An Open-Label, 24-Week Study to Investigate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color
Phase: PHASE3
Conditions: Atopic Dermatitis
Sponsor: Eli Lilly and Company

Protocol J2T-MC-KGBP(c)
An Open-Label, 24-Week Study to Investigate the Safety and Efficacy of Lebrikizumab in Adult 
and Adolescent Participants with Moderate-to-Severe Atopic Dermatitis and Skin of Color
NCT05372419   
Approval Date: 29-Sep-2023 

CONFIDENTIAL 
J2T-MC-KGBP(c) 
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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 lebrikizumab (LY3650150), 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: 
An Open-Label, 24-Week Study to Investigate the Safety and Efficacy of Lebrikizumab in Adult 
and Adolescent Participants with Moderate-to-Severe Atopic Dermatitis and Skin of Color 
Protocol Number: J2T-MC-KGBP 
Amendment Number: c 
Compound: lebrikizumab (LY3650150) 
Brief Title: 
A Study to Assess the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants 
with Moderate-to-Severe Atopic Dermatitis and Skin of Color 
Study Phase: 3b 
Sponsor Name: Eli Lilly and Company 
Legal Registered Address: Indianapolis, Indiana, USA 46285 
Regulatory Agency Identifier Number: 
IND: 119866 
Approval Date: Protocol Amendment (c) Electronically Signed and Approved by Lilly on date 
provided below. 
Document ID: VV-CLIN-093431 
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Medical Monitor Name and Contact Information will be provided separately. 
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Protocol Amendment Summary of Changes Table  
 
DOCUMENT HISTORY 
Document 
Date 
Amendment b 
27-Apr-2023 
Amendment a 
12-Oct-2022 
Original Protocol 
15-Aug-2022 
Amendment [c]  
Overall Rationale for the Amendment: 
The main rationale for this amendment is to update the number of trial participants.  
Section # and Name 
Description of 
Change 
Brief Rationale 
1.1. Synopsis, 1.2. Schema, 
and 4.1. Overall Design 
Modified the 
enrollment goal to 
approximately 95 
participants 
To enable exploratory biomarker 
analyses  
9.5. Sample Size 
Determination 
Added rationale for 
increase in study 
participant 
enrollment 
10.11. Appendix 11: 
Abbreviations and Definitions 
Added definition for 
“SoA” 
Clarification 
10.12. Appendix 12: Protocol 
Amendment History 
Added amendment 
(b) summary of 
changes table 
To update the amendment history 
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Table of Contents  
1. 
Protocol Summary ..........................................................................................................8 
1.1. 
Synopsis ............................................................................................................................8 
1.2. 
Schema ............................................................................................................................12 
1.3. 
Schedule of Activities (SoA) ..........................................................................................13 
2. 
Introduction ...................................................................................................................21 
2.1. 
Study Rationale ...............................................................................................................21 
2.2. 
Background .....................................................................................................................21 
2.3. 
Benefit/Risk Assessment ................................................................................................24 
3. 
Objectives, Endpoints, and Estimands .......................................................................26 
4. 
Study Design ..................................................................................................................30 
4.1. 
Overall Design ................................................................................................................30 
4.2. 
Scientific Rationale for Study Design ............................................................................30 
4.2.1. 
Participant Input into Design ..........................................................................................31 
4.3. 
Justification for Dose ......................................................................................................31 
4.4. 
End of Study Definition ..................................................................................................31 
5. 
Study Population ...........................................................................................................32 
5.1. 
Inclusion Criteria ............................................................................................................32 
5.2. 
Exclusion Criteria ...........................................................................................................33 
5.3. 
Lifestyle Considerations .................................................................................................35 
5.4. 
Screen Failures ................................................................................................................36 
5.4.1. 
Rescreening for Individuals Who Failed Screening .......................................................36 
5.5. 
Criteria for Temporarily Delaying Enrollment/Administration of 
Study Intervention of a Participant .................................................................................36 
6. 
Study Intervention(s) and Concomitant Therapy .....................................................37 
6.1. 
Study Intervention(s) Administered................................................................................37 
6.1.1. 
Medical Devices..............................................................................................................37 
6.2. 
Preparation, Handling, Storage, and Accountability ......................................................37 
6.3. 
Measures to Minimize Bias: Randomization and Blinding ............................................38 
6.4. 
Study Intervention Compliance ......................................................................................38 
6.5. 
Dose Modification ..........................................................................................................38 
6.6. 
Continued Access to Study Intervention after the End of the 
Study ...............................................................................................................................38 
6.7. 
Treatment of Overdose ...................................................................................................39 
6.8. 
Concomitant Therapy .....................................................................................................39 
6.8.1. 
Permitted Treatments and Procedures ............................................................................39 
6.8.2. 
Prohibited Treatments and Procedures ...........................................................................40 
6.8.3. 
Non-Medicated Moisturizers ..........................................................................................41 
6.8.4. 
Topical Treatment for Atopic Dermatitis .......................................................................41 
6.8.5. 
Rescue Medicine for Atopic Dermatitis .........................................................................42 
7. 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal........................................................................................43 
7.1. 
Discontinuation of Study Intervention ............................................................................43 
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7.1.1. 
Liver Chemistry Stopping Criteria ..................................................................................44 
7.1.2. 
Temporary Discontinuation of Study Intervention .........................................................45 
7.2. 
Participant Discontinuation/Withdrawal from the Study ................................................45 
7.3. 
Lost to Follow up ............................................................................................................46 
8. 
Study Assessments and Procedures.............................................................................47 
8.1. 
Efficacy Assessments .....................................................................................................47 
8.1.1. 
Eczema Area and Severity Index ....................................................................................47 
8.1.2. 
Investigator’s Global Assessment (IGA) ........................................................................47 
8.1.3. 
Body Surface Area (BSA) ..............................................................................................48 
8.1.4. 
Face-Investigator’s Global Assessment (F-IGA)............................................................48 
8.1.5. 
Post-inflammatory Dyschromia Scale (PDS) .................................................................48 
8.1.6. 
Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) .....................................48 
8.1.7. 
Pruritus NRS ...................................................................................................................49 
8.1.8. 
Sleep-Loss Scale .............................................................................................................49 
8.1.9. 
Skin Pain Numeric Rating Scale (Skin Pain NRS) .........................................................49 
8.1.10. Patient-Oriented Eczema Measure (POEM) ...................................................................49 
8.1.11. Dermatology Life Quality Index/Children’s Dermatology Life 
Quality Index (DLQI/cDLQI) .........................................................................................49 
8.1.12. Atopic Dermatitis Control Tool (ADCT) .......................................................................50 
8.1.13. Work Productivity and Activity Impairment Questionnaire–
Atopic Dermatitis (WPAI-AD) .......................................................................................50 
8.1.14. Participant-Reported Satisfaction Question ....................................................................50 
8.1.15. Fitzpatrick Skin Phototype Assessment ..........................................................................50 
8.2. 
Safety Assessments .........................................................................................................51 
8.2.1. 
Clinical Safety Laboratory Tests ....................................................................................51 
8.2.2. 
Hepatic Safety .................................................................................................................52 
8.2.3. 
Hepatitis B Testing and Monitoring ...............................................................................54 
8.2.4. 
Hepatitis C Testing .........................................................................................................55 
8.3. 
Adverse Events, Serious Adverse Events, and Product 
Complaints ......................................................................................................................55 
8.3.1. 
Timing and Mechanism for Collecting Events ...............................................................56 
8.3.2. 
Pregnancy ........................................................................................................................57 
8.3.3. 
Adverse Events of Special Interest .................................................................................59 
8.3.4. 
Facial Dermatitis .............................................................................................................59 
8.3.5. 
Hypersensitivity ..............................................................................................................59 
8.3.6. 
Injection Site Reactions ..................................................................................................59 
8.4. 
Pharmacokinetics ............................................................................................................60 
8.5. 
Pharmacodynamics .........................................................................................................60 
8.6. 
Genetics ..........................................................................................................................60 
8.7. 
Biomarkers ......................................................................................................................60 
8.8. 
Immunogenicity Assessments.........................................................................................60 
8.9. 
Health Economics ...........................................................................................................61 
9. 
Statistical Considerations .............................................................................................62 
9.1. 
Statistical Hypotheses .....................................................................................................62 
9.2. 
Analyses Sets ..................................................................................................................62 
9.3. 
Statistical Analyses .........................................................................................................62 
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9.3.1. 
General Considerations ...................................................................................................62 
9.3.2. 
Primary Endpoint(s)/Estimand(s) Analysis ....................................................................63 
9.3.3. 
Secondary Endpoint(s)/Estimand(s) Analysis ................................................................63 
9.3.4. 
Exploratory Endpoint(s) Analysis...................................................................................63 
9.3.5. 
Safety Analyses ...............................................................................................................63 
9.3.6. 
Other Analyses ................................................................................................................63 
9.4. 
Interim Analysis ..............................................................................................................64 
9.5. 
Sample Size Determination ............................................................................................64 
10. 
Supporting Documentation and Operational Considerations ..................................66 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations ................................................................................................................66 
10.1.1. Regulatory and Ethical Considerations ...........................................................................66 
10.1.2. Financial Disclosure........................................................................................................66 
10.1.3. Informed Consent Process ..............................................................................................67 
10.1.4. Data Protection................................................................................................................67 
10.1.5. Dissemination of Clinical Study Data.............................................................................68 
10.1.6. Data Quality Assurance ..................................................................................................68 
10.1.7. Source Documents ..........................................................................................................70 
10.1.8. Study and Site Start and Closure ....................................................................................70 
10.1.9. Publication Policy ...........................................................................................................71 
10.1.10. Investigator Information .................................................................................................71 
10.1.11. Sample Retention ............................................................................................................71 
10.2. 
Appendix 2: Clinical Laboratory Tests ...........................................................................72 
10.2.1. Laboratory Samples to be Obtained at the Time of a Systemic 
Hypersensitivity Event ....................................................................................................74 
10.3. 
Appendix 3: Adverse Events and Serious Adverse Events: 
Definitions and Procedures for Recording, Evaluating, Follow-
up, and Reporting ............................................................................................................76 
10.3.1. Definition of AE .............................................................................................................76 
10.3.2. Definition of SAE ...........................................................................................................77 
10.3.3. Definition of Product Complaints ...................................................................................78 
10.3.4. Recording and Follow-Up of AE and/or SAE and Product 
Complaints ......................................................................................................................79 
10.3.5. Reporting of SAEs ..........................................................................................................81 
10.3.6. Regulatory Reporting Requirements ...............................................................................81 
10.4. 
Appendix 4: Contraceptive and Barrier Guidance ..........................................................82 
10.4.1. Definitions.......................................................................................................................82 
10.4.2. Contraception Guidance..................................................................................................82 
10.5. 
Appendix 5: Genetics......................................................................................................85 
10.6. 
Appendix 6: Liver Safety: Suggested Actions and Follow-up 
Assessments ....................................................................................................................86 
10.7. 
Appendix 7: American Academy of Dermatology: Criteria for 
the Diagnosis and Assessment of Atopic Dermatitis ......................................................88 
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10.8. 
Appendix 8: Medical Device Adverse Events (AEs), Adverse 
Device Effects (ADEs), Serious Adverse Events (SAEs) and 
Device Deficiencies: Definition and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ............................................................................89 
10.9. 
Appendix 9: Examples of Infections That May Be Considered 
Opportunistic in the Setting of Biologic Therapy ...........................................................90 
10.10. 
Appendix 10: Provisions for Changes in Study Conduct During 
Exceptional Circumstances .............................................................................................92 
10.11. 
Appendix 11: Abbreviations and Definitions .................................................................94 
10.12. 
Appendix 12: Protocol Amendment History ..................................................................98 
11. 
References ....................................................................................................................101 
 
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1. 
Protocol Summary  
1.1. 
Synopsis  
Protocol Title: 
An Open-Label, 24-Week Study to Investigate the Safety and Efficacy of Lebrikizumab in Adult 
and Adolescent Participants with Moderate-to-Severe Atopic Dermatitis and Skin of Color 
Brief Title: 
A Study to Assess the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants 
with Moderate-to-Severe Atopic Dermatitis and Skin of Color 
Rationale: 
Atopic dermatitis (AD) is a chronic heterogeneous inflammatory disorder caused by skin barrier 
dysfunction and dysregulation of the immune response. In patients with AD, IL-13, a central 
pathogenic mediator in the disease, is overexpressed, driving multiple aspects of AD 
pathophysiology by promoting T-helper Type 2 (Th2) cell inflammation and resulting in skin 
barrier dysfunction, itch, infection, and lichenification. There is a paucity of data to guide 
diagnosis and treatment in populations traditionally under-represented in clinical trials, including 
patients with skin of color (Price et al. 2021; Chen et al. 2021). Compounding this issue is the 
complexity of diagnosing moderate-to-severe AD in this patient population, partially due to 
historical lack of representation in medical education resources and in some cases, limited 
exposure to patients with skin of color in medical training (Ebede et al. 2005; Adelekun et al. 
2020; Ibraheim et al. 2021; Kurtti et al. 2022). The nuances of identifying erythema in patients 
with skin of color not only affect the accurate and timely diagnosis of AD but also confound the 
use of AD scales commonly used in clinical trials (Zhao et al. 2015). The aforementioned 
challenges may also delay the use of systemic therapies. 
Phase 3 studies have demonstrated that lebrikizumab is effective in treating participants with 
moderate-to-severe AD. Subgroup analyses have shown that the efficacy is comparable in 
participants of African or Asian descent. This study will complement these findings with a focus 
on patients with skin of color, will include objectives and endpoints commonly evaluated in AD 
clinical trials, and will additionally evaluate novel endpoints, including face-Investigator’s 
Global Assessment (F-IGA), Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD), 
Post-inflammatory Dyschromia Scale (PDS), and AD-related changes in erythema, 
hypopigmentation, and hyperpigmentation. 
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Objectives, Endpoints, and Estimands: 
Objectives 
Endpoints 
Primary 
 
 
To assess the effect of lebrikizumab 250 mg 
Q2W in reducing the signs and symptoms of 
AD in participants with moderate-to-severe 
AD and skin of color  
 
Percentage of participants achieving EASI-75 
(≥75% reduction from baseline in EASI) at 
Week 16  
Secondary 
 
 
To evaluate the effect of treatment with 
lebrikizumab in the signs and symptoms of 
AD and health outcome measures, in 
participants with moderate-to-severe AD and 
skin of color  
 
Percentage of participants achieving EASI-75 at 
Week 24 
 
Percentage of participants with an IGA score of 0 
or 1 and a reduction ≥2 points from baseline to 
Weeks 16 and 24 
 
Percentage change in EASI total from baseline to 
Weeks 16 and 24 
 
Change in EASI total from baseline to Weeks 16 
and 24 
 
Percentage of participants achieving EASI 90 at 
Weeks 16 and 24 
 
Percentage of participants with a Pruritus NRS of 
≥4 points at baseline who achieve a 4-point 
reduction at Weeks 16 and 24 
 
Percentage of participants with a Pruritus NRS 
≥3 points at baseline who achieve at least 3-point 
reduction at Weeks 16 and 24 
 
Percentage change in Pruritus NRS score from 
baseline to Weeks 16 and 24 
 
Percentage of participants with a Sleep-Loss Scale 
score of ≥2 points at baseline who achieve a 
2-point reduction at Weeks 16 and 24 
 
Percentage change in Sleep-Loss Scale score from 
baseline to Weeks 16 and 24 
 
Percentage of participants with a Skin Pain NRS of 
≥4 points at baseline who achieve a 4-point 
reduction from baseline to Weeks 16 and 24 
 
Change in POEM from baseline to Weeks 16 and 
24 
 
Change in DLQI from baseline to Weeks 16 and 
24 in participants ≥ 16 years at baseline 
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 
Change in cDLQI from baseline to Weeks 16 and 
24 in participants < 16 years at baseline  
 
Percentage of participants with a DLQI of 
≥4 points at baseline who achieve a ≥4-point 
improvement in DLQI at Weeks 16 and 24 in 
participants ≥16 years at baseline 
Abbreviations: AD = atopic dermatitis; cDLQI = Children’s DLQI; DLQI = Dermatology Life Quality Index; EASI 
= Eczema Area and Severity Index; IGA = Investigator’s Global Assessment; NRS = numeric rating scale; 
POEM = Patient-Oriented Eczema Measure; Q2W = once every 2 weeks. 
NOTE: Endpoints in the table above collected by visit references data collection visits. 
Primary estimand 
The primary clinical question of interest is: What is the intervention effect in percentage of 
participants achieving at least 75% improvement from baseline in Eczema Area and Severity 
Index (EASI) after 16 weeks of lebrikizumab 250 mg Q2W intervention in participants with skin 
of color and moderate-to-severe AD who remain on study treatment until Week 16. 
The estimand is described by the following attributes: 
Population: participants with skin of color and moderate-to-severe AD who met inclusion and 
exclusion criteria and who remained on study treatment until Week 16. Further details can be 
found in Section 5. 
Endpoint: whether participants achieve at least 75% improvement from baseline in EASI at 
Week 16. 
Intercurrent events: There are no intercurrent events for this population since participants who 
initiate rescue medication are discontinued from the study and hence study treatment. Therefore, 
participants who stay on study treatment through Week 16 will not have an intercurrent event 
such as initiating rescue medication or permanently discontinuing treatment. 
Population-level summary: percentage of participants achieving EASI 75 response at Week 16. 
 
Secondary estimand(s) 
There is no secondary estimand planned at this stage; however, additional estimands might be 
specified in the statistical analysis plan. 
Overall Design: 
Study J2T-MC-KGBP (KGBP) is a single group treatment, open-label, Phase 3b study, which is 
24 weeks in treatment duration. The study is designed to evaluate the safety and efficacy of 
lebrikizumab in adolescent and adult participants with skin of color and moderate-to-severe AD. 
During the 24-week Treatment Period, approximately 95 participants will receive treatment.  
 500 mg subcutaneous (SC) once every 2 weeks (Q2W) loading dose at baseline and 
Week 2, followed by 250 mg SC Q2W until Week 16. 
 Responders, defined as achieving IGA (0,1) or EASI-75 at Week 16, will receive 
250 mg SC once every 4 weeks (Q4W). 
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 Inadequate responders at Week 16 will continue to receive 250 mg SC Q2W. 
Brief Summary: 
The purpose of this study is to measure percentage of participants achieving EASI-75 at Week 
16 with lebrikizumab in adolescent and adult participants with skin of color and moderate-to-
severe AD. 
Study details include 
● The planned study duration will be up to 38 weeks. 
● The treatment duration will be up to 24 weeks. 
● The visit frequency will be every 2 weeks for the first 2 visits, then every 4 weeks 
thereafter. 
Number of Participants: 
Approximately 95 participants will be enrolled to study intervention. Because the inclusion of 
Black and African American patients is historically limited in clinical trials and given the focus 
of skin of color in this study, the majority of the patients in this study will be of Black or African 
American race (approximately 55 participants). The remainder of the participants may be of any 
race other than White, with enrollment of up to 10% Asian participants. 
Intervention Groups and Duration: 
Lebrikizumab drug product is provided as sterile liquids and contain no preservatives. 
Intervention Name 
Lebrikizumab 
Dose Formulation 
250 mg (125 mg/mL), 2 mL Solution 
Dosage Level 
Loading Dose: 
Week 0: 500 mg (2 injections of 250 mg) 
Week 2: 500 mg (2 injections of 250 mg) 
 
Post-loading dose: 
Week 4-16: 250 mg SC Q2W (1 injection of 250 mg) 
Responders at Week 16: 250 mg SC Q4W (1 injection of 250 mg) at W20 
Inadequate responders at Week 16: 250 mg SC Q2W (1 injection of 250 mg) 
at W18, W20, and W22 
Route of Administration 
SC 
Abbreviations: mg = milligram; mL = milliliter; SC = subcutaneously; Q2W = once every 2 weeks; Q4W = once 
every 4 weeks; W = week. 
 
Data Monitoring Committee: No 
 
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1.2. 
Schema  
 
 
Abbreviations: EASI = Eczema Area and Severity Index; IGA = Investigator’s Global Assessment; n = number; Q2W = once every 2 weeks; Q4W = once every 
4 weeks; SC = subcutaneous; W = week. 
a Weeks 12 and 20 are phone visits. 
b 30-day screening window. 
c Lebrikizumab loading dose of 500 mg SC will be administered at baseline and Week 2. 
d Responders: Participants who reach IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75). Inadequate responders 
are participants who do not reach these criteria. 
e The safety follow-up visit will occur approximately 12 weeks after last study intervention injection. 
 
