An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
Phase: PHASE3
Conditions: Atopic Dermatitis
Sponsor: Eli Lilly and Company

Clinical Study Protocol J2T-DM-KGAE Amendment 1 
 
An open-label, single-arm study to assess the safety and efficacy of lebrikizumab in adolescent 
patients with moderate-to-severe atopic dermatitis  
NCT04250350  
Approval Date: 12-May-2020 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
Lebrikizumab 
Dermira, Inc. 
Confidential  
Page 1 
 
 
AN OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE SAFETY AND EFFICACY OF 
LEBRIKIZUMAB IN ADOLESCENT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC 
DERMATITIS 
Protocol Number 
DRM06-AD17/J2T-DM-KGAE 
Protocol Final Date 
14 November 2019 
Study Drug 
Lebrikizumab (DRM06/LY3650150) 
IND Number 
119866 
EudraCT Number 
2019-004301-28 
Sponsor 
 
 
Dermira, Inc. 
275 Middlefield Road 
Suite 150 
Menlo Park, CA 94025 
USA 
Amendment (1) Date 
12 May 2020 
Medical Monitor 
 
 
 
PPD

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
Lebrikizumab 
Dermira, Inc. 
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PROTOCOL AMENDMENT 1 (SUMMARY OF CHANGES) 
The table below summarizes new changes being introduced to Amendment 1. Minor 
corrections/additions may not be included. 
Protocol Section 
Description of Change 
Rationale 
Protocol Title 
page and Protocol 
Header 
throughout, 
Signature Pages 
Added Eli Lilly protocol and investigational 
product unique identifiers. 
References Eli Lilly 
and Company 
protocol and 
investigational 
product identifiers 
Title Page, 
Signature Page 
New Medical Monitor identified for study. 
Personnel change 
Throughout 
Changed “open-label extension” to “long-term 
extension”. 
To align with the 
rollover protocol 
design 
Acronyms 
Updated 
Consistency with 
protocol changes 
Protocol Synopsis Included “Asia Pacific region” to study site 
locations 
Update to reflect 
participating study 
site locations 
Protocol Synopsis 
and Section 3 
Patients completing this 52-week study will be 
offered “active lebrikizumab” treatment in the 
long-term extension study, DRM06-AD07. 
Added a clearer definition of the timing of the end 
of the study per EU Regulation 536-2014: 
Annex 1 D.17.o. 
Added clearer definition of a patient being 
considered to have completed the study. 
Clarification 
 
 
Clarification per 
European (EU) 
Regulation 536-2014: 
Annex 1 D.17.o 
Protocol 
Synopsis, 
Section 2, 3.2 and 
4.1  
Defined age of study population as <18 years. 
Clarification 
Section 1.4  
Added dose regimen.  
Clarification 
Section 1.5 
Study Conduct Statements expanded to include 
language on protocol compliance. IRB/IEC 
review, applicable guidelines, laws and 
regulations and compensation per the EU 
regulation 536-2014: Annex 1 D.17.a. 
Clarification per EU 
regulation 536-2014: 
Annex 1 D.17.a 
Synopsis, 
Section 2.1  
Added primary endpoint. 
Clarification 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
Lebrikizumab 
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Protocol Section 
Description of Change 
Rationale 
Section 2.2  
Added details for secondary endpoints. 
Clarification 
Section 3.2  
Removed text concerning prospective approval of 
protocol deviations. 
Statement repeated 
text in Section 4 
Section 4.1  
Inclusion criterion #7: Added “non-medicated, 
non-prescription”. 
Inclusion criteria #9: “acceptable contraception” 
changed to “highly effective”. List of highly 
effective contraceptive measures revised.  
Inclusion criteria #10: males must use an effective 
barrier method of contraception for a minimum of 
18 weeks following the last dose (changed from 
three months. 
Clarification 
Clarification  
 
 
Consistency with 
female requirements 
for inclusion 
Section 4.2  
Exclusion criteria #3: “Eucrisa” replaced with 
“phosphodiesterase-4 inhibitors”. 
Exclusion criterion #6: add “medicated” 
Exclusion criteria #9: deleted reference to 
ACQ-5. 
Globally recognized 
nomenclature 
Clarification 
Correction to error in 
protocol; ACQ-5 not 
utilized in this study 
Section 5.1  
Delete reference to placebo solution. 
 
 
Removed details concerning investigational 
product. 
Correction to error in 
protocol; no placebo 
used in this study 
Details provided in 
other study-related 
documents 
Section 5.2  
Added “according to the country’s regulatory 
requirements”. 
Clarification 
Section 5.4.1  
Removed details concerning administration at 
clinic.  Added reference to Directions for Use. 
Details provided in 
Directions for Use 
Section 6.1  
Added instructions on the use of systemic 
corticosteroids. Removed “severe” from 
description of infections. 
Clarification 
 
Systemic antibiotics 
allowed for all acute 
infections. 
Section 6.3  
Clarified how topical and systemic treatments for 
AD may be used in the trial.   
Clarification 
Section 6.4 
Deleted and moved text to Section 6.3. 
Clarification 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
Lebrikizumab 
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Protocol Section 
Description of Change 
Rationale 
Section 7, 8.4.3 
and Schedule of 
Visit and 
Procedures 
Added hormone testing: estradiol in female 
patients and testosterone in male patients at 
screening, weeks 16, 32 and 52. 
Safety monitoring to 
assess sexual 
maturation 
Section 7.1 and 
8.1.2  
Added “review immunization record”. 
To ensure PI reviews 
prior to inclusion in 
trial 
Section 7.4, 
Section 7.19, 
Schedule of Visit 
and Procedures 
Added PK sample collection in addition to the 
ADA sample. 
FDA 
recommendation 
Section 7.6 
Added collection of urine sample for urinalysis 
Correction for 
protocol consistency: 
listed in the Schedule 
of Events and 
Procedures 
Section 7.18  
Deleted and combined with Section 7.17. 
Same procedures 
conducted for Week 
52 and Early 
Termination visit   
Section 7.19  
Changed follow-up visit from phone call to 
onsite. 
Allow collection of 
PK and ADA 
samples 
Section 8.2.1, 
Appendices 3, 4, 
5 and 6 
Deleted efficacy scales and patient reported 
outcome instruments. 
Use of validated 
scales and 
instruments are 
provided in other 
study related 
materials and don’t 
need to be duplicated 
in protocol. 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
Lebrikizumab 
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Protocol Section 
Description of Change 
Rationale 
Section 8.4.3, 
Schedule of 
Visits and 
Procedures 
Removed requirement to perform TB screening 
serology 
No scientific rational 
to believe patients 
exposed to 
lebrikizumab are at 
higher risk to develop 
or reactivate TB. In 
countries where 
tuberculosis is a 
common disease and 
where required by 
regulatory authorities 
or ethics boards, a 
specific addendum 
will allow TB 
screening and 
management as per 
local guidelines. 
Section 8.4.4.3  
Added examples of medical events. 
Clarification 
Section 8.4.4.4  
Expanded language notifying investigators of 
responsibilities of prompt reporting of SAEs, 
reporting requirements to IRB/IECs and the 
sponsors obligations to report safety information 
per EU Regulation 536-2014: Annex 1 D.20.c. 
Per EU Regulation 
536-2014: Annex 1 
D.20.c 
Section 8.4.5 
Added new section to describe process for 
product complaints 
Addition of Product 
Complaint Handling 
process 
Section 8.6.2  
Removed “systemic” from description of rescue 
medication outlined in Section 6.3 
Changed reference from Section 5.4 to 6.3. 
Clarification 
 
Clarification 
Section 8.6.3  and 
Section 9.1  
Removed text concerning treatment group blind. 
Clarification: study is 
not blinded 
Section 9.1.1  
Removed “and have at least one post-baseline 
assessment”. 
Clarification: All 
patients who receive a 
dose will be included in 
the Safety Population 
Sections 9.2, 9.7 
and 9.8 
Removed “by treatment group”. 
Clarification: study has 
only 1 treatment group 
Section 9.6  
Provided additional details on exposure and 
compliance. Defined ‘compliant’. 
Clarification 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
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Protocol Section 
Description of Change 
Rationale 
Section 9.8  
Added “Growth monitoring of adolescents will be 
summarized.” 
Clarification 
Section 9.9  
Updated sample size determination section to 
reflect that safety exposure determined sample 
size for this study.   
Clarification 
Section 9.10  
Added new section (Section 9.10) to describe 
plan for interim analyses. 
Per ICH E9 
Section 10.2  
Provided detail on consent process for minors 
who reach majority during the study. 
Clarification 
Section 10.3  
Added new section (Section 10.3) regarding 
protection of patient data and maintenance of 
patient confidentiality. 
Per EU Regulation 
536-2014: Annex 1 
D.17.ak 
EU Regulation 536-
2014: Annex 1 D.17.al, 
EU Regulation 536-
2014: Annex 1 
D.17.am 
Section 10.7  
Added new section (Section 10.7) on publication 
policy. 
Per EU Regulation 
536-2014: Annex 1 
D.17.ai 
 
 
 

Study Protocol: ORM06-AD17iJ2T-DM-KGAE 
Lebrikizumab 
SPONSOR SIGNATURE PAGE 
AN OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE S.-'\.FETY AND EFFICACY OF 
LEBRIKIZUMAB TN ADOLESCENT PATIENTS WITH ~tODERA TE-TO-SEVERE A TOPIC 
DERMATITIS 
Protocol Number 
Protocol Final Date 
Amendment (I) Date 
DRM06-AD17/J2T·DM-KGAE 
14 November 2019 
12 May 2020 
The signature below constinnes approval of this: protocol. I certify thai I have the authority to 
approve this protocol on behalf of the Sponsor, Demlira, Inc. The study will be conducted in 
accordance with this protocol and all applicable laws, rules, and regulations and International 
Council for Harmonisation ofTeclmical Requirements for Pharmaceuticals for Human Use 
{ICH) guidelines for Good Clinical Practice (GCP), regulations of the United States (US) Food 
and Drug Administration (FDA), and the ethical principles that have their origin in the 
Declaration of Helsinki. 
Authorized by: 
Dem1ira, Inc. 
Confidemiai 
Page 7 
PPD

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
Lebrikizumab 
Dermira, Inc. 
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Page 8 
INVESTIGATOR SIGNATURE PAGE 
AN OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE SAFETY AND EFFICACY OF 
LEBRIKIZUMAB IN ADOLESCENT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC 
DERMATITIS 
Protocol Number: 
DRM06-AD17/J2T-DM-KGAE 
Protocol Final Date: 
14 November 2019 
Amendment (1) Date: 
12 May 2020 
 
I have read this protocol, including the appendices, and agree that it contains all necessary details 
for carrying out the study as described. I will conduct this protocol as outlined herein, according 
to the ethical principles that have their origin in the Declaration of Helsinki, International 
Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 
(ICH) guidelines for Good Clinical Practice (GCP) and applicable laws, rules and regulatory 
requirement(s) including those of the United States (US) Food and Drug Administration (FDA). 
I agree to obtain the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
approval of the protocol and informed consent prior to the start of the study. 
I agree to obtain formal written informed consent in accordance with applicable federal and local 
regulations and international guidelines from all patients prior to their entry into the study. 
I have received and reviewed the Investigator’s Brochure including the potential risks and side 
effects of the product and instructions for use. 
I agree to report to the Sponsor any adverse events that occur during the study in accordance 
with the ICH GCP guideline and the protocol. 
I agree to ensure that all associates, colleagues, and employees assisting me with the conduct of 
the study are informed of their responsibilities in meeting the above commitments and the 
commitments set forth in the Investigator’s Agreement. 
I agree to maintain adequate and accurate records and to make those records available for 
inspection in accordance with the ICH GCP guideline, and federal and local requirements. 
I understand that the study may be terminated, or enrollment suspended at any time by the 
Sponsor, with or without cause, or by me if it becomes necessary to protect the best interests of 
the study patients. 
_____________________________________ 
___________________________ 
Investigator’s Signature 
Date 
 
