A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)
Phase: PHASE3
Conditions: Atopic Dermatitis
Sponsor: Eli Lilly and Company

Protocol Addendum J2T-DM-KGAA (2) 
A Long-Term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients with 
Moderate-to-Severe Atopic Dermatitis
NCT04392154
Approval Date: 14-Dec-2022

Der mira, I nc.  
C o nfi de ntial  
P a ge 1  
A  L O N G -T E R M S T U D Y T O A S S E S S T H E S A F E T Y A N D E F FI C A C Y O F L E B RI KI Z U M A B 
I N P A TI E N T S WI T H M O D E R A T E-T O -S E V E R E A T O PI C D E R M A TI TI S  
Pr ot oc ol N u m ber  
D R M 0 6 -A D 0 7 /J 2 T -D M -K G A A  
Pr ot oc ol Fi n al D ate  
2 7  M arc h 2 0 2 0  
St u d y Dr u g  
Le bri kiz u m a b ( D R M 0 6 / L Y 3 6 5 0 1 5 0) 
I N D N u m ber 
E u dr a C T N u m ber  
1 1 9 8 6 6  
2 0 2 0 -0 0 1 2 1 1 -2 4  
S p o ns or  
Der mir a, I nc. , a w h oll y o w ne d s u bsi di ar y of Eli Lill y 
a n d C o m p a n y  
Lill y C or p or ate Ce nter  
I n di a n a p olis In di a n a,  4 6 2 8 5  
U S A  
Me dic al M o nit or  
 P h ar m D 
Me dic al Direct or  
D oc u me nt I D  
V V -C LI N -0 7 5 0 8 7
C O N FI D E N TI A L I N F O R M A TI O N  
Der mira, I n c., a w h oll y o w ne d s u bsi diar y of Eli Lill y a n d C o m pa n y . T he i nf or mati o n c o ntai ne d 
herei n is c o nfi de ntial a n d t he pr o prietar y pr o pert y of  Der mira. A n y use or discl os ure of s uc h 
i nf or mati o n wit h o ut t he pri or writte n a ut h orizati o n of Der mira is e x pressl y pr o hi bite d. 
A p pr o v al D ate: Pr ot oc ol A me n d me nt ( 2 ) Electr o nicall y  Si g ne d a n d  A p pr o ve d  b y Lill y  o n  date 
pr o vi de d bel o w.  
A p pr o ve d o n 1 4 Dec 2 0 2 2 G M T
P P D
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PROTOCOL AMENDMENT 2 (SUMMARY OF CHANGES)  
DOCUMENT HISTORY 
Document 
Date 
Amendment 1 
12-Dec-2020 
Original Protocol 
27-Mar-2020 
The table below summarizes new changes being introduced to Amendment 2. Minor corrections 
or additions may not be included. 
Protocol Section 
Description of Change 
Rationale 
Title Page 
Updated Sponsor address and 
Sponsor Medical Director 
Change in Sponsor address 
and Medical Director 
Sponsor Signature Page 
Change in Medical Director 
Update 
Protocol Synopsis 
Updated as per the changes 
made to the sections in the 
main body 
Clarification 
Section 1.4. Rationale for 
Dose and Treatment Regimen 
Corrected the age to <18 
years 
Correction 
Section 3 Study Design and 
Section 5.3 Study Drug 
Assignment 
Clarified when 
DRM06-AD18 participants 
receive blinded and open 
label study drug 
Clarification 
Section 5.4 Study Blinding 
Clarified unblinded interim 
analysis regarding 
DRM06-AD18 
Clarification 
Section 6.1 Permitted and 
Prohibited Treatments and 
Procedures 
Included live vaccines are not 
permitted during the trial 
To clarify guidance on 
vaccine use 
Section 8.2.4.2 Adverse 
Events of Special Interest 
(AESIs) 
Deleted the time that the 
sponsor or designee should 
report the AESIs 
Included that additional data 
will be collected in eCRF 
Included that “the 
investigator or designee” may 
discuss discontinuation of 
study drug or dose changes 
Clarification 
Section 8.2.8 Infections and 
Opportunistic Infections 
Included this section 
To match information 
provided with site training 
Section 8.2.9 Product 
Complaints 
Included product complaints 
language 
To match information 
provided with site training 
Section 9.1.1 Populations 
Analyzed 
Included details related to 
mITT population 
Clarification to match SAP 
Section 11 References 
Included the reference 
Winthrop KL et al 
Update 
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Section 12 Appendices: 
Appendix 1 Schedule of 
Visits and Procedures 
Included footnote 11 
Clarification 
Section 12 Appendices: 
Appendix 3 Protocol 
Amendment History 
Included amendment 1 
summary of changes 
Update 
Throughout the document 
Replaced SOA with 
Appendix 1 
Correction 
 
 
 