 
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1.3. 
Schedule of Activities (SoA)  
  
Period I 
Period II 
Period III 
Comments 
 
Screening 
Baseline 
Treatment Period 
Post-
treatment 
Follow-Up 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
ED 
801 
  
Week Relative to Study 
Drug Start 
≤30 (days) 
0 
2 
4 
8 
12 
16 
20 
24 
— 
12 weeks post 
last dose 
  
Visit Interval Tolerance 
(Days) 
  
— 
±3 
±3 
±5 
±5 
±5 
±5 
±5 
— 
±7 
  
Visit Detail 
  
  
  
  
  
T 
  
T 
  
  
  
 
Informed consent and 
assent 
X 
  
  
  
  
  
  
  
  
  
  
The informed consent must be signed before any 
protocol-specific tests or procedures are 
performed. 
Parent or legally authorized representative signs 
ICF as appropriate per local requirements. 
Assent will be collected as specified by ethics 
board. See Section 10.1.3 for additional details. 
Inclusion and exclusion 
criteria, review and 
confirm 
X 
X 
  
  
  
  
  
  
  
  
  
Inclusion or exclusion criteria should be confirmed 
prior to drug assignment and administration of first 
dose of study intervention.  
Demographics 
X 
  
  
  
  
  
  
  
  
  
  
Includes 
 
ethnicity, sex, and race 
 
full date of birth for participants 12-17 
years of age, and 
 
year of birth for participants ≥18 years 
of age. 
Preexisting conditions 
and medical history, 
including relevant 
surgical history 
X 
  
  
  
  
  
  
  
  
  
  
All conditions ongoing and relevant past surgical 
and medical history should be collected.  
Prespecified medical 
history (indication and 
history of interest)  
X 
  
  
  
  
  
  
  
  
  
  
Additional data for the indication and 
comorbidities of interest are collected (including 
conjunctivitis and facial dermatitis). 
Record prior treatments 
for indication 
X 
  
  
  
  
  
  
  
  
  
  
Includes medications and therapies for AD. 
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Period I 
Period II 
Period III 
Comments 
 
Screening 
Baseline 
Treatment Period 
Post-
treatment 
Follow-Up 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
ED 
801 
  
Week Relative to Study 
Drug Start 
≤30 (days) 
0 
2 
4 
8 
12 
16 
20 
24 
— 
12 weeks post 
last dose 
  
Visit Interval Tolerance 
(Days) 
  
— 
±3 
±3 
±5 
±5 
±5 
±5 
±5 
— 
±7 
  
Visit Detail 
  
  
  
  
  
T 
  
T 
  
  
  
 
Review immunization 
record 
X 
  
  
  
  
  
  
  
  
  
  
The investigator should review the vaccination 
status of each pediatric participant <18 years of 
age to assess if the participant is up to date with 
immunizations following the local guidelines for 
vaccination with vaccines intended to prevent 
infectious disease prior to enrolling participants 
into the study. 
For participants who are under-vaccinated, the 
investigator should document the benefit or risk 
rationale for enrolling the participants in the study. 
Review menarche status 
with date of menarche, if 
applicable 
X 
X 
X 
X 
X 
  
X 
  
X 
X 
  
For participants <18 years of age. 
If the participant reaches menarche at any time 
during the trial and is sexually active, pregnancy 
testing and contraception requirements will apply. 
See Section 10.4, Appendix 4.  
Concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
AEs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Any events that occur after signing the ICF or 
assent are considered AEs as defined in Section 
10.3, Appendix 3. For AESIs, additional data 
could be collected (Section 8.3.3). 
Physical Evaluation 
Height 
X 
 
  
  
  
  
 
  
X 
 
  
  
Weight 
X 
X 
 
 
 
  
X 
  
X 
X 
  
  
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Period I 
Period II 
Period III 
Comments 
 
Screening 
Baseline 
Treatment Period 
Post-
treatment 
Follow-Up 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
ED 
801 
  
Week Relative to Study 
Drug Start 
≤30 (days) 
0 
2 
4 
8 
12 
16 
20 
24 
— 
12 weeks post 
last dose 
  
Visit Interval Tolerance 
(Days) 
  
— 
±3 
±3 
±5 
±5 
±5 
±5 
±5 
— 
±7 
  
Visit Detail 
  
  
  
  
  
T 
  
T 
  
  
  
 
Vital signs 
X 
X 
 
 
 
  
X 
  
X 
X 
  
Includes pulse rate, blood pressure, respiratory 
rate, and temperature. Measured after participant 
has been sitting at least 5 minutes. Use size 
appropriate blood pressure cuff.  
Physical examination 
X 
  
  
  
  
  
  
  
X 
X 
  
The physical examination is performed (excludes 
pelvic and rectal, unless clinically indicated). Full 
skin examination is required for BSA calculation. 
Symptom-directed 
physical assessment 
  
X 
X 
X 
X 
  
X 
  
  
  
X 
As indicated based on participant status and 
standard of care. May be performed by qualified 
personnel per local regulations.  
Participant Diary (Electronic) 
Diary dispensed 
X 
  
  
  
  
  
  
  
  
  
  
Diary includes daily collection of Pruritus NRS, 
Sleep-Loss Scale, and Skin Pain NRS; weekly 
collection of POEM; bi-weekly collection of study 
drug administration information (as applicable). 
TCS usage will be collected daily beginning at V2. 
Pruritus NRS and Sleep-Loss Scale should be 
completed a minimum of 4 of 7 days before 
baseline. 
Review diary for 
completion of PRO and 
TCS assessments  
  
X 
X 
X 
X 
X 
X 
X 
X 
X 
  
For details of these assessments, see Section 8.1. 
Drug administration 
diary compliance check 
  
  
  
  
X 
X 
X 
X 
X 
X 
  
 
Diary return 
  
  
  
  
  
  
  
  
X 
X 
  
  
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Period I 
Period II 
Period III 
Comments 
 
Screening 
Baseline 
Treatment Period 
Post-
treatment 
Follow-Up 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
ED 
801 
  
Week Relative to Study 
Drug Start 
≤30 (days) 
0 
2 
4 
8 
12 
16 
20 
24 
— 
12 weeks post 
last dose 
  
Visit Interval Tolerance 
(Days) 
  
— 
±3 
±3 
±5 
±5 
±5 
±5 
±5 
— 
±7 
  
Visit Detail 
  
  
  
  
  
T 
  
T 
  
  
  
 
PROs (Electronic) 
Complete prior to any clinical administered assessments  
PO-SCORAD 
  
X 
  
  
  
  
X 
  
X 
X 
  
  
DLQI  
  
X 
  
  
  
  
X 
  
X 
X 
  
Only for participants >16 years of age at baseline. 
cDLQI 
  
X 
  
  
  
  
X 
  
X 
X 
  
Only for participants <16 years of age at baseline. 
WPAI-AD 
  
X 
  
  
  
  
X 
  
X 
X 
  
  
ADCT 
  
X 
  
 X 
  
  
X 
  
X 
X 
  
  
Participant-Reported 
Satisfaction Question 
  
 
  
  
  
  
X 
  
X 
X 
  
  
Clinician-Administered Assessments (Electronic) 
IGA 
 X 
X 
X 
X 
X 
  
X 
  
X 
X 
  
  
F-IGA  
  
X 
X  
X 
X  
  
X 
  
X 
X 
  
  
EASI 
 X 
X 
X 
X 
X 
  
X 
  
X 
X 
  
  
BSA 
X 
X 
X 
X 
X 
 
X 
 
X 
X 
 
 
PDS 
  
X 
  
  
  
  
X 
  
X 
X 
  
  
Clinician-Administered Assessments (Paper) 
Fitzpatrick Skin Type 
Assessment 
 X 
 
  
  
  
  
  
  
  
  
  
 
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J2T-MC-KGBP(c) 
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Period I 
Period II 
Period III 
Comments 
 
Screening 
Baseline 
Treatment Period 
Post-
treatment 
Follow-Up 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
ED 
801 
  
Week Relative to Study 
Drug Start 
≤30 (days) 
0 
2 
4 
8 
12 
16 
20 
24 
— 
12 weeks post 
last dose 
  
Visit Interval Tolerance 
(Days) 
  
— 
±3 
±3 
±5 
±5 
±5 
±5 
±5 
— 
±7 
  
Visit Detail 
  
  
  
  
  
T 
  
T 
  
  
  
 
Participant Education and Supplies 
Participant or caregiver 
instructions on diary 
completion 
X 
  
  
  
  
  
  
  
  
  
  
Education can also be performed on an as-needed 
basis.  
Remind participant of 
TCS usage restrictions 
and expectations 
X 
  
  
  
  
  
  
  
  
  
  
Required 2-week wash out of TCS prior to Visit 2. 
See Sections 6.8.1, 6.8.2, and 6.8.5 for TCS usage. 
Train participant and/or 
caregiver on study 
intervention 
administration 
  
  
 X 
X 
  
  
  
  
  
  
  
Participants and/or caregivers need to be 
adequately trained on injection technique prior to 
administering injections. 
Training can be done at Week 2 and/or Week 4 
prior to self-administration.  
Dispense ancillary 
supplies 
  
  
  
X 
X 
  
X 
  
  
  
  
  
Laboratory Tests and Sample Collections 
Hematology 
X 
X 
  
X 
  
  
X 
  
X 
X 
X 
  
Clinical chemistry  
X 
X 
  
  
  
  
X 
  
X 
X 
X 
  
Serum pregnancy 
X 
  
  
  
  
  
  
  
  
  
  
Only for WOCBP. Pregnancy tests prior to first 
dose of study intervention for females ≥12 years of 
age if menarche reached or if there is reason to 
believe the participant is sexually active. 
Pregnancy test results from baseline must be 
known prior to first dose of study intervention. See 
Section 10.4, Appendix 4. 
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Period I 
Period II 
Period III 
Comments 
 
Screening 
Baseline 
Treatment Period 
Post-
treatment 
Follow-Up 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
ED 
801 
  
Week Relative to Study 
Drug Start 
≤30 (days) 
0 
2 
4 
8 
12 
16 
20 
24 
— 
12 weeks post 
last dose 
  
Visit Interval Tolerance 
(Days) 
  
— 
±3 
±3 
±5 
±5 
±5 
±5 
±5 
— 
±7 
  
Visit Detail 
  
  
  
  
  
T 
  
T 
  
  
  
 
Urine pregnancy (local) 
  
X 
  
X 
X 
  
X 
  
X 
X 
 
Collect for WOCBP only. Done locally and prior 
to administering study intervention. Additional 
pregnancy tests, beyond those required per the 
SoA, should be performed at any time during the 
trial if a menstrual period is missed or there is 
clinical suspicion of pregnancy. See Section 10.4, 
Appendix 4. 
If required per local regulations and/or institutional 
guidelines, pregnancy testing can occur at other 
times during the study treatment period. 
HIV screening tests 
X 
  
  
  
  
  
  
  
  
  
  
  
HCV screening tests  
X 
  
  
  
  
  
  
  
  
  
  
If anti-HCV is positive, it must be followed by a 
HCV RNA test. See Section 8.2.4.  
HBV screening tests  
X 
  
  
  
  
  
  
  
  
  
  
Includes testing for HBsAg, HBcAb, and HBsAb. 
HBV DNA 
X 
  
  
  
  
  
X 
  
  
X 
X 
If HBsAg is negative and HBcAb is positive at 
screening, further testing for HBV DNA is 
required. See Section 8.2.3. 
Exploratory biomarkers  
  
X 
  
X 
  
  
X 
  
X 
X 
  
Collect prior to dosing. 
IgE 
  
X 
  
X 
  
  
X 
  
X 
X 
  
Collect prior to dosing. 
PK samples 
 
X 
 
X 
 
 
 
 
X 
X 
 
Samples to be collected prior to dosing. 
If an immediate or nonimmediate systemic drug 
hypersensitivity reaction occurs, in any participant, 
then also collect an additional unscheduled sample 
as detailed in Section 8.4. 
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Period I 
Period II 
Period III 
Comments 
 
Screening 
Baseline 
Treatment Period 
Post-
treatment 
Follow-Up 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
ED 
801 
  
Week Relative to Study 
Drug Start 
≤30 (days) 
0 
2 
4 
8 
12 
16 
20 
24 
— 
12 weeks post 
last dose 
  
Visit Interval Tolerance 
(Days) 
  
— 
±3 
±3 
±5 
±5 
±5 
±5 
±5 
— 
±7 
  
Visit Detail 
  
  
  
  
  
T 
  
T 
  
  
  
 
Immunogenicity (ADA) 
samples 
 
X 
 
X 
 
 
 
 
X 
X 
 
Samples to be collected prior to dosing. 
If an immediate or nonimmediate systemic drug 
hypersensitivity reaction occurs, in any participant, 
then also collect an additional unscheduled sample 
as detailed in Section 10.2.1. 
Stored Samples 
Genetics sample 
  
X 
  
  
  
  
  
  
  
  
  
Sample can be obtained at or after the specified 
visit. 
Exploratory biomarker 
samples  
  
X 
  
X 
  
  
X 
  
X 
X 
  
Collect prior to dosing. 
Registration and Dosing 
Register visit with IWRS 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
  
Dispense study 
intervention via IWRS 
  
X 
X 
X 
X 
  
X 
  
  
  
  
  
Administer study 
intervention in clinic 
  
X 
X 
X 
X 
  
X 
  
  
  
  
Week 0 (Visit 2) and Week 2, dose to be 
administered in the clinic by site.  
Weeks 4, 8, and 16 dosing to be performed in 
clinic administered by site or participant or 
caregiver.  
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Period I 
Period II 
Period III 
Comments 
 
Screening 
Baseline 
Treatment Period 
Post-
treatment 
Follow-Up 
 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
ED 
801 
  
Week Relative to Study 
Drug Start 
≤30 (days) 
0 
2 
4 
8 
12 
16 
20 
24 
— 
12 weeks post 
last dose 
  
Visit Interval Tolerance 
(Days) 
  
— 
±3 
±3 
±5 
±5 
±5 
±5 
±5 
— 
±7 
  
Visit Detail 
  
  
  
  
  
T 
  
T 
  
  
  
 
Dispense study 
intervention to 
participant for at home 
dosing 
  
  
  
X 
X 
  
X 
  
  
  
  
Injections will be administered by participant or 
caregiver at home on Weeks 6, 10, 12, and 14. 
Responders at Week 16 who will receive Q4W 
dose will administer study intervention at 
Week 20. 
Inadequate responders at Week 16 who will 
receive Q2W dosing will administer study 
intervention at Weeks 18, 20, and 22. 
Observe participant or 
caregiver administer 
study intervention in 
clinic 
  
  
  
X 
  
  
  
  
  
  
  
  
Participant returns study 
intervention and 
injection supplies 
  
  
  
  
X 
  
X 
  
X 
X 
  
If study intervention was administered at home by 
participant, the injection supplies should be saved 
and returned at the next on-site visit. 
Assess study 
intervention compliance 
 
 
 
 
X 
 
X 
 
X 
 
 
 
Abbreviations: AD = atopic dermatitis; ADA = anti-drug antibody; ADCT = atopic dermatitis control tool; AE = adverse event; AESI = adverse event of special 
interest; BSA = body surface area; cDLQI = Children’s Dermatology Life Quality Index; DLQI = Dermatology Life Quality Index; DNA = deoxyribonucleic 
acid; EASI = Eczema Area and Severity Index; ED = early discontinuation; F-IGA = Face-IGA; HBcAb = hepatitis B core antibody; HBsAb = hepatitis B 
surface antibody; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; 
ICF = informed consent form; IGA = investigator global assessment; IgE = immunoglobulin E; IWRS = interactive web-response system; NRS = numeric 
rating scale; PDS = Post-inflammatory Dyschromia Scale; PO-SCORAD = Patient-Oriented SCORing Atopic Dermatitis; POEM = Patient-Oriented Eczema 
Measure; PRO = patient-reported outcome; Q2W = once every 2 weeks; Q4W = once every 4 weeks; SoA = schedule of activities; T = telephone; TCS = 
topical corticosteroids; WOCBP = women of child-bearing potential; WPAI-AD = Work Productivity and Activity Impairment Questionnaire - Atopic 
Dermatitis. 
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J2T-MC-KGBP(c) 
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2. 
Introduction  
Lebrikizumab (LY3650150) is a monoclonal antibody based on the immunoglobulin G4 (IgG4) 
antibody stabilized by a mutated Fc region. Lebrikizumab binds with high affinity specifically to 
soluble interleukin (IL)-13 and blocks IL-13 signaling through the IL-4 receptor alpha (IL-
4R)/IL-13 receptor alpha 1 (IL-13R1) pathway, thereby preventing the downstream effects of 
human IL-13 with high potency. Blockade of IL-13 signaling is expected to be of benefit in 
diseases in which IL-13 is a key contributor to the disease pathogenesis. 
2.1. 
Study Rationale  
Atopic dermatitis (AD) is a chronic heterogeneous inflammatory disorder caused by skin barrier 
dysfunction and dysregulation of the immune response. In patients with AD, IL-13, a central 
pathogenic mediator in the disease, is overexpressed, driving multiple aspects of AD 
pathophysiology by promoting T-helper Type 2 (Th2) cell inflammation and resulting in skin 
barrier dysfunction, itch, infection, and lichenification. There is a paucity of data to guide 
diagnosis and treatment in populations traditionally under-represented in clinical trials, including 
patients with skin of color (Price et al. 2021; Chen et al. 2021). Compounding this issue is the 
complexity of diagnosing moderate-to-severe AD in this patient population, partially due to 
historical lack of representation in medical education resources and in some cases, limited 
exposure to patients with skin of color in medical training (Ebede et al. 2005; Adelekun et al. 
2020; Ibraheim et al. 2021; Kurtti et al. 2022). Finally, the nuances of identifying erythema in 
patients with skin of color not only affect the accurate and timely diagnosis of AD but also 
confound the use of AD scales commonly used in clinical trials (Zhao et al. 2015). 
Phase 3 studies have demonstrated that lebrikizumab is effective in treating participants with 
moderate-to-severe AD. Subgroup analyses have shown that the efficacy is comparable in 
participants of African and Asian descent; however, lebrikizumab clinical studies dedicated to 
skin of color participants have not been conducted to date. 
This study aims to complement the Phase 3 findings with a focus on patients with skin of color, 
will include objectives and endpoints commonly evaluated in AD clinical trials, and will 
additionally evaluate novel endpoints, including face-Investigator’s Global Assessment (F-IGA), 
Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD), Post-inflammatory Dyschromia 
Scale (PDS), and AD-related changes in erythema, hypopigmentation, and hyperpigmentation. 
Data on racial subgroups are generally reported in clinical trials; however, the race definition 
may not capture skin of color population appropriately. The results from this study will provide 
important scientific insights in interpreting the clinical response in this rigorously defined skin of 
color population compared to those reported from race-based post hoc subgroup analyses. 
2.2. 
Background  
Atopic dermatitis is a complex heterogeneous disease that is determined by genetic, 
environmental, and immunologic factors (Werfel et al. 2016; Simon et al. 2019). Genetic studies 
of AD (Bieber 2012; Auriemma et al. 2013; Weidinger et al. 2018) have shown that genes 
encoding for cytokines involved in the regulation of the immune system (IL-4, IL-5, and IL-13) 
are strongly associated with the development of AD (Novak et al. 2002; He et al. 2003; 
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J2T-MC-KGBP(c) 
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Hummelshoj et al. 2003). In addition, variants of genes that encode for proteins involved in skin 
barrier function, such as filaggrin (FLG) and loricrin (LOR), are also associated with AD (Van 
Bever and Llanora 2011). 
Reduced epithelial barrier function, which represents the first line of protection against the 
environment, is thought to lead to sensitization to environmental allergens, associated with 
elevated IgE (Werfel et al. 2016) and consistent with the presence in the skin of Type 2 cytokines 
(IL-4, IL-5, IL-9, IL-13, IL-25, IL-31, IL-33, and thymic stromal lymphopoietin) and 
inflammation. Type 2 cytokines increase epidermal thickening, sensitization, inflammation, and 
pruritus and decrease the expression of antimicrobial peptides and the barrier proteins FLG, 
LOR, and involucrin. Interleukin 13 in particular can reduce epithelial integrity and barrier 
function through downregulation of FLG, LOR, and involucrin (Kim et al. 2008) and can act on 
keratinocytes in the skin to downregulate their differentiation (Howell et al. 2008). Interleukin 13 
also induces T-cell chemoattractants that mediate T-cell infiltration into AD lesions (Purwar et 
al. 2006) and may also induce IL-5 expression and eosinophil infiltration through the induction 
of eosinophil chemoattractants (Esche et al. 2004). Increased expression of IL-13 has 
consistently been reported in AD skin lesions and is associated with disease severity (Hamid et 
al. 1996; Jeong et al. 2003; Tazawa et al. 2004; La Grutta et al. 2005; Neis et al. 2006; Choy et 
al. 2012; Suárez-Fariñas et al. 2013). 
A Phase 2b, double-blind, placebo-controlled study of adult participants with investigator global 
assessment (IGA) (3,4), Eczema Area and Severity Index (EASI) (≥16), body surface area (BSA) 
≥10%, chronic AD for at least 1 year, and for whom topical treatment was inadequate or 
inadvisable showed that participants taking lebrikizumab loading dose followed by 250 mg 
subcutaneous (SC) once every 2 weeks (Q2W) met primary endpoint criteria of EASI least-
squares mean % change, with % change -72.1, p value <0.001, at 16 weeks (Guttman-Yassky et 
al. 2020). Statistical significance was also reached for the secondary endpoints IGA 0,1 response, 
EASI50, EASI75, EASI90, mean percentage BSA involvement change from baseline, and 
Pruritus NRS change from baseline. The top-line results from 2 randomized, controlled, 
monotherapy Phase 3 studies of lebrikizumab (ADvocate 1 and ADvocate 2) and a third 
completed Phase 3 trial of lebrikizumab in combination with topical steroids (ADhere) 
demonstrated positive risk benefit in adult and adolescent patients with moderate-to-severe AD 
at Week 16. 
Recruitment and inclusion of patients of color in dermatologic therapy trials, including AD 
studies, is historically limited (Chen et al. 2022). The Phase 2b lebrikizumab study included 16-
28 (30.7% to 35.6%) Black or African American participants in each of the 4 arms of the study; 
10% and 21% in pivotal Phase 3 studies respectively; these numbers are a significant increase 
compared to historical pharmaceutical dermatologic studies (Chen et al. 2022). However, more 
work is needed to fully characterize, support, and treat skin of color populations with AD. While 
these patient populations were represented in the clinical studies, further assessment in the 
context of a focused study and clinical assessments specific to patients of color will generate an 
expanded dataset on the benefit: risk balance of lebrikizumab in this patient group. 
Epidemiology of Atopic Dermatitis 
There is a paucity of data describing the prevalence of AD in skin of color populations, with 
ranges of 6% to 15.89% in Black and/or African American race, 8% to 9.1% in Asian race, and 
6% in Hispanic ethnicity in the United States (US) (Silverberg and Hanifin 2013). In 
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J2T-MC-KGBP(c) 
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comparison, the 1-year prevalence of AD among adults in the US is estimated between 2% and 
7% (Harrop et al. 2007; Chiesa Fuxench et al. 2018; Sacotte and Silverberg 2018), and 
approximately 30% of adult patients with AD have moderate-to-severe disease (Bieber and 
Straeter 2015). 
Clinical Manifestations 
Clinically, AD is characterized by erythematous macules, papules, and/or plaques with scale, 
lichenification, and intense pruritus (Bieber 2008), which, along with the distribution, chronicity, 
and history of skin lesions, form the basis for making a diagnosis of AD. Flares are frequently 
triggered by exposure to environmental factors, irritants, and allergens (Bieber and Novak 2009). 
Several clinical patterns, with differing distributions of skin lesions in distinct age groups and 
skin types, have been noted (Weidinger and Novak 2016; Weidinger et al. 2018; Sangha 2021). 
Classic AD lesions, which are most common in adolescents and adults, present on the antecubital 
and popliteal fossae. Lesions frequently localize to the face and neck, and a considerable portion 
of patients (around 30%) develop atopic hand dermatitis, which may interfere with workplace 
activities. Lesions may have associated lichenification and crusting, and patients with AD may 
be at increased risk for bacterial cutaneous superinfection. 
Individuals of African descent may be more likely to present with lichenoid papules or profound 
xerosis (Jungersted et al. 2010, Muizzuddin et al. 2010), and erythema may be masked by 
pigmentation or appear purple, light brown or ashen gray. Perifollicular accentuation, a more 
scattered pattern, and greater extensor involvement are possible. In addition, there may be a 
greater burden of post-inflammatory hyperpigmentation and/or hypopigmentation in this 
population (Kaufman et al. 2018; Silverberg et al. 2019). Individuals of Asian descent may have 
AD features clinically consistent with both AD and psoriasis, with more well-demarcated, scaly 
plaques with greater lichenification and perifollicular accentuation (Noda et al. 2015; Kaufman 
et al. 2018; Brunner and Guttman-Yassky 2019). In contrast, patients of Hispanic ethnicity are at 
higher risk of severe, more recalcitrant AD, and may have greater trunk involvement (Wei et al. 
2018; Silverberg et al. 2019). 
Quality of Life 
Patients with AD have a high disease burden, and their quality of life is significantly affected. In 
one study, AD was shown to have a greater negative effect on patient mental health than diabetes 
and hypertension (Zuberbier et al. 2006). Patients with moderate-to-severe AD have a higher 
prevalence of social dysfunction and sleep impairment, which are directly related to the severity 
of the disease (Williams et al. 2008). Depression, anxiety, and social dysfunction not only affect 
patients with AD but also affect their caregivers (Zuberbier et al. 2006). Compared with 
patients with psoriasis, patients with AD have lower physical vitality, social functioning, 
emotional, and mental health scores (Kiebert et al. 2002). There are limited data specifically 
addressing quality of life (QoL) in patients with skin of color and AD. A study of almost 1000 
adults with AD at a US academic center showed that more severe health-related QoL impairment 
was observed in Black and Asian patients (Schwartzman et al 2022). More robust data on the 
quality of life for patients with skin of color and moderate-to-severe AD are needed. 
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Treatment for Atopic Dermatitis 
The therapeutic approach to AD consists primarily of trigger avoidance, skin hydration, and use 
of moisturizers and anti-inflammatory therapies consisting predominantly of topical 
corticosteroids (TCS). For patients with deeper skin tones, it is also important to address the need 
for improvement or clearance of post-inflammatory hyperpigmentation and hypopigmentation 
(Davis and Callender 2010). In many patients, treatment with TCS provides some measure of 
symptomatic relief but does not always adequately control the disease. In patients with persistent 
moderate-to-severe disease not responding adequately to TCS, the step-up options include 
topical calcineurin inhibitors, phototherapy and immunosuppressive agents, such as oral or 
injected corticosteroids, cyclosporine, azathioprine, methotrexate, and mycophenolate mofetil. In 
2017, dupilumab was approved for the treatment of adult patients with moderate-to-severe AD, 
and in 2021, an IL-13 antagonist, tralokinumab, was approved for adults with moderate-to-severe 
AD. Also in 2021, the topical Janus kinase (JAK) inhibitor ruxolitinib was approved for the 
treatment of mild-to-moderate AD in adults and children aged 12 and older, and in 2022, the oral 
JAK inhibitors, upadacitinib and abrocitinib, were approved for treatment of moderate-to-severe 
AD in adults and children aged 12 and older and adults, respectively. Despite these treatments, 
there remains a major societal burden for those with AD and a significant unmet medical need 
for treatment. Traditional systemic therapies, including cyclosporine, methotrexate, 
mycophenolate mofetil, and azathioprine, are not FDA approved, have potential side effects, and 
may require intensive lab monitoring; the JAKs, upadacitinib and abrocitinib, have a safety 
signal that may not be appealing for many patients and providers and are therefore commonly 
not chosen as first-line therapy, and although dupilumab and tralokinumab are approved 
biologics, specific studies on skin of color populations have not been completed, signaling a 
clinical care gap (Seegräber et al 2018; Gooderham et al 2018). This study will fill this clinical 
gap by evaluating the standard AD outcomes characterization of novel endpoints that are 
important for individuals with skin of color. 
A detailed description of the chemistry, pharmacology, efficacy, and safety of lebrikizumab is 
provided in the Investigator’s Brochure (IB). 
2.3. 
Benefit/Risk Assessment  
As of 22 September 2021, cumulatively, approximately 7795 participants have been enrolled into 
the lebrikizumab clinical program, of which approximately 6374 participants have received 
lebrikizumab. Lebrikizumab has been given to 525 healthy people and 5849 study participants 
with AD, asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, and 
Hodgkin’s lymphoma. Approximately 2051 have been treated with lebrikizumab in the Phase 2 
and Phase 3 AD programs. 
The use of lebrikizumab for the treatment of AD is supported by numerous preclinical studies 
demonstrating that AD is characterized by the increased expression of IL-13 in skin. Moreover, 
Phase 2 efficacy studies of lebrikizumab (J2T-DM-KGAG/TREBLE, J2T-DM-KGAH/ARBAN, 
and J2T-DM-KGAF/DRM06-AD01) demonstrated significant clinical benefit in participants 
with AD. The top-line results from the 2 monotherapy Phase 3 studies of lebrikizumab 
(ADvocate 1 and ADvocate 2) achieved the primary and all key secondary endpoints, including 
skin clearance and itch improvement at Week 16. A third completed pivotal Phase 3 trial of 
lebrikizumab in combination with topical steroids (ADhere) also met all primary and key 
secondary endpoints at Week 16. 
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Potential risks associated with lebrikizumab include conjunctivitis, eosinophilia and eosinophilic 
conditions, herpes zoster and herpes infections (Section 8.3.3), anaphylaxis and hypersensitivity 
reactions (Section 8.3.5), and other infections (Section 8.3.3.1). 
In the initial 16-week, placebo-controlled period of ADvocate 1 and ADvocate 2, the incidence 
of treatment-emergent adverse events (TEAEs) and serious adverse event (SAEs) among patients 
treated with lebrikizumab was consistent with that of the previous Phase 2 lebrikizumab studies 
in AD. The most common AEs included conjunctivitis, nasopharyngitis, and headache for 
lebrikizumab-treated patients. Discontinuations due to AEs were similar in the lebrikizumab 
group (1.4%) compared to placebo (1.7%). The safety profile of lebrikizumab observed in the 3 
Phase 3 studies was found to be consistent with prior lebrikizumab studies in AD. 
No immediate systemic hypersensitivity or anaphylaxis events were reported in the Phase 3 trials 
ADvocate 1, ADvocate 2, and ADhere. No parasitic or opportunistic infections were reported. 
No eosinophilic-related events were reported. 
Participants will be monitored for these events and will be provided appropriate intervention or 
supportive care as needed. If events occur, additional testing and data collection may be required 
as described further in Section 8.3.3, 8.3.5, and 8.3.6. 
Additionally, to monitor participant safety during the course of the study, the Sponsor will 
conduct trial-level safety reviews at periodic intervals throughout the study. 
In summary, in the context of the cumulative knowledge for lebrikizumab, the benefit/risk 
balance is assessed to be acceptable for testing in this Phase 3b study. 
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events of lebrikizumab may be found in the IB or Development Safety Update 
Report. 
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3. 
Objectives, Endpoints, and Estimands  
Objectives 
Endpoints 
Primary 
 