_____________________________________ 
Investigator’s Name (print) 
 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
Lebrikizumab 
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PROTOCOL SYNOPSIS 
Title: 
An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of 
Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic 
Dermatitis 
Protocol Number: 
DRM06-AD17 
Phase: 
3 
Number of Sites: 
Approximately 70 sites in North America, Asia Pacific region and the 
European Union (EU). 
Study Population: 
Adolescent patients (≥12 to <18 years weighing ≥40 kg) with moderate-to-severe atopic 
dermatitis (AD) who are candidates for systemic therapy.  
Sample Size: 
200 patients 
Study Objective: 
To evaluate the safety and efficacy of lebrikizumab in adolescent patients (≥12 to <18 years 
weighing ≥40 kg) with moderate-to-severe AD. 
Duration of Patient Participation: 
Screening: Maximum duration of 30 days 
Treatment Period: 52 weeks  
Safety Followup: 12 weeks after last dose administered at Week 50 
Maximum total participation: 66 weeks  
Study Treatment: 
Lebrikizumab, 250 mg (2 mL injection of 125 mg/mL)  
Study Design: 
This open-label, single arm study is 52 weeks in duration. The study is designed to assess the 
safety and efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic 
dermatitis.  
Eligible patients (≥12 to <18 years weighing ≥40 kg) will have moderate-to-severe atopic 
dermatitis for at least one year, defined according to the American Academy of Dermatology 
Consensus Criteria, have an Eczema Area and Severity Index Score (EASI) of ≥16, an 
Investigator Global Assessment (IGA) score of ≥3 and a body surface area (BSA) of ≥10%.  
Approximately 200 patients will receive 250 mg lebrikizumab (loading doses of 500 mg given 
at Baseline and Week 2) by subcutaneous (SC) injection every 2 weeks (Q2W). Study drug 
injections will be administered in the clinic through Week 8 and patients or their caregivers will 
be instructed on self-administration of the study drug for injections following the Week 8 visit. 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
Lebrikizumab 
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Efficacy will be measured using the Investigator’s Global Assessment (IGA), Eczema Area and 
Severity Instrument (EASI) and body surface area (BSA).  
Safety will be assessed by monitoring adverse events, serum chemistry, hematology, hormones 
and urinalysis laboratory testing, physical examination, pulse and blood pressure.  An 
independent Data Safety Monitoring Board will monitor patient safety by conducting formal 
reviews of accumulated safety data periodically throughout the trial.  
Quality of life and impact of disease will be assessed using the Dermatology Life Quality Index 
(DLQI)/ Children’s Dermatology Life Quality Index (CDLQI) and Patient-Reported Outcomes 
Measurement Information System (PROMIS)® Anxiety and Depression measures.  
Serum samples will be collected for pharmacokinetic analysis and immunogenicity.   
Patients completing this 52-week study will be offered active lebrikizumab treatment in a 
separate long-term extension study (DRM06-AD07). 
Patients who early terminate or choose not to enter the long-term extension study will undergo 
a safety follow-up visit approximately 12 weeks after the last study drug injection.  
A patient is considered to have completed the study if he/she has completed all required phases 
of the study including the last visit shown in the Schedule of Visits and Procedures.  For 
patients continuing into the long-term extension study, the last study visit is the Week 52 visit.  
For patients who do not continue into the long-term extension study, the last study visit is the 
safety follow-up visit, occurring approximately 12 weeks after the last study drug 
administration.   
The end of the study is defined as the date of the last visit of the last patient in the study shown 
in the Schedule of Visits and Procedures. 
Primary Endpoint: 
Describe the proportion of patients discontinued from study treatment due to adverse events 
through the last treatment visit. 
 
 
 
 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
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TABLE OF CONTENTS 
PROTOCOL AMENDMENT 1 (SUMMARY OF CHANGES) ....................................................2 
SPONSOR SIGNATURE PAGE ....................................................................................................7 
INVESTIGATOR SIGNATURE PAGE .........................................................................................8 
PROTOCOL SYNOPSIS ................................................................................................................9 
ACRONYMS .................................................................................................................................15 
1. 
BACKGROUND ........................................................................................................17 
1.1. 
Atopic Dermatitis ........................................................................................................17 
1.1.1. 
Epidemiology of Pediatric Atopic Dermatitis ............................................................17 
1.1.2. 
Clinical Manifestations ...............................................................................................17 
1.1.3. 
Treatment for AD .......................................................................................................18 
1.2. 
Lebrikizumab ..............................................................................................................18 
1.3. 
Study Rationale and Benefit-Risk Assessment ...........................................................19 
1.3.1. 
Scientific Rationale .....................................................................................................19 
1.3.1.1. 
Summary of Study GS29250 (TREBLE) ...................................................................19 
1.3.1.2. 
Summary of Study GS29735 (ARBAN) ....................................................................20 
1.3.1.3. 
Summary of Dose Ranging Study DRM06-AD01 .....................................................21 
1.3.1.4. 
Summary of DRM06-AD03 Phase 1 PK Study .........................................................22 
1.4. 
Rationale for Dose and Treatment Regimen ..............................................................22 
1.5. 
Study Conduct Statement ...........................................................................................23 
2. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................24 
2.1. 
Primary Endpoint ........................................................................................................24 
2.2. 
Secondary Endpoints ..................................................................................................24 
3. 
STUDY DESIGN .......................................................................................................25 
3.1. 
Duration of the Study ..................................................................................................26 
3.2. 
Study Population and Number of Patients ..................................................................26 
4. 
SELECTION OF PATIENTS.....................................................................................26 
4.1. 
Inclusion Criteria ........................................................................................................26 
4.2. 
Exclusion Criteria .......................................................................................................27 
5. 
STUDY DRUG ...........................................................................................................28 
5.1. 
Investigational Medicinal Product ..............................................................................28 
5.2. 
Storage and Labeling ..................................................................................................28 

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5.3. 
Study Drug Assignment ..............................................................................................29 
5.4. 
Study Drug Administration.........................................................................................29 
5.4.1. 
Instructions for Administration in the Clinic ..............................................................29 
5.4.2. 
Instructions for Administration at Home ....................................................................29 
5.5. 
Study Drug Accountability .........................................................................................29 
6. 
CONCOMITANT MEDICATIONS AND PROCEDURES ......................................30 
6.1. 
Permitted and Prohibited Treatments and Procedures ................................................30 
6.2. 
Moisturizers ................................................................................................................31 
6.3. 
Treatments for AD ......................................................................................................31 
7. 
STUDY PROCEDURES ............................................................................................31 
7.1. 
Screening Visit (Day -30 to -7) ..................................................................................31 
7.2. 
Baseline Visit (Day 1) Period .....................................................................................32 
7.3. 
Week 2 (± 3 Days) ......................................................................................................32 
7.4. 
Week 4 (± 3 Days) ......................................................................................................32 
7.5. 
Week 6 (± 3 Days) ......................................................................................................32 
7.6. 
Week 8 (± 3 Days) ......................................................................................................33 
7.7. 
Week 12 (± 3 Days) ....................................................................................................33 
7.8. 
Week 16 (± 3 Days) ....................................................................................................33 
7.9. 
Week 20 (± 5 Days) ....................................................................................................34 
7.10. 
Week 24 (± 5 Days) ....................................................................................................34 
7.11. 
Week 28 (± 5 Days) ....................................................................................................34 
7.12. 
Week 32 (± 5 Days) ....................................................................................................34 
7.13. 
Week 36 (± 5 Days) ....................................................................................................35 
7.14. 
Week 40 (± 5 Days) ....................................................................................................35 
7.15. 
Week 44 (± 5 Days) ....................................................................................................35 
7.16. 
Week 48 (± 5 Days) ....................................................................................................35 
7.17. 
Week 52/Early Termination (± 5 Days) .....................................................................35 
7.18. 
Safety Follow-up Visit ................................................................................................36 
7.19. 
Unscheduled Visits .....................................................................................................36 
8. 
DETAILS OF ASSESSMENTS .................................................................................36 
8.1. 
Screening Assessments ...............................................................................................36 
8.1.1. 
Demographic Information ..........................................................................................36 
8.1.2. 
Medical History ..........................................................................................................36 

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8.2. 
Assessment of Efficacy ...............................................................................................37 
8.2.1. 
Investigator Global Assessment (IGA) .......................................................................37 
8.2.2. 
Eczema Area and Severity Index (EASI) ...................................................................37 
8.2.3. 
Body Surface Area (BSA) ..........................................................................................37 
8.3. 
Patient Reported Outcomes and Health-Related Quality of Life ...............................37 
8.3.1. 
Dermatology Life Quality Index (DLQI) ...................................................................37 
8.3.2. 
PROMIS® (Patient-Reported Outcomes Measurement Information System): 
Anxiety and Depression ..............................................................................................38 
8.4. 
Assessment of Safety ..................................................................................................38 
8.4.1. 
Physical Examination .................................................................................................38 
8.4.2. 
Vital Signs ..................................................................................................................38 
8.4.3. 
Laboratory Evaluations ...............................................................................................38 
8.4.4. 
Adverse Events ...........................................................................................................39 
8.4.4.1. 
Reporting ....................................................................................................................40 
8.4.4.2. 
Adverse Events of Special Interest (AESIs) ...............................................................40 
8.4.4.3. 
Serious Adverse Events (SAEs) .................................................................................41 
8.4.4.4. 
Reporting of SAEs ......................................................................................................41 
8.4.5. 
Product Complaints ....................................................................................................42 
8.4.6. 
Pregnancy ...................................................................................................................43 
8.4.7. 
Hypersensitivity Reactions .........................................................................................44 
8.5. 
PK and ADA Sampling ..............................................................................................44 
8.6. 
Study Termination ......................................................................................................44 
8.6.1. 
Early Termination of Study Patients...........................................................................44 
8.6.2. 
Study Drug Discontinuation .......................................................................................45 
8.6.3. 
Data Safety Monitoring Board ....................................................................................45 
9. 
STATISTICAL CONSIDERATIONS .......................................................................45 
9.1. 
General Statistical Methodology ................................................................................45 
9.1.1. 
Populations Analyzed .................................................................................................46 
9.2. 
Efficacy Analysis ........................................................................................................46 
9.3. 
PK Analysis ................................................................................................................46 
9.4. 
Anti-Drug Antibody Data Analysis ............................................................................46 
9.5. 
Immunogenicity Data Analysis ..................................................................................46 
9.6. 
Exposure and Compliance ..........................................................................................46 

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9.7. 
Adverse Events ...........................................................................................................46 
9.8. 
Other Safety Data .......................................................................................................47 
9.9. 
Sample-Size Determination ........................................................................................47 
9.10. 
Interim Analyses .........................................................................................................47 
10. 
ADMINISTRATION ..................................................................................................47 
10.1. 
Compliance with the Protocol ....................................................................................47 
10.2. 
Informed Consent Procedures.....................................................................................47 
10.3. 
Data Protection and Confidentiality ...........................................................................48 
10.4. 
Study Documentation and the eCRF ..........................................................................49 
10.5. 
Study Monitoring ........................................................................................................49 
10.6. 
Retention of Study Documentation ............................................................................49 
10.7. 
Data Publication ..........................................................................................................50 
11. 
REFERENCES ...........................................................................................................51 
12. 
APPENDICES ............................................................................................................54 
Appendix 1. Schedule of Visits and Procedures .........................................................................54 
Appendix 2. American Academy of Dermatology Consensus Criteria for Chronic 
Atopic Dermatitis ........................................................................................................55 
 
LIST OF TABLES 
Table 1: 
Laboratory Parameters ................................................................................................39 
 
 

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ACRONYMS 
Acronym 
Term 
ACQ-5 
Asthma Control Questionnaire 
AD 
atopic dermatitis 
ADA 
anti-drug antibody 
AE 
adverse event 
AESI 
adverse event of special interest 
AUC 
area under the curve 
AUC0-t 
AUC from 0 to time t 
AUCinf 
AUC from 0 to infinity 
AUClast 
AUC from time 0 to the last time with quantifiable concentration 
BSA 
body surface area 
C 
Celsius  
Cmax 
maximum (or peak) serum concentration 
D/d 
Day 
DLQI/CDLQI 
Dermatology Life Quality Index/Children’s Dermatology Life Quality Index 
DSMB 
Data Safety Monitoring Board 
EASI 
Eczema Area and Severity Index 
EASI-50 
50% reduction in EASI from Baseline 
EASI-75 
75% reduction in EASI from Baseline 
EASI-90 
90% reduction in EASI from Baseline 
eCRF 
electronic case report form 
ET 
early termination 
EU 
European Union 
FDA 
Food and Drug Administration 
FLG 
filaggrin 
GCP 
good clinical practice 
HIV 
human immunodeficiency virus 
ICF 
informed consent form 
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
IEC 
independent ethics committee 
IFN 
interferon 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
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Acronym 
Term 
Ig 
immunoglobin  
IGA 
Investigator Global Assessment 
IgE 
Immunoglobulin E 
IL 
interleukin 
IRB 
institutional review board 
LOR 
loricrin 
MCH 
mean corpuscular hemoglobin 
MedDRA 
Medical Dictionary for Regulatory Activities 
nAB 
neutralizing antibodies 
PFS-NSD 
pre-filled syringe with a pre-assembled needle safety device 
PK 
pharmacokinetics 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
Q2W 
every 2 weeks 
Q4W 
every 4 weeks 
SAE 
serious adverse event 
SC 
subcutaneous 
SCORAD 
SCORing Atopic Dermatitis 
SCORAD-50 
50% reduction in SCORAD  
SCORAD-75 
75% reduction in SCORAD 
SD 
standard deviation 
SOC 
system organ class 
TB 
tuberculosis 
TCI 
topical calcineurin inhibitor 
TCS 
topical corticosteroid 
TEAE 
treatment-emergent adverse event 
US/USA 
United States 
W 
week 
WOCBP 
women of childbearing potential 
 
 
 