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Der mira, I nc.  
C o nfi de ntial   
P a ge 4  
S P O N S O R SI G N A T U R E P A G E   
A  L O N G -T E R M S T U D Y T O A S S E S S T H E S A F E T Y A N D E F FI C A C Y O F L E B RI KI Z U M A B 
I N P A TI E N T S WI T H M O D E R A T E-T O -S E V E R E A T O PI C D E R M A TI TI S  
 
Pr ot oc ol N u m ber:  
D R M 0 6 -A D 0 7 / J 2 T-D M -K G A A  
 
Pr ot oc ol Fi n al D ate:  
2 7  M arc h 2 0 2 0  
 
A me n d me nt ( 1) D ate:  
1 2  Dece m b er  2 0 2 0  
 
T he si g n at ure bel o w c o nstit utes a p pr o val of t his pr ot oc ol. I certif y t hat I ha ve t he a ut h orit y t o 
a p pr o ve t his pr ot oc ol o n be half of t he S p o ns or, Der mira, I n c. T he st u d y will be c o n d ucte d i n 
acc or da nce wit h t his pr ot oc ol a n d all a p plica ble l a ws, r ules, a n d  re g ulati o ns a n d I nter n ati o nal 
C o u ncil f or Har m o nisati o n of Tec h nic al Re q uire me nts f or P har mace uticals f or H u ma n Use  
(I C H) g ui deli nes f or G o o d Cli nical Practice ( G C P) , re g ulati o ns of t he U nit e d States ( U S) F o o d 
a n d Dr u g A d mi nistrati o n ( F D A), a n d t he et hical pri nci ples t hat ha ve t heir ori gi n i n t he 
Declarati o n of Helsi n ki.  
 
 
A ut h oriz e d b y:  
 
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
S p o ns or Si g nat ure  
Date  
 P har m D 
Me dical Direct or  
 
 
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INVESTIGATOR SIGNATURE PAGE  
A LONG-TERM STUDY TO ASSESS THE SAFETY AND EFFICACY OF LEBRIKIZUMAB 
IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS 
 
Protocol Number:  
DRM06-AD07/J2T-DM-KGAA 
 
Protocol Final Date: 
27 March 2020 
 
Amendment (1) Date 
12 December 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 
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) 
 