 
To assess the effect of lebrikizumab 
250 mg Q2W in reducing the signs 
and symptoms of AD in participants 
with moderate-to-severe AD and skin 
of color  
 
Percentage of participants achieving EASI-75 
(≥75% reduction from baseline in EASI) at 
Week 16  
Secondary 
 
 
To evaluate the effect of treatment 
with lebrikizumab in the signs and 
symptoms of AD and health outcome 
measures, in participants with 
moderate-to-severe AD and skin of 
color  
 
Percentage of participants achieving EASI-75 at 
Week 24 
 
Percentage of participants with an IGA score of 
0 or 1 and a reduction ≥2 points from baseline to 
Weeks 16 and 24 
 
Percentage change in EASI total from baseline 
to Weeks 16 and 24 
 
Change in EASI total from baseline to Weeks 16 
and 24 
 
Percentage of participants achieving EASI 90 at 
Weeks 16 and 24 
 
Percentage of participants with a Pruritus NRS 
of ≥4 points at baseline who achieve a 4-point 
reduction at Weeks 16 and 24 
 
Percentage of participants with a Pruritus NRS 
≥3 points at baseline who achieve at least 3-
point reduction at Weeks 16 and 24 
 
Percentage change in Pruritus NRS score from 
baseline to Weeks 16 and 24 
 
Percentage of participants with a Sleep-Loss 
Scale score of ≥2 points at baseline who achieve 
a 2-point reduction at Weeks 16 and 24 
 
Percentage change in Sleep-Loss Scale score 
from baseline to Weeks 16 and 24 
 
Percentage of participants with a Skin Pain NRS 
of ≥4 points at baseline who achieve a 4-point 
reduction from baseline to Weeks 16 and 24 
 
Change in POEM from baseline to Weeks 16 
and 24 
 
Change in DLQI from baseline to Weeks 16 and 
24 for participants ≥16 years of age at baseline 
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 
Change in cDLQI from baseline to Weeks 16 
and 24 for participants <16 years of age at 
baseline 
 
Percentage of participants with a DLQI of 
≥4 points at baseline who achieve a ≥4-point 
improvement in DLQI at Weeks 16 and 24 for 
participants ≥16 years of age at baseline 
Exploratory 
 
 
To evaluate the efficacy and health 
outcome measures of lebrikizumab 
from baseline by visit in participants 
with skin of color and 
moderate-to-severe AD 
 
Percentage change in PO-SCORAD from 
baseline by visit 
 
Change in Post-inflammatory Dyschromia Scale 
from baseline by visit 
 
Percentage change in ADCT from baseline by 
visit 
 
Using WPAI-AD by visit, change in baseline in 
o absenteeism in those who are currently 
employed (working for pay) 
o 
presenteeism in those who are currently 
employed (working for pay) 
o overall work impairment in those who 
are currently employed (working for 
pay), and 
o impairment in activities (all 
participants) 
 
Percentage of participants with an F-IGA score 
of 0 or 1 and a reduction ≥2 points from baseline 
by visit 
 
Lichenification change from baseline (calculated 
from EASI) 
 
Participant satisfaction change from baseline (1 
question) 
 
Percentage of participants achieving EASI-75 by 
visit 
 
Percentage of participants with an IGA score of 
0 or 1 and a reduction ≥2 points from baseline 
by visit 
 
Percentage change in EASI total by visit 
 
Change in EASI total by visit 
 
Percentage of participants achieving EASI-90 by 
visit 
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 
Percentage of participants with a Pruritus NRS 
of ≥4 points at baseline who achieve a 4-point 
reduction by visit 
 
Percentage of participants with a Pruritus NRS 
of ≥3 points at baseline who achieve a 3-point 
reduction by visit 
 
Percentage change in Pruritus NRS score by 
visit 
 
Percentage of participants with a Sleep-Loss 
Scale score of ≥2 points at baseline who achieve 
a 2-point reduction by visit 
 
Percentage change in Sleep-Loss Scale score 
from baseline by visit 
 
Percentage of participants with a Skin Pain NRS 
of ≥4 points at baseline who achieve a 4-point 
reduction from baseline by visit 
 
Change from baseline in POEM by visit 
 
To discern responder variability 
within the study and to track 
response variability to lebrikizumab 
 
Changes from baseline in serum proteins related 
to AD pathogenesis: Refer to Appendix 2 
Abbreviations: AD = atopic dermatitis; ADCT = atopic dermatitis control tool; cDLQI = Children’s DLQI; DLQI = 
Dermatology Life Quality Index; EASI = Eczema Area and Severity Index; F-IGA = face-IGA; IGA = 
Investigator’s Global Assessment; NRS = numeric rating scale; PDS = Post-inflammatory Dyschromia Scale; 
POEM = Patient-Oriented Eczema Measure; PO-SCORAD = Patient-Oriented SCORing Atopic Dermatitis; Q2W = 
once every 2 weeks; WPAI-AD = Work Productivity and Activity Impairment Questionnaire–Atopic Dermatitis. 
 
NOTE: Endpoints in the table above collected by visit references data collection visits. 
Primary estimand 
The primary clinical question of interest is: What is the intervention effect in percentage of 
participants achieving at least 75% improvement from baseline in EASI-75 after 16 weeks of 
lebrikizumab 250 mg Q2W intervention in participants with skin of color and moderate-to-severe 
AD who remain on study treatment until Week 16. 
The estimand is described by the following attributes: 
Population: participants with skin of color and moderate-to-severe AD who met inclusion and 
exclusion criteria and who remained on study treatment until Week 16. Further details can be 
found in Section 5. 
Endpoint: whether participants achieve at least 75% improvement from baseline in EASI at 
Week 16. 
Intercurrent events: There are no intercurrent events for this population since participants who 
initiate rescue medication are discontinued from the study and hence study treatment. Therefore, 
participants who stay on study treatment through Week 16 will not have an intercurrent event 
such as initiating rescue medication or permanently discontinuing treatment. Further details on 
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study interventions and concomitant medications, including rescue treatments, can be found in 
Section 6.8.1. 
Population-level summary: percentage of participants achieving EASI 75 response at Week 16. 
 
Secondary estimand(s) 
There is no secondary estimand planed at this stage; however, additional estimands might be 
specified in the statistical analysis plan (SAP). 
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4. 
Study Design  
4.1. 
Overall Design  
Study J2T-MC-KGBP (KGBP) is a single group treatment, open-label, Phase 3b study, which is 
24 weeks in treatment duration. The study is designed to evaluate the safety and efficacy of 
lebrikizumab in adolescent and adult participants with skin of color and moderate-to-severe AD. 
Study Periods 
This trial has 3 study periods: 
 Screening (Visit 1: ≤30 days prior to baseline) 
 Treatment (Visits 2-9: 24 weeks) 
 Safety follow-up (Visit 801: approximately 12 weeks after last treatment) 
Visit Types 
Study visits at Week 12 (Visit 6) and Week 20 (Visit 8) will be performed virtually, that is, via 
telephone or telemedicine tools. 
All other visits will be conducted at the clinical trial site. 
Dosing 
During the 24-week Treatment Period, approximately 95 participants will receive treatment: 
 500 mg subcutaneous (SC) once every 2 weeks (Q2W) loading dose at baseline and 
Week 2, followed by 250 mg SC Q2W until Week 16. 
 Responders, defined as achieving IGA (0,1) or EASI-75 at Week 16, will receive 
250 mg SC Q4W. 
 Inadequate responders at Week 16 will continue to receive 250 mg SC Q2W. 
The study population is described in Section 5. 
The efficacy and safety assessments are described in Sections 8.1 and 8.2, respectively. 
4.2. 
Scientific Rationale for Study Design  
There is a paucity of data to guide diagnosis and treatment in populations traditionally under-
represented in clinical trials, including patients with skin of color. The present study will 
evaluate the safety and efficacy of the skin of color population with clinical assessment methods 
suitable for this population to complement the already existing data on racial subgroups from the 
lebrikizumab clinical programs. Clinical studies (Phase 2a Study GS29250 and Phase 2b Study 
DRM06 AD01) with lebrikizumab demonstrated significant clinical benefit in participants with 
AD. Additional detailed discussion of the lebrikizumab studies is provided in the lebrikizumab 
IB. The top-line results from 2 randomized controlled monotherapy Phase 3 studies of 
lebrikizumab (ADvocate 1 and Advocate 2) and a third completed Phase 3 trial of lebrikizumab 
in combination with topical steroids (ADhere) demonstrated positive risk benefit in adult and 
adolescent patients with moderate-to-severe AD at Week 16. Additional detailed discussion of 
the lebrikizumab studies is provided in the lebrikizumab IB. Since randomized controlled data 
are already available, this study will be conducted as an open-label study to mimic the real-world 
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experience. We will use Week 16 as the primary endpoint in this study and will also evaluate the 
safety and efficacy until Week 24 to understand the durability of effect post Week 16. 
In this study, collection of demographic information includes race and ethnicity. The scientific 
rationale is based on the need to assess variable response in safety and efficacy based on race or 
ethnicity. This question can be answered only if all the relevant data are collected. 
4.2.1. 
Participant Input into Design  
Throughout this protocol, the term “participant” is used to indicate an individual who participates 
in a clinical trial, either as a recipient of an investigational drug or as a control. This usage 
reflects preferences indicated by patient advocates to more accurately reflect the role of people 
who take part in clinical trials. 
 