Study Protocol: DRM06-AD17/J2T-DM-KGAE 
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Page 17 
1. 
BACKGROUND 
1.1. 
Atopic Dermatitis 
Atopic dermatitis (AD) is a complex disease that is determined by genetic, environmental and 
immunologic factors (Werfel, 2016; Simon, 2019).  
Genetic studies of AD (Auriemma, 2013; Bieber, 2012; Weidinger 2018) have shown that genes 
encoding for cytokines involved in the regulation of the immune system (human interleukin 
(IL)-4, IL-5, and IL-13), are strongly associated with the development of AD (He, 2003; 
Hummelshoj, 2003; Novak, 2002). 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, 2011). Since FLG plays a central role in skin barrier integrity, loss of 
function mutations of the FLG gene is considered a major contributor to the development of 
early childhood AD (Bieber, 2008; Tanei, 2009; Bieber, 2012; Flohr, 2013).  
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 immunoglobulin E (IgE) (present in about 50% to 80% of all patients with AD, 
particularly in children [Werfel, 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 
[TSLP]) and inflammation. Type 2 cytokines increase epidermal thickening, sensitization, 
inflammation, pruritus and decrease the expression of antimicrobial peptides and the barrier 
proteins FLG, LOR, and involucrin. IL-13 in particular can reduce epithelial integrity and barrier 
function through downregulation of FLG, LOR, and involucrin (Kim, 2008) and can act on 
keratinocytes in the skin to downregulate their differentiation (Howell, 2008). IL-13 also induces 
T-cell chemoattractants that mediate T-cell infiltration into AD lesions (Purwar, 2006) and may 
also induce IL-5 expression and eosinophil infiltration through the induction of eosinophil 
chemoattractants (Esche, 2004). Increased expression of IL-13 has consistently been reported in 
AD skin lesions and is associated with disease severity (Choy, 2012; Hamid, 1996; Jeong, 2003; 
La Grutta, 2005; Neis, 2006; Suarez-Farinas, 2013; Tazawa, 2004). The ubiquitous presence of 
IL-13 in the skin of patients with AD supports the evaluation of anti-IL-13 therapies in patients 
with AD.  
1.1.1. 
Epidemiology of Pediatric Atopic Dermatitis 
AD is one of the most common chronic medical diseases—15‒30% of children and 2‒10% of 
adults are affected, and the prevalence appears to have increased over the past two to three 
decades (Williams, 2008), with some geographic variability. With respect to disease severity, 
about 67% of AD pediatric patients have mild disease, 14 to 26% have moderate disease and 2 to 
7% have severe disease (Silverberg, 2017). Approximately 85% of all cases of AD begin before 
age 5, with up to 70% of children having spontaneous remission before adolescence 
(Bieber, 2008; Hua, 2014; Illi, 2004).  
1.1.2. 
Clinical Manifestations 
Clinically, AD is characterized by xerosis, erythematous crusted eruption (dermatosis), 
lichenification and intense pruritus (Bieber, 2008) which, along with the distribution, chronicity 
and history of skin lesions, form the basis for making the diagnosis AD. Flares are frequently 

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triggered by exposure to environmental factors, irritants, and allergens (Bieber, 2009). Several 
clinical patterns, with differing distributions of skin lesions in distinct age groups, have been 
noted (Weidinger, 2016; Weidinger, 2018). 
The infantile stage (up to 2 years of age) is characterized by eczema that is usually localized to 
the face, scalp, and extensor aspects of the arms and legs. The lesions are characterized by 
pruritic, red, eczematous plaques, erythema, papules, vesicles, excoriations, oozing, and 
formation of crusts.  
The adult stage (from puberty onwards) is less predictable. Affected patients may have had only 
a few outbreaks since infancy, or they may have had a chronic, relapsing course. Lesions 
frequently localize to the face and neck (head-and neck dermatitis), as well in the flexures of the 
elbows and knees, and a considerable portion of patients (around 30%) develop atopic hand 
eczema, which may interfere with workplace activities. Like affected children, adolescents and 
adults commonly have lichenification of the flexures and have facial dermatitis. 
Patients with AD have a high disease burden and their quality of life (QoL) is significantly 
affected. In one study, AD was shown to have a greater negative effect on patient mental health 
than diabetes and hypertension (Zuberbier, 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, 2008). Depression, anxiety, and social dysfunction not only 
affect patients with AD, but also affect their caregivers (Zuberbier, 2006). Compared with 
psoriasis, another common and debilitating skin disease, patients with AD have lower physical 
vitality, social functioning, role-emotional, and mental health scores (Kiebert, 2002).  
1.1.3. 
Treatment for AD 
The therapeutic approach to AD consists primarily of trigger avoidance, skin hydration with 
bathing, and use of moisturizers and anti-inflammatory therapies consisting predominantly of 
topical corticosteroids (TCS). In many patients, treatment with TCS provides some measure of 
symptomatic relief but does not always adequately control the disease. In those patients who 
have persistent moderate-to-severe disease not responding adequately to TCS, the step-up 
options include topical calcineurin inhibitors (TCIs), phototherapy, and immunosuppressive 
agents such as oral corticosteroids, cyclosporine, azathioprine, methotrexate, and mycophenolate 
mofetil. Among these, only cyclosporine is approved for treatment of moderate-to-severe AD 
[nationally licensed in many European countries, but not in the United States (US)], and its use is 
limited to patients ≥16 years for a maximum treatment period of 8 weeks. Recently, a clinically 
efficacious and relatively safe treatment, anti-IL-4R monoclonal antibody, dupilumab, was 
approved for the treatment of adult and adolescent patients with moderate-to-severe AD. Despite 
these treatments, AD remains a major societal burden and a significant unmet medical need.  
1.2. 
Lebrikizumab 
Lebrikizumab is a humanized monoclonal immunoglobulin (Ig) G4 antibody (huIgG4) with a 
mutation in the hinge region that increases stability. Lebrikizumab binds specifically to soluble 
IL-13 with high affinity, and potently inhibits IL-13 signaling through the IL-4Rα/IL-13Rα1 
complex. Because lebrikizumab binds to IL-13 in a non-receptor binding domain (i.e., a portion 
of the molecule not involved in binding to its receptor), antibody-bound IL-13 can still bind its 
receptor (IL-13Rα1), but the engaged receptor complex cannot be activated.  

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1.3. 
Study Rationale and Benefit-Risk Assessment 
1.3.1. 
Scientific Rationale 
The use of lebrikizumab for AD is supported by numerous preclinical studies demonstrating that 
AD is characterized by the increased expression of IL-13 in skin. Moreover, clinical trials (a 
Phase 2a study GS29250 [Section 1.3.1.1] and a Phase 2b study DRM06-AD01 
[Section 1.3.1.3]) with lebrikizumab demonstrated significant clinical benefit in patients with 
AD. Additional detailed discussion of the lebrikizumab studies is provided in the lebrikizumab 
Investigator’s Brochure. 
1.3.1.1. 
Summary of Study GS29250 (TREBLE) 
Study Design 
TREBLE was a Phase 2, global, randomized, double-blind, placebo-controlled trial designed to 
evaluate the safety and efficacy of lebrikizumab in adult patients (18–75 years of age) with 
persistent moderate to severe AD, inadequately controlled by TCS. The study consisted of 
3 study periods: a run-in period (2 weeks), a treatment period (12 weeks), and a safety follow-up 
period (8 weeks). Patients applied emollient at least once daily and TCS of medium potency to 
all active skin lesions twice daily through the study. A total of 212 patients were randomized as 
follows: 53 to the lebrikizumab 250 mg, single dose group; 53 to the lebrikizumab 125 mg, 
single dose group; 52 to the lebrikizumab 125 mg administered every 4 weeks (Q4W) group; and 
54 to the placebo Q4W group.  
Efficacy Results 
• Eczema Area and Severity Index (EASI)-50 at Week 12 (primary endpoint) was 
achieved by patients treated with lebrikizumab 125 mg Q4W, with a treatment 
difference between this group and placebo) of 20.1% p = 0.0261). 
• Lebrikizumab 125 mg Q4W group demonstrated statistically significant differences 
from placebo in EASI-75 and SCORing Atopic Dermatitis (SCORAD)-50 and 
adjusted mean change from baseline to Week 12. 
Safety Results 
• Injection-site reactions occurred infrequently (1.3% all lebrikizumab treated vs. 1.9% 
placebo); all events were non-serious, lasted a median of 1 to 3 days, and did not lead 
to treatment discontinuation or interruption. 
• Herpes viral infections and zoster occurred infrequently, but only among 
lebrikizumab-treated patients (6 of 156 [3.8%]); all events were non-serious, and 
none led to treatment discontinuation or dose interruption of lebrikizumab. 
• Eosinophil-associated adverse events (AEs) were reported infrequently, but only 
occurred among lebrikizumab-treated patients (3.2%); however, all events were 
non-serious, did not result in interruption of treatment, and there were no other 
associated clinical symptoms noted. 
• Allergic conjunctivitis events were only reported in lebrikizumab-treated patients 
(8 of 156 patients [5.1%] vs. 0% in placebo treated patients); all events were non-

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serious, did not lead to treatment discontinuation, all events recovered or resolved, 
and all patients had a history of asthma. Imbalances in allergic conjunctivitis events 
were not reported in previous lebrikizumab trials. 
• The overall incidence of skin infection (noted in the system organ class [SOC] of 
infections and infestations) was 9.6% in all lebrikizumab arms combined, compared 
to 22% in the placebo arm. 
Conclusions 
The results of this trial suggested that lebrikizumab (on a background of mandatory twice daily 
TCS treatment) provided some treatment benefit, as measured through EASI and SCORAD, but 
also suggested that higher lebrikizumab dosing might provide greater clinical benefit. In 
addition, lebrikizumab was well tolerated with a safety profile generally consistent with that 
observed in previous trials conducted in other indications.  
1.3.1.2. 
Summary of Study GS29735 (ARBAN) 
Study Design 
ARBAN was a Phase 2, randomized, open-label study designed to evaluate the safety and 
efficacy of lebrikizumab monotherapy in adult patients (18–75 years of age) with persistent 
moderate to severe AD, who were inadequately controlled by TCS. A total of 55 patients were 
randomized to treatment: 28 to lebrikizumab 125 mg Q4W and 27 to TCS.  
Efficacy Results 
• EASI-50 was achieved by 53.6% and 51.9% of patients in the lebrikizumab and TCS 
groups, respectively, with a treatment difference of 1.7%. EASI-75 was achieved by 
39.3% and 37.0% of patients in the 2 groups, respectively, with a treatment difference 
of 2.3%. 
• Investigator Global Assessment (IGA) scores of 0 or 1 were observed for 7.1% of 
patients in the lebrikizumab group and 25.9% of patients in the TCS group, giving a 
treatment difference of −18.8% (95% CI: −37.9%, 0.3%). 
• The percent of patients achieving SCORAD-50 or SCORAD-75 showed treatment 
differences of −19.3% and −7.5%, respectively. 
Safety Results 
• AEs were reported for a higher proportion of patients in the lebrikizumab group 
compared with the TCS group (64.3% vs. 37.0%); a higher proportion of patients in 
the lebrikizumab group, compared with the TCS group, had an AE in the SOC of 
infections and infestations (42.9% vs. 25.9%). Upper respiratory tract infections were 
more common in the lebrikizumab group (14.3% vs. 3.7%). 
• The overall incidence of skin infection (in the SOC of infections and infestations) was 
17.9% in the lebrikizumab group and 7.4% in the placebo/TCS group. 
• No serious AEs (SAEs), deaths, anaphylaxis, malignancy, protocol-defined parasitic 
or targeted intracellular infections of interest, herpes viral infections or zoster, or 
eosinophilia-associated AEs were reported. 