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PROTOCOL SYNOPSIS  
Title: 
A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab 
in Patients with Moderate-to-Severe Atopic Dermatitis 
Protocol Number: 
DRM06-AD07/J2T-DM-KGAA 
Phase: 
3 
Number of Sites: 
Approximately 200 sites in North America, the European Union and 
Asia/Pacific region. 
Study Population: 
Adolescent patients (≥12 to <18 years weighing ≥40 kg) and adults who completed the 
DRM06-AD04, DRM06-AD05, DRM06-AD06, DRM06-AD17 or DRM06-AD18 trial 
Sample Size:  
Approximately 900 patients may enroll in this long-term extension study.  
Study Objectives: 
To evaluate the long-term safety and efficacy of lebrikizumab in patients with moderate-to-
severe atopic dermatitis (AD). 
Duration of Patient Participation: 
Maximum total participation: up to 110 weeks (100 weeks on study plus a 12-week follow up 
safety visit after the last injection of study drug at Week 98).  
Study Treatment: 
Lebrikizumab, 250 mg (2 mL injection of 125 mg/mL)  
Study Design:  
Patients who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study 
(parent study), DRM06-AD04, DRM06-AD05, DRM06-AD06, DRM06-AD17 or DRM06-
AD18, will be offered the opportunity to enroll in this study. This 100-week study is designed 
to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic 
dermatitis.  
Patients will be considered enrolled once all baseline procedures have been completed and the 
investigator has determined that the patient meets the inclusion and exclusion criteria. Two 
treatment regimens will be assessed: 250 mg lebrikizumab, administered every 2 weeks (Q2W) 
and 250 mg lebrikizumab, administered every 4 weeks (Q4W). The regimen assigned to each 
patient will be based on the treatment received in the patient’s respective parent trial.  
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For the monotherapy trials, DRM06-AD04 and DRM06-AD05: 
 Patients who were re-randomized, in the Maintenance Phase, to either 250 mg 
lebrikizumab Q2W or 250 mg lebrikizumab Q4W will continue to receive the same 
active treatment regimen.  
 Patients who were receiving placebo in the Maintenance Phase will receive a loading 
dose of 500 mg lebrikizumab at the time of enrollment (Baseline) and at Week 2 
followed by 250 mg lebrikizumab Q2W.  
 Patients who were moved to the Escape Arm will continue to receive open label 250 mg 
lebrikizumab Q2W.  
 Treatment regimen assignment will remain blinded during the long-term extension 
study until unblinding (see Section below), except for patients from an escape arm, who 
will receive open-label study drug. Placebo injections will be utilized in order to 
maintain the blind and ensure that all patients receive the same number and frequency 
of injections regardless of treatment regimen assignment. 
For the TCS Combination trial, DRM06-AD06: 
 Patients receiving 250 mg lebrikizumab Q2W who achieve an IGA 0,1 or an Eczema 
Area and Severity Index (EASI) -75 response (≥EASI-75) at Week 16 will be randomly 
allocated to receive 250 mg lebrikizumab Q2W or 250 mg lebrikizumab Q4W, in a 2:1 
fashion, Q2W:Q4W, respectively. 
 Patients receiving 250 mg lebrikizumab Q2W who do not achieve an IGA 0,1 or an 
EASI-75 response (<EASI-75) at Week 16 will receive 250 mg lebrikizumab Q2W.  
 Patients who were receiving placebo will receive a loading dose of 500 mg 
lebrikizumab at the time of enrollment (Baseline) and at Week 2 followed by 250 mg 
lebrikizumab Q2W. 
 Patients who were receiving rescue treatment and were initially randomized to 
lebrikizumab will receive 250 mg lebrikizumab Q2W.  
 Patients who were receiving rescue treatment and were initially randomized to placebo 
will receive a loading dose of 500 mg lebrikizumab at the time of enrollment (Baseline) 
and at Week 2 followed by 250 mg lebrikizumab Q2W. 
 Treatment regimen assignment will remain blinded during the long-term extension 
study until unblinding (see Section below). Placebo injections will be utilized in order 
to maintain the blind and ensure that all patients receive the same number and 
frequency of injections regardless of treatment regimen assignment. 
For the Adolescent Safety trial, DRM06-AD17:  
 All patients will continue to receive open label 250 mg lebrikizumab Q2W. 
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For the Vaccine trial, DRM06-AD18: 
 Patients receiving 250 mg lebrikizumab Q2W will continue to receive 250 mg 
lebrikizumab Q2W (blinded study drug at Baseline and Week 2, then open-label study 
drug beginning at Week 4). 
 Patients who were receiving placebo will receive a loading dose of 500 mg 
lebrikizumab at the time of enrollment (Baseline) and at Week 2 followed by open-label 
250 mg lebrikizumab Q2W. 
 Treatment regimen assignment will remain blinded during the long-term extension 
study until unblinding (until DRM06-AD18 study unblinded). Placebo injections will 
be utilized in order to maintain the blind and ensure that all patients receive the same 
number and frequency of injections regardless of treatment regimen assignment. 
Patients who are not already administering study drug at home will be instructed on self-
administration and allowed to inject study drug at home.  
Patients will return to the clinic at Weeks 2, 4, 16 and every 12 weeks thereafter, through 
Week 100, for safety and efficacy assessments. Patients not achieving an EASI-50 (from parent 
study baseline) by Week 16, maintaining an EASI-50 response, or not achieving clinical benefit 
based on PI discretion should be terminated from this study.  
Efficacy will be assessed using the Investigator Global Assessment (IGA), EASI and Body 
Surface Area (BSA). Patients who have been completing daily pruritus and sleep-loss 
assessments and weekly Patient-Oriented Eczema Measure (POEM) assessments as part of 
their participation in the parent trial (DRM06-AD04, DRM06-AD05, DRM06-AD06, and 
DRM06-AD18), will continue to collect this information in the long-term extension study (See 
Appendix 1). Patients who participated in the DRM06-AD06 study will continue to collect 
daily topical corticosteroid (TCS) and topical calcineurin inhibitor (TCI) use.  
Safety will be assessed by monitoring the collection of adverse events, serum chemistry, 
hematology and urinalysis laboratory testing, physical examination, and vital signs. 
Serum samples will be collected for pharmacokinetic analysis and immunogenicity.  
Patients completing this study or who early terminate will return to the clinic for a safety 
follow-up visit 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 as shown in the Schedule of Visits and Procedures. 
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. 
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An unblinded interim analysis will be performed to support regulatory submissions. Additional 
interim analyses may also be performed for regulatory interactions, safety updates, and 
disclosures. 
Primary Endpoint: 
Describe the proportion of patients discontinued from study treatment due to adverse events 
through the last treatment visit. 
 