No participant input was provided for this study design. 
4.3. 
Justification for Dose  
The lebrikizumab dosing regimen of 500 mg loading dose at baseline and Week 2, followed by 
250 mg Q2W up to, and including Week 16, was selected based on an evaluation of safety, 
efficacy, and PK data from the Phase 2 and Phase 3 lebrikizumab trials. 
In the lebrikizumab Phase 3 programs, IGA 0/1 or EASI-75 responders at Week 16 were re-
randomized to Q4W, Q2W, or withdrawal arms, and inadequate responders were assigned to 
Q2W dosing. These Phase 3 results have demonstrated that lebrikizumab Q4W and Q2W are 
similar in efficacy, and that inadequate responders benefited from continued Q2W dosing. The 
dose regimens in the present study post Week 16 are based on the results of these Phase 3 
studies. 
Adolescent Participants 
In this Phase 3b study, adolescent participants (≥12 to <18 years weighing ≥40 kg) will be 
included and will receive the same doses of lebrikizumab as adult participants. Pharmacokinetic 
analyses of SC doses of lebrikizumab reveal similar kinetics for adults and adolescents ≥12 to 
<18 years. Although maximal exposures are slightly higher for any given dose in adolescent 
participants, due to their lower weight ranges, the safety profile observed in adolescent 
participants is comparable to the safety profile observed in adults. Therefore, a similar exposure-
response relationship is expected in this age group compared to adults based on partial 
extrapolation and propose to include adolescent participants in this study. It is expected that the 
adolescent AD participants ≥40 kg will demonstrate a similar overall safety profile as adult 
participants. 
4.4. 
End of Study Definition  
A participant is considered to have completed the study if the participant has completed all 
periods of the study, including the last scheduled procedure shown in the SoA. 
The end of the study is defined as the date of the last visit of the last participant in the study or 
last scheduled procedure shown in the SoA for the last participant in the study. 
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5. 
Study Population  
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion Criteria  
Participants are eligible to be included in the study only if all of the following criteria apply: 
Age 
1. Participants must be ≥12 years of age inclusive, at the time of signing the informed 
consent/assent. 
Type of Participant and Disease Characteristics 
2. Participants who are self-reported race other than White, including but not limited to 
persons who self-identify as Black or African American, American Indian or Alaska 
Native, Asian, Native Hawaiian, or Other Pacific Islander. 
3. Participants who are Fitzpatrick phototype IV-VI (Section 8.1.15). 
4. Have chronic AD (according to American Academy of Dermatology Consensus Criteria; 
Eichenfield et al. 2014; Appendix 7, Section 10.7) that has been present for ≥1 year 
before screening visit. 
5. Have EASI ≥16 at the baseline visit. 
6. Have Investigator’s Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline 
visit. 
7. Have ≥10% BSA of AD involvement at the baseline visit. 
8. Have a history of inadequate response to treatment with topical medications; or 
determination that topical treatments are otherwise medically inadvisable. 
Weight 
9. For adolescent participants, body weight ≥40 kg at baseline. 
Sex and Contraceptive/Barrier Requirements 
10.  Male and/or female 
a. No male contraception is required except in compliance with specific local 
government study requirements. 
b. Female participants of child-bearing potential must agree to remain abstinent 
(refrain from heterosexual intercourse) or use a highly effective contraceptive 
method during the treatment period and for at least 18 weeks after the last dose of 
study drug. Women not of child-bearing potential (WNOCBP) may participate 
without any contraception requirements. For definitions of women of child-
bearing potential (WOCBP) and WNOCBP, see Section 10.4, Appendix 4. 
Contraceptive use by participants should be consistent with local regulations regarding the 
methods of contraception for those participating in clinical studies. For the contraception 
requirements of this protocol, see Section 10.4, Appendix 4. 
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Informed Consent 
11. Informed consent/assent 
a. For adult participants: capable of giving signed informed consent as described in 
Appendix 1, which includes compliance with the requirements and restrictions 
listed in the ICF and in this protocol. 
b. For adolescent participants: a parent or legal guardian must be able to read, 
understand, and give documented informed consent for a child to participate in 
this study as described in Section 10.1.3, which includes compliance with the 
requirements and restrictions listed in the ICF and in this protocol. 
NOTE: Adolescents reaching the age of majority while on study must provide 
consent to continue participation in the study. 
Other 
12. Are willing and able to comply with all clinic visits and study-related procedures and 
questionnaires. 
5.2. 
Exclusion Criteria  
Participants are excluded from the study if any of the following criteria apply: 
Medical Conditions 
13. History of human immunodeficiency virus (HIV) infection or positive HIV serology at 
screening. 
14. Have a current infection or chronic infection with hepatitis B virus (HBV) at screening, 
that is, positive for hepatitis B surface antigen (HBsAg) and/or polymerase chain reaction 
positive for HBV DNA (Section 8.2.3). 
15. Have a current infection with hepatitis C virus (HCV) at screening, that is, positive for 
HCV RNA (Section 8.2.4). 
16. Have an uncontrolled chronic disease that might require multiple intermittent uses of oral 
corticosteroids at screening (as defined by the investigator). 
17. Have uncontrolled asthma that 
a. might require bursts of oral or systemic corticosteroids, or 
b. required the following due to ≥1 exacerbations within 12 months before baseline 
i. systemic (oral and/or parenteral) corticosteroid treatment, or 
ii. hospitalization for >24 hours. 
18. Have known liver cirrhosis and/or chronic hepatitis of any etiology. 
19. History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, 
within 5 years before the screening, except completely treated in situ carcinoma of the 
cervix of completely treated and resolved non-metastatic squamous or basal cell 
carcinoma of the skin with no evidence of recurrence in the past 12 weeks. 
20. Are diagnosed with active endoparasitic infections or at high risk of these infections. 
21. Have a known or suspected history of immunosuppression, including history of invasive 
opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, 
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coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution; or 
unusually frequent, recurrent, or prolonged infections, per the investigator’s judgment. 
22. Have presence of skin comorbidities that may interfere with study assessments. 
23. Have a severe concomitant illness(es) that in the investigator’s judgment would adversely 
affect the participant’s participation in the study. 
24. Have any other medical or psychological condition that in the opinion of the investigator 
may suggest a new and/or insufficiently understood disease, may present an unreasonable 
risk to the study participant because of his/her participation in this clinical trial, may 
make participant’s participation unreliable, or may interfere with study assessments. 
25. Have had any of the following types of infection within 3 months of screening or develop 
any of these infections during screening: 
a. Serious (requiring hospitalization, and/or intravenous or equivalent oral antibiotic 
treatment) 
b. Opportunistic (as defined in Winthrop et al. 2015, see Section 10.9, Appendix 9) 
NOTE: Herpes zoster is considered active and ongoing until all vesicles are dry 
and crusted over. 
c. Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer) 
d. Recurring (including, but not limited to recurring cellulitis, chronic osteomyelitis) 
NOTE: Participants with only recurrent, mild, and uncomplicated orolabial and/or 
genital herpes may be discussed with the sponsor’s medical monitor to determine 
whether the participants meet this exclusion criterion. 
26. Have an active or acute infection requiring treatment with systemic antibiotics, antivirals, 
antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit 
(baseline; Visit 2), or superficial skin infections within 1 week before the baseline visit. 
NOTE:  
Participants may be rescreened after infections resolves. 
Participants who have an upper respiratory infection, a vaginal candida infection, 
or an oral candida infection and who are being treated only symptomatically and 
not requiring systemic anti-infectives may be considered for enrollment if other 
study eligibility criteria are met. Enrollment of participants with other 
uncomplicated local infections should be discussed with the sponsor’s designated 
medical monitor. 
Prior/Concomitant Therapy 
27. Prior treatment with tralokinumab. 
28. Prior treatment with dupilumab. 
29. Treatment with topical agents: corticosteroids, calcineurin inhibitors, JAK inhibitors, or 
phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline visit. 
30. Treatment with any of the following agents within 4 weeks prior to the baseline visit: 
a. systemic immunosuppressive or immunomodulating drugs (e.g., systemic 
corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, 
methotrexate, and other immunosuppressants) 
b. small molecules (e.g. JAK inhibitors) 
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c. phototherapy and photochemotherapy for AD. 
31. Have regularly used (more than 2 visits per week) a tanning booth or parlor within 4 
weeks of the screening visit (Visit 1). 
32. Are currently receiving build-up dosing of allergen immunotherapy (allergy shots). 
33. Treatment with B-cell-depleting biologics, including rituximab, within 6 months prior to 
the baseline visit. 
34. Use of prescription moisturizers within 7 days of the baseline visit. 
35. Have received any live attenuated vaccine within less than 4 weeks of the baseline visit, 
or intend to receive a live attenuated vaccine during the study, or within 4 weeks after 
receiving the last dose of study intervention. 
NOTE: The following are not considered live vaccines: RNA vaccines, vaccines with 
inactive viral elements, and/or nonreplicating viral vector vaccines. 
36. Have received a Bacillus Calmette-Guerin (BCG) vaccination or treatment within less 
than 4 weeks before the baseline visit, or intend to receive BCG vaccination or treatment 
during the study. 
37. Use of cannabis or cannabinoids for the treatment of pruritus, pain, and/or AD. 
Diagnostic Assessments 
38. In the opinion of the investigator, have any clinically significant laboratory results from 
the chemistry or hematology tests obtained at the screening visit (Visit 1). 
Prior/Concurrent Clinical Study Experience 
39. Are currently enrolled in any other clinical study involving an investigational product or 
any other type of medical research judged not to be scientifically or medically compatible 
with this study. 
40. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), 
whichever is longer prior to the baseline visit. 
41. Have received a dose of lebrikizumab in any prior lebrikizumab clinical study. 
Other Exclusions 
42. Are Lilly employees, or are employees of any third-party involved in study who require 
exclusion of their employees. 
43. 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. 
44. Are pregnant or breastfeeding or are planning to become pregnant or to breastfeed during 
the study. 
45. Have a known hypersensitivity to any component of lebrikizumab. 
46. Participant or caregiver who is unwilling to administer SC injections of study medication. 
5.3. 
Lifestyle Considerations  
Not applicable. 
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5.4. 
Screen Failures  
A screen failure occurs when a participant who consents to participate in the clinical study is not 
subsequently enrolled in the study. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure participants to meet the Consolidated Standards of 
Reporting Trials publishing requirements and to respond to queries from regulatory authorities. 
Minimal information includes demography, screen failure details, eligibility criteria, and any 
SAE. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened as defined below. Rescreened participants should be assigned a new participant 
number for every screening or rescreening event. 
5.4.1. 
Rescreening for Individuals Who Failed Screening  
Informed consent for rescreenings 
Individuals who are to be rescreened must first sign a new ICF (Appendix 10, Section 10.1.3). 
Such individuals will be assigned a new participant number. 
Rescreening after failure to meet study entry criteria 
An individual who does not meet the criteria for participation in this study for any reason may be 
rescreened one time. 
When rescreening, all of the screening tests and procedures should be repeated. 
5.5. 
Criteria for Temporarily Delaying Enrollment/Administration of 
Study Intervention of a Participant  
Not applicable. 
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6. 
Study Intervention(s) and Concomitant Therapy  
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, or medical device(s) intended to be administered to/used by a study participant 
according to the study protocol. 
6.1. 
Study Intervention(s) Administered  
Lebrikizumab drug product is provided as sterile liquids and contain no preservatives. 
Intervention Name 
Lebrikizumab 
Dose Formulation 
250 mg (125 mg/mL), 2 mL Solution 
Dosage Level 
Loading Dose: 
Week 0: 500 mg (2 injections of 250 mg) 
Week 2: 500 mg (2 injections of 250 mg) 
 
Post-loading Dose:  
Weeks 4-16: 250 mg SC Q2W (1 injection of 250 mg) 
Responders at Week 16: 250 mg SC Q4W (1 injection of 250 mg) at W20 
Inadequate responders at Week 16: 250 mg SC Q2W (1 injection of 250 mg) 
at W18, W20, and W22 
Route of Administration 
SC 
Abbreviations: mg = milligram; mL = milliliter; SC = subcutaneously; Q2W = once every 2 weeks; Q4W = once 
every 4 weeks; W = week. 
 
6.1.1. 
Medical Devices  
1. Lebrikizumab will be administered using a sterile prefilled syringe with needle safety 
device. Each prefilled syringe is intended for a single 2 mL dose (250 mg) administered 
subcutaneously device. 
2. Instructions on how to use the device will be provided. 
3. All PCs, including malfunction, use error, and inadequate labeling, shall be documented 
and reported by the investigator throughout the clinical investigation (see Section 8.2.2) 
and appropriately managed by the sponsor. 
6.2. 
Preparation, Handling, Storage, and Accountability  
1. The investigator or designee must confirm appropriate storage conditions have been 
maintained during transit for all study intervention received and any discrepancies are 
reported and resolved before use of the study intervention. 
2. Only participants enrolled in the study may receive study intervention. Only authorized 
study personnel may supply, prepare, or administer study intervention, except for study 
intervention intended to be administered by the participant or caregiver. All study 
intervention must be stored in a secure, environmentally controlled, and monitored 
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(manual or automated) area in accordance with the labeled storage conditions with access 
limited to the investigator and authorized study personnel. 
3. The investigator or authorized study personnel are responsible for study intervention 
accountability, reconciliation, and record maintenance (that is, receipt, reconciliation, and 
final disposition records). 
4. Further guidance and information for the final disposition of unused study interventions 
are provided in the Study Reference Manual. 
6.3. 
Measures to Minimize Bias: Randomization and Blinding  
In this open-label study, potential bias will be reduced by specifying treatment response 
ascertained from all eligible participants and safety reporting. Adherence to the study design 
requirements, including those specified in the SoA, is essential and required for study conduct. 
The site will contact the interactive web-response system (IWRS), prior to the start of study 
intervention administration and at the primary endpoint for each eligible participant, to provide 
demographic information and IGA/EASI results, respectively. 
6.4. 
Study Intervention Compliance  
Study intervention will be administered under medical supervision by the investigator or 
designee at the baseline (Week 0, Visit 2) and Week 2 (Visit 3) visits. The dose of study 
intervention and study participant identification will be confirmed prior to dispensing study drug. 
The date and time of each dose administered will be recorded in the source documents and will 
be provided to the sponsor as requested. 
Beginning Week 4 (Visit 4), the participant/caregiver will be encouraged to administer the study 
intervention while in the clinic or at home. Participants may choose to continue to receive study 
drug injections administered by trained clinic staff for any visit occurring in the clinic. Home 
dosing must be self-administered or given by a caregiver that has received proper injection 
technique training. 
When participants self-administer study intervention(s) at home, compliance with study 
intervention will be assessed at each visit. Compliance will be assessed by direct questioning, 
counting returned injection supplies and documented in the source documents. 
A record of the number of lebrikizumab injections supplies dispensed to and administered by 
each participant or caregiver must be maintained and reconciled with study intervention and 
compliance records. 
6.5. 
Dose Modification  
Dose modifications of lebrikizumab are not allowed in this study 
6.6. 
Continued Access to Study Intervention after the End of the Study  
Lebrikizumab will be made available to eligible participants who complete Visit 9 (Week 24) via 
the Continued Access addendum, until lebrikizumab is commercially available in the US. Please 
refer to KGBP Protocol Addendum 3 for additional information. Otherwise, lebrikizumab will 
not be provided after participants exit this study.  
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6.7. 
Treatment of Overdose  
For this study, any dose of lebrikizumab greater than 500 mg (baseline and Week 2) and 250 mg 
Q2W (Week 4 and beyond) will be considered an overdose. 
Sponsor does not recommend specific treatment for an overdose. 
In the event of an overdose, the investigator/treating physician should: 
● Contact the medical monitor immediately. 
● Evaluate the participant to determine, in consultation with the medical monitor, 
whether study intervention should be interrupted or whether the dose should be 
reduced. 
● Closely monitor the participant for any AE/SAE and laboratory abnormalities 
until lebrikizumab can no longer be detected systemically (at least 18 weeks). 
6.8. 
Concomitant Therapy  
Any medication or vaccine, including over-the-counter or prescription medicines, vitamins, 
antacids, and/or herbal supplements, that the participant is receiving at the time of enrollment or 
receives during the study must be recorded along with 
● reason for use 
● dates of administration including start and end dates, and 
● dosage information including dose and frequency for concomitant therapy of 
special interest. 
The medical monitor should be contacted prior to entering the participant into the study if there 
are any questions regarding concomitant or prior therapy. 
Participants should be instructed to consult with the investigator prior to initiating any new 
medication (either self-administered non-prescription drugs or prescription therapy prescribed by 
another physician) while participating in the study. The investigator is expected to examine the 
acceptability of all concomitant medications, topical preparations, and dietary supplements taken 
by participants in the study. 
The use of any concomitant medication must relate to an AE listed on the AE case report form 
(CRF) or the participant’s medical history, unless the medication is a supplement or used as 
preventive care. 
6.8.1. 
Permitted Treatments and Procedures  
The following therapies will be permitted during the study: 
Permitted Concomitant Medications and 
Vaccines 
Comments  
Medications 
 
Medications for medical conditions other than 
AD, e.g., hypertension and diabetes 
 
Low and/or mid-potency TCS, TCIs (e.g., 
tacrolimus and pimecrolimus), or topical PDE-4 
Permitted as needed on AD lesions and must 
be documented in the diary. 
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Permitted Concomitant Medications and 
Vaccines 
Comments  
inhibitors (e.g., crisaborole) for treatment of 
AD 
High-potency TCS for treatment of AD 
Permitted up to 10 days 
Non-medicated moisturizers 
 
Intranasal corticosteroids 
 
Inhaled corticosteroids and bronchodilators to 
control asthma 
 
Single intra-articular (bursa, tendons, and 
ligaments) corticosteroid injection 
 
Non-sedating antihistamines  
 
Ophthalmic drugs containing antihistamines, 
corticosteroids, or other immunosuppressants 
 
Allergen immunotherapies 
If on maintenance dose. 
Leukotriene inhibitors 
 
Systemic and topical anti-infectives 
For treatment of acute infections.  
Sedating systemic antihistamines including, but 
not limited to, alimemazine, chlorphenamine, 
clemastine, cyproheptadine, diphenhydramine, 
hydroxyzine, ketotifen, and promethazine 
On an as-needed basis. 
Systemic or oral sleep aid medications 
On an as-needed basis. 
Recreational use of cannabis and cannabinoid 
Not allowed for the treatment of pruritus, 
pain and/or AD 
Vaccines 
 
Non-live vaccinations 
Including non-live SARS-CoV-2 vaccines, 
RNA vaccines, vaccines with inactive viral 
elements, and/or non-replicating viral 
vectors that are clinically indicated. 
Abbreviations: AD = atopic dermatitis; PDE-4 = phosphodiesterase-4; RNA = Ribonucleic acid; SARS-CoV-2 = 
severe acute respiratory syndrome coronavirus 2; TCI = topical calcineurin inhibitors; TCS = topical 
corticosteroids. 
NOTE: in the context of this table, “during the study” = from screening to post-treatment safety follow-up 
visit. 
6.8.2. 
Prohibited Treatments and Procedures  
The following therapies will be prohibited during the study: 
Prohibited Concomitant Medications, 
Vaccinations, and Procedures 
Comments  
Medications or procedures 
 
Systemic corticosteroids (IM, PO, or IV) 
NOTE: If used for treatment of AEs, it will 
be considered as rescue medication (see 
Section 6.8.5). 
Any investigational drug other than the study 
drug 
 
B cell-depleting biologics, including rituximab 
 
Other biologic agents (other than the study 
interventions) 
 
Topical JAK inhibitor for treatment of AD 
Any use will be considered as rescue 
medication (see Section 6.8.5) 
TCS (high potency) 
Use for >10 days is prohibited 
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Prohibited Concomitant Medications, 
Vaccinations, and Procedures 
Comments  
Medications or therapies for other medical conditions 
known to affect AD (e.g., immunosuppressive or 
immunomodulating drugs, such as systemic 
corticosteroids, mycophenolate mofetil, IFN-γ, JAK 
inhibitors, cyclosporine, azathioprine, or methotrexate; 
phototherapy or PUVA; or systemic PDE-4 inhibitors) 
 
Systemic and topical anti-infectives 
For chronic treatment during the study. 
Planned or anticipated major medical 
procedures or surgeries 
 
Tanning booth or parlor 
 
Bleach bath 
 
Use of cannabis or cannabinoids for the 
treatment of pruritus, pain, and/or AD 
 
Vaccines 
 
Live or live attenuated vaccines, as well as 
BCG vaccine 
 
Abbreviations: AD = atopic dermatitis; AE = adverse event; BCG = Bacillus Calmette-Guerin; IFN-γ = interferon-
gamma; IM = intramuscular; IV = intravenous; JAK = Janus kinase; PDE 4 = phosphodiesterase-4; PUVA = 
photochemotherapy; TCS = topical corticosteroids; PO = by mouth. 
NOTE: in the context of this table, “during the study” = from screening to post-treatment safety follow-up 
visit. 
6.8.3. 
Non-Medicated Moisturizers  
Participants may apply a stable dose of non-medicated topical moisturizer at least twice daily for 
≥7 days prior to the baseline visit and throughout the study. 
The participants may continue their current over-the-counter moisturizer regimen, if approved by 
the investigator. 
All moisturizer use should be recorded in the CRF. 
6.8.4. 
Topical Treatment for Atopic Dermatitis  
The goal of this Phase 3b study is to demonstrate the safety and efficacy of lebrikizumab for 
moderate-to-severe AD in participants with skin of color. Regular use of non-medicated, non-
prescription moisturizers should be used by all participants. During this study, topical therapies 
may be needed if the participant experiences intolerable clinical worsening of symptoms. If 
needed, investigators are encouraged to recommend therapy in a staged fashion, beginning with a 
topical low-potency treatment first, then topical mid-potency treatment if needed. In sensitive 
skin areas, i.e., face, neck, intertriginous, and genital areas, only low-potency topical treatments 
should be used. 
If AD lesions recur or a participant experiences a flare, as needed use of low- and/or mid-
potency TCS, TCI (tacrolimus or pimecrolimus), and/or topical PDE4 inhibitors (crisaborole) 
may be initiated at the participant’s discretion but must be communicated to the investigator and 
documented in the patient diary or as concomitant medications. . Escalation to high-potency 
topical corticosteroid medications should only occur if participants do not respond adequately 
after at least 7 days of low- or mid-potency TCS, TCI, and/or topical PDE4 
inhibitors.(Section 6.8.5). Use of high-potency TCS for more than 10 days is considered rescue 
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therapy. Participants that receive Rescue Therapy must be discontinued from the study (see 
Section 7.1). All topical prescription therapy usage must be recorded in the CRF or diary. 
6.8.5. 
Rescue Medicine for Atopic Dermatitis  
The goal of this Phase 3b study is to demonstrate the safety and efficacy of lebrikizumab for 
moderate-to-severe AD in participants with skin of color. To be consistent with real world 
practice, defined topical medications are allowed in this study (see Section 6.8.4). Rescue 
therapies may be needed if the participant experiences intolerable clinical worsening of 
symptoms. Escalation to high-potency topical TCS, topical JAKs, phototherapy, and/or systemic 
medications, including but not limited to corticosteroids, immunosuppressants, biologics, small 
molecules, etc., for the treatment of AD should only occur if participants do not respond 
adequately after at least 7 days of low- or mid-potency TCS, TCI, and/or topical PDE4 
inhibitors. Any use of topical JAKs, phototherapy, and/or systemic medications will be 
considered Rescue Therapy. Use of high-potency TCS for more than 10 days is also considered 
Rescue Therapy. Participants that receive Rescue Therapy must be discontinued from the study 
(see Section 7.1). All rescue medication must be recorded in the CRF. 
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7. 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal  
Discontinuation of specific sites or of the study as a whole are handled as part of Appendix 1. 
7.1. 
Discontinuation of Study Intervention  
When necessary, a participant may be permanently discontinued from study intervention. If so, 
the participant will remain in the study to complete procedures for an early discontinuation visit 
and post-treatment follow-up, if applicable, as shown in the SoA. 
A participant should be permanently discontinued from study intervention if 
 the participant becomes pregnant during the study 
 in the opinion of the investigator, the participant should permanently discontinue the 
study intervention for safety reasons 
 the participant develops a malignancy, except for successfully treated basal or 
squamous cell skin carcinoma 
 the participant tests positive for HBV DNA (see Section 8.2.3) 
 the participant tests positive for HCV RNA (Section 8.2.4) 
 if the participant experiences a hepatic event or liver test abnormality as specified in 
the liver chemistry stopping criteria (see Section 7.1.1) 
 the participant develops HIV infection 
 the participant develops any infection that is opportunistic, such as active tuberculosis 
and other infections whose nature or course may suggest an immuno-compromised 
status 
 the participant requires rescue medication treatment for symptoms of AD in the 
treatment period, and 
 the participant has an AE or an SAE or a clinically significant change in a laboratory 
value that, in the opinion of the investigator, merits discontinuation of study 
intervention and appropriate measures being taken. 
Hepatitis 
 prior to discontinuation of any immunomodulatory and/or immunosuppressive 
therapy due to hepatitis, including study intervention, the participant is to be referred 
to, evaluated, and managed by a specialist physician with expertise in evaluation and 
management of viral hepatitis. 
 the timing of discontinuation from study intervention relative to the initiation of any 
antiviral treatment for hepatitis is to be based on the recommendation of the 
consulting specialist physician, in conjunction with the investigator, and aligned with 
medical guidelines and standard of care. 
Hypersensitivity 
 if the investigator determines that a systemic hypersensitivity reaction has occurred 
related to study intervention administration, the participant may be permanently 
discontinued from the study intervention, and the sponsor’s designated medical 
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monitor should be notified. If the investigator is uncertain about whether a systemic 
hypersensitivity reaction has occurred and whether discontinuation of study 
intervention is warranted, the investigator may consult the sponsor. 
7.1.1. 
Liver Chemistry Stopping Criteria  
The study drug should be interrupted and close hepatic monitoring initiated (see Section 8.2.2) if 
1 or more of these conditions occur: 
Elevationa 
Exceptiona 
ALT or AST >8x ULN 
 
ALT or AST >5x ULN for more than 2 weeks 
 
ALT or AST >3x ULN and either TBL >2x ULN or 
INR >1.5  
For participants with Gilbert’s 
syndrome: If baseline direct 
bilirubin is >0.5 mg/dL, then 
doubling of direct bilirubin should 
be used for drug interruption 
decisions rather than TBL >2x 
ULN. 
ALT or AST >3x ULN with the appearance of 
fatigue, nausea, vomiting, right upper quadrant pain 
or tenderness, fever, and/or rash 
 
ALP >3x ULN, when the source of increased ALP is 
the liver 
 
ALP >2.5x ULN and TBL >2x ULN  
For participants with Gilbert’s 
syndrome: If baseline direct 
bilirubin is >0.5 mg/dL, then 
doubling of direct bilirubin should 
be used for drug interruption 
decisions rather than TBL >2x 
ULN. 
ALP >2.5x ULN with the appearance of fatigue, 
nausea, vomiting, right upper quadrant pain or 
tenderness, fever, and/or rash 
 