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Conclusions 
Lebrikizumab was well tolerated at the dose of 125 mg Q4W; the safety profile was generally 
consistent with previous experience with lebrikizumab in previous trials.  
1.3.1.3. 
Summary of Dose Ranging Study DRM06-AD01 
Study Design 
DRM06-AD01 was a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging 
study to evaluate the safety and efficacy of lebrikizumab in adult patients with moderate to 
severe AD. 280 patients were randomized to 1 of 4 treatment groups (in a 3:3:3:2 ratio): 73 to 
lebrikizumab 125 mg Q4W (with a loading dose of 250 mg); 80 to lebrikizumab 250 mg Q4W 
(with a loading dose of 500 mg); 75 to lebrikizumab 250 mg administered every 2 weeks (Q2W) 
(with a loading dose of 500 mg given at baseline and Week 2); 52 to placebo Q2W.  
Efficacy Results 
• Statistically significantly greater proportions of patients in each of the lebrikizumab 
250 mg Q4W and 250 mg Q2W groups achieved EASI-50, EASI-75, or EASI-90 at 
Week 16 than the placebo group.  
• A statistically significantly greater proportion of patients in each of the lebrikizumab 
250 mg Q4W and 250 mg Q2W groups had both an IGA score of 0 or 1 and a 
≥2-point improvement in IGA score at Week 16 than the placebo group.  
• The lebrikizumab 250 mg Q2W group had a statistically significantly greater 
proportion of patients who achieved a ≥4-point improvement in pruritus numerical 
rating scale (NRS) compared with the placebo group. 
• Positive changes in pruritus correlated with positive changes in sleep; the 
lebrikizumab 250 mg Q4W and 250 mg Q2W groups had statistically significant 
percent reductions in sleep loss due to itching compared with placebo (p=0.0459 and 
p=0.0062, respectively). 
Safety Results 
• The incidences of conjunctivitis (2.6% all lebrikizumab groups, 0 placebo), herpes 
infections (2.2% all lebrikizumab groups, 0 placebo), and herpes zoster (0.9% all 
lebrikizumab groups, 0 placebo) were relatively low. 
• Three patients (1.3%) in the lebrikizumab groups and 2 patients (3.8%) in the placebo 
group had an SAE. Those reported in the lebrikizumab groups were severe chest pain 
(1 patient in the 250 mg Q2W group), femur fracture of moderate severity (1 patient 
in the 125 mg Q4W group), and panic attack of moderate severity (1 patient in the 
250 mg Q2W group). Those reported in the placebo group were severe chronic 
obstructive pulmonary disease, severe edema peripheral, and severe pulmonary 
embolism. All SAEs were considered by the investigator as not related to study drug. 
• Most AEs were considered not related to study drug; those considered related were 
reported for 16.2% of patients in the lebrikizumab groups and 5.8% of patients in the 
placebo group  

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Conclusions  
This Phase 2b study showed that higher doses of lebrikizumab provided greater clinical benefit. 
All lebrikizumab doses induced statistically significant reductions in EASI scores compared to 
placebo, and a good dose response was observed for all primary and key secondary efficacy 
endpoints. The best response for all endpoints was observed with the highest lebrikizumab dose 
(250 mg Q2W), although the next highest dose (250 mg Q4W) also induced significant 
improvement in virtually all endpoints. All doses of lebrikizumab were well tolerated, without a 
dose response noted; AEs were generally mild or moderate and considered unrelated to study 
drug. These results provided the basis for dose selection for the pivotal Phase 3 studies.  
1.3.1.4. 
Summary of DRM06-AD03 Phase 1 PK Study 
Study Design 
DRM06-AD03 was a Phase 1, randomized, parallel-group study to evaluate the 
pharmacokinetics (PK) and safety of lebrikizumab in healthy adult volunteers (18 to 45 years of 
age, inclusive). A total of 41 subjects were randomized as follows: 21 subjects received two 
1-mL (125 mg) subcutaneous (SC) injections and 20 subjects received one 2-mL (250 mg) SC 
injection. The primary objective was to compare the PK (AUC, Cmax) of the 2 lebrikizumab 
dosing regimens. Blood samples were collected prior to dosing and on Days 2, 4, 6, 8, 11, 15, 29, 
43, 57, 71, 85 and 99 for PK and Day 29, 43, 57, 71, 85 and 99 for anti-drug antibodies (ADA).  
Pharmacokinetic Results 
For each AUC comparison (i.e., AUClast, AUCinf, and AUC0-57d) geometric mean ratios were 
close to 1 with 90% CIs within the range of 80% to 125%, except for AUCinf, which was just 
above the upper bound, with a value of 132%. The Cmax geometric mean ratio was 0.89 with a 
90% CI of 73%–108%.  
Conclusions 
Both the AUC and Cmax results indicated similar overall exposure between the 2 lebrikizumab 
dosing regimens evaluated in this study, i.e., two 1-mL (125 mg) SC injections versus one 2-mL 
(250 mg) SC injection. Data from this study support the use of the 2-mL (250 mg) pre-filled 
syringe with a pre-assembled needle safety device (PFS-NSD) in the Phase 3 pivotal trials. 
1.4. 
Rationale for Dose and Treatment Regimen 
The dosing regimen of 500 mg loading dose at baseline, followed by 250 mg Q2W lebrikizumab 
was selected for study in this trial, based on an evaluation of safety, efficacy and PK data from 
the DRM06-AD01 and DRM06-AD03 trials (Section 1.3.1.3 and 1.3.1.4).  
The DRM06-AD03 PK study conducted in healthy adults demonstrated that a single SC injection 
of 2-mL (250 mg) of lebrikizumab delivered comparable levels of lebrikizumab as did two 1-mL 
(125 mg) SC injections.  This simulated the conditions under which study drug will be 
administered in Phase 3, further supporting the dose and treatment regimen for Phase 3 trials, 
lebrikizumab 250mg Q2W with a loading dose of 500 mg given at Baseline and Week 2. 

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Adolescent Patients 
In this Phase 3 study, adolescent patients (≥12 to <18 years weighing ≥40 kg), will receive 250 
mg lebrikizumab (loading dose of 500 mg given at Baseline and Week 2) by subcutaneous 
injection every 2 weeks (Q2W) which is the same dose of lebrikizumab administered in the 
adolescent/adult Phase 3 studies.  . The justification for this approach is as follows:  
Both adults and adolescent patients have similar disease characteristics, typified by prominent 
Type 2 skin inflammation and similar clinical manifestations. In addition, both groups tend to 
have similar efficacy outcomes in response to therapies, including dupilumab (Simpson, 2018; 
Treister, 2019). Pharmacokinetic modeling and simulations of lebrikizumab dosing (population 
PK modeling of pooled data from 2259 adult asthma patients and a subsequent external posterior 
predictive check with lebrikizumab PK data from the DRM06-AD01 trial in adult AD patients) 
revealed similar kinetics for adults and adolescent patients, 12 to <18 years of age. The maximal 
exposures are predicted to be slightly (≤ 35%) higher in adolescent patients than in adults for any 
given dose due to the lower adolescent weight ranges and lebrikizumab exposure dependence on 
weight; however, the safety profile in adolescent patients, based on the exposure-response 
relationship analysis and on partial extrapolation, is comparable to that observed in adults.  
1.5. 
Study Conduct Statement 
This study will be conducted in accordance with the protocol and with the following: 
• Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
• Applicable ICH Good Clinical Practice (GCP) Guidelines 
• Applicable laws and regulations 
The protocol, protocol amendments, informed consent form (ICF), Investigator Brochure, and 
other relevant documents (e.g., advertisements) must be submitted to an independent review 
committee (IRB)/independent ethics committee (IEC) by the investigator and reviewed and 
approved by the IRB/IEC before the study is initiated. 
Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants. 
The investigator will be responsible for the following: 
• 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 [and/or UADEs] or other significant safety 
findings as required by IRB/IEC procedures 

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• Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 Code of Federal Regulations (CFR), ICH guidelines, the 
IRB/IEC, European regulation 536/2014 for clinical studies (if applicable), and all 
other applicable local regulations 
Investigator sites are compensated for participation in the study as detailed in the clinical trial 
agreement. 
2. 
STUDY OBJECTIVES AND ENDPOINTS 
To evaluate the safety and efficacy of lebrikizumab in adolescent patients (≥12 to <18 years 
weighing ≥40 kg) with moderate-to-severe AD. 
2.1. 
Primary Endpoint 
Describe the proportion of patients discontinued from study treatment due to adverse events 
through the last treatment visit. 
2.2. 
Secondary Endpoints 
Over the duration of the study: 
• Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from 
Baseline 
• Percentage of patients achieving response of EASI-75 (≥75% reduction from Baseline in 
EASI score) 
• Percentage change from baseline in EASI score and percentage of patients achieving 
EASI-50 and EASI-90 (≥50 and ≥90% reduction from Baseline in EASI score, 
respectively) 
• Change from baseline in body surface area (BSA) 
• Change from baseline in Patient-Reported Outcomes Information System (PROMIS)® 
Anxiety and Depression measures 
• Change from baseline and improvement in Dermatology Life Quality Index 
(DLQI)/Children’s Dermatology Life Quality Index (CDLQI) 
• Pharmacokinetics (PK)  
 

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3. 
STUDY DESIGN 
This open-label, single arm study is 52 weeks in duration. The study is designed to assess the 
safety and efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic 
dermatitis (Figure 1).  
Eligible patients (≥12 to <18 years weighing ≥40 kg) will have moderate-to-severe atopic 
dermatitis for at least one year, defined according to the American Academy of Dermatology 
Consensus Criteria, have an Eczema Area and Severity Index Score (EASI) of ≥16, an 
Investigator Global Assessment (IGA) score of ≥3 and a body surface area (BSA) of ≥10%.  
Approximately 200 patients will receive 250 mg lebrikizumab (loading doses of 500 mg given at 
Baseline and Week 2) by subcutaneous (SC) injection every 2 weeks (Q2W). Study drug 
injections will be administered in the clinic through Week 8 and patients or their caregivers will 
be instructed on self-administration of the study drug for injections following the Week 8 visit. 
Efficacy will be measured using the Investigator’s Global Assessment (IGA), Eczema Area and 
Severity Instrument (EASI) and body surface area (BSA).  
Safety will be assessed by monitoring adverse events, serum chemistry, hematology, hormones 
and urinalysis laboratory testing, physical examination, pulse and blood pressure.  An 
independent Data Safety Monitoring Board will monitor patient safety by conducting formal 
reviews of accumulated safety data periodically throughout the trial.  
Quality of life and impact of disease will be assessed using the Dermatology Life Quality Index 
(DLQI)/ Children’s Dermatology Life Quality Index (CDLQI) and Patient-Reported Outcomes 
Measurement Information System (PROMIS)® Anxiety and Depression measures.  
Serum samples will be collected for pharmacokinetic analysis and immunogenicity.   
Patients completing this 52-week study will be offered active lebrikizumab treatment in a 
separate long-term extension study (DRM06-AD07). 
Patients who early terminate or choose not to enter the long-term extension study will undergo a 
safety follow-up visit approximately 12 weeks after the last study drug injection.  
A patient is considered to have completed the study if he/she has completed all required phases 
of the study including the last visit shown in the Schedule of Visits and Procedures.  For patients 
continuing into the long-term extension study, the last study visit is the Week 52 visit.  For 
patients who do not continue into the long-term extension study, the last study visit is the safety 
follow-up visit, occurring approximately 12 weeks after the last study drug administration.   
The end of the study is defined as the date of the last visit of the last patient in the study shown in 
the Schedule of Visits and Procedures. 
Figure 1: Study Schema 
 

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3.1. 
Duration of the Study 
The total duration of a patient’s participation in this study will be approximately 66 weeks 
(Screening: maximum duration of 30 days; Treatment Period: 52 weeks; Safety Follow Up: 
12 weeks from last dose at Week 50)  
3.2. 
Study Population and Number of Patients 
Approximately 200 adolescent patients (≥12 to <18 years, weighing ≥40 kg).  
4. 
SELECTION OF PATIENTS 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
4.1. 
Inclusion Criteria 
Patients must meet all the following criteria to be eligible for this study: 
1. Male or female adolescent (≥12 years to <18 years and weighing ≥40 kg). 
2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that 
has been present for ≥1 year before the screening visit (see Appendix 2). 
3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit. 
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit.  
5. ≥10% body surface area (BSA) of AD involvement at the baseline visit. 
6. History of inadequate response to treatment with topical medications; or determination 
that topical treatments are otherwise medically inadvisable. 
7. Apply a stable dose of non-medicated, non-prescription moisturizer at least twice daily 
for ≥7 days prior to the baseline visit. 
8. Willing and able to comply with all clinic visits and study-related procedures and 
questionnaires. 
9. For women of childbearing potential: 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 lebrikizumab.  
 
NOTE: A woman of childbearing potential is defined as a postmenarcheal female, who 
has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no 
identified cause other than menopause) and has not undergone surgical sterilization 
(removal of ovaries and/or uterus). 
 