 
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TABLE OF CONTENTS 
PROTOCOL AMENDMENT 2 (SUMMARY OF CHANGES) ....................................................2 
SPONSOR SIGNATURE PAGE ....................................................................................................4 
INVESTIGATOR SIGNATURE PAGE .........................................................................................5 
PROTOCOL SYNOPSIS ................................................................................................................6 
TABLE OF CONTENTS ...............................................................................................................10 
LIST OF TABLES .........................................................................................................................13 
ACRONYMS .................................................................................................................................14 
1. 
BACKGROUND ........................................................................................................17 
1.1. 
Atopic Dermatitis ........................................................................................................17 
1.1.1. 
Epidemiology of Pediatric Atopic Dermatitis ............................................................17 
1.1.2. 
Clinical Manifestations ...............................................................................................18 
1.1.3. 
Treatment for AD .......................................................................................................18 
1.2. 
Lebrikizumab ..............................................................................................................19 
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 .........................................................23 
1.4. 
Rationale for Dose and Treatment Regimen ..............................................................23 
1.5. 
Study Conduct Statement ...........................................................................................24 
2. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................25 
2.1. 
Study Objective ..........................................................................................................25 
2.2. 
Primary Endpoint ........................................................................................................25 
2.3. 
Secondary Endpoints ..................................................................................................25 
3. 
STUDY DESIGN .......................................................................................................26 
3.1. 
Duration of the Study ..................................................................................................28 
3.2. 
Study Population and Number of Patients ..................................................................28 
4. 
SELECTION OF PATIENTS.....................................................................................29 
4.1. 
Inclusion Criteria ........................................................................................................29 
4.2. 
Exclusion Criteria .......................................................................................................30 
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5. 
STUDY DRUG ...........................................................................................................31 
5.1. 
Investigational Medicinal Product ..............................................................................31 
5.2. 
Storage and Labeling ..................................................................................................31 
5.3. 
Study Drug Assignment ..............................................................................................31 
5.4. 
Study Blinding ............................................................................................................32 
5.5. 
Study Drug Administration.........................................................................................33 
5.5.1. 
Instructions for Administration in the Clinic ..............................................................33 
5.5.2. 
Instructions for Administration at Home ....................................................................33 
5.6. 
Study Drug Accountability .........................................................................................33 
6. 
CONCOMITANT MEDICATIONS AND PROCEDURES ......................................34 
6.1. 
Permitted and Prohibited Treatments and Procedures ................................................34 
6.2. 
Moisturizers ................................................................................................................34 
6.3. 
Treatments for AD ......................................................................................................35 
7. 
STUDY PROCEDURES ............................................................................................36 
7.1. 
Baseline Visit (Day 1) ................................................................................................36 
7.2. 
Week 2 (± 3 Days) ......................................................................................................36 
7.3. 
Week 4 (± 3 Days) ......................................................................................................37 
7.4. 
Week 16 (± 5 Days) ....................................................................................................37 
7.5. 
Week 28 (± 5 Days) ....................................................................................................38 
7.6. 
Week 40 (± 5 Days) ....................................................................................................39 
7.7. 
Week 52 (± 5 Days) ....................................................................................................39 
7.8. 
Week 64 (± 5 Days) ....................................................................................................40 
7.9. 
Week 76 (± 5 Days) ....................................................................................................41 
7.10. 
Week 88 (± 5 Days) ....................................................................................................41 
7.11. 
Week 100 / Early Termination (± 5 Days) .................................................................42 
7.12. 
Safety Follow-up (± 5 Days) ......................................................................................42 
7.13. 
Unscheduled Visits .....................................................................................................43 
8. 
DETAILS OF ASSESSMENTS .................................................................................44 
8.1. 
Assessment of Efficacy ...............................................................................................44 
8.1.1. 
Investigator Global Assessment (IGA) .......................................................................44 
8.1.2. 
Eczema Area and Severity Index (EASI) ...................................................................44 
8.1.3. 
Body Surface Area (BSA) ..........................................................................................44 
8.1.4. 
Pruritus ........................................................................................................................44 
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8.1.5. 
Sleep-Loss ...................................................................................................................44 
8.1.6. 
Patient Oriented Eczema Measure (POEM) ...............................................................45 
8.1.7. 
Skin Pain Numeric Rating Scale (NRS) .....................................................................45 
8.2. 
ASSESSMENT OF SAFETY .....................................................................................45 
8.2.1. 
Physical Examination .................................................................................................45 
8.2.2. 
Vital Signs ..................................................................................................................45 
8.2.3. 
Laboratory Evaluations ...............................................................................................45 
8.2.4. 
Adverse Events ...........................................................................................................47 
8.2.4.1. 
Reporting ....................................................................................................................48 
8.2.4.2. 
Adverse Events of Special Interest (AESIs) ...............................................................48 
8.2.4.3. 
Serious Adverse Events (SAEs) .................................................................................49 
8.2.4.4. 
Reporting of SAEs ......................................................................................................49 
8.2.5. 
Pregnancy ...................................................................................................................51 
8.2.6. 
Hypersensitivity Reactions .........................................................................................51 
8.2.7. 
Hepatic Safety Monitoring .........................................................................................51 
8.2.7.1. 
Additional Hepatic Data Collection in Participants Who have Abnormal 
Liver Tests during the Study .......................................................................................53 
8.2.7.2. 
Hepatitis B Testing and Monitoring ...........................................................................53 
8.2.7.3. 
Hepatitis C Testing and Monitoring ...........................................................................53 
8.2.8. 
Infections and Opportunistic Infections ......................................................................53 
8.2.9. 
Product Complaints ....................................................................................................54 
8.3. 
PK and ADA Sampling ..............................................................................................54 
8.4. 
Study Termination ......................................................................................................54 
8.4.1. 
Early Termination of Study Patients...........................................................................55 
8.4.2. 
Discontinuation of Inadvertently Enrolled Patients ....................................................55 
8.4.3. 
Study Drug Discontinuation .......................................................................................56 
8.4.3.1. 
Temporary Study Drug Discontinuation ....................................................................56 
8.4.3.2. 
Permanent Study Drug Discontinuation .....................................................................56 
8.5. 
Data Safety Monitoring Board ....................................................................................57 
9. 
STATISTICAL CONSIDERATIONS .......................................................................58 
9.1. 
General Statistical Methodology ................................................................................58 
9.1.1. 
Populations Analyzed .................................................................................................58 
9.1.2. 
Baseline Definition .....................................................................................................59 
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9.2. 
EFFICACY ASSESSMENTS ....................................................................................59 
9.3. 
Exposure and Compliance ..........................................................................................60 
9.4. 
Adverse Events ...........................................................................................................60 
9.5. 
Other Safety Data .......................................................................................................60 
9.6. 
Sample-Size Determination ........................................................................................60 
9.7. 
Pharmacokinetics Analysis .........................................................................................61 
10. 
ADMINISTRATION ..................................................................................................62 
10.1. 
Compliance with the Protocol ....................................................................................62 
10.2. 
Informed Consent Procedures.....................................................................................62 
10.3. 
Data Protection and Confidentiality ...........................................................................63 
10.4. 
Study Documentation and the eCRF ..........................................................................63 
10.5. 
Study Monitoring ........................................................................................................64 
10.6. 
Retention of Study Documentation ............................................................................64 
10.7. 
Publication Policy .......................................................................................................64 
11. 
REFERENCES ...........................................................................................................65 
12. 
APPENDICES ............................................................................................................68 
APPENDIX 1. SCHEDULE OF VISITS AND PROCEDURES ...............................................68 
APPENDIX 2. LIVER SAFETY: SUGGESTED ACTIONS AND FOLLOW-UP 
ASSESSMENTS.........................................................................................................70 
APPENDIX 3. PROTOCOL AMENDMENT (1) HISTORY ....................................................72 
 