Source: FDA Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical 
Evaluation, July 2009 and other consensus guidelines, with minor modifications 
Abbreviations: ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; 
INR = international normalized ratio; TBL = total bilirubin; ULN = upper limit of normal. 
a All ULN values should be age adjusted (AAULN) for participants <18 years of age. 
Resumption of the study intervention can be considered only in consultation with the Lilly-
designated medical monitor and only if liver test results return to baseline and if a self-limiting 
non-drug etiology is identified. Otherwise, study intervention should be discontinued.  
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7.1.2. 
Temporary Discontinuation of Study Intervention  
Temporary withholding of study intervention is required if the participant meets any of the 
following infection-related criteria during the study: 
● Serious or opportunistic infections, as defined in Section 5.2. Study intervention is 
to be withheld until resolution of all acute clinical signs and symptoms, and 
completion of all appropriate anti-infective treatment. 
● HBV DNA results that are reported as positive, or as detecting HBV DNA, but 
HBV DNA is below the level of quantification. In this situation, the sponsor’s 
designated medical monitor should be contacted regarding the participant’s status. 
HBV DNA testing is to be repeated as soon as is feasible. If HBV DNA is 
confirmed as positive, the participant must be permanently discontinued from 
study intervention as described in Section 7.1. 
 If a participant <18 years of age loses a clinically significant amount of weight 
(below 40 kg), the investigator should assess rationale for weight loss and use 
clinical judgment to determine if the participant should temporarily discontinue 
the treatment. 
7.2. 
Participant Discontinuation/Withdrawal from the Study  
Discontinuation is expected to be uncommon. 
A participant may withdraw from the study: 
● at any time at the participant’s own request 
● at the request of the participant’s designee (for example, parents or legal 
guardian) 
● at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons 
● if enrolled in any other clinical study involving an investigational product, or 
enrolled in any other type of medical research judged not to be scientifically or 
medically compatible with this study, and 
● if the participant, for any reason, requires treatment with a therapeutic agent that 
is prohibited by the protocol and has been demonstrated to be effective for 
treatment of the study indication. In this case, discontinuation from the study 
occurs prior to introduction of the new agent. 
At the time of discontinuing from the study, the participant will complete procedures for an early 
discontinuation visit and post-treatment follow-up, if applicable, as shown in the SoA. If the 
participant has not already discontinued the study intervention, the participant will be 
permanently discontinued from the study intervention at the time of the decision to discontinue 
the study. 
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. If a participant 
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withdraws from the study, the participant may request destruction of any samples taken and not 
tested, and the investigator must document this in the site study records. 
7.3. 
Lost to Follow up  
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. Site personnel or designee are 
expected to make diligent attempts to contact participants who fail to return for a scheduled visit 
or were otherwise unable to be followed up by the site. 
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8. 
Study Assessments and Procedures  
● Study procedures and their timing are summarized in the SoA. 
● Immediate safety concerns should be discussed with the sponsor immediately 
upon occurrence or awareness to determine if the participant should continue or 
discontinue study intervention. 
● Adherence to the study design requirements, including those specified in the SoA, 
is essential and required for study conduct. 
● All screening evaluations must be completed and reviewed to confirm that 
potential participants meet all eligibility criteria. The investigator will maintain a 
screening log to record details of all participants screened and to confirm 
eligibility or record reasons for screening failure, as applicable. 
8.1. 
Efficacy Assessments  
8.1.1. 
Eczema Area and Severity Index  
The EASI is an investigator-reported, 20-item scale that evaluates 2 dimensions of AD: extent of 
disease at 4 body regions (head or neck, trunk, upper and lower extremities) and 4 clinical signs 
(erythema, induration or papulation, excoriation, and lichenification). The clinical signs are 
assessed for severity on a scale of 0 (absent) to 3 (severe). 
The scores are added up for each of the 4 body regions. The assigned percentages of BSA for 
each section of the body are 10% for head or neck, 20% for upper extremities, 30% for trunk, 
and 40% for lower extremities, respectively. Each subtotal score is multiplied by the BSA 
represented by that region. 
In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage 
of AD-affected skin in that area: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 
(50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores is multiplied 
by the area affected. The resulting EASI ranges from 0 to 72 points, with the highest score 
indicating worse severity of AD (Hanifin et al. 2001). The recall period of this scale is present 
time. 
Assessors must be trained and certified by the sponsor prior to conducting this assessment. A 
single assessor should be assigned to each participant for as many visits as possible to avoid 
inter-assessor variability in scoring. The recall period of this assessment is present time. 
8.1.2. 
Investigator’s Global Assessment (IGA)  
The IGA is an investigator-reported, single-item scale that rates the severity of the participant’s 
AD. The IGA is composed of a 5-point scale ranging from 0 (clear) to 4 (severe), and a score is 
selected using descriptors that best describe the overall appearance of the lesions at a given time 
point. 
Assessors must be trained and certified by the sponsor prior to conducting this assessment. A 
single assessor should be assigned to each participant for as many visits as possible to avoid 
inter-assessor variability in scoring. The recall period of this assessment is present time. 
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8.1.3. 
Body Surface Area (BSA)  
BSA is an investigator-reported assessment, which estimates the extent of disease or skin 
involvement of a participant’s AD. BSA is expressed as a percentage of total body surface and 
will be reported by body location. The recall period of this assessment is present time. 
Assessors must be trained and certified by the sponsor prior to conducting this assessment. A 
single assessor should be assigned to each participant for as many visits as possible to avoid 
inter-assessor variability in scoring 
8.1.4. 
Face-Investigator’s Global Assessment (F-IGA)  
The F-IGA is an investigator-administered, single-item scale that rates the severity of the 
participant’s AD on the face. The F-IGA is composed of a 5-point scale ranging from 0 (clear) to 
4 (severe), and a score is selected using descriptors that best describe the overall appearance of 
the facial lesions at a given time point. 
Assessors must be trained and certified by the sponsor prior to conducting this assessment. A 
single assessor should be assigned to each participant for as many visits as possible to avoid 
inter-assessor variability in scoring. The recall period of this assessment is present time. 
8.1.5. 
Post-inflammatory Dyschromia Scale (PDS)  
The PDS is an investigator assessment of cutaneous post-inflammatory hyperpigmentation 
and/or hypopigmentation which is completed at the visit per the SoA. This is a measure of post-
inflammatory cutaneous change; as such, pigmented actively inflamed AD lesions should not be 
evaluated with this scale. Areas of normal pigmentation, with no post-inflammatory hyper- or 
hypo- pigmentation, will receive a score of 0. Areas of post-inflammatory hyperpigmentation, as 
compared to adjacent normal skin tone (0), should receive a score of 1 (mild/barely perceptible 
hyperpigmentation), 2 (moderate/clearly perceptible hyperpigmentation) or 3 (severe/prominent 
hyperpigmentation). Areas of post-inflammatory hypopigmentation, as compared to adjacent 
normal skin tone (0), should receive a score of -1 (mild/barely perceptible hypopigmentation), -2 
(moderate/clearly perceptible hypopigmentation) or -3 (severe/prominent hypopigmentation). 
8.1.6. 
Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD)  
The PO-SCORAD is a patient-reported scale used to evaluate the condition of a patient’s eczema 
over the last 3 days in both adults and adolescent participants. Questions cover the spread of the 
eczema over the body’s surface, the severity of dry skin outside of eczema-affected areas, the 
symptom intensity on eczema-affected areas (including redness/darkness, swelling, oozing/scabs, 
scratch marks, and thickening of the skin), the intensity of eczema-related itching, and trouble 
sleeping. There are 9 items, and response options vary across each item. For the questions about 
symptom intensity, an accompanying user guide shows visual and descriptive anchors for each 
response option. The PO-SCORAD total score ranges from 0 to 104, with higher scores 
indicating more severe AD (Stalder et al. 2011; Faye et al. 2020). The recall period of this scale 
is over the last 3 days. 
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8.1.7. 
Pruritus NRS  
The Pruritus Numeric Rating Scale (NRS) is a participant-reported, single-item, daily, 11-point 
scale. The Pruritus NRS is used by participants to rate their worst itch severity over the past 24 
hours with 0 indicating “No itch” and 10 indicating “Worst itch imaginable.” Assessments will 
be recorded daily by the participant. The minimal clinically important change is 3 points. 
(Yosipovitch et al. 2019; Yosipovitch et al. 2021). 
Participants will record the pruritus assessments daily using an electronic diary at home. As 
indicated in the SoA (Section 1.3), initial electronic diary entries for Pruritus NRS should be 
completed a minimum of 4 of 7 days before baseline. 
8.1.8. 
Sleep-Loss Scale  
The Sleep-Loss Scale is a participant-reported, single-item, daily scale that measures the extent 
of sleep-loss due to interference of itch over the last night. The Sleep-Loss Scale is rated based 
on a 5-point Likert scale (0 [not at all] to 4 [unable to sleep at all]). Assessment will be recorded 
daily by the participant. The minimal clinically important change is 3 points. (Yosipovitch et al. 
2021). 
Participants will record the pruritus assessments daily using an electronic diary at home. As 
indicated in the SoA (Section 1.3), initial electronic diary entries for Sleep-Loss Scale should be 
completed a minimum of 4 of 7 days before baseline. 
8.1.9. 
Skin Pain Numeric Rating Scale (Skin Pain NRS)  
The Skin Pain NRS is a participant-reported, 11-point horizontal scale anchored at 0 and 10, with 
0 representing “no pain” and 10 representing “worst pain imaginable.” Overall severity of a 
participant’s skin pain is indicated by selecting the number that best describes the worst level of 
skin pain in the past 24 hours. Assessment will be recorded daily by the participant (Newton et 
al. 2019; Silverberg et al. 2021). 
8.1.10. 
Patient-Oriented Eczema Measure (POEM)  
The POEM is a simple, participant-reported, 7-item scale that assesses disease severity in 
children and adults. Participants respond to questions about the frequency of 7 symptoms 
(itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) 
over the past week. Response categories include “No days,” “1-2 days,” “3-4 days,” “5-6 days,” 
and “Every day” with corresponding scores of 0, 1, 2, 3, and 4, respectively. Scores range from 0 
to 28, with higher total scores indicating greater disease severity (Charman et al. 2004). 
8.1.11. 
Dermatology Life Quality Index/Children’s Dermatology Life Quality Index 
(DLQI/cDLQI)  
The Dermatology Life Quality Index (DLQI) is a simple, participant-reported, 10-item, QoL 
questionnaire in adults that covers 6 domains (symptoms and feelings, daily activities, leisure, 
work and school, personal relationships, and treatment). The recall period of this scale is over the 
“last week.” Response categories include “not at all,”, “a little”, “a lot,” and “very much,” with 
corresponding scores of 0, 1, 2, and 3, respectively, and unanswered (or “not relevant”) 
responses scored as 0. Scores range from 0 to 30 with higher scores indicating greater 
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impairment of QoL. A DLQI total score of 0 to 1 is considered as having no effect on a 
participant’s health-related QoL (Hongbo et al. 2005), and a 4-point change from baseline is 
considered as the minimal clinically important difference threshold (Khilji et al. 2002; Basra et 
al. 2015). 
Participants <16 years at baseline will complete the children’s DLQI (cDLQI) and should 
continue to complete the cDLQI for the duration of the study. 
8.1.12. 
Atopic Dermatitis Control Tool (ADCT)  
The Atopic Dermatitis Control Tool (ADCT) is a patient-reported, simple, brief tool for adults 
and adolescents that evaluates 6 symptoms and effects associated with AD over the past week: 
overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem 
with sleep, impact on daily activities, and impact on mood or emotions. Each of the 6 ADCT 
items has a score range from 0 (no problem) to 4 (worst), rating the severity of each concept; the 
total score ranges from 0 to 24, which is the summation of the responses to all the items. A score 
of ≥7 points was derived as the threshold to identify patients “not in control”. The threshold for 
meaningful within-person change was estimated to be 5 points (Simpson et al. 2019; Pariser et 
al. 2020). 
8.1.13. 
Work Productivity and Activity Impairment Questionnaire–Atopic Dermatitis 
(WPAI-AD)  
The Work Productivity and Activity Impairment Questionnaire–Atopic Dermatitis (WPAI-AD) 
is a participant-reported, 6-item questionnaire that records impairment due to AD over the past 7 
days in adolescents and adults. The WPAI-AD consists of 6 items grouped into 4 domains: 
absenteeism (work time missed), presenteeism (impairment at work/reduced on the job 
effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), 
and activity impairment. Absenteeism, presentism, and work productivity will only be reported 
by those who are currently employed (working for pay) at the time of the scale completion. The 
recall period for the scale is over the past 7 days. Scores are calculated as impairment 
percentages (Reilly et al. 1993), with higher scores indicating greater impairment and less 
productivity. 
8.1.14. 
Participant-Reported Satisfaction Question  
The question on participant satisfaction asks “How satisfied are you with this treatment’s ability 
to treat your skin condition?” The response options range from 1 (not satisfied) to 5 (completely 
satisfied). 
8.1.15. 
Fitzpatrick Skin Phototype Assessment  
The Fitzpatrick Scale is a clinician-rated scale and is based on a participant’s cutaneous reaction 
to sun exposure and baseline skin pigmentation. Fitzpatrick skin phototypes range from I to VI, 
with a score of I indicating “always burns, does not tan, white skin tone”, and a score of VI 
indicating “never burns, tans very easily, skin color black” (High et al. 2012). Investigators will 
follow the descriptive terms included in this protocol when recording the Fitzpatrick skin 
phototype. The sun sensitivity measure will represent the Fitzpatrick Scale score for each 
participant. The recall period for this scale is the present time. 
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8.2. 
Safety Assessments  
Planned time points for all safety assessments are provided in the SoA. 
The routine safety assessments include physical examinations, clinical safety laboratory tests 
(including hematology and chemistry), and collection of vital signs and spontaneously reported 
AEs. The study design includes a Post-treatment Follow-Up Period with at least 1 study visit for 
safety assessments. 
8.2.1. 
Clinical Safety Laboratory Tests  
● See Appendix 2 for the list of clinical laboratory tests to be performed and the 
SoA for the timing and frequency. 
● Local anesthetics 
○ Use of local anesthetics (e.g., EMLA cream) consistent with local prescribing 
information are permitted during the study visit to ease discomfort associated with 
venipunctures. 
● The investigator must review the laboratory results, document this review, and 
report any clinically relevant changes occurring during the study as an AE. The 
laboratory results must be retained with source documents unless a Source 
Document Agreement or comparable document cites an electronic location that 
accommodates the expected retention duration. Clinically significant abnormal 
laboratory findings are those which are not associated with the underlying disease, 
unless judged by the investigator to be more severe than expected for the 
participant's condition. 
● All laboratory tests with values considered clinically significantly abnormal 
during participation in the study or within 28 days after the last dose of study 
intervention should be repeated until the values return to normal or baseline or are 
no longer considered clinically significant by the investigator or medical monitor. 
○ If such values do not return to normal or baseline within a period of time 
judged reasonable by the investigator, the etiology should be identified and 
the sponsor notified. 
○ All protocol-required laboratory assessments, as defined in Appendix 2, must 
be conducted in accordance with the SoA, standard collection requirements, 
and laboratory manual. 
● If laboratory values from non-protocol specified laboratory assessments 
performed at an investigator-designated local laboratory require a change in 
participant management or are considered clinically significant by the 
investigator, for example, SAE or AE or dose modification, then report the 
information as an AE. 
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8.2.2. 
Hepatic Safety  
Close hepatic monitoringa 
Laboratory tests (Appendix 6), including alanine aminotransferase (ALT), aspartate 
aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (TBL), direct bilirubin, 
gamma-glutamyl transferase, and creatine kinase, should be repeated within 48 to 72 hours to 
confirm the abnormality and to determine if it is increasing or decreasing, if 1 or more of these 
conditions occur: 
If a participant with baseline 
results of...  
develops the following elevations: 
ALT or AST <1.5x ULN 
ALT or AST ≥3x ULN 
ALP <1.5x ULN 
ALP ≥2x ULN 
TBL <1.5x ULN 
TBL ≥2x ULN (except for patients with Gilbert’s 
syndrome) 
ALT or AST ≥1.5x ULN 
ALT or AST ≥2x baseline 
ALP ≥1.5x ULN 
ALP ≥2x baseline 
TBL ≥1.5x ULN 
TBL ≥1.5x baseline (except for patients with Gilbert’s 
syndrome) 
Abbreviations: ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; 
TBL = total bilirubin; ULN = upper limit of normal. 
a All ULN values should be age adjusted (AAULN) for participants <18 years of age. 
If the abnormality persists or worsens, clinical and laboratory monitoring, and evaluation for 
possible causes of abnormal liver tests should be initiated by the investigator in consultation with 
the Lilly-designated medical monitor. At a minimum, this evaluation should include physical 
examination and a thorough medical history, including symptoms, recent illnesses (for example, 
heart failure, systemic infection, hypotension, or seizures), recent travel, history of concomitant 
medications (including over-the-counter), herbal and dietary supplements, and history of alcohol 
drinking and other substance abuse. 
Initially, monitoring of symptoms and hepatic biochemical tests should be done at a frequency of 
1 to 3 times weekly, based on the participant’s clinical condition and hepatic biochemical tests. 
Subsequently, the frequency of monitoring may be lowered to once every 1 to 2 weeks, if the 
participant’s clinical condition and lab results stabilize. Monitoring of ALT, AST, ALP, and TBL 
should continue until levels normalize or return to approximate baseline levels. For participants 
<18 years of age, special care should be taken to minimize the volume of blood taken during 
hepatic monitoring. 
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Comprehensive hepatic evaluationa 
A comprehensive evaluation should be performed to search for possible causes of liver injury if 
one or more of these conditions occur: 
If a participant with baseline 
results of...  
develops the following elevations: 
ALT or AST <1.5x ULN 
ALT or AST ≥3x ULN with hepatic signs or symptoms
b, or 
ALT or AST ≥5x ULN 
ALP <1.5x ULN 
ALP ≥3x ULN 
TBL <1.5x ULN 
TBL ≥2x ULN (except for patients with Gilbert’s syndrome) 
ALT or AST ≥1.5x ULN 
ALT or AST ≥2x baseline with hepatic signs or symptoms
b, or 
ALT or AST ≥3x baseline 
ALP ≥1.5x ULN 
ALP ≥2x baseline 
TBL ≥1.5x ULN 
TBL ≥2x baseline (except for patients with Gilbert’s 
syndrome)  
Abbreviations: ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = aspartate aminotransferase; 
TBL = total bilirubin; ULN = upper limit of normal. 
a All ULN values should be age adjusted (AAULN) for participants <18 years of age. 
b Hepatic signs or symptoms are severe fatigue, nausea, vomiting, right upper quadrant abdominal pain, fever, and/or 
rash. 
For Adult Participants (≥18 years old) 
At a minimum, this evaluation should include physical examination and a thorough medical 
history, as outlined above, as well as tests for prothrombin time-international normalized ratio ; 
tests for viral hepatitis A, B, C, or E; tests for autoimmune hepatitis; and an abdominal imaging 
study, for example, ultrasound or computed tomography scan. 
Based on the patient’s history and initial results, further testing should be considered in 
consultation with the Lilly-designated medical monitor, including tests for hepatitis D virus, 
cytomegalovirus, Epstein-Barr virus, acetaminophen levels, acetaminophen protein adducts, 
urine toxicology screen, Wilson’s disease, blood alcohol levels, urinary ethyl glucuronide, and 
blood phosphatidylethanol. Based on the circumstances and the investigator’s assessment of the 
participant’s clinical condition, the investigator should consider referring the participant for a 
hepatologist or gastroenterologist consultation, magnetic resonance cholangiopancreatography, 
endoscopic retrograde cholangiopancreatography, cardiac echocardiogram, or a liver biopsy. 
For Adolescent Participants (<18 years old) 
At a minimum, this evaluation should include physical examination and a thorough medical 
history, as outlined above, as well as tests for prothrombin time-international normalized ratio 
and direct bilirubin, if total bilirubin was elevated. 
Based on the participant’s age, medical history and initial results, further testing should be 
considered in consultation with the Lilly-designated medical monitor, including tests for viral 
hepatitis A, B, C, E; autoimmune hepatitis; or an abdominal imaging study, for example, 
ultrasound, MRI, or computed tomography scan). Consider additional tests, based on the medical 
history and clinical picture, including tests for hepatitis D virus, cytomegalovirus, Epstein-Barr 
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virus, acetaminophen levels, acetaminophen protein adducts, urine toxicology screen, Wilson’s 
disease, blood alcohol levels, urinary ethyl glucuronide, and blood phosphatidylethanol. Special 
care should be taken to prioritize more pertinent blood tests and minimize the volume of blood 
taken during hepatic evaluation. Based on the circumstances and the investigator’s assessment of 
the participant’s clinical condition, the investigator should consider referring the participant for a 
pediatric hepatologist or gastroenterologist consultation, magnetic resonance 
cholangiopancreatography, endoscopic retrograde cholangiopancreatography, cardiac 
echocardiogram, or a liver biopsy as deemed appropriate for the clinical condition and 
participant’s age. 
Additional hepatic data collection (hepatic safety CRF) in study participants 
who have abnormal liver tests during the study 
Additional hepatic safety data collection in hepatic safety CRF should be performed in study 
participants who meet 1 or more of the following 5 conditions:a 
 Elevation of serum ALT to ≥5x ULN on 2 or more consecutive blood tests, (if baseline 
ALT <1.5x ULN) 
o In participants with baseline ALT ≥1.5x ULN, the threshold is ALT ≥3x baseline 
on 2 or more consecutive tests 
 Elevated TBL to ≥2x ULN (if baseline TBL <1.5x ULN) (except for cases of known 
Gilbert’s syndrome) 
o In participants with baseline TBL ≥1.5x ULN, the threshold should be TBL ≥2x 
baseline 
 Elevation of serum ALP to ≥2x ULN on 2 or more consecutive blood tests (if baseline 
ALP <1.5x ULN) 
o In participants with baseline ALP ≥1.5x ULN, the threshold is ALP ≥2x baseline 
on 2 or more consecutive blood tests 
 Hepatic event considered to be a SAE 
 Discontinuation of study drug due to a hepatic event 
NOTE: the interval between the 2 consecutive blood tests should be at least 2 days. 
a All ULN values should be age adjusted (AAULN) for participants <18 years of age. 
8.2.3. 
Hepatitis B Testing and Monitoring  
As specified in the SoA (Section 1.3), initial testing for HBV infection includes HBsAg and 
hepatitis B core antibody (HBcAb.). 
● If HBsAg is positive, the participant is excluded. 
● If HBsAg is negative and HBcAb is negative, the participant is not excluded. 
● If HBsAg is negative and HBcAb is positive, further testing for HBV DNA is 
required. 
○ If the screening HBV DNA is positive, the participant is excluded. 
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○ If the screening HBV DNA is negative, the participant is not excluded. Repeat 
testing for HBV DNA is required at least every 3 months during the study as 
described in the SoA. 
Management of enrolled participants with detectable HBV DNA during the study 
If HBV DNA is detected, study intervention will be temporarily withheld or permanently 
discontinued, as described in Sections 7.1.2 and 7.1, and the participant should be referred for 
appropriate follow-up medical care. 
8.2.4. 
Hepatitis C Testing  
As specified in the SoA (Section 1.3), initial testing for HCV infection includes testing for 
antibodies to HCV (anti-HCV). 
● If anti-HCV is positive, a test for circulating HCV RNA is required. 
● If HCV RNA test is negative, the participant is not excluded. 
● If HCV RNA test is positive, the participant is excluded (see Section 5.2). 
Participants who have had HCV infection and have been successfully treated, defined as a 
sustained virologic response (HCV RNA by polymerase chain reaction negative for at least 24 
weeks following treatment completion) are not excluded on the basis of HCV as long as HCV 
RNA test is negative at screening. 
If HCV RNA is detected during the study, the study intervention will be discontinued 
(Section 7.1), and the participant should receive appropriate follow-up medical care. 
8.3. 
Adverse Events, Serious Adverse Events, and Product Complaints  
The definitions of the following events can be found in Appendix 3: 
 AEs 
 SAEs and  
 PCs 
These events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, 
or the participant's legally authorized representative). 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet these definitions and remain responsible for following up events that 
are serious, considered related to the study intervention or study procedures, or that caused the 
participant to discontinue the study intervention or study (see Section 6). 
Care will be taken not to introduce bias when detecting events. Open-ended and non-leading 
verbal questioning of the participant is the preferred method to inquire about event occurrences. 
After the initial report, the investigator is required to proactively follow each participant at 
subsequent visits/contacts. All SAEs and AEs of special interest (as defined in Section 8.3.3) will 
be followed until resolution, stabilization, the event is otherwise explained, or the participant is 
lost to follow-up (as defined in Section 7.3). For PCs, the investigator is responsible for ensuring 
that follow-up includes any supplemental investigations as indicated to elucidate the nature 
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and/or causality. Further information on follow-up procedures is provided in Section 10.3, 
Appendix 3. 
8.3.1. 
Timing and Mechanism for Collecting Events  
This table describes the timing, deadlines, and mechanism for collecting events. 
Event 
Collection 
Start 
Collection 
Stop 
Timing for Reporting 
to Sponsor or 
Designee 
Mechanism for 
Reporting 
Back-up 
Method of 
Reporting 
Adverse Event 
AE 
Signing of 
the ICF 
Participation 
in study has 
ended 
As soon as possible 
upon site awareness 
AE CRF 
N/A 
Serious Adverse Event 
SAE and SAE 
updates – prior 
to start of study 
intervention and 
deemed 
reasonably 
possibly related 
to study 
procedures 
Signing of 
the ICF 
Start of 
intervention 
Within 24 hours of 
awareness 
SAE paper form 
SAE paper 
form 
SAE and SAE 
updates – after 
start of study 
intervention 
Start of 
intervention 
Participation 
in study has 
ended 
Within 24 hours of 
awareness 
SAE paper form 
SAE paper 
form 
SAEa – after 
participant’s 
study 
participation has 
ended and the 
investigator 
becomes aware 
After 
participant’s 
study 
participation 
has ended 
N/A 
Promptly 
SAE paper form 
N/A 
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Event 
Collection 
Start 
Collection 
Stop 
Timing for Reporting 
to Sponsor or 
Designee 
Mechanism for 
Reporting 
Back-up 
Method of 
Reporting 
Pregnancy 
Pregnancy in 
female 
participants and 
female partners 
of male 
participants 
After the 
start of study 
intervention 
At least 18 
weeks after 
the last dose 
of study 
intervention. 
Within 24 hours (see 
Section 8.3.2) 
Pregnancy paper 
form 
Pregnancy 
paper form 
Product Complaints 
PC associated 
with an SAE or 
might have led 
to an SAE 
Start of study 
intervention 
End of study 
intervention 
Within 24 hours of 
awareness 
PC form 
N/A 
PC not 
associated with 
an SAE 
Start of study 
intervention 
End of study 
intervention 
Within 1 business day 
of awareness 
PC form 
N/A 
Updated PC 
information 
— 
— 
As soon as possible 
upon site awareness 
Originally 
completed PC form 
with all changes 
signed and dated by 
the investigator 
N/A 
PC, (if 
investigator 
becomes aware) 
Participation 
in study has 
ended 
N/A 
Promptly 
PC form 
 