NOTE: The following are highly effective contraceptive methods: combined (estrogen 
and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) 
associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, 
injectable, implantable) associated with inhibition of ovulation, intrauterine device, 

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intrauterine hormone-releasing system, bilateral tubal occlusion, bilateral tubal ligation, 
vasectomized partner, or sexual abstinence. The reliability of sexual abstinence should be 
evaluated in relation to the duration of the clinical trial and the preferred and usual 
lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or 
postovulation methods) and withdrawal are not acceptable methods of contraception. 
10. Male patients must agree to use an effective barrier method of contraception during the 
study and for a minimum of 18 weeks following the last dose of study drug if sexually 
active with a female of child-bearing potential 
11. Provide signed informed consent/assent as described in Section 10.2.  
4.2. 
Exclusion Criteria 
Patients meeting any of the criteria below will be excluded from this study: 
1. Participation in a prior lebrikizumab clinical study. 
2. History of anaphylaxis as defined by the Sampson criteria (Sampson, 2006). 
3. Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 
inhibitors (e.g., crisaborole) within 1 week prior to the baseline visit. 
4. Treatment with any of the following agents within 4 weeks prior to the baseline visit: 
a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, 
cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, 
methotrexate, etc.) 
b. Phototherapy and photochemotherapy (PUVA) for AD. 
5. Treatment with the following prior to the baseline visit: 
a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is 
longer. 
b. Dupilumab within 8 weeks. 
c. B cell-depleting biologics, including to rituximab, within 6 months. 
d. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer. 
6. Use of medicated prescription moisturizers within 7 days of the baseline visit.  
7. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the 
screening visit. 
8. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or 
planned during the study. 
9. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., 
co-morbid severe uncontrolled asthma (history of ≥2 asthma exacerbations within the last 
12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or 
hospitalization for > 24 hours). 
10. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, 
antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or 

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superficial skin infections within 1 week before the baseline visit.  
NOTE: patients may be rescreened after infection resolves. 
11. Evidence of active acute or chronic hepatitis (as defined by the Department of Health & 
Human Services Centers for Disease Control and Prevention) or known liver cirrhosis.  
12. Diagnosed active endoparasitic infections or at high risk of these infections. 
13. Known or suspected history of immunosuppression, including history of invasive 
opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis, 
coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or 
unusually frequent, recurrent, or prolonged infections, per the Investigator’s judgment. 
14. History of human immunodeficiency virus (HIV) infection or positive HIV serology at 
screening. 
15. In the Investigator’s opinion, any clinically significant laboratory results from the 
chemistry, hematology or urinalysis tests obtained at the screening visit. 
16. Presence of skin comorbidities that may interfere with study assessments. 
17. History of malignancy, including mycosis fungoides, within 5 years before the screening 
visit, except completely treated in situ carcinoma of the cervix, completely treated and 
resolved non-metastatic squamous or basal cell carcinoma of the skin. 
18. Severe concomitant illness(es) that in the Investigator’s judgment would adversely affect 
the patient’s participation in the study. 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 patient because of his/her 
participation in this clinical trial, may make patient’s participation unreliable, or may 
interfere with study assessments.  
19. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed 
during the study. 
5. 
STUDY DRUG  
5.1. 
Investigational Medicinal Product  
Lebrikizumab will be provided to the investigator by the sponsor. Investigational product will be 
supplied as a solution for subcutaneous injection in a single-use, sterile pre-filled syringe with a 
pre-assembled needle safety device (PFS-NSD). Each pre-filled syringe is manufactured to 
contain 250 mg lebrikizumab (2mL injection of 125 mg/mL). 
5.2. 
Storage and Labeling 
Study drug is to be stored under refrigerated conditions (2‒8°C) and protected from excessive 
light and heat. Study drug should not be frozen, shaken or stored at room temperature. 
Temperature excursions outside of 2‒8°C must be reported to the Sponsor or the designee. 
Each PFS-NSD will be packaged in a carton and labeled according to the country’s regulatory 
requirements.  

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5.3. 
Study Drug Assignment 
Patients will be considered enrolled into this study once all Baseline procedures have been 
completed and the patient has met the inclusion and exclusion criteria.  Open-label study drug 
will be assigned to each patient using an electronic data capture system (an electronic trial supply 
management system for drug accountability purposes) at each in clinic visit.  All patients will 
receive open label treatment as follows: 
• Lebrikizumab 250 mg Q2W: 500mg lebrikizumab administered at Baseline and 
Week 2 (loading dose) and 250 mg given every two weeks (Q2W) through Week 52.  
5.4. 
Study Drug Administration 
Study drug will be administered subcutaneously to all patients in the clinic by designated and 
trained site staff from Baseline through the Week 8 visit and at all other scheduled clinic visits. 
Following the Week 8 visit, patients will be allowed to administer study drug at home. Sufficient 
study drug should be dispensed to cover at home administrations through next study visit. 
5.4.1. 
Instructions for Administration in the Clinic 
Syringes should be at room temperature prior to injection (refer to the applicable Instructions for 
Use provided by the Sponsor). 
5.4.2. 
Instructions for Administration at Home 
Patients or caregivers will be instructed to self-administer study drug at the Week 8 visit.   
Study site staff will instruct the patient or their caregiver on the proper injection technique and 
the patient or their caregiver will demonstrate for site staff proper injection technique prior to 
beginning at-home administration. An instruction card with details of the injection procedures 
will be provided to the patient/caregiver to take home.  
Patients or caregivers who are not capable of administering study drug at home may continue to 
receive study drug injections in the clinic. 
5.5. 
Study Drug Accountability 
The Investigator must keep an accurate record of the number of cartons received, the study drug 
dispensed/used, and those returned to the Sponsor or designee. The Sponsor or designee will 
provide forms to facilitate inventory control. All study-drug accountability forms and treatment 
logs must be retained in the Investigator’s permanent study file, and these records must be 
available for inspection at any time by the Sponsor, its designees, or by regulatory agencies. 
The study monitor will perform drug accountability for all study drug at the site, and will assist 
in returning all used, unused, and expired study drug, to the Sponsor/designees, or destroy it 
according to the study site’s standard operating procedure, if accepted by the Sponsor. 

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6. 
CONCOMITANT MEDICATIONS AND PROCEDURES 
All medications (including over-the-counter drugs, vitamins, and antacids) and over-the-counter 
emollient(s) taken/used at screening and throughout the study must be recorded. Patients 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 patients 
participating in the trial. 
• Medication entries should be specific to product name (if a combination drug product) 
and spelled correctly.  
• The brand and specific product name for any over-the-counter emollient(s) should be 
noted and spelled correctly. 
• Information on the dose, unit, frequency, route of administration, start date, 
discontinuation date, indication, and reason for use will be recorded.  
• The use of any concomitant medication must relate to an AE listed on the AE electronic 
case report form (eCRF) or the patient's medical history unless it is a supplement or used 
as preventative care. 
6.1. 
Permitted and Prohibited Treatments and Procedures 
The use of concomitant medications for other medical conditions (e.g., hypertension, diabetes, 
acute infections) is permitted during this study. Inhaled corticosteroids and bronchodilators to 
control asthma are permitted. 
The introduction of medications or therapies for other medical conditions known to affect AD 
(e.g., systemic corticosteroids, mycophenolate-mofetil, IFN-y, Janus kinase inhibitors, TCI, 
cyclosporine, azathioprine, methotrexate, phototherapy, or photochemotherapy, crisaborole) are 
not permitted during the study. If systemic corticosteroids are required for treatment of AE or 
other medical conditions (e.g. worsening of existing condition such as asthma exacerbation), it 
can be used for short periods of time as per medical judgement. Patients requiring long-term 
systemic corticosteroids for treatment of AE or other medical conditions must be discontinued 
from the study. 
Acute infections can be treated with systemic antibiotics, the use of which must be recorded in 
the eCRF. However, chronic treatment with systemic antibiotics is not permitted.  
Additional drugs are to be avoided during the study unless required to treat an AE or for the 
treatment of an ongoing medical problem. If the need for concomitant medication arises, the 
investigator should base decisions on the patient and clinical factors. Any additional medication 
(including the limited use of therapeutic agents which, if used under treatment regimens other 
than for treatment an AE or for appropriate medical management, might be considered therapies) 
whether prescription or over-the-counter, used at baseline and/or during the course of the study, 
must be documented with the start and stop dates. 
The use of a tanning booth/parlor is not permitted during the trial. 
Planned or anticipated major medical procedures or surgeries should be avoided during the trial.  

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All concomitant medications and procedures must be recorded in the eCRF. 
6.2. 
Moisturizers 
Non-medicated moisturizers are to be used during the study. Patients may continue her/his 
current over-the-counter moisturizer regimen, if approved by the Investigator. Non-medicated 
moisturizer should be used daily throughout the study.  
6.3. 
Treatments for AD  
TCS, TCIs and PDE4 inhibitors may be used as needed to treat disease flares during the trial.  
Patients who may require short-term systemic treatment for symptoms of AD will be assessed on 
a case-by-case basis and must be discussed with the Medical Monitor prior to initiating 
treatment.   
Cannabinoid treatments for AD are prohibited. 
Patients requiring long-term systemic treatment for symptoms of AD (e.g., non-responders) must 
be discontinued from the study.  
Medications used for AD must be recorded in the eCRF.   
7. 
STUDY PROCEDURES 
The required procedures for each study visit are outlined in Appendix 1. The timing of each 
study day is relative to the day of initial dosing (Day 1, Baseline). 
7.1. 
Screening Visit (Day -30 to -7) 
The purpose of the screening visit/period is to ensure that appropriate patients are entered into 
the study and that they remain stable during the pre-treatment period.  
• Obtain written informed consent/assent prior to performing any study procedures 
• Review Inclusion/Exclusion Criteria 
• Complete medical history/review of systems 
• Collect demographic information 
• Measure vital signs 
• Review immunization record  
• Perform a complete physical examination, including height and weight 
• Collect concomitant medication and procedure/therapy information 
• Complete the following assessments: Investigator’s Global Assessment (IGA), Body 
Surface Area (BSA), and Eczema Area and Severity Index (EASI) 
• Draw blood samples for laboratory tests, including serum pregnancy 
• Draw blood sample for hormone testing  

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• Collect urine sample for urinalysis 
• Instruct the patient to apply a moisturizer at least twice daily 
7.2. 
Baseline Visit (Day 1) Period 
• Administer the DLQI/CDLQI and PROMIS anxiety and depression measures 
• Update medical history/review of systems and concomitant medication and 
procedure/therapy information 
• Complete the following assessments: IGA, BSA, and EASI 
• Measure vital signs 
• Draw a pre-dose blood sample for PK and anti-drug antibody (ADA) testing 
• Conduct urine pregnancy test (WOCBP only) 
• Re-assess and confirm patient eligibility (Inclusion/Exclusion criteria) 
• Enroll the patient and administer study drug  
7.3. 
Week 2 (± 3 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Administer study drug 
• Confirm moisturizer use  
7.4. 
Week 4 (± 3 Days) 
• Complete the following assessments: IGA, BSA and EASI 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Draw a pre-dose blood sample for PK and ADA testing  
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug 
• Confirm moisturizer use  
7.5. 
Week 6 (± 3 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 

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• Administer study drug 
7.6. 
Week 8 (± 3 Days) 
• Complete the following assessments: IGA, BSA and EASI 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Confirm moisturizer use  
• Measure vital signs 
• Draw blood samples for laboratory tests  
• Collect a urine sample for urinalysis 
• Conduct urine pregnancy test (WOCBP only) 
• Train the patient to self-administer study drug  
• Administer study drug and dispense study drug for next injection 
7.7. 
Week 12 (± 3 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 
7.8. 
Week 16 (± 3 Days)  
• Administer the DLQI/CDLQI and PROMIS anxiety and depression measures 
• Complete the following assessments: IGA, BSA, and EASI  
• Perform a complete physical examination, including height and weight 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Draw pre-dose blood samples for laboratory tests, PK and ADA testing 
• Draw blood sample for hormone testing 
• Collect a urine sample for urinalysis 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 

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7.9. 
Week 20 (± 5 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 
7.10. 
Week 24 (± 5 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 
7.11. 
Week 28 (± 5 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 
7.12. 
Week 32 (± 5 Days) 
• Administer the DLQI/CDLQI and PROMIS anxiety and depression measures 
• Complete the following assessments: IGA, BSA and EASI 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Perform a complete physical examination, including height and weight 
• Measure vital signs 
• Draw pre-dose blood samples for laboratory tests, PK and ADA testing  
• Draw blood sample for hormone testing 
• Collect urine sample for urinalysis 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 

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7.13. 
Week 36 (± 5 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 
7.14. 
Week 40 (± 5 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 
7.15. 
Week 44 (± 5 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 
7.16. 
Week 48 (± 5 Days) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug and dispense study drug for next injection 
7.17. 
Week 52/Early Termination (± 5 Days) 
• Administer the DLQI/CDLQI and PROMIS anxiety and depression measures 
• Complete the following assessments: IGA, BSA, and EASI  
• Perform a complete physical examination, including height and weight  
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Measure vital signs 

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• Draw pre-dose blood samples for laboratory tests, PK and ADA testing 
• Draw blood sample for hormone testing 
• Collect a urine sample for urinalysis 
• Conduct urine pregnancy test (WOCBP only) 
7.18. 
Safety Follow-up Visit  
Patients who terminate early from the study or do not enroll in the long-term extension study, 
DRM06-AD07, will undergo a follow up visit 12 weeks after the last study drug injection. 
• Update AEs and concomitant mediations and procedures that were ongoing at study 
termination 
• Draw blood samples for PK and ADA testing 
7.19. 
Unscheduled Visits 
If an unscheduled visit is necessary, the following assessments should be included in the visit 
along with any assessments that are the reason for the visit (e.g., blood draw for a repeat of 
abnormal lab values): 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• If the reason for the unscheduled visit is an exacerbation of atopic dermatitis, 
complete the following assessments: IGA, BSA and EASI  
8. 
DETAILS OF ASSESSMENTS 
8.1. 
Screening Assessments  
8.1.1. 
Demographic Information 
Patient age, gender at birth, ethnicity and race will be collected. Race and ethnicity information 
will only be used to support sub-group analyses assessing phenotype with treatment response. 
The collection of a patient’s race and ethnicity is particularly important, given recent descriptions 
of disease heterogeneity in AD, with diverse phenotypes and endotypes described based on age, 
disease chronicity, ethnicity, genetics, IgE status, and underlying molecular mechanisms 
(Czarnowicki, 2019). 
8.1.2. 
Medical History 
A complete medical history will be collected and include immunization record, clinically 
relevant medical conditions, or surgeries, including more specific information on a history of 
conjunctivitis and herpes infection/zoster. Information on the patient’s AD and comorbidities 
(past history of asthma, allergic rhinitis, food allergies, alopecia) will be collected and include 
the date of onset, extent of involvement and past treatments for AD and comorbidities.  