LIST OF TABLES  
Table 1: 
Laboratory Parameters ................................................................................................47 
Table 2: 
Schedule of Visits and Procedures: Baseline Through End of Study .........................68 
 
 
 
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ACRONYMS  
Acronym 
Term 
AD 
atopic dermatitis 
ADA 
anti-drug antibody 
AE 
adverse event 
AESI 
adverse event of special interest 
ALP  
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
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 
CK 
creatine kinase 
CSR 
clinical study report 
DRM06-AD04 
Also known as: J2T-DM-KGAB 
DRM06-AD05 
Also known as: J2T-DM-KGAC 
DRM06-AD06 
Also known as: J2T-DM-KGAD 
DRM06-AD07 
Also known as: J2T-DM-KGAA 
DRM06-AD17 
Also known as: J2T-DM-KGAE 
DRM06-AD18 
Also known as: J2T-MC-KGAK 
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 
FDA 
Food and Drug Administration 
FLG 
Filaggrin 
GCP 
good clinical practice 
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Acronym 
Term 
GGT 
gamma-glutamyl transferase 
HBV 
hepatitis B 
HCV 
hepatitis C 
ICF 
informed consent form 
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
IEC 
independent ethics committee 
IFN 
Interferon 
Ig 
immunoglobin 
IGA 
Investigator Global Assessment 
IL 
Interleukin 
IRB 
institutional review board 
ITT 
intent-to-treat 
LOR 
Loricrin 
MedDRA 
Medical Dictionary for Regulatory Activities 
nAB 
neutralizing antibodies 
NRS 
numerical rating scale 
PFS-NSD 
pre-filled syringe with a pre-assembled needle safety device 
PI 
principal investigator 
PK 
Pharmacokinetics 
POEM 
Patient Oriented Eczema Measure 
Q2W 
every 2 weeks 
Q4W 
every 4 weeks 
SAE 
serious adverse event 
SAS® 
statistical analysis software 
SC 
Subcutaneous 
SCORAD 
SCORing Atopic Dermatitis 
SCORAD-50 
50% reduction in SCORAD from baseline to a given timepoint 
SCORAD-75 
75% reduction in SCORAD from baseline to a given timepoint 
SOC 
system organ class 
TBL 
total bilirubin level 
TCI 
topical calcineurin inhibitor 
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Acronym 
Term 
TCS 
topical corticosteroid 
TEAE 
treatment-emergent adverse event 
ULN 
upper limits of normal 
US/USA 
United States 
W 
Week 
WOCBP 
women of childbearing potential 
 