Abbreviations: AE = adverse event; ICF = informed consent form; N/A = not applicable; PC = product complaint 
SAE = serious adverse event. 
a Serious adverse events should not be reported unless the investigator deems them to be possibly related to study 
treatment or study participation. 
8.3.2. 
Pregnancy  
Collection of pregnancy information 
Male participants with partners who become pregnant 
● The investigator will attempt to collect pregnancy information on any male 
participant’s female partner who becomes pregnant while the male participant is 
in this study. This applies only to male participants who receive study 
intervention. 
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● After learning of a pregnancy in the female partner of a study participant, the 
investigator  
o will request a consent or assent to release information from the pregnant 
female partner directly, and 
o within 24 hours after obtaining this consent or assent, will record pregnancy 
information on the appropriate form and submit it to the sponsor. 
The female partner will also be followed to determine the outcome of the 
pregnancy. Information on the status of the mother and child will be forwarded to 
the sponsor. Generally, the follow-up will be no longer than 6 to 8 weeks 
following the estimated delivery date. Any termination of the pregnancy will be 
reported regardless of gestational age, fetal status (presence or absence of 
anomalies), or indication for the procedure. 
Female participants who become pregnant 
● The investigator will collect pregnancy information on any female participant 
who becomes pregnant while participating in this study. The initial information 
will be recorded on the appropriate form and submitted to the sponsor within 24 
hours of learning of a participant’s pregnancy. 
● The participant will be followed to determine the outcome of the pregnancy. The 
investigator will collect follow-up information on the participant and the neonate 
and the information will be forwarded to the sponsor. Generally, follow-up will 
not be required for longer than 6 to 8 weeks beyond the estimated delivery date. 
Any termination of pregnancy will be reported, regardless of gestational age, fetal 
status (presence or absence of anomalies) or indication for the procedure. 
● While pregnancy itself is not considered to be an AE or SAE, any pregnancy 
complication or elective termination of a pregnancy for medical reasons will be 
reported as an AE or SAE. 
● A spontaneous abortion (occurring at <20 weeks gestational age) or still birth 
(occurring at ≥20 weeks gestational age) is always considered to be an SAE and 
will be reported as such.  
● Any post-study pregnancy related SAE considered reasonably related to the study 
intervention by the investigator will be reported to the sponsor as described in 
protocol Section 8.3.1. While the investigator is not obligated to actively seek this 
information in former study participants, he or she may learn of an SAE through 
spontaneous reporting. 
● Any female participant who becomes pregnant while participating in the study 
will discontinue study intervention. If the participant is discontinued from the 
study, follow the standard discontinuation process and continue directly to the 
follow-up phase. The follow-up on the pregnancy outcome should continue 
independent of intervention or study discontinuation. 
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Prior to continuation of study intervention following pregnancy, the following must occur: 
● The sponsor and the relevant institutional review board/independent ethics committee 
(IRB/IEC) give written approval. 
● The participant gives signed informed consent (and assent, as applicable). 
● The investigator agrees to monitor the outcome of the pregnancy and the status of the 
participant and the participant’s offspring. 
8.3.3. Adverse Events of Special Interest  
The following TEAEs will be designated AE of special interest (AESI): 
 conjunctivitis 
 herpes infection or zoster, and 
 parasitic infection or an infection related to an intracellular pathogen. 
If these AESIs are reported, sites will be prompted to collect additional data. Participant records 
must include any follow-up information regarding these AESI. Study intervention should be 
discontinued if an AE is deemed persistent and if continuation of study intervention would not be 
in the best interest of the participant. Discuss discontinuation of study intervention with the 
sponsor or designee prior to implementation. 
8.3.3.1. 
Infections, Including Serious Infections and Opportunistic Infections  
Completion of the Infection CRF page is required for each infection reported as an AE or SAE. 
The sponsor will identify infections considered to be opportunistic based on the article by 
Winthrop et al. (2015) (Section 10.9, Appendix 9). 
8.3.4. 
Facial Dermatitis  
Completion of the facial dermatitis follow-up CRF page is required for each facial dermatitis 
event reported as an AE or SAE. 
8.3.5. 
Hypersensitivity  
Many drugs, including oral agents and biologic agents, carry the risk of systemic hypersensitivity 
reactions. If such a reaction occurs, additional data should be provided to the sponsor in the 
designated CRFs. 
Sites should have appropriately trained medical staff and appropriate medical equipment 
available when study participants are receiving study intervention. It is recommended that 
participants who experience a systemic hypersensitivity reaction be treated per national and 
international guidelines. 
In the case of a suspected systemic hypersensitivity event, additional blood samples should be 
collected as described in Section 10.2.1. Laboratory results are provided to the sponsor via the 
central laboratory. 
8.3.6. 
Injection Site Reactions  
Symptoms and signs of a local injection site reaction may include erythema, induration, pain, 
pruritus, and edema. 
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If an injection site reaction is reported by a participant or site staff, the injection site reaction 
CRF will be used to capture additional information about this reaction (for example, injection-
site pain, degree and area of erythema, induration, pruritis, and edema). 
8.4. 
Pharmacokinetics  
At the visits and times specified in the SoA, venous blood samples will be collected and stored 
for potential analysis of serum concentrations of lebrikizumab. 
Samples will be stored at a facility designated by the sponsor and may be assessed at a later date 
at a laboratory approved by the sponsor using a validated enzyme-linked immunosorbent assay 
method. 
Instructions for the collection and handling of blood samples will be provided by the sponsor. 
The actual data and time (24-hour clock time) of each sample and the most recent lebrikizumab 
dose prior to PK blood draw must be recorded. 
Sample retention is described in Section 10.1.11. Bioanalytical samples collected to measure 
investigational product concentrations will be retained for a maximum of 1 year following last 
participant visit for the study. During this time, samples remaining after the bioanalysis may be 
used for exploratory analyses such as bioanalytical assay validation or cross-validation exercises. 
8.5. 
Pharmacodynamics  
Pharmacodynamic parameters are not evaluated in this study. 
8.6. 
Genetics  
A blood sample for DNA isolation will be collected from participants. 
See Section 10.5, Appendix 5 for Information regarding genetic research and Section 10.1.11 for 
details about sample retention and custody. 
8.7. 
Biomarkers  
 Serum samples will be collected to discern responder variability within the study and to 
track response variability to lebrikizumab. Biomarkers will include but not limited to 
 
Samples will be collected according to the schedule described 
in the SoA and as detailed in laboratory manual provided separately to sites. 
 The sponsor may store samples according to Section 10.1.11. Additionally, with 
participants’ consent, samples may be used for further research by the sponsor or others 
such as universities or other companies to contribute to the understanding of AD or other 
diseases, the development of related or new treatments, or research methods. 
8.8. 
Immunogenicity Assessments  
At the visits and times specified in the SoA, venous blood samples will be collected for the 
purpose of determining antibody production against lebrikizumab. To aid interpretation of these 
results, a blood sample for PK analysis will be collected at the same time points. 
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All samples for immunogenicity should be taken pre-dose when applicable and possible. 
Instructions for the collection and handling of blood samples will be provided by the sponsor. 
The actual date and time (24-hour clock time) of each sample collection will be recorded. 
Immunogenicity samples will be stored at a facility designated by the sponsor and may be 
assessed at a later date using a validated assay designed to detect anti-drug antibodies (ADAs) in 
the presence of lebrikizumab at a laboratory designated by the sponsor. Samples may also be 
used for the development and control of an immunogenicity assay. 
Treatment-emergent ADAs are defined in Section 9.3.6.4. 
Sample retention is described in Section 10.1.11. 
8.9. 
Health Economics  
Health economics and/or medical resource utilization will not be collected as part of this study. 
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9. 
Statistical Considerations  
The SAP will be finalized prior to first patient visit, and it will include a more technical and 
detailed description of the statistical analyses described in this section. This section is a summary 
of the planned statistical analyses of the most important endpoints, including primary and key 
secondary endpoints. 
9.1. 
Statistical Hypotheses  
The primary objective is to evaluate efficacy of lebrikizumab 250 mg Q2W on reducing skin 
sign of AD, measured by percentage of patients who achieve at least 75% improvement in 
baseline EASI at Week 16 in participants with skin of color. 
This is an open-label study, no statistical hypothesis will be tested. No inferential statistical 
analysis will be performed. 
9.2. 
Analyses Sets  
Participant Analysis Set 
Description 
ITT population 
All enrolled participants. Participants will be included in the analyses 
according to the planned intervention. 
Safety population 
All enrolled participants who are exposed to study intervention. 
Abbreviation: ITT = intent-to-treat. 
9.3. 
Statistical Analyses  
9.3.1. General Considerations  
Statistical analysis of this study will be the responsibility of Eli Lilly and Company (Lilly) or its 
designee. A detailed SAP describing the statistical methodologies will be developed by Lilly or 
its designee. 
Any change to the data analysis methods described in the protocol will require an amendment 
ONLY if it changes a principal feature of the protocol. Any other change to the data analysis 
methods described in the protocol, and the justification for making the change, will be described 
in the clinical study report (CSR). Additional exploratory analyses of the data will be conducted 
as deemed appropriate. 
All analyses will be descriptive. Frequencies, percentages and 90% confidence interval (CI) for 
percentages will be reported for discrete efficacy endpoints. Mean, standard deviation, minimum, 
Q1, median, Q3, maximum, and the number of participants will be reported for continuous 
efficacy endpoints. AEs, discontinuation, and other categorical safety data will be summarized 
using frequencies and percentage. Continuous vital signs, body weight, and other continuous 
safety variables including laboratory variables will be summarized descriptively as well. 
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9.3.2. 
Primary Endpoint(s)/Estimand(s) Analysis  
The primary endpoint is EASI 75 response rate at Week 16. The primary clinical question of 
interest is: What is the intervention effect in percentage of participants achieving EASI 75 after 
16 weeks of lebrikizumab 250 mg intervention in participants with skin of color and moderate-
to-severe AD who remain on study treatment until Week 16. There are no intercurrent events 
since participants who initiate rescue medication are discontinued from the study and hence 
study treatment. Therefore, participants who stay on study treatment through Week 16 will not 
have an intercurrent event such as initiating rescue medication or permanently discontinuing 
treatment. All observed data will be included in summary statistics. All summary statistics will 
be based on observed data. 
9.3.3. 
Secondary Endpoint(s)/Estimand(s) Analysis  
Secondary endpoints specified in Section 3 will be analyzed similarly to the primary endpoint of 
the primary estimand, that is, using all observed data.  
9.3.4. 
Exploratory Endpoint(s) Analysis  
Other exploratory endpoints specified in Section 3 will be summarized using all observed data. 
9.3.5. 
Safety Analyses  
All safety data will be descriptively summarized using the safety population. 
TEAEs are defined as AEs that first occurred or worsened in severity after the first dose of study 
treatment. The number and percentage of participants who experienced at least 1 TEAE will be 
summarized using the most current version of MedDRA (Medical Dictionary for Regulatory 
Activities) by system organ class (or body system) and by each preferred term. SAEs and AEs 
that lead to discontinuation of study intervention 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 participants in corresponding categories. Shift tables might be presented for 
selected measures. 
Observed values and changes from baseline (predose or screening if missing) for vital signs and 
physical characteristics will be descriptively summarized by time point. 
The SAP may include additional safety analyses if needed. 
9.3.6. 
Other Analyses  
9.3.6.1. 
Subgroup Analyses  
Subgroup (subpopulation) analyses of the primary and some secondary endpoints at Weeks 16 
and 24 may be conducted for intent-to-treat set. Subgroup to be evaluated may include baseline 
severity, sex, age, race, Fitzpatrick skin type. 
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Definitions for the levels of the subgroup variables and any additional subgroup analyses will be 
defined in the SAP. All subgroup analyses will be descriptive and should be treated as 
exploratory. 
9.3.6.2. 
Biomarker Analyses  
Biomarker analyses will be described in the SAP. 
9.3.6.3. 
Pharmacokinetic Analyses  
Pharmacokinetic samples will be stored and may be later assessed. If assessed, pharmacokinetic 
analyses may be described in the SAP 
9.3.6.4. 
Immunogenicity Assessments  
Immunogenicity samples will be stored and may be later assessed. If assessed, the frequency and 
percentage of participants with pre-existing anti-drug antibody (ADA) and who are treatment-
emergent ADA positive (TE ADA+) to lebrikizumab will be tabulated. 
Treatment-emergent ADAs are defined as participants 
 with a 2-fold (1 dilution) increase in titer than the minimum required dilution if no 
ADAs were detected at baseline (treatment-induced ADA), or 
 with a 4-fold (2 dilutions) increase in titer compared with baseline if ADAs were 
detected at baseline (treatment-boosted ADA). 
The distribution of titers and frequency of neutralizing antibodies (if assessed) for TE ADA+ 
participants may also be tabulated. 
The relationship between the presence of ADA and PK parameters, efficacy response or safety to 
lebrikizumab may also be assessed. 
Additional details may be provided in the SAP. 
9.4. 
Interim Analysis  
One interim analysis (primary lock) will be conducted after all enrolled participants have been 
evaluated at Week 16 or discontinued prior to Week 16. This interim database lock will include 
all efficacy and safety data collected by the cutoff date. Due to the open-label and descriptive 
nature of this study, this is no unblind nor alpha adjustment. 
Additional analyses and snapshots of study data may be performed to fulfill the need for 
regulatory interactions or publication purposes. 
The SAP will describe the planned interim analyses in greater detail. 
9.5. 
Sample Size Determination  
Based on the available data, EASI 75 response rate is approximately 50%. A total sample size of 
at least 80 enrolled participants will provide >95% probability that the half-width of the 2-sided 
90% CI of EASI 75 is at most 10%. This study will enroll approximately 95 participants to 
enable exploratory biomarker analyses. 
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The 2-sided 90% CI of EASI 75 response rates based on Wilson score method are summarized 
for a sample size of 80 participants in the table below. The CIs are provided as reference rather 
than a basis of any decision criteria. 
Estimated 90% Confidence Interval with Sample Size of 80 Participants 
Response Rate (%) 
Lower Limit (%) 
Upper Limit (%) 
40 
31.46 
49.19 
45 
36.16 
54.16 
50 
40.96 
59.04 
55 
45.84 
63.84 
60 
50.81 
68.54 
65 
55.87 
73.15 
70 
61.03 
77.66 
 