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8.2. 
Assessment of Efficacy 
Each patient’s AD will be assessed as specified in the Schedule of Visits and Procedures. 
Whenever possible, the same assessor should perform all assessments on a given patient over the 
course of the study.  
8.2.1. 
Investigator Global Assessment (IGA) 
The IGA is a static assessment and rates the severity of the patient’s AD. The IGA is comprised 
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. It is not necessary 
that all characteristics under Morphological Description be present. Assessors must be trained 
and certified by the Sponsor prior to conducting this assessment. The IGA must be conducted 
prior to conducting the EASI and BSA assessments. A single assessor should be assigned to each 
individual patient for as many visits as possible, to avoid inter-assessor variability in scoring. 
8.2.2. 
Eczema Area and Severity Index (EASI) 
The EASI is used to assess the severity and extent of AD; it is a composite index with scores 
ranging from 0 to 72, with the higher values indicating more severe and/or extensive disease.  
A grade of 0 to 72 will be assessed by the Investigator or designee. Assessors must be trained 
and certified by the Sponsor prior to conducting this assessment.  
8.2.3. 
Body Surface Area (BSA) 
The BSA assessment estimates the extent of disease or skin involvement with respect to AD and 
is expressed as a percentage of total body surface. BSA will be determined by the Investigator or 
designee using the patient palm = 1% rule. Assessors must be trained and certified by the 
Sponsor prior to conducting this assessment. 
8.3. 
Patient Reported Outcomes and Health-Related Quality of Life 
Patient reported outcome and quality of life measures should all be completed prior to other 
study assessments.  
8.3.1. 
Dermatology Life Quality Index (DLQI) 
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the 
quality of life of an affected person. The 10 questions cover the following topics: symptoms, 
embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close 
relationships, sex, and treatment, over the previous week. Questions are scored from 0 to 3, 
giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) 
to 30 (meaning maximum impact on quality of life). A high score is indicative of a poor quality 
of life. Patients ≤16 years will complete the Children’s Dermatology Life Quality Index 
(CDLQI) and should continue to complete the CDLQI for the duration of the study. 
DLQI/CDLQI is completed by the patient in the study clinic. 

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8.3.2. 
PROMIS® (Patient-Reported Outcomes Measurement Information System): 
Anxiety and Depression 
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-
centered measures that evaluates and monitors physical, mental, and social health in adults and 
children. Pediatric and tools for anxiety and depression. Patients ≤17 years will complete 
pediatric versions for the duration of the study. The PROMIS measures will be completed by the 
patient in the study clinic. 
8.4. 
Assessment of Safety 
8.4.1. 
Physical Examination 
A complete physical examination will be conducted at screening and Week 52 and cover general 
appearance, dermatological, head, ears, eyes, nose, throat, respiratory, cardiovascular, 
abdominal, neurological, musculoskeletal, and lymphatic body systems. Height and weight will 
also be recorded per the Schedule of Event and Procedures. At subsequent study visits, a 
symptom-directed physical examination may be conducted at the discretion of the Investigator. 
Findings will be recorded as medical history or AE in the eCRF. 
8.4.2. 
Vital Signs 
Vital signs, including body temperature, respiratory rate (breath per minute), pulse (beats per 
minute), and blood pressure (mmHg), will be obtained with the patient in the seated position, 
after sitting for at least 5 minutes. Any abnormal findings which are new or worsened in severity 
and clinically significant, in the opinion of the Investigator, will be recorded as an AE. Vital sign 
measurements will be recorded in the eCRF. 
8.4.3. 
Laboratory Evaluations  
Laboratory tests will be analyzed using a central laboratory and include hematology with 
differential, serology, a standard chemistry panel (including liver-function tests), total 
cholesterol, hormones, standard urine testing, and urine pregnancy test for women who are not 
post-menopausal or surgically sterile. Blood and urine will be collected from each patient as 
specified in the Schedule of Visits and Procedures or as clinically indicated. Laboratory data will 
be transferred to the clinical database. 

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Table 1: 
Laboratory Parameters 
Hematology 
Chemistry 
Urine 
Hormones 
CBC with differential: 
Hematocrit  
Hemoglobin 
Red blood cells 
White blood cells 
Mean corpuscular 
hemoglobin (MCH) 
MCH concentration  
Mean corpuscular 
volume  
RBC morphology 
Platelet count 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
 
Screening Only:  
HIV Antibody (HIV Ab) 
Hepatitis B Antibody 
(HBcAb) 
Hepatitis B Antigen 
(HBsAg) 
Hepatitis C Antibody 
(Hep C Ab) 
 
Sodium 
Potassium 
Chloride  
Calcium 
Phosphorus 
Bicarbonate 
Uric Acid 
Blood urea nitrogen 
Creatinine 
Total Protein 
Albumin 
Aspartate 
aminotransferase 
Alanine aminotransferase 
Lactic dehydrogenase 
Gamma-glutamyl 
transpeptidase 
Alkaline phosphatase 
Bilirubin (total and direct) 
Total cholesterol 
Non-fasting glucose 
 
For All Female Patients 
(WOCBP) At Screening: 
Serum beta human 
chorionic gonadotropin 
pH 
Specific gravity 
Protein 
Glucose 
Ketones 
Bilirubin 
Blood 
Nitrite 
Urobilinogen 
Leukocyte esterase  
 
At All Visits Except 
Screening (WOCBP 
only): 
Urine beta human 
chorionic gonadotropin  
Estradiol (for females 
only) 
Testosterone (for males 
only) 
8.4.4. 
Adverse Events  
Adverse events will be monitored throughout the study. Patients will be instructed to inform the 
Investigator and/or study staff of any AEs. At each visit, patients will be asked about AEs in a 
non-specific manner using open-ended questions so as not to bias the response (e.g., How have 
you been since the last visit?). Specific inquiry regarding reported AEs will be conducted when 
applicable. All AEs will be documented and recorded in the patient’s eCRF. 
Any patient who has an AE (serious or non-serious) will be evaluated by the Investigator and 
treated and followed until the symptom(s) return to normal or to clinically acceptable levels, as 
judged by the Investigator. A physician, either at the clinical site, or at a nearby hospital 
emergency room, will administer treatment for any serious AEs (SAEs), if necessary. When 
appropriate, medical tests and examinations will be performed to document resolution of 
event(s). 

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8.4.4.1. 
Reporting 
Only AEs that occur during or following study treatment with the study drug will be reported in 
the AE section of the eCRF. Events occurring prior to study treatment with the drug will be 
reported in the Medical History section of the eCRF. All AEs occurring during the study will be 
individually recorded in the eCRF. Any condition present prior to administration of study drug 
and that worsens after administration of study drug should be reported as an AE. Information 
regarding the onset, duration, severity, action taken, outcome, and relationship to study drug will 
be recorded.  
New or worsening abnormal laboratory values and/or vital signs are to be recorded as AEs if 
they are considered to be of clinical significance by the Investigator or meet the criteria of an 
SAE as described in Section 8.4.4.3. Unless an overall diagnosis is described, signs and 
symptoms must be reported as individual AEs in the eCRF; a diagnosis is preferred.  
The severity of an AE will be designated as mild, moderate or severe. The term “severe” is used 
to describe the intensity of an AE; the event itself, however, may be of relatively minor clinical 
significance (e.g., ‘severe’ upper respiratory infection). Severity is not the same as “serious”. 
Seriousness of AEs is based on the outcome/action of an AE. (See Section 8.4.4.3.) 
The relationship of the AE to the study treatment should be determined by the Investigator and 
will be based on the following two definitions: 
Not related: The AE is judged to not be associated with the study drug and is most likely 
attributable to another cause. 
Related: A causal relationship between the AE and the study drug is a reasonable possibility, 
i.e., there is evidence (e.g., dechallenge/rechallenge) or other clinical arguments to suggest a 
causal relationship between the AE and study treatment.  
8.4.4.2. 
Adverse Events of Special Interest (AESIs) 
The following treatment emergent adverse events are being designated adverse events of special 
interest (AESI):  
• conjunctivitis 
• herpes infection or zoster  
• parasitic infection or an infection related to an intracellular pathogen  
AESIs should be reported to the Sponsor or designee within 48 hours of knowledge of the event. 
Additional data will be collected for AESIs on study-specific AESI forms will be provided to the 
site. Patient records must include any follow-up information regarding these AESIs.  
Study drug should be discontinued if an adverse event is deemed persistent and if continuation of 
study drug would not be in the best interest of the patient. Discuss discontinuation of study drug 
or dose changes with the Sponsor or designee prior to implementation.  

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8.4.4.3. 
Serious Adverse Events (SAEs) 
An SAE is defined as any untoward medical occurrence that,  
• Results in death 
• Is in the opinion of the Investigator immediately life threatening (i.e., the patient is at 
immediate risk of death; it does not include a reaction that, had it occurred in a more 
severe form, might have caused death) 
• Requires inpatient hospitalization or results in prolongation of an existing 
hospitalization 
• Results in persistent or significant disability or incapacity 
• Is a congenital anomaly or birth defect 
• Is an important medical event that may not be immediately life-threatening, result in 
death, or require hospitalization, but based on appropriate medical judgment, it 
jeopardizes the patient, or may require medical or surgical intervention to prevent one 
of the outcomes listed. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the 
development of drug dependency or drug abuse. 
The Investigator should institute any clinically necessary supplementary investigation of SAE 
information. In the case of patient death, any post-mortem findings/reports will be requested. 
8.4.4.4. 
Reporting of SAEs 
All SAEs, as defined in Section 8.4.4.3, regardless of causal relationship, must be reported to the 
Sponsor or designee within 24 hours of the Investigator becoming aware of the event. As soon as 
the Investigator becomes aware of an AE that meets the criteria for an SAE, the SAE should be 
documented to the extent that information is available.  
SAEs will be recorded from the time of informed consent/assent until the end of the study. 
If, in the opinion of the Investigator, an SAE occurring outside the specified time window 
(i.e., following patient completion or terminations of the study) is deemed to be drug-related, the 
event should be reported with 24 hours. 
SAEs must be recorded on study-specific SAE forms which will be provided to the site. The 
minimum information required for SAE reporting includes the identity of the principal 
investigator (PI), site number, patient number, event description, SAE term(s), reason why the 
event is considered serious (i.e., the seriousness criteria), and PI’s assessment of the relationship 
of the event to study drug. Additional SAE information including medications or other 
therapeutic measures used to treat the event, and the outcome/resolution of the event should also 
be recorded on the SAE form. 
In all cases, the Investigator should continue to monitor the clinical situation and report all 
material facts relating to the progression or outcome of the SAE. The Investigator may be 
required to provide supplementary information as requested by the Sponsor or its designee. 