 
 
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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 (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 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).  
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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 
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 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 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.  
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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 
human interleukin (IL)-13 with high affinity, and potently inhibits IL-13 signaling through the 
IL-4R/IL-13R1 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-13R1), but the engaged receptor complex cannot be 
activated.  
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 Q4W group; and 54 to the placebo Q4W 
group.  
Efficacy Results 
 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-50 (SCORAD-50) and adjusted 
mean change from baseline to Week 12. 
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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-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%. 
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 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. 
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. A total of 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 administered every 4 weeks (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.  
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 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. 
 Four patients (1.8%) in the lebrikizumab groups and 2 patients (3.8%) in the placebo 
group had an SAE. Those reported in the lebrikizumab groups were  
o severe chest pain (1 patient in the 250 mg Q2W group) 
o severe hernial eventration (1 patient in the 125 mg Q4W group) 
o femur fracture of moderate severity (1 patient in the 125 mg Q4W group), and  
o 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  
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.  
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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  
For the Phase 3 development program, a dosing regimen of 500 mg loading dose at baseline and 
Week 2, followed by 250 mg Q2W lebrikizumab was selected for study in the Induction Period 
(baseline to Week 16), based on an evaluation of safety, efficacy and PK data from the 
DRM06-AD01 and DRM06-AD03 trials (Sections 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 250 mg Q2W 
with a loading dose of 500 mg given at Baseline and Week 2.  
Following Induction, the Phase 3 development program will assess the long term safety and 
efficacy of both a 250 mg lebrikizumab Q2W dosing regimen and a 250 mg lebrikizumab Q4W 
dosing regimen in order to determine whether one or both regimens, one which involves less 
frequent dosing, might be effective in maintaining disease control over an extended period of 
time.  
Adolescent Patients 
In this Phase 3 study, adolescent patients (≥12 to <18 years weighing ≥40 kg), will be included 
and will receive the same doses of lebrikizumab described above for adults. The justification for 
this approach is as follows:  
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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 
 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.  
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2. 
STUDY OBJECTIVES AND ENDPOINTS  
2.1. 
Study Objective  
The objective of this study is to assess the long-term safety and efficacy of lebrikizumab in 
patients with moderate-to-severe AD. 
2.2. 
Primary Endpoint  
Describe the proportion of patients discontinued from study treatment due to adverse events 
through the last treatment visit. 
2.3. 
Secondary Endpoints  
Over the duration of the study: 
 Proportion of patients with a response of IGA 0 or 1 
 Proportion of patients achieving response of EASI-75 from baseline of parent study. 
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3. 
STUDY DESIGN  
Patients who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study, 
DRM06-AD04, DRM06-AD05, DRM06-AD06, DRM06-AD17 or DRM06-AD18, will be 
offered the opportunity to enroll in this study. This 100-week study is designed to assess the 
long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis.  
Patients will be considered enrolled once all baseline procedures have been completed and the 
investigator has determined that the patient meets the inclusion and exclusion criteria. Two 
treatment regimens will be assessed: 250 mg lebrikizumab, administered every 2 weeks (Q2W) 
and 250 mg lebrikizumab, administered every 4 weeks (Q4W). The regimen assigned to each 
patient will be based on the treatment received in the patient’s respective parent trial.  
For the monotherapy trials, DRM06-AD04 and DRM06-AD05: 
 Patients who were re-randomized, in the Maintenance Phase, to either 250 mg 
lebrikizumab Q2W or 250 mg lebrikizumab Q4W will continue to receive the same 
active treatment regimen.  
 Patients who were receiving placebo in the Maintenance Phase will receive a loading 
dose of 500 mg lebrikizumab at the time of enrollment (Baseline) and at Week 2 
followed by 250 mg lebrikizumab Q2W.  
 Patients who were moved to the Escape Arm will continue to receive open label 250 mg 
lebrikizumab Q2W.  
 Treatment regimen assignment will remain blinded during the long-term extension study 
until unblinding (see Section below), except for patients from an escape arm, who will 