 
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10. 
Supporting Documentation and Operational Considerations  
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations  
10.1.1. 
Regulatory and Ethical Considerations  
● This study will be conducted in accordance with the protocol and with the 
following: 
○ Consensus ethical principles derived from international guidelines including 
the Declaration of Helsinki and Council for International Organizations of 
Medical Sciences International Ethical Guidelines 
○ Applicable ICH GCP Guidelines 
○ International Organization for Standardization 14155 
○ Applicable laws and regulations 
● The protocol, protocol amendments, ICF, IB, and other relevant documents (for 
example, advertisements) must be submitted to an IRB/IEC by the investigator 
and reviewed and approved by the IRB/IEC before the study is initiated. 
● Any amendments to the protocol will require IRB/IEC approval before 
implementation of changes made to the study design, except for changes 
necessary to eliminate an immediate hazard to study participants. 
● Protocols and any substantial amendments to the protocol will require health 
authority approval prior to initiation except for changes necessary to eliminate an 
immediate hazard to study participants. 
● The investigator will be responsible for the following: 
○ Providing written summaries of the status of the study to the IRB/IEC 
annually or more frequently in accordance with the requirements, policies, and 
procedures established by the IRB/IEC 
○ Notifying the IRB/IEC of SAEs or other significant safety findings as required 
by IRB/IEC procedures 
○ Providing oversight of study conduct for participants under their responsibility 
and adherence to requirements of 21 Code of Federal Regulations , ICH 
guidelines, the IRB/IEC, European regulation 536/2014 for clinical studies (if 
applicable), and all other applicable local regulations 
● Investigator sites are compensated for participation in the study as detailed in the 
clinical trial agreement. 
10.1.2. 
Financial Disclosure  
Investigators and sub-investigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
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certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing information on financial interests during the course of the study and for 
1 year after completion of the study. 
10.1.3. 
Informed Consent Process  
● The investigator or the investigator’s representative will explain the nature of the 
study, including the risks and benefits, to the participant (or the participant’s 
legally authorized representative) and answer all questions regarding the study. 
● Participants must be informed that their participation is voluntary. Participants (or 
the participant’s legally authorized representative) will be required to sign a 
statement of informed consent/assent that meets the requirements of 21 Code of 
Federal Regulations 50, local regulations, ICH guidelines, privacy and data 
protection requirements, where applicable, and the IRB/IEC or study center. 
● For adult participants, the medical record must include a statement that written 
informed consent was obtained before the participant was entered in the study and 
the date the written consent was obtained. The authorized person obtaining the 
informed consent must also sign the ICF. 
● For adolescent participants, the medical record must include a statement that legally 
acceptable representative or parent(s) consent and child/adolescent assent (if deemed 
appropriate by local ethics review) was obtained before the participant was enrolled in 
the study and the date the written consent was obtained. The medical record should also 
describe how the clinical investigator determined that the person signing the ICF was the 
participant’s legally acceptable representative or parent(s). The acceptable person 
obtaining the informed consent must also sign the ICF. Adolescent participants who 
become 18 years of age while on study, will need to re-consent. 
● Participants (or their legally acceptable representative, parent(s), or legal 
guardian) must be reconsented (or re-assented) to the most current version of the 
ICF(s) during their participation in the study. 
● A copy of the ICF(s) must be provided to the participant (or the participant’s 
legally authorized representative) and is kept on file. 
Participants who are rescreened are required to sign a new ICF. 
10.1.4. 
Data Protection  
● Participants will be assigned a unique identifier by the sponsor. Any participant 
records, datasets, or tissue samples that are transferred to the sponsor will contain 
the identifier only; participant names or any information which would make the 
participant identifiable will not be transferred. 
● The participant must be informed that the participant’s personal study-related data 
will be used by the sponsor in accordance with local data protection law. The 
level of disclosure must also be explained to the participant who will be required 
to give consent for their data to be used as described in the informed consent. 
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● The participant must be informed that their medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by 
the sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
● The sponsor has processes in place to ensure data protection, information security, 
and data integrity. These processes include appropriate contingency plan(s) for 
appropriate and timely response in the event of a data security breach. 
10.1.5. 
Dissemination of Clinical Study Data  
Reports 
The sponsor will disclose a summary of study information, including tabular study results, on 
publicly available websites where required by local law or regulation. 
Data 
The sponsor provides access to all individual participant data collected during the trial, after 
anonymization, with the exception of pharmacokinetic or genetic data. Data are available to 
request 6 months after the indication studied has been approved in the US and EU and after 
primary publication acceptance, whichever is later. No expiration date of data requests is 
currently set once data are made available. 
Access is provided after a proposal has been approved by an independent review committee 
identified for this purpose and after receipt of a signed data sharing agreement. Data and 
documents, including the study protocol, SAP, CSR, and blank or annotated case report forms, 
will be provided in a secure data sharing environment for up to 2 years per proposal. 
For details on submitting a request, see the instructions provided at www.vivli.org. 
10.1.6. 
Data Quality Assurance  
● All participant data relating to the study will be recorded on printed or electronic 
CRFs unless transmitted to the sponsor or designee electronically (for example, 
laboratory data). The investigator is responsible for verifying that data entries are 
accurate and correct by physically or electronically signing the CRF. 
● The investigator must maintain accurate documentation (source data) that 
supports the information entered in the CRF. 
● The investigator must permit study-related monitoring, audits, IRB/IEC review, 
and regulatory agency inspections and provide direct access to source data 
documents. 
● Quality tolerance limits (QTLs) will be pre-defined to identify systematic issues 
that can impact participant safety and/or reliability of study results. These pre-
defined parameters will be monitored during the study and important excursions 
from the QTLs and remedial actions taken will be summarized in the CSR. 
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● Monitoring details describing strategy (for example, risk-based initiatives in 
operations and quality such as risk management and mitigation strategies and 
analytical risk-based monitoring), methods, responsibilities and requirements, 
including handling of noncompliance issues and monitoring techniques are 
provided in the Monitoring Plan. 
● The sponsor or designee is responsible for the data management of this study 
including quality checking of the data. 
● The sponsor assumes accountability for actions delegated to other individuals (for 
example, contract research organizations). 
● Study monitors will perform ongoing source data verification to confirm that data 
transcribed into the CRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are 
being protected; and that the study is being conducted in accordance with the 
currently approved protocol and any other study agreements, ICH GCP, and all 
applicable regulatory requirements. 
● Records and documents, including signed ICFs, pertaining to the conduct of this 
study must be retained by the investigator for the time period outlined in the 
clinical trial agreement unless local regulations or institutional policies require a 
longer retention period. No records may be destroyed during the retention period 
without the written approval of the sponsor. No records may be transferred to 
another location or party without written notification to the sponsor. 
● In addition, sponsor or its representatives will periodically check a sample of the 
participant data recorded against source documents at the study site. The study 
may be audited by sponsor or its representatives, and/or regulatory agencies at 
any time. Investigators will be given notice before an audit occurs. 
Data Capture System 
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness 
of the data reported to the sponsor. 
An electronic data capture system (EDC) will be used in this study for the collection of CRF 
data. The investigator maintains a separate source for the data entered by the investigator or 
designee into the sponsor-provided EDC system. The investigator is responsible for the 
identification of any data to be considered source and for the confirmation that data reported are 
accurate and complete by signing the CRF. 
Additionally, the skin assessment using the Fitzpatrick Skin Type scale will be collected by the 
authorized study personnel, via a paper source document and will be transcribed by the 
authorized study personnel into the EDC system. 
Additionally, electronic clinical outcome assessment (eCOA) data (participant-focused outcome 
instrument) will be directly recorded by the participant/investigator site personnel, into an 
instrument (for example, hand-held smart phone or tablet). The eCOA data will serve as the 
source documentation, and the investigator does not maintain a separate written or electronic 
record of these data. 
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Data collected via the sponsor-provided data capture system(s) will be stored at third-parties. The 
investigator will have continuous access to the data during the study and until decommissioning 
of the data capture system(s). Prior to decommissioning, the investigator will receive or access 
an archival copy of pertinent data for retention. 
Data managed by a central vendor, such as laboratory test data, will be stored electronically in 
the central vendor’s database system and reports will be provided to the investigator for review 
and retention. Data will subsequently be transferred from the central vendor to the sponsor data 
warehouse. 
Data from complaint forms submitted to the sponsor will be encoded and stored in the global 
product complaint management system. 
10.1.7. 
Source Documents  
● Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected. Source documents are filed at the 
investigator’s site. 
● Data reported on or entered in the CRF and are transcribed from source 
documents must be consistent with the source documents or the discrepancies 
must be explained. The investigator may need to request previous medical records 
or transfer records, depending on the study. Also, current medical records must be 
available. 
● Definition of what constitutes source data can be found in Section 10.1.6. 
10.1.8. 
Study and Site Start and Closure  
First Act of Recruitment 
The study start date is the date on which the clinical study will be open for recruitment of 
participants. 
The first act of recruitment is the first site open and will be the study start date. 
Study or Site Termination 
The sponsor or sponsor’s designee reserves the right to close the study site or terminate the study 
at any time for any reason at the sole discretion of the sponsor. Study sites will be closed upon 
study completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
For study termination: 
● Discontinuation of further study intervention development 
For site termination: 
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● Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines 
● Inadequate recruitment (evaluated after a reasonable amount of time) of 
participants by the investigator 
● Total number of participants included earlier than expected. 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up. 
10.1.9. 
Publication Policy  
In accordance with the sponsor’s publication policy, the results of this study will be submitted 
for publication by a peer-reviewed journal. 
10.1.10. 
Investigator Information  
Researchers with appropriate education, training, and experience, as determined by the sponsor, 
will participate as investigators in this clinical trial. 
10.1.11. 
Sample Retention  
Sample retention enables use of new technologies, response to regulatory questions, and 
investigation of variable response that may not be observed until later in the development 
of lebrikizumab or after lebrikizumab become(s) commercially available moderate-to-severe AD. 
 
Sample Type 
Custodian 
Retention Period after 
Last Participant Visit 
Biomarkers 
Sponsor or Designee 
7 years 
PK 
Sponsor or Designee 
1 year 
Genetics 
Sponsor or Designee 
7 years 
Immunogenicity 
Sponsor or Designee 
7 years 
 Abbreviation: PK = pharmacokinetics. 
 
  
 
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10.2. 
Appendix 2: Clinical Laboratory Tests  
● The tests detailed in the table below will be performed by the central laboratory. 
● In circumstances where the sponsor approves local laboratory testing in lieu of 
central laboratory testing (in the table below), the local laboratory must be 
qualified in accordance with applicable local regulations. 
● Protocol-specific requirements for inclusion or exclusion of participants are 
detailed in Section 5 of the protocol. 
● Additional tests may be performed at any time during the study as determined 
necessary by the investigator or required by local regulations. 
● Investigators must document their review of the laboratory safety results. 
Clinical Laboratory Tests  
Comments  
Hematology 
Assayed by Lilly-designated laboratory 
Hemoglobin 
  
Hematocrit 
  
Erythrocyte count (RBCs) 
  
Mean cell volume  
  
Mean cell hemoglobin 
  
Mean cell hemoglobin concentration  
  
Absolute Neutrophil Count (Calculation) 
(Definition - include Segs and Bands or 
Segs, Bands and other immature cells)  
  
Leukocytes (WBCs)  
  
Differential 
  
Percent and absolutes count of: 
  
 Neutrophils, segmented 
  
 Neutrophils, bands 
  
 Lymphocytes 
  
 Monocytes 
  
 Eosinophils 
  
 Basophils 
  
Platelets 
  
Cell morphology (RBCs and WBCs) 
  
  
  
Clinical Chemistry 
Assayed by Lilly-designated laboratory 
Sodium 
  
Potassium 
  
Chloride 
  
Bicarbonate 
  
Total bilirubin 
  
Direct bilirubin 
  
ALP 
  
ALT 
  
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Clinical Laboratory Tests  
Comments  
AST 
  
GGT 
  
BUN 
  
Creatinine  
  
CK 
  
Uric acid 
  
Total protein 
  
Albumin 
  
Calcium 
  
Phosphorus 
  
LDH 
  
  
  
Hormones (female) 
  
Serum Pregnancy  
Assayed by Lilly-designated laboratory.  
Urine Pregnancy 
Assayed and Evaluated locally  
  
  
HIV and Hepatitis Serology 
Assayed by Lilly-designated laboratory 
HIV testing  
  
HCV testing: 
  
 HCV antibody  
  
 HCV RNA 
  
HBV testing:  
  
 HBV DNA  
Performed only for participants who test positive for 
HBcAb.  
 HBcAb 
  
 HBsAg  
  
 HBsAb 
  
Exploratory Biomarkers  
Assayed by Lilly-designated laboratory.  
Results will not be provided to the investigative sites. 
 
  
Immunoglobulins 
Assayed by Lilly-designated laboratory.  
Results will not be provided to the investigative sites. 
IgE (Serum) 
  
  
  
Genetics Sample 
Assayed by Lilly-designated laboratory.  
Results will not be provided to the investigative sites. 
  
  
Exploratory Biomarker storage samples 
Assayed by Lilly-designated laboratory.  
Results will not be provided to the investigative sites. 
Serum 
  
 
 
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Clinical Laboratory Tests  
Comments  
Immunogenicity (ADA) samples 
Assayed by Lilly-designated laboratory.  
Results will not be provided to the investigative sites. 
Anti-LY3650150 antibodies 
 
Pharmacokinetic Samples – LY3650150 
concentration 
Assayed by Lilly-designated laboratory.  
Results will not be provided to the investigative sites. 
 
Abbreviations: ADA = anti-drug antibodies; ALP = alkaline phosphatase; ALT = alanine aminotransferase; AST = 
aspartate aminotransferase; BUN = blood urea nitrogen; CK = creatine kinase; GGT = Gamma-glutamyl 
transferase; HBcAb = hepatitis B core antibody; HBsAb = hepatitis B surface antibody; HBsAg = hepatitis B 
surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; IgE = 
immunoglobulin E; IL = interleukin; LDH = lactic dehydrogenase; PK = pharmacokinetics; RBC = red blood 
cells; WBC = white blood cells. 
10.2.1. 
Laboratory Samples to be Obtained at the Time of a Systemic Hypersensitivity 
Event  
Purpose of collecting samples after a systemic hypersensitivity event 
The samples listed in this appendix are not collected for acute study participant management. 
The sponsor will use the laboratory tests results from these samples to characterize 
hypersensitivity events across the clinical development program. 
When to collect samples after a systemic hypersensitivity event occurs 
Collect the samples listed below if a systemic hypersensitivity event is suspected. The timing 
should be as designated in the table, assuming the participant has been stabilized. 
Obtain follow-up predose samples at the next regularly scheduled laboratory sample collection 
(ideally prior to the next dose after the event) to assess post-event return-to-baseline values. 
 
Timing 
Laboratory Test a 
Collect from 30 minutes to 4 hours 
after the start of the event. 
● NOTE: The optimal 
collection time is from 1 to 2 
hours after the start of event. 
Tryptase 
Collect only if not already collected 
on the same day as the event. 
● NOTE: If collecting, 
collect up to 12 hours after the 
start of the event. 
Lebrikizumab anti-drug antibodies (ADA) 
Lebrikizumab concentration 
a All samples for hypersensitivity testing will be assayed by Lilly-designated laboratory. Results will not be 
provided to the study site. If samples are not collected or are collected outside the specified time period, this will 
not be considered a protocol deviation. 
What information to record 
Record the date and time when the samples are collected. 
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Allowed additional testing for participant management 
The investigator may perform additional tests locally, if clinically indicated, for acute study 
participant management. 
 
 
 
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10.3. 
Appendix 3: Adverse Events and Serious Adverse Events: Definitions 
and Procedures for Recording, Evaluating, Follow-up, and 
Reporting  
 The definitions and procedures detailed in this appendix are in accordance with 
International Organization for Standardization 14155. 
 Both the investigator and the sponsor will comply with all local medical device 
reporting requirements. 
 The detection and documentation procedures described in this protocol apply to all 
sponsor medical devices provided for use in the study. See Section 6.1.1 for the list of 
sponsor medical devices). 
10.3.1. 
Definition of AE  
AE Definition 
 An AE is any untoward medical occurrence in a participant administered a 
pharmaceutical product and which does not necessarily have a causal relationship 
with the study intervention. An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding), symptom, or disease 
(new or exacerbated) temporally associated with the use of a medicinal 
(investigational) product, whether or not related to the medicinal (investigational) 
product. 
 An AE is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory finding) in study 
participants, users, or other persons, whether or not related to the investigational 
medical device. This definition includes events related to the investigational 
medical device or comparator and events related to the procedures involved except 
for events in users or other persons, which only include events related to 
investigational devices. 
 
Events Meeting the AE Definition 
 Any abnormal laboratory test results (hematology or clinical chemistry) or other 
safety assessments (for example, electrocardiogram, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically 
significant in the medical and scientific judgment of the investigator (that is, not 
related to progression of underlying disease). 
 Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
 New condition detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study. 
 Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
 Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
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an AE/SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae. 
 Lack of efficacy or failure of expected pharmacological action per se will not be 
reported as an AE or SAE. Such instances will be captured in the efficacy 
assessments. However, the signs, symptoms, and/or clinical sequelae resulting from 
lack of efficacy will be reported as AE or SAE if they fulfill the definition of an AE 
or SAE.  
 
Events NOT Meeting the AE Definition 
 Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition. 
 The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition. 
 Medical or surgical procedure (for example, endoscopy, appendectomy): the 
condition that leads to the procedure is the AE. 
 Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
 Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) 
present or detected at the start of the study that do not worsen. 
10.3.2. 
Definition of SAE  
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or 
more of the criteria listed: 
a. Results in death 
b. Is life-threatening 
The term life-threatening in the definition of serious refers to an event in which the participant 
was at risk of death at the time of the event. It does not refer to an event, which hypothetically 
might have caused death, if it were more severe. 
c. Requires inpatient hospitalization or prolongation of existing hospitalization 
 In general, hospitalization signifies that the participant has been admitted to 
hospital or emergency ward (usually involving at least an overnight stay) for 
observation and/or treatment that would not have been appropriate in the 
physician’s office or outpatient setting. Complications that occur during 
hospitalization are AEs. If a complication prolongs hospitalization or fulfills any 
other serious criteria, the event is serious. When in doubt as to whether 
hospitalization occurred or was necessary, the AE should be considered serious. 
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 Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline is not considered an AE. 
d. Results in persistent disability/incapacity 
 The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
 This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (for example, sprained ankle) which may interfere 
with or prevent everyday life functions but do not constitute a substantial 
disruption. 
e. Is a congenital anomaly/birth defect 
 Abnormal pregnancy outcomes (for example, spontaneous abortion, fetal death, 
stillbirth, congenital anomalies, ectopic pregnancy) are considered SAEs. 
f. Other situations: 
 Medical or scientific judgment should be exercised by the investigator in deciding 
whether SAE reporting is appropriate in other situations such as important medical 
events that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the participant or may require medical or 
surgical intervention to prevent one of the other outcomes listed in the above 
definition. These events should usually be considered serious. 
 
Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse.  
g. Resulted in medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.  
 
10.3.3. 
Definition of Product Complaints  
Product Complaint 
 A PC is any written, electronic, or oral communication that alleges deficiencies related 
to the identity, quality, durability, reliability, safety, effectiveness or performance of a 
study intervention. When the ability to use the study intervention safely is impacted, 
the following are also PCs: 
o Deficiencies in labeling information, and 
o Use errors for device or drug-device combination products due to ergonomic 
design elements of the product. 
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 Product complaints related to study interventions used in clinical trials are collected to 
ensure the safety of participants, monitor quality, and to facilitate process and product 
improvements. 
 Investigators will instruct participants to contact the site as soon as possible if he or she 
has a PC or problem with the study intervention so that the situation can be assessed. 
 An event may meet the definition of both a PC and an AE/SAE. In such cases, it 
should be reported as both a PC and as an AE/SAE. 
 
10.3.4. 
Recording and Follow-Up of AE and/or SAE and Product Complaints  
AE, SAE, and Product Complaint Recording 
 When an AE/SAE/PC occurs, it is the responsibility of the investigator to review all 
documentation (for example, hospital progress notes, laboratory reports, and 
diagnostics reports) related to the event. 
 The investigator will then record all relevant AE/SAE/PC information in the 
participant’s medical records, in accordance with the investigator’s normal clinical 
practice. AE/SAE information is reported on the appropriate CRF page and PC 
information is reported on the PC Form. 
o NOTE: An event may meet the definition of both a PC and an AE/SAE. In such 
cases, it should be reported as both a PC and as an AE/SAE. 
 It is not acceptable for the investigator to send photocopies of the participant’s medical 
records to Sponsor or designee in lieu of completion of the CRF page for AE/SAE and 
the PC Form for PCs. 
 There may be instances when copies of medical records for certain cases are requested 
by Sponsor or designee. In this case, all participant identifiers, with the exception of 
the participant number, will be redacted on the copies of the medical records before 
submission to Sponsor or designee. 
 The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE/SAE.  
Assessment of Intensity 
The investigator will make an assessment of intensity for each AE and SAE reported during 
the study and assign it to one of the following categories: 
 Mild: A type of adverse event that is usually transient and may require only 
minimal treatment or therapeutic intervention. The event does not generally 
interfere with usual activities of daily living. 
 Moderate: A type of adverse event that is usually alleviated with additional specific 
therapeutic intervention. The event interferes with usual activities of daily living, 
causing discomfort but poses no significant or permanent risk of harm to the 
research participant. 
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 Severe: A type of adverse event that interrupts usual activities of daily living, or 
significantly affects clinical status, or may require intensive therapeutic 
intervention. An AE that is assessed as severe should not be confused with a SAE. 
Severe is a category utilized for rating the intensity of an event; and both AEs and 
SAEs can be assessed as severe. 
An event is defined as “serious” when it meets at least one of the predefined 
outcomes as described in the definition of an SAE, NOT when it is rated as severe.  
 
Assessment of Causality 
 The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE. The investigator will use clinical judgment 
to determine the relationship/ 
 A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out. 
 Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated. 
 The investigator will also consult the IB in their assessment. 
 For each AE/SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE/SAE and has provided an assessment of causality. 
 There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to Sponsor or designee. 
However, it is very important that the investigator always make an assessment of 
causality for every event before the initial transmission of the SAE data to Sponsor 
or designee. 
 The investigator may change their opinion of causality in light of follow-up 
information and send a SAE follow-up report with the updated causality 
assessment. 
 The causality assessment is one of the criteria used when determining regulatory 
reporting requirements. 
 
Follow-up of AEs and SAEs 
 The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by Sponsor 
or designee to elucidate the nature and/or causality of the AE or SAE as fully as 
possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other health care 
professionals. 
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 If a participant dies during participation in the study or during a recognized follow-
up period, the investigator will provide Sponsor or designee with a copy of any 
post-mortem findings including histopathology. 
10.3.5. 
Reporting of SAEs  
SAE Reporting via Paper Form 
 Facsimile transmission of the SAE paper form is the preferred method to transmit 
this information to the medical monitor or the SAE coordinator. 
 Initial notification via telephone does not replace the need for the investigator to 
complete and sign the SAE CRF pages within the designated reporting time frames. 
 Contacts for SAE reporting can be found in SAE form. 
10.3.6. 
Regulatory Reporting Requirements  
SAE Regulatory Reporting 
 Prompt notification by the investigator to the sponsor of a SAE is essential so 
that legal obligations and ethical responsibilities towards the safety of 
participants and the safety of a study intervention under clinical investigation 
are met. 
● The sponsor has a legal responsibility to notify both the local regulatory 
authority and other regulatory agencies about the safety of a study intervention 
under clinical investigation. The sponsor will evaluate the reported SAEs, 
including confirmation of relatedness and assessment of expectedness. The 
sponsor has processes for safety reports for identification, recording, and 
expedited reporting of suspected unexpected serious adverse reactions 
according to local regulatory requirements. The sponsor will comply with 
country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, Institutional Review Boards (IRB)/Independent Ethics 
Committees (IEC), and investigators. 
● An investigator who receives an investigator safety report describing a SAE or 
other specific safety information (for example, summary or listing of SAEs) 
from the sponsor will review and then file it along with the IB and will notify 
the IRB/IEC, if appropriate according to local requirements.  
 
 
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10.4. 
Appendix 4: Contraceptive and Barrier Guidance  
10.4.1. 
Definitions  
Women of child-bearing potential (WOCBP) 
Females are considered WOCBP if they have had at least 1 cycle of menses. 
Any amount of spotting or bleeding should be considered menarche. 
Women not of child-bearing potential (WNOCBP) 
 females are considered WNOCBP if they have a congenital anomaly such as 
Mullerian agenesis, 
 are infertile due to surgical sterilization, or 
 are postmenopausal. 
Examples of surgical sterilization include total hysterectomy, bilateral salpingo-oophorectomy, 
bilateral salpingectomy, or bilateral oophorectomy. 
Postmenopausal 
The postmenopausal state is defined as ≥1 year without a menstrual period confirmed by follicle 
stimulating hormone test. 
10.4.2. 
Contraception Guidance  
Guidance for WOCBP 
This outlines the rules for WOCBP to ensure they do not become pregnant during the study. 
 