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When reporting SAEs, the following additional points should be considered: 
• Although signs, symptoms, and tests that support the diagnosis of an SAE should be 
provided, the Investigator should report the diagnosis or syndrome as the SAE term. 
• Death should not be reported as an SAE, but as an outcome of a specific SAE (unless 
the event preceding the death is unknown). If an autopsy was performed, the autopsy 
report should be provided. 
Although most hospitalizations necessitate reporting of an SAE, some hospitalizations do not:  
• Hospitalization for elective or previously scheduled surgery, or for a procedure for a 
pre-existing condition that has not worsened after administration of study drug (e.g., a 
previously scheduled ventral hernia repair). SAEs must, however, be reported for any 
surgical or procedural complication that lead to prolongation of the hospitalization. 
• Events that result in hospital stays for observation of <24 hours and that do not 
require a therapeutic intervention/treatment (e.g., an emergency room visit for 
hematuria that results in a diagnosis of cystitis and discharge to home on oral 
antibiotics). 
The Sponsor will process and evaluate all SAEs as soon as the reports are received. For each 
SAE received, the Sponsor will determine whether the criteria for expedited reporting to relevant 
regulatory authorities have been met.  
The Sponsor will assess the likelihood that each SAE is related to study treatment, with the 
current Investigator’s Brochure used as the reference document to assess expectedness of the 
event to study drug. 
Prompt notification by the investigator to the sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
intervention under clinical investigation are met. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, Institutional Review Boards (IRB)/Independent Ethics Committees 
(IEC), and investigators. 
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (e.g., summary or listing of SAEs) from the sponsor will review and then file 
it along with the Investigator’s Brochure and will notify the IRB/IEC, if appropriate, according 
to local requirements. 
8.4.5. 
Product Complaints 
A product complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, durability, reliability, safety, effectiveness or performance of a 
trial intervention. The sponsor collects product complaints on investigational products and drug 
delivery systems used in clinical studies in order to ensure the safety of study participants, 
monitor quality, and to facilitate process and product improvements. Participants will be 

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instructed to contact the investigator as soon as possible if he or she has a complaint or problem 
with the investigational product or drug delivery system so that the situation can be assessed. 
Time Period for Detecting Product Complaints 
●    Product complaints that result in an adverse event will be detected, documented, 
and reported to the sponsor during all periods of the study in which the drug is 
used. 
●    If the investigator learns of any product complaint at any time after a participant 
has been discharged from the study, and such incident is considered reasonably 
related to a drug provided for the study, the investigator will promptly notify the 
sponsor. 
Prompt Reporting of Product Complaints to Sponsor 
●    Product complaints will be reported to the sponsor within 24 hours after the 
investigator becomes aware of the complaint. 
●    The Product Complaint Form will be sent to the sponsor. 
Follow-up of Product Complaints 
●    Follow-up applies to all participants, including those who discontinue study 
intervention. 
●    The investigator is responsible for ensuring that follow-up includes any 
supplemental investigations as indicated to elucidate the nature and/or causality of 
the product complaint. 
●    New or updated information will be recorded on the originally completed form 
with all changes signed and dated by the investigator and submitted to the 
sponsor. 
8.4.6. 
Pregnancy 
The investigator should notify the Sponsor immediately regarding a pregnancy in a (1) female 
clinical trial patient or (2) female partner of a male clinical trial patient.  
Pregnant female patients must be withdrawn from study drug.  
If a female partner of a male patient becomes pregnant or suspects she is pregnant by the male 
patient, the male patient will be advised by the study Investigator to have his female pregnant 
partner inform her treating physician immediately.  
The Investigator must perform medical assessments as clinically indicated and continue to follow 
the patient for ≥4 weeks after delivery. Medical details for both the mother and baby must be 
obtained.  
The Investigator must complete a study-specific Pregnancy Form upon confirmation of a 
pregnancy. Pregnancy reporting forms will be provided to the site. 

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8.4.7. 
Hypersensitivity Reactions 
Patients experiencing any hypersensitivity reaction should receive appropriate symptomatic 
medical care, as needed. Patients should be instructed to inform the site if a hypersensitivity 
reaction occurs. At the next study visit, a blood sample must be collected for immunogenicity 
analysis. The Sponsor or designee should be immediately consulted, particularly if the 
hypersensitivity reaction might be attributed to the study drug, and particularly if the reaction is 
severe, for discussions about discontinuing the study medication. 
8.5. 
PK and ADA Sampling 
Serum PK and ADA samples will be collected in all patients. Positive ADA results may be 
further evaluated for neutralizing antibodies (nAB). The procedural instructions will be provided 
in a separate PK and Serum Antibody Sampling manual. 
8.6. 
Study Termination 
The Sponsor has the right to terminate the study at any time. Should the study be terminated, the 
decision and reason will be communicated in writing by the Sponsor to the Investigator and 
request that all patients be discontinued. Patients should be scheduled for an Early Termination 
visit. The entire study will be stopped if: 
• Evidence has emerged that, in the collective opinion of the Investigators at each site 
with the concurrence of the Sponsor, or the sole opinion of the Sponsor, continuation 
of the study is unnecessary or unethical 
• The stated objectives of the study are achieved 
• The Sponsor discontinues the development of the study drug 
All data available for the patient at the time of study discontinuation must be recorded in the 
patient’s records and the eCRF. 
8.6.1. 
Early Termination of Study Patients 
The Investigator will make reasonable efforts to keep each patient in the study. However, 
patients may terminate or be terminated early from the study for the following reasons: 
• Voluntarily withdrawal of consent to participate in the study participation, at any time 
• Adverse event, laboratory abnormality or inter-current illness which, in the opinion of 
the Investigator, indicates that continued treatment and/or participation in the study is 
not in the best interest of the patient 
• Serious protocol violation, persistent non-compliance or requirement for medication 
or procedure prohibited by the protocol 
• Lost to follow-up 
Patients who are terminated early from the study will have an Early Termination visit scheduled 
as soon as possible (see Section 7.18). All information, including the reason for early termination 
will be recorded in the patient’s study records and in the eCRF.   

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Two attempts of contact (e.g., telephone contact) followed by a certified letter of contact to the 
patient must be documented in a patient’s study records for all patients who are believed to be 
lost to follow-up.  
8.6.2. 
Study Drug Discontinuation 
Study drug must be discontinued for patients who experience the following: 
• Inter-current illness that would, in the judgment of the Investigator, affect 
assessments of clinical status to a significant degree 
• Treatment-related AEs that are clinically significant, deemed persistent, in the 
judgment of the Investigator 
• Unacceptable toxicity 
• Pregnancy 
• Use of rescue medication as outlined in Section 6.3 
Patients who discontinue study drug permanently during study participation must be scheduled 
for an Early Termination visit (Section 7.18). 
8.6.3. 
Data Safety Monitoring Board 
An independent data safety monitoring board (DSMB) comprised of members who are 
independent of the study sponsor and study investigators will monitor patient safety by 
conducting formal reviews of accumulated safety data.  
The DSMB will provide the sponsor with appropriate recommendations on the conduct of the 
clinical study to ensure the protection and safety of the patients enrolled in the study. The DSMB 
will also institute any measures that may be required for ensuring the integrity of the study 
results during the study execution. 
All activities and responsibilities of the DSMB are described in the DRM06 DSMB charter. 
9. 
STATISTICAL CONSIDERATIONS 
9.1. 
General Statistical Methodology 
CCI

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9.1.1. 
Populations Analyzed 
All non-PK analyses will be performed using the Safety Population. All patients who receive at 
least one confirmed dose of lebrikizumab 250 mg will be included in the Safety Population. 
The number of patients included in the Safety population will be summarized. 
All PK analyses will be performed using the PK population. All patients who are enrolled and 
have a pre-dose sample and at least one post-dose analyzable sample will be included in the PK 
population. 
9.2. 
Efficacy Analysis 
Efficacy endpoints IGA, BSA, EASI Percent Change from Baseline, EASI-50, EASI-75, and 
EASI-90 will be summarized by visit. 
9.3. 
PK Analysis 
Plasma concentration data will be tabulated and summarized (geometric mean, arithmetic mean, 
minimum, maximum, SD, and % coefficient of variation) by treatment group for each visit at 
which samples were taken. 
9.4. 
Anti-Drug Antibody Data Analysis 
The ADA variables will be analyzed using descriptive statistics. Positive ADA results may be 
further evaluated for neutralizing antibodies.  
9.5. 
Immunogenicity Data Analysis 
Listings will be provided for immunogenicity data. 
9.6. 
Exposure and Compliance 
The extent of exposure to study drug will be summarized by total number of days of exposure, 
total number of injections, number of missed injections, and number and percentage of patients 
who are compliant. An injection is considered the full set of injections specified by the protocol.  
A patient will be considered compliant with the dosing regimen if the patient received ≥75% of 
the expected number of injections while enrolled in the study. 
9.7. 
Adverse Events 
All AEs occurring during the study will be recorded and coded using the Medical Dictionary for 
Regulatory Activities (MedDRA). Treatment-emergent AEs (TEAEs) are defined as AEs with an 
onset date on or after the date of the first injection of study drug. TEAEs will be summarized, 
including the number of patients reporting an event, system organ class, preferred term, severity, 
relationship to study drug, and seriousness for the safety population. All serious AEs as well as 
AEs that led to study discontinuation will be listed by patient. 
The denominator used for the treatment period will correspond to the number of patients in the 
safety population. Data will also be corrected for exposure and reported per 100 patient-years. 

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9.8. 
Other Safety Data 
Laboratory data will be presented in a by-patient listing. Any clinically significant laboratory 
abnormalities will be captured as AEs. Changes from Baseline in safety laboratory values will be 
summarized by treatment group at each follow-up evaluation during the treatment period using 
descriptive statistics or frequency tables as applicable. Tables and listings will be in SAS format. 
Additionally, changes from Baseline in safety laboratory values will be summarized using shift 
tables according to normal ranges.  
Vital signs will be presented as absolute values and changes from Baseline using descriptive 
statistics. 
Medical histories will be coded using the MedDRA dictionary and presented in a by-patient 
listing. Concomitant medications will be coded using the World Health Organization drug 
dictionary. Concomitant medications will be summarized by treatment, drug class, and preferred 
term. Physical examination data will be presented in a by-patient listing. Growth monitoring of 
adolescents will be summarized. 
9.9. 
Sample-Size Determination 
9.10. 
Interim Analyses 
Interim analyses may be performed for regulatory interactions, safety updates, and disclosures. 
A final database lock will be conducted after all patients have either completed the 12 Week 
follow-up visit for this study, discontinued early or, entered the long-term extension study, 
DRM06-AD07.    
10. 
ADMINISTRATION 
10.1. 
Compliance with the Protocol  
The study shall be conducted as described in this protocol. All revisions to the protocol must be 
prepared by the Sponsor. The Investigator will not implement any deviation or change to the 
protocol without prior review and documented approval/favorable opinion from the IRB/IEC of 
an amendment, except where necessary to eliminate an immediate hazard(s) to study patients. 
Any significant deviation must be documented and submitted to the IRB/IEC, the Sponsor or 
designee, and, if required, Regulatory Authority(ies). Documentation of approval signed by the 
chairperson or designee of the IRB(s)/EC(s) must be sent to the Sponsor and/or designee. 
10.2. 
Informed Consent Procedures 
The Informed Consent Form (ICF) will include all elements required by ICH/GCP and 
applicable regulatory requirements and will adhere to GCP and to the ethical principles that have 
their origin in the Declaration of Helsinki. The consent form will also include a statement that 
the Sponsor and regulatory authorities have direct access to patient records.  
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Prior to the beginning of the study, the Investigator will have the IRB/IEC’s written opinion 
(approval/favorable) of the written informed consent form and any other information to be 
provided to the patients. 
The Investigator must provide the patient or legally acceptable representative with a copy of the 
consent form and written information about the study in the language in which the patient is most 
proficient. The language must be non-technical and easily understood. The Investigator should 
allow time necessary for patient or patient's legally acceptable representative to inquire about the 
details of the study, then informed consent must be signed and personally dated by the patient or 
the patient's legally acceptable representative, by the Investigator and/or by the person who 
conducted the informed consent discussion. The patient or legally acceptable representative 
should receive a copy of the signed informed consent and any other written information provided 
to study patients prior to patient's participation in the study. 
The informed consent and any other information provided to patients or the patient's legally 
acceptable representative, should be revised whenever important new information becomes 
available that is relevant to the patient's consent, and should receive IRB/IEC approval/ favorable 
opinion prior to use. The Investigator, or a person designated by the Investigator should fully 
inform the patient or the patient's legally acceptable representative of all pertinent aspects of the 
study and of any new information relevant to the patient's willingness to continue participation in 
the study. This communication to the patient should be documented in the source note.  
During a patient's participation in the study, any updates to the consent form or to the written 
information will be provided to the patient in writing. 
For patients considered to be minors according to the national legislation in each country, the 
written consent of the parent or legal guardian must be obtained, as well as the assent of the 
minor according to his or her capacity to understand the information provided. Patients enrolled 
as minors who attain legal adulthood during the course of the study must consent in their own 
right at that time. 
10.3. 
Data Protection and Confidentiality 
Study patients must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the patient who will be required to give consent for their data to be used as 
described in the informed consent.  
Patients must be informed that his/her medical records may be examined by Clinical Quality 
Assurance auditors or other authorized personnel appointed by the sponsor, by appropriate 
IRB/IEC members, and by inspectors from regulatory authorities. 
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 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. 