receive open-label study drug. Placebo injections will be utilized in order to maintain the 
blind and ensure that all patients receive the same number and frequency of injections 
regardless of treatment regimen assignment. 
For the TCS Combination trial, DRM06-AD06: 
 Patients receiving 250 mg lebrikizumab Q2W who achieve an IGA 0,1 or an EASI-75 
response (≥EASI-75) at Week 16 will be randomly allocated to receive 250 mg 
lebrikizumab Q2W or 250 mg lebrikizumab Q4W, in a 2:1 fashion, Q2W:Q4W, 
respectively. 
 Patients receiving 250 mg lebrikizumab Q2W who do not achieve an IGA 0,1 or an 
EASI-75 response (<EASI-75) at Week 16 will receive 250 mg lebrikizumab Q2W.  
 Patients who were receiving placebo will receive a loading dose of 500 mg lebrikizumab 
at the time of enrollment (Baseline) and at Week 2 followed by 250 mg lebrikizumab 
Q2W. 
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 Patients who were receiving rescue treatment and were initially randomized to 
lebrikizumab will receive 250 mg lebrikizumab Q2W.  
 Patients who were receiving rescue treatment and were initially randomized to placebo 
will receive a loading dose of 500 mg lebrikizumab at the time of enrollment (Baseline) 
and at Week 2 followed by 250 mg lebrikizumab Q2W. 
 Treatment regimen assignment will remain blinded during the long-term extension study 
until unblinding (see Section below). Placebo injections will be utilized in order to 
maintain the blind and ensure that all patients receive the same number and frequency of 
injections regardless of treatment regimen assignment. 
For the Adolescent Safety trial, DRM06-AD17:  
 All patients will continue to receive open label 250 mg lebrikizumab Q2W. 
For the Vaccine trial, DRM06-AD18: 
 Patients receiving 250 mg lebrikizumab Q2W will continue to receive 250 mg 
lebrikizumab Q2W (blinded study drug at Baseline and Week 2, then open-label study 
drug beginning at Week 4). 
 Patients who were receiving placebo will receive a blinded loading dose of 500 mg 
lebrikizumab at the time of enrollment (Baseline) and at Week 2 followed by open-label 
250 mg lebrikizumab Q2W. 
 Treatment regimen assignment will remain blinded during the long-term extension study 
until unblinding (until DRM06-AD18 study unblinded). Placebo injections will be 
utilized in order to maintain the blind and ensure that all patients receive the same 
number and frequency of injections regardless of treatment regimen assignment. 
Patients who are not already administering study drug at home will be instructed on self-
administration and allowed to inject study drug at home.  
Patients will return to the clinic at Weeks 2, 4, 16 and every 12 weeks thereafter, through 
Week 100, for safety and efficacy assessments. Patients not achieving an EASI-50 (from parent 
study baseline) by Week 16, maintaining an EASI-50 response, or not achieving clinical benefit 
based on PI discretion should be terminated from this study.  
Efficacy will be assessed using the Investigator Global Assessment (IGA), EASI and Body 
Surface Area (BSA). Patients who have been completing daily pruritus and sleep-loss 
assessments and weekly Patient-Oriented Eczema Measure (POEM) assessments as part of their 
participation in the parent trial (DRM06-AD04, DRM06-AD05, DRM06-AD06, and DRM06-
AD18), will continue to collect this information in the long-term extension study (See 
Appendix 1). Patients who participated in the DRM06-AD06 study will continue to collect daily 
TCS/TCI use.  Patients who participated in the DRM06-AD18 study will continue to be collected 
daily Skin Pain NRS.   
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Safety will be assessed by monitoring the collection of adverse events, serum chemistry, 
hematology and urinalysis laboratory testing, physical examination, pulse and blood pressure. 
Serum samples will be collected for pharmacokinetic analysis and immunogenicity.  
Patients completing this study or who early terminate will return to the clinic for a safety follow-
up visit 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 as shown in the Schedule of Visits and Procedures. 
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. 
3.1. 
Duration of the Study  
The maximum duration of a patient’s participation in this study will be up to 110 weeks (100 
weeks in study plus safety follow-up visit 12 weeks following the last injection of study drug at 
Week 98).  
3.2. 
Study Population and Number of Patients  
Approximately 900 patients, who have completed a prior lebrikizumab study, are expected to 
enroll in this study.  
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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. Received treatment in a Dermira- or Lilly-sponsored lebrikizumab study, DRM06-AD04, 
DRM06-AD05, DRM06-AD06, DRM06-AD17 or DRM06-AD18 (parent trial) and have 
adequately completed the study treatments and last patient visit of the parent trial.  
2. Willing and able to comply with all clinic visits and study-related procedures. 
3. 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 or placebo.  
NOTE: A woman of childbearing potential (WOCBP) 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 (IUD), 
intrauterine hormone-releasing system (IUS), 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. 
If the highly effective contraceptive methods are contraindicated or strictly declined by 
the patient, acceptable birth control methods may be considered. These may include a 
combination of the following methods: 
• 
male or female condom with spermicide and 
• 
cap, diaphragm, or sponge with spermicide. 