WOCBP who are completely abstinent as their preferred and usual lifestyle, or in a same-sex 
relationship as their preferred and usual lifestyle: 
Must… 
Must not… 
agree to either 
remain abstinent or 
stay in a same-sex 
relationship without 
sexual relationships 
with males 
 use periodic abstinence methods 
o calendar 
o ovulation 
o symptothermal, or 
o post-ovulation 
 declare abstinence just for the duration of a trial, or 
 use the withdrawal method 
 
WOCBP who are NOT completely abstinent as their preferred and usual lifestyle, or NOT in a 
same-sex relationship as their preferred and usual lifestyle, must do the following: 
Topic 
Condition 
Pregnancy testing 
Have a negative serum test result at screening (or upon a participant 
that reaches menarche during the trial and is sexually active) followed 
by a negative urine result within 24 hours prior to treatment exposure. 
See the protocol SoA for subsequent pregnancy testing requirements. 
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Topic 
Condition 
Contraception 
Agree to use 1 highly effective method of contraception, or a 
combination of 2 effective methods of contraception. 
 
These forms of contraception must be used for the duration of the 
study. 
 
Examples of different forms of contraception: 
Methods 
Examples 
Highly effective contraception (less than 1% 
failure rate) 
 
female sterilization 
 
combination oral contraceptive pill 
 progestin-only contraceptive pill 
(mini-pill) 
 
implanted contraceptives 
 
injectable contraceptives 
 
contraceptive patch (only women 
<198 pounds or 90 kg) 
 
total abstinence 
 
vasectomy, if only sexual partner 
 
fallopian tube implants, if confirmed 
by hysterosalpingogram 
 
combined contraceptive vaginal ring, 
or 
 
intrauterine devices 
Effective contraception  
 
male or female condoms with spermicide 
 
diaphragms with spermicide or cervical 
sponges 
 
barrier method with use of a spermicide 
o condom with spermicide 
o diaphragm with spermicide, or 
o female condom with spermicide 
 
NOTE: The barrier method must include use of a 
spermicide (that is, condom with spermicide, 
diaphragm with spermicide, and female condom 
with spermicide) to be considered effective. 
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Methods 
Examples 
Ineffective forms of contraception 
 
spermicide alone 
 
immunocontraceptives 
 
periodic abstinence 
 
fertility awareness (calendar method, 
temperature method, combination of 
above 2, cervical mucus, 
symptothermal) 
 
withdrawal 
 
post coital douche, and 
 
lactational amenorrhea 
Guidance for all men 
Males may participate in this trial. 
No male contraception is required except in compliance with specific local government study 
requirements. 
 
 
 
 
 
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10.5. 
Appendix 5: Genetics  
Use/Analysis of DNA 
● Genetic variation may impact a participant’s response to study intervention, 
susceptibility to, and severity and progression of disease. Variable response to 
study intervention may be due to genetic determinants that impact drug 
absorption, distribution, metabolism, and excretion; mechanism of action of the 
drug; disease etiology; and/or molecular subtype of the disease being treated. 
Therefore, where local regulations and IRB/IEC allow, a sample will be collected 
for DNA analysis from consenting participants. 
● DNA samples will be used for research related to lebrikizumab or moderate-to-
severe AD and related diseases. They may also be used to develop tests/assays 
including diagnostic tests related to lebrikizumab and moderate-to-severe AD. 
Genetic research may consist of the analysis of one or more candidate genes or 
the analysis of genetic markers throughout the genome or analysis of the entire 
genome (as appropriate). 
● The samples may be analyzed as part of a multi-study assessment of genetic 
factors involved in the response to lebrikizumab or study interventions of this 
class to understand study disease or related conditions. 
● The results of genetic analyses may be reported in the CSR or in a separate study 
summary. 
● The sponsor will store the DNA samples in a secure storage space with adequate 
measures to protect confidentiality. 
● The samples will be retained while research on lebrikizumab continues but no 
longer than 15 years or other period as per local requirements. 
 
 
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10.6. 
Appendix 6: Liver Safety: Suggested Actions and Follow-up 
Assessments  
 
Hepatic Evaluation Testing 
See Section 8.2.2 for guidance on appropriate test selection. 
The Lilly-designated central laboratory should complete the analysis of all selected testing 
except for testing listed in the investigator-designated local laboratory table. The central 
laboratory will report results if a validated test or calculation is available. 
Local testing may be performed in addition to central testing when necessary for immediate 
participant management. 
The local laboratory must be qualified in accordance with applicable local regulations. 
Tests assayed by Lilly-designated central laboratory 
Hepatic Hematology Panel 
Hepatitis A virus (HAV) testing: 
  Hemoglobin 
  HAV total antibody 
  Hematocrit 
  HAV IgM antibody 
  Erythrocytes (RBCs - red blood cells) 
Hepatitis B virus (HBV) testing: 
  Leukocytes (WBCs - white blood cells) 
  Hepatitis B surface antigen (HBsAg) 
  Differential: 
  Hepatitis B surface antibody (anti-HBs) 
    Neutrophils, segmented 
  Hepatitis B core total antibody (anti-HBc) 
    Lymphocytes 
  Hepatitis B core IgM antibody 
    Monocytes 
  HBV DNA a 
    Basophils 
Hepatitis C virus (HCV) testing: 
    Eosinophils 
  HCV antibody 
  Platelets 
  HCV RNA a 
  Cell morphology (RBC and WBC) 
Hepatitis D virus (HDV) testing: 
Hepatic Clinical Chemistry Panel 
  HDV antibody 
  Total bilirubin 
Hepatitis E virus (HEV) testing: 
  Direct bilirubin 
  HEV IgG antibody 
  Alkaline phosphatase (ALP) 
  HEV IgM antibody 
  Alanine aminotransferase (ALT) 
  HEV RNA a 
  Aspartate aminotransferase (AST) 
Anti-nuclear antibody (ANA) 
  Gamma-glutamyl transferase (GGT) 
Anti-smooth muscle antibody (ASMA) b 
  Creatine kinase (CK) 
Anti-actin antibody c 
Hepatic Coagulation Panel 
Immunoglobulin IgA (quantitative) 
  Prothrombin time, INR (PT-INR) 
Immunoglobulin IgG (quantitative) 
Urine Chemistry 
Immunoglobulin IgM (quantitative) 
  Drug screen 
Epstein-Barr virus (EBV) testing: 
Haptoglobin 
  EBV antibody 
a 
Reflex/confirmation dependent on regulatory requirements, testing availability, or both. 
b 
Not required if anti-actin antibody is tested. 
c 
Not required if anti-smooth muscle antibody (ASMA) is tested. 
 
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Tests assayed ONLY by investigator-designated local laboratory  
Acetaminophen 
Cytomegalovirus (CMV) testing: 
Acetaminophen protein adducts 
  CMV antibody 
Alkaline phosphatase isoenzymes 
  CMV DNA a 
Ceruloplasmin 
Herpes simplex virus (HSV) testing: 
Copper 
  HSV (Type 1 and 2) antibody 
Ethyl alcohol (EtOH) 
  HSV (Type 1 and 2) DNA a 
Phosphatidylethanol (PEth) 
Liver kidney microsomal type 1 (LKM-1) antibody 
Urine Chemistry 
Microbiology  
  Ethyl glucuronide (EtG) 
Culture: 
Epstein-Barr virus (EBV) testing: 
  Blood 
  EBV DNA a 
  Urine 
 
a 
Reflex/confirmation dependent on regulatory requirements, testing availability, or both. 
 
 
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10.7. 
Appendix 7: American Academy of Dermatology: Criteria for the 
Diagnosis and Assessment of Atopic Dermatitis  
Features to be considered in diagnosis of patients with AD: 
Essential Features—Must be present: 
 pruritus 
 eczema (acute, subacute, chronic) 
o typical morphology and age-specific patterns* 
o chronic or relapsing history 
*Patterns include: 
1) facial, neck, and extensor involvement in infants and children  
2) current or previous flexural lesions in any age group 
3) sparing of the groin and axillary regions 
Important Features—Seen in most cases, adding support to the diagnosis: 
 early age of onset 
 atopy 
o personal and/or family history 
o Immunoglobulin E reactivity 
 xerosis 
 
Associated Features—These clinical associations help to suggest the diagnosis of AD 
but are too nonspecific to be used for defining or detecting AD for research and 
epidemiologic studies: 
 
atypical vascular responses (for example, facial pallor, white dermographism, delayed 
blanch response) 
 
keratosis pilaris/pityriasis alba/hyperlinear palms/ichthyosis 
 
ocular/periorbital changes 
 
other regional findings (for example. perioral changes/periauricular lesions) 
 
perifollicular accentuation/lichenification/prurigo lesions 
 
Exclusionary Features—It should be noted that a diagnosis of AD depends on 
excluding conditions, such as: 
 
scabies 
 
seborrheic dermatitis 
 
contact dermatitis (irritant or allergic) 
 
ichthyoses 
 
cutaneous T-cell lymphoma 
 
psoriasis 
 
photosensitivity dermatoses 
 
immune deficiency diseases 
 
erythroderma of other causes 
Source: Eichenfield et al. Guidelines of care for the management of atopic dermatitis: Section 1. 
Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-3351. 
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10.8. Appendix 8: Medical Device Adverse Events (AEs), Adverse Device 
Effects (ADEs), Serious Adverse Events (SAEs) and Device Deficiencies: 
Definition and Procedures for Recording, Evaluating, Follow-up, and 
Reporting  
Refer to Appendix 3 for definitions and procedures for recording, evaluating, follow-up, and 
reporting of all events. 
 
 
 
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10.9. 
Appendix 9: Examples of Infections That May Be Considered 
Opportunistic in the Setting of Biologic Therapy  
This table lists examples of infections that may be considered opportunistic in the context of 
biologic therapy. This table is provided to aid the investigator in recognizing infections that may 
be considered opportunistic. This list is not exhaustive. For data analysis, infections will be 
categorized by Lilly as opportunistic according to the article by Winthrop et al. (2015). 
 
 
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Examples of infections that may be considered opportunistic in the setting of biologic 
therapy 
Bacterial 
 
Bartonellosis (disseminated disease only) 
 
Campylobacteriosis (invasive disease only) 
 
Legionellosis 
 
Listeriosis (invasive disease only) 
 
Nocardiosis 
 
Tuberculosis 
 
Non-tuberculous mycobacterial disease  
 
Salmonellosis (invasive disease only)  
 
Shigellosis (invasive disease only) 
 
Vibriosis (invasive disease due to Vibrio vulnificus) 
Viral 
 
BK virus disease including polyomavirus-associated nephropathy 
 
Cytomegalovirus disease 
 
Hepatitis B virus reactivation 
 
Hepatitis C virus progression 
 
Herpes simplex (invasive disease only) 
 
Herpes zoster (any form) 
 
Post-transplant lymphoproliferative disorder (Epstein-Barr virus) 
 
Progressive multifocal leukoencephalopathy (PML), John Cunningham (JC) virus  
Fungal 
 
Aspergillosis (invasive disease only) 
 
Blastomycosis 
 
Candidiasis (invasive disease or oropharyngeal, esophageal. Not isolated lingual) 
 
Coccidioidomycosis 
 
Cryptococcosis 
 
Histoplasmosis 
 
Paracoccidioides infections 
 
Penicilliosis 
 
Pneumocystosis 
 
Sporotrichosis 
 
Other invasive molds: Mucormycosis (zygomycosis) (Rhizopus, Mucor, and Lichtheimia), 
Scedosporium/Pseudallescheria boydii, Fusarium 
Parasitic 
 
Leishmaniasis (visceral only) 
 
Strongyloidiasis (hyperinfection syndrome or disseminated disease) 
 
Microsporidiosis 
 
Toxoplasmosis 
 
Trypanosoma cruzi infection (Chagas’ disease progression) (disseminated disease only) 
 
Cryptosporidiosis (chronic disease only) 
Source: Based on Winthrop et al. (2015). 
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10.10. 
Appendix 10: 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 Ethical Review Boards, regulatory bodies, and any other relevant local 
authorities, implementation of these exceptional circumstance changes will not typically require 
additional notification to these groups, unless they have specific requirements in which 
notification is required (for example, upon implementation and suspension of changes). All 
approvals and notifications must be retained in the study records. 
If the sponsor grants written approval for changes in study conduct, the sponsor will also provide 
additional written guidance, if needed. 
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 GCP, enabling 
participants to continue safely in the study and maintaining the integrity of the study. 
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 if written 
sponsor approval is given. 
Screening period guidance 
If the study screening window exceeds 30 days due to the exceptional circumstances, the 
participant would be considered a screen failure and may be rescreened if written sponsor 
approval is given. 
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The screening procedures per the SoA in the protocol should be followed (starting at Visit 1) to 
ensure participant eligibility by the baseline visit (Visit 2). Before rescreening, the participant 
must sign a new ICF and receive a new identification number through IWRS. 
 
Adjustments to visit windows 
Whenever possible and safe to do so, as determined by the investigator’s discretion, participants 
should complete the usual SoA. To maximize the possibility that these visits can be conducted as 
on-site visits, the windows for visits may be adjusted, upon further guidance and written 
approval 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 
Weeks 2-14  
±7 days 
Week 16 
±7 days 
Post-treatment safety follow-
up (12 weeks after last dose) 
±14 days  
 
For participants whose visits have extended windows, subsequent dosing should be 
a minimum of 7 days apart if the visit window is expanded due to exceptional circumstances. 
NOTE: 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 
Documentation 
Changes to study conduct will be documented. 
Sites will identify and document the details of how participants, visit window adjustments and or 
rescreening were affected by exceptional circumstances. 
 
 
 
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10.11. 
Appendix 11: Abbreviations and Definitions  
Term 
Definition 
AAULN 
age adjusted ULN 
AD 
atopic dermatitis 
ADCT 
Atopic Dermatitis Control Tool 
ADA 
anti-drug antibody 
AE 
adverse event 
AESI 
AE of special interest 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
anti-HCV 
antibodies to HCV 
AST 
aspartate aminotransferase 
BSA 
body surface area 
CDLQI 
Children’s DLQI 
CI 
confidence interval 
COA 
clinical outcome assessment 
complaint 
A complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, purity, durability, reliability, safety or effectiveness, or 
performance of a drug or drug delivery system. 
compliance 
Adherence to all study-related, good clinical practice (GCP), and applicable regulatory 
requirements. 
CRF 
case report form; a printed, optical, or electronic document designed to record all of the 
protocol-required information to be reported to the sponsor for each trial participant. 
CSR 
clinical study report 
Device deficiencies 
Equivalent to product complaint 
DLQI 
Dermatology Life Quality Index 
EASI 
Eczema Area and Severity Index 
eCOA 
electronic COA 
EDC 
electronic data capture 
enroll 
The act of assigning a participant to a treatment. Participants who are enrolled in the 
study are those who have been assigned to a treatment. 
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enter 
Participants entered into a study are those who sign the informed consent form directly 
or through their legally acceptable representatives. 
F-IGA 
Face-IGA 
FLG 
filaggrin 
GCP 
good clinical practice 
HBcAb 
hepatitis B core antibody 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IGA 
Investigator’s Global Assessment 
IgE 
immunoglobulin E 
IL 
interleukin 
IL-4R 
IL-4 receptor alpha 
IL-13R1 
IL-13 receptor alpha 1 
informed consent 
A process by which a participant voluntarily confirms their willingness to participate in 
a particular study, after having been informed of all aspects of the study that are 
relevant to the participant’s decision to participate. Informed consent is documented by 
means of a written, signed and dated informed consent form. 
interim analysis 
An interim analysis is an analysis of clinical study data, separated into treatment groups, 
that is conducted before the final reporting database is created/locked. 
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. 
IRB/IEC 
institutional review board/independent ethics committee 
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ITT 
intention to treat: The principle that asserts that the effect of a treatment policy can be 
best assessed by evaluating on the basis of the intention to treat a participant (that is, the 
planned treatment regimen) rather than the actual treatment given. It has the 
consequence that participant assigned to a treatment group should be followed up, 
assessed, and analyzed as members of that group irrespective of their compliance to the 
planned course of treatment. 
IWRS 
interactive web-response system 
JAK 
Janus kinase 
LOR 
loricrin 
NRS 
numeric rating scale 
participant 
Equivalent to CDISC term “subject”: an individual who participates in a clinical trial, 
either as recipient of an investigational medicinal product or as a control 
PC 
product complaint 
PDS 
Post-inflammatory Dyschromia Scale 
PK 
pharmacokinetic 
POEM 
Patient-Oriented Eczema Measure 
PO-SCORAD 
Patient-Oriented SCORAD 
PRO 
patient-reported outcomes 
Q2W 
once every 2 weeks 
Q4W 
once every 4 weeks 
QTL 
quality tolerance limits 
QoL 
quality of life 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SC 
subcutaneous 
SCORAD 
SCORing Atopic Dermatitis 
screen 
The act of determining if an individual meets minimum requirements to become part of 
a pool of potential candidates for participation in a clinical study.  
SoA 
schedule of activities 
TBL 
total bilirubin 
TCI 
topical calcineurin inhibitor 
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TCS 
topical corticosteroids 
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, and does not necessarily have to have a causal relationship 
with this treatment. 
Th2 
T-helper Type 2 
ULN 
upper limit of normal 
WOCBP 
Women of childbearing potential 
 
 
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10.12. 
Appendix 12: Protocol Amendment History  
The Protocol Amendment Summary of Changes Table for the current amendment is located 
directly before the Table of Contents (TOC). 
Amendment [b]: 27-April-2023 
This amendment is considered to be substantial. 
The amendment is considered to be substantial because it is likely to have a significant impact on 
the interpretation of the data generated in the clinical study. 
Overall Rationale for the Amendment: 
The main rationale for this amendment is provided below. 
Section # and Name 
Description of Change 
Brief Rationale 
1.1. Synopsis and  
3. Objectives, Endpoints, 
and Estimands 
Revised the primary 
clinical research 
question and the 
attributes of the primary 
estimand. 
To ensure that the primary clinical 
research question, primary estimand, 
and primary analysis are in alignment. 
The original treatment policy estimand 
is not aligned with the as-observed 
analysis. 
6.6. Continued Access to 
Study Intervention after 
the End of the Study 
Updated to allow 
continued access to 
lebrikizumab for 
eligible participants 
who complete Visit 9 
(Week 24) 
Provide an uninterrupted supply of 
lebrikizumab to qualified participants, 
via the Continued Access addendum, 
until lebrikizumab is commercially 
available in the US 
6.8.1 Permitted 
Treatments and 
Procedures 
Added use of high-
potency TCS up to 10 
days 
Permitting high-potency TCS for up to 
10 days is similar to the real-world 
setting 
6.8.2 Prohibited 
Treatments and 
Procedures 
Comment updated for 
topical JAK inhibitor 
for treatment of AD 
Added use of high-
potency TCS for >10 
days 
Alignment with rescue treatment for 
Atopic Dermatitis 
6.8.3 Non-medicated 
moisturizers 
Clarified permitted use 
by adding the word 
‘may’ 
The intent is to convey that the use of 
emollients is not mandatory but 
recommended 
6.8.4 Topical treatment 
for Atopic Dermatitis 
Added use of high-
potency TCS > 10 days 
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Section # and Name 
Description of Change 
Brief Rationale 
6.8.5 Rescue treatment 
for Atopic Dermatitis 
Added use of high-
potency TCS > 10 days 
Permitting high-potency TCS for > 10 
days will be considered as rescue 
medication 
7.1. Discontinuation of 
Study Intervention 
Added “the participant 
requires rescue 
medication treatment 
for symptoms of AD in 
the treatment period”  
Removed “participant 
requires high-potency 
TCS or systemic 
treatment for symptoms 
of AD in the treatment 
period” 
Alignment with rescue treatment for 
Atopic Dermatitis 
9.2. Analyses Sets 
Added “population” to 
describe ITT and Safety 
analysis set 
Clarification 
9.3.2. Primary 
Endpoint(s)/Estimand(s) 
Analysis 
Revised the primary 
clinical question of 
interest 
To align primary estimand with primary 
analysis. The original treatment policy 
estimand is not aligned with the as-
observed analysis 
9.3.3. Secondary 
Endpoint(s)/Estimand(s) 
Analysis 
Removed reference to 
the treatment policy 
strategy for secondary 
endpoints. 
To clarify that secondary endpoints will 
be analyzed similarly to the primary 
endpoint of the primary estimand, that 
is, using all observed data. The original 
treatment policy estimand is not aligned 
with the as-observed analysis 
9.3.4. Exploratory 
Endpoint(s) Analysis 
Removed reference to 
the treatment policy 
strategy for exploratory 
endpoints 
To clarify that exploratory endpoints 
will be analyzed similarly to the primary 
endpoint of the primary estimand, that 
is, using all observed data. The original 
treatment policy estimand is not aligned 
with the as-observed analysis 
9.5. Sample Size 
Determination 
Replaced “power” with 
“probability”  
Correction 
10.3.6. Regulatory 
Reporting Requirements 
SAE Regulatory 
Reporting 
Added text for 
suspected unexpected 
serious adverse 
reactions 
Alignment with latest guidance 
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Section # and Name 
Description of Change 
Brief Rationale 
Throughout  
Minor editorial changes 
have been made 
throughout  
These are minor, therefore they have not 
been individually summarized 
Amendment [a]: 12-October-2022  
This amendment is considered to be nonsubstantial. 
Overall Rationale for the Amendment: 
To correct the Schedule of Activities.  
 
Section # and 
Name 
Description of Change 
Brief Rationale 
Section 1.3 
Schedule of 
Activities 
 Collection of ADCT added 
in V4/W4  
 Post-treatment Follow-Up 
Urine pregnancy removed 
from V801 
 Inadvertently excluded in prior 
version  
 
 Inadvertently included in prior 
version, not required as 
participants no longer receiving 
study drug at V801  
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11. 
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