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10.4. 
Study Documentation and the eCRF 
This protocol is to be signed by the investigator responsible for the conduct of this study at the 
study site. A copy of the signed protocol signature page is to be provided to the Sponsor and 
retained in the study site’s Regulatory Binder.  
The Investigator is responsible for ensuring that all study data are accurately recorded on the 
eCRFs or other study data collection tools. All eCRF entries must be supported by the patient’s 
medical records or source notes. The Investigator must ensure that study observations and 
findings are legible and recorded accurately and completely. 
Original reports, traces and films must be reviewed, signed and dated, and retained by the 
Investigator for future reference.  
The Investigator is expected to promptly review all study data recorded in the patient’s source 
records. Completed eCRFs must be promptly reviewed, signed, and dated by the Investigator or 
Sub-Investigator at the end of the study. Corrections to data entered into the eCRF will be 
handled through an electronic query. Corrections to patients’ medical or source records should be 
legible, initialed and dated. At the end of the study, an electronic copy of the investigator’s 
eCRFs will be provided to the Investigator. The Investigator is to retain these data. The 
Investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on eCRFs. Refer to Section 10.6 regarding 
retention requirements. 
An Investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation for each patient treated 
with the study drug or entered as a control in the investigation. Data reported on the eCRFs that 
are derived from source documents must be consistent with the source documents or the 
discrepancies must be explained.  
10.5. 
Study Monitoring 
The Sponsor or designee will be responsible for the monitoring of the study. Study monitors will 
contact and visit the Investigators at regular intervals throughout the study to verify adherence to 
the protocol, and assess the completeness, consistency, and accuracy of the data by comparing 
patients’ medical records with entries in the eCRF.  
The study monitor must be allowed access to laboratory test reports and other patient records 
needed to verify the entries on the eCRF, provided patient confidentiality is maintained in 
accordance with local requirements. These records, and other relevant data, may also be 
reviewed by appropriate qualified personnel independent from the Sponsor or designee, who is 
appointed to audit the study. Patient confidentiality will be maintained at all times. 
By agreeing to participate in this research study, the Investigators agree to co-operate with the 
study monitor to ensure that any problems detected during the monitoring visits are promptly 
resolved. 
10.6. 
Retention of Study Documentation 
The Investigator must retain study drug disposition records, copies of CRFs and all study-related 
source documents for the maximum period required by applicable regulations and guidelines, or 

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Institution procedures, or for the period specified by the Sponsor, whichever is longer. The 
Investigator must contact the Sponsor prior to destroying any records associated with the study. 
If the Investigator withdraws from the study (e.g., relocation, retirement), the records shall be 
transferred to a mutually agreed upon designee (e.g., another Investigator, IRB). Notice of such 
transfer will be given in writing to the Sponsor or designee. 
If the Investigator cannot guarantee this archiving requirement for any or all the documents at the 
investigational site, arrangements must be made between the Investigator and the Sponsor to 
store these in a secure archive facility outside the site so they can be returned to the Investigator 
in case of a regulatory audit. When source documents are required for the continued care of the 
patient, appropriate copies should be made for storage outside of the site. 
10.7. 
Data Publication  
In accordance with the sponsor’s publication policy the results of this study will be submitted for 
publication by a peer-reviewed journal. 

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11. 
REFERENCES 
Auriemma M, Vianale G, Amerio P, Reale M. Cytokines and T cells in atopic dermatitis. Eur 
Cytokine Netw. 2013;24(1):37-44. 
Bieber T, Novak N. Pathogenesis of atopic dermatitis: new developments. Curr Allergy Asthma 
Rep 2009;9(4):291-294. 
Bieber T. Atopic dermatitis 2.0: from the clinical phenotype to the molecular taxonomy and 
stratified medicine. Allergy. 2012;67(12):1475-1482. 
Bieber T. Atopic dermatitis. N Engl J Med. 2008;358(14):1483-1494. 
Choy DF, Hsu DK, Seshasayee D, et al. Comparative transcriptomic analyses of atopic 
dermatitis and psoriasis reveal shared neutrophilic inflammation. J Allergy Clin Immunol. 
2012;130(6):1335-1343. 
Czarnowicki T, He H, Krueger JG, Guttman-Yassky E. Atopic dermatitis endotypes and 
implications for targeted therapeutics. J Allergy Clin Immunol. 2019;143(1):1-11. 
Eichenfield LF, Tom WL, Chamlin SL, 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):338-351.  
Esche C, de Benedetto A, Beck LA. Keratinocytes in atopic dermatitis: inflammatory signals. 
Curr Allergy Asthma Rep. 2004;4(4):276-284. 
Flohr C, Irvine AD. Systemic therapies for severe atopic dermatitis in children and adults. 
J Allergy Clin Immunol. 2013;132(3):774-774.e6. 
Hamid Q, Naseer T, Minshall EM, Song YL, Boguniewicz M, Leung DY. In vivo expression of 
IL-12 and IL-13 in atopic dermatitis. J Allergy Clin Immunol. 1996;98(1):225-231. 
He JQ, Chan-Yeung M, Becker AB, et al. Genetic variants of the IL13 and IL4 genes and atopic 
diseases in at-risk children. Genes Immun. 2003;4(5):385-389. 
Howell MD, Fairchild HR, Kim BE, et al. Th2 cytokines act on S100/A11 to downregulate 
keratinocyte differentiation. J Invest Dermatol. 2008;128(9):2248-2258. 
Hua TC, Hwang CY, Chen YJ et al. The natural course of early-onset atopic dermatitis in 
Taiwan: a population-based cohort study. Br J Dermatol. 2014;170(1):130-135.  
Hummelshoj T, Bodtger U, Datta P, et al. Association between an interleukin-13 promoter 
polymorphism and atopy. Eur J Immunogenet. 2003;30(5):355-359. 
Illi S, von Mutius E, Lau S, et al. The natural course of atopic dermatitis from birth to age 
7 years and the association with asthma. J Allergy Clin Immunol. 2004;113(5):925-931. 
Jeong CW, Ahn KS, Rho NK, et al. Differential in vivo cytokine mRNA expression in lesional 
skin of intrinsic vs. extrinsic atopic dermatitis patients using semiquantitative RT-PCR. 
Clin Exp Allergy. 2003;33(12):1717-1724. 
Kiebert, G, Sorensen SV, Revicki D, et al. Atopic dermatitis is associated with a decrement in 
health-related quality of life. Int J Dermatol. 2002;41(3):151-158. 

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Kim BE, Leung DY, Boguniewicz M, Howell MD. Loricrin and involucrin expression is down-
regulated by Th2 cytokines through STAT-6. Clin Immunol. 2008;126(3):332-337. 
La Grutta S, Richiusa P, Pizzolanti G, et al. CD4(+)IL-13(+) cells in peripheral blood well 
correlates with the severity of atopic dermatitis in children. Allergy. 2005;60(3):391-395. 
Neis MM, Peters B, Dreuw A, et al. Enhanced expression levels of IL-31 correlate with IL-4 and 
IL-13 in atopic and allergic contact dermatitis. J Allergy Clin Immunol. 2006;118(4):930-
937. 
Novak N, Kruse S, Kraft S, et al. Dichotomic nature of atopic dermatitis reflected by combined 
analysis of monocyte immunophenotyping and single nucleotide polymorphisms of the 
interleukin-4/interleukin-13 receptor gene: the dichotomy of extrinsic and intrinsic atopic 
dermatitis. J Invest Dermatol. 2002;119(4):870-875. 
Purwar R, Werfel T, Wittmann M. IL-13-stimulated human keratinocytes preferentially attract 
CD4+CCR4+ T cells: possible role in atopic dermatitis. J Invest Dermatol. 
2006;126(5):1043-1051. 
Sampson HA, Munoz-Furlong A, Campbell RL, et al. Second symposium on the definition and 
management of anaphylaxis: summary report. Second National Institute of Allergy and 
Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin 
Immunol. 2006;117(2):391-397. 
Silverberg JI. Public Health Burden and Epidemiology of Atopic Dermatitis. Dermatol Clin. 
2017;35(3):283-289. 
Simon D, Wollenberg A, Renz H, Simon HU. Atopic Dermatitis: Collegium Internationale 
Allergologicum (CIA) Update 2019. Int Arch Allergy Immunol. 2019;178(3):207-218. 
Simpson E, Paller A, Siegfried E, et al. Dupilumab efficacy and safety in adolescents with 
moderate-to-severe atopic dermatitis: Results from a multicenter, randomized, placebo-
controlled, double-blind parallel-group, phase 3 study. Presented at the EADV Congress, 
September 12-16th, 2018, Paris, France. 
Suarez-Farinas M, Dhingra N, Gittler J, et al. Intrinsic atopic dermatitis shows similar TH2 and 
higher TH17 immune activation compared with extrinsic atopic dermatitis. J Allergy Clin 
Immunol. 2013;132(2):361-370.  
Tanei R. Atopic dermatitis in the elderly. Inflamm Allergy Drug Targets. 2009;8(5):398-404. 
Tazawa T, Sugiura H, Sugiura Y, Uehara M. Relative importance of IL-4 and IL-13 in lesional 
skin of atopic dermatitis. Arch Dermatol Res. 2004;295(11):459-464. 
Treister AD, Lio PA. Long-term off-label dupilumab in pediatric atopic dermatitis: A case series. 
Pediatr Dermatol. 2019;36(1):85-88.  
Van Bever HP, Llanora G. Features of childhood atopic dermatitis. Asian Pac J Allergy 
Immunol. 2011;29(1):15-24. 
Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nat Rev Dis 
Primers. 2018;4(1):1. 
Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122. 

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Werfel T, Allam JP, Biedermann T, et al. Cellular and molecular immunologic mechanisms in 
patients with atopic dermatitis. J Allergy Clin Immunol. 2016;138(2):336-349. 
Williams H, Stewart A, von Mutius E, et al. Is eczema really on the increase worldwide? J 
Allergy Clin Immunol. 2008;121(4):947-954.e15. 
Zuberbier, T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic 
dermatitis. J Allergy Clin Immunol. 2006;118(1):226-232. 

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12. 
APPENDICES 
APPENDIX 1. SCHEDULE OF VISITS AND PROCEDURES 
Study Procedure 
Screening 
Baseline 
Treatment 
Safety 
Day (D); Week (W) 
D-30 to -7 
D1 
W2 
W4 
W6 
W8 
W12 
W16 
W20 
W24 
W28 
W32 
W36 
W40 
W44 
W48 
W52/ET 
12W Post 
Visit Window 
 
 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
Informed Consent/Assent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion, Med Hx, Demographics 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Review Immunization Record 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Safety 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Physical Exam, Weight/Height 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
X 
 
HIV, Hepatitis 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematology, Chemistry, Urinalysis 
X 
 
 
 
 
X 
 
X 
 
 
 
X 
 
 
 
 
X 
 
Pregnancy Test  
Serum 
urine 
 
urine 
 
urine 
urine 
urine 
urine 
urine 
urine 
urine 
urine 
urine 
urine 
urine 
urine 
 
Hormone Testing1 
X 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
X 
 
Adverse Events 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Meds & Procedures 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Efficacy and Patient Reported Outcomes 
IGA, BSA, EASI 
X 
X 
 
X 
 
X 
 
X 
 
 
 
X 
 
 
 
 
X 
 
DLQI/CDLQI22 
 
X 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
X 
 
PROMIS Anxiety & Depression2 
 
X 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
X 
 
Pharmacokinetics (PK) and Immunogenicity (ADA) 
Pre-dose PK 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
X 
X 
Pre-dose ADA3 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
X 
X 
Study Drug 
Administer Study Drug 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Instruction on Self-Administration 
  
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Dispense Drug for At-Home Injection 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
1 Collect estradiol for females only. Collect testosterone for males only 2  Patient reported outcome and quality of life measures should all be completed prior to other study assessments; 3 nAB testing conducted for positive treatment-emergent ADA 
responses.  Additional immunogenicity sample collected for any patient experiencing a hypersensitivity reaction during study.   
 
 
 

Study Protocol: DRM06-AD17 
Lebrikizumab 
Dermira, Inc. 
Confidential  
Page 55 
APPENDIX 2. AMERICAN ACADEMY OF DERMATOLOGY 
CONSENSUS CRITERIA FOR CHRONIC ATOPIC 
DERMATITIS 
Atopic dermatitis: Diagnosis recommendations 
Patients with presumed atopic dermatitis should have their diagnosis based on the criteria 
summarized below. On occasion, skin biopsy specimens or other tests (such as serum 
immunoglobulin E, potassium hydroxide preparation, patch testing, and/or genetic testing) may 
be helpful to rule out other or associated skin conditions.  
Level of Evidence: III Strength of Recommendation: C 
Essential features — must be present: 
• Pruritus  
• Eczema (acute, subacute, chronic) 
• Typical morphology and age specific patterns* 
• 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 
• Personal and/or family history 
• Immunoglobulin E reactivity 
• Xerosis 
Associated features — These clinical associations help to suggest the diagnosis of atopic 
dermatitis but are too nonspecific to be used for defining or detecting atopic dermatitis for 
research and epidemiologic studies: 
• Atypical vascular responses (e.g., facial pallor, white dermographism, delayed blanch 
response) 
• Keratosis pilaris/ pityriasis alba/ hyperlinear palms/ icthyosis 
• Ocular/periorbital changes 
• Perifollicular accentuation/ lichenification/ prurigo lesions 

Study Protocol: DRM06-AD17 
Lebrikizumab 
Dermira, Inc. 
Confidential  
Page 56 
Exclusionary conditions — It should be noted that a diagnosis of atopic dermatitis depends on 
excluding conditions, such as: 
• Scabies 
• Seborrheic dermatitis 
• Contact dermatitis (irritant or allergic) 
• Icthyoses 
• Cutaneous T-cell lymphoma 
• Psoriasis  
• Photosensitivity dermatoses 
• Immune deficiency diseases 
• Erythroderma of other causes 
adapted from Eichenfield, 2014.