’s receipt of the trial supplies. 
 Site/sponsor confirms appropriate ethics review board notification. 
 Alternate delivery of IP should be performed in a manner that does not compromise 
treatment blinding and ensures product integrity. The existing protocol requirements 
for product accountability remain unchanged, including the verification of 
participant’s receipt of study supplies. 
 When delivering supplies to a location other than the study site (for example, 
participant’s home), the investigator, sponsor, or both should ensure oversight of the 
shipping process to ensure accountability and product quality (that is, storage 
conditions maintained and intact packaging upon receipt). 
 Instructions may be provided to the participant or designee on the final disposition of 
any unused or completed study supplies. 
4. Screening period guidance 
Not Applicable 
5. Adjustments to visit windows 
Whenever possible and safe to do so, as determined by the investigator’s discretion, 
participants should complete the usual Schedule of Activities. To maximize the possibility 
that these visits can be conducted as on-site visits, the windows for visits may be adjusted, 
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upon further guidance from the sponsor. This minimizes missing data and preserves the 
intended conduct of the study. 
This table describes the allowed adjustments to visit windows. 
Visit Number 
Tolerance 
Visits 11 
Visits 11 (Week 52) may be conducted within 7 days before 
the intended date, or up to 28 days after the intended date 
All other Visits 
All other visits should be conducted as per the visit window 
the stated in the Schedule of Activities in Section 2.2 
 
Documentation 
Changes to study conduct will be documented: 
 Sites will identify and document the details of how participants, visit types, and 
conducted activities were affected by exceptional circumstances. 
Dispensing/shipment records of study intervention and relevant communications, 
including delegation, should be filed with site study records. 
 Source documents generated at a location other than the study site should be part of 
the investigator’s source documentation and should be transferred to the site in a 
secure and timely manner. 
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