4. Male patients are not required to use any contraception except in compliance with 
specific local government study requirements. 
5. Provide signed informed consent/assent as described in Section 10.2.  
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4.2. 
Exclusion Criteria  
Patients meeting any of the criteria below will not be included in this study: 
1. Patients who, during their participation in the parent trial, developed a serious adverse 
event (SAE) deemed related to lebrikizumab, which in the opinion of the investigator or 
of the medical monitor could indicate that continued treatment with lebrikizumab may 
present an unreasonable risk for the patient. * 
2. Patients who, during their participation in the parent trial, developed an AE that was 
deemed related to lebrikizumab and led to study treatment discontinuation, which in the 
opinion of the investigator or of the medical monitor could indicate that continued 
treatment with lebrikizumab may present an unreasonable risk for the patient. * 
3. Conditions in the previous parent study consistent with protocol-defined criteria for 
permanent study drug discontinuation, if deemed related to lebrikizumab or led to 
investigator - or sponsor-initiated withdrawal of patient from the study (e.g., non-
compliance, inability to complete study assessments, etc.). * 
4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed 
during the study. 
* Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions 
deemed related to the study treatment will be considered related to lebrikizumab. 
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5. 
STUDY DRUG  
5.1. 
Investigational Medicinal Product  
Lebrikizumab and placebo will be supplied to the investigator by the sponsor. Investigational 
product will be supplied as solution in a single use, sterile pre-filled syringe with a pre-
assembled needle safety device (PFS-NSD), containing lebrikizumab or placebo. The 2-mL 
syringe of lebrikizumab is manufactured to contain 250 mg. Lebrikizumab cannot be 
distinguished visually from placebo. 
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. 
Clinical trial material will be labeled according to each country’s regulatory requirements.  
5.3. 
Study Drug Assignment  
Assignment to treatment will be as follows: 
For the monotherapy trials, DRM06-AD04 and DRM06-AD05: 
 Patients who were re-randomized, in the Maintenance Phase, to either 250 mg 
lebrikizumab Q2W or 250 mg lebrikizumab Q4W will continue to receive the same 
active treatment regimen.  
 Patients who were receiving placebo in the Maintenance Phase will receive a loading 
dose of 500 mg lebrikizumab at the time of enrollment (Baseline) and at Week 2 
followed by 250 mg lebrikizumab Q2W.  
 Patients who were moved to the Escape Arm will continue to receive open label 250 mg 
lebrikizumab Q2W.  
 Treatment regimen assignment will remain blinded during the long-term extension study 
until unblinding (see Section below), except for patients from an escape arm, who will 
receive open-label study drug. Placebo injections will be utilized in order to maintain the 
blind and ensure that all patients receive the same number and frequency of injections 
regardless of treatment regimen assignment. 
For the TCS Combination trial, DRM06-AD06: 
 Patients receiving 250 mg lebrikizumab Q2W who achieve an IGA 0,1 or an EASI-75 
response (≥EASI-75) at Week 16 will be randomly allocated to receive 250 mg 
lebrikizumab Q2W or 250 mg lebrikizumab Q4W, in a 2:1 fashion, Q2W:Q4W, 
respectively. 
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 Patients receiving 250 mg lebrikizumab Q2W who do not achieve an IGA 0,1 or an 
EASI-75 response (<EASI-75) at Week 16 will receive 250 mg lebrikizumab Q2W.  
 Patients who were receiving placebo will receive a loading dose of 500 mg lebrikizumab 
at the time of enrollment (Baseline) and at Week 2 followed by 250 mg lebrikizumab 
Q2W. 
 Patients who were receiving rescue treatment and were initially randomized to 
lebrikizumab will receive 250 mg lebrikizumab Q2W.  
 Patients who were receiving rescue treatment and were initially randomized to placebo 
will receive a loading dose of 500 mg lebrikizumab at the time of enrollment (Baseline) 
and at Week 2 followed by 250 mg lebrikizumab Q2W. 
 Treatment regimen assignment will remain blinded during the long-term extension study 
until unblinding (see Section below). Placebo injections will be utilized in order to 
maintain the blind and ensure that all patients receive the same number and frequency of 
injections regardless of treatment regimen assignment. 
For the Adolescent Safety trial, DRM06-AD17:  
 All patients will continue to receive open label 250 mg lebrikizumab Q2W. 
For the Vaccine trial, DRM06-AD18: 
 Patients receiving 250 mg lebrikizumab Q2W will continue to receive 250 mg 
lebrikizumab Q2W (blinded study drug at Baseline and Week 2, then open-label study 
drug beginning at Week 4). 
 Patients who were receiving placebo will receive a loading dose of 500 mg lebrikizumab 
at the time of enrollment (Baseline) and at Week 2 followed by open-label 250 mg 
lebrikizumab Q2W. 
 Treatment regimen assignment will remain blinded during the long-term extension study 
until unblinding (until DRM06-AD18 study unblinded). Placebo injections will be 
utilized in order to maintain the blind and ensure that all patients receive the same 
number and frequency of injections regardless of treatment regimen assignment.  
For treatment assignments after unblinding, see Section below.  
5.4. 
Study Blinding  
For trials where blinding to treatment will be maintained, the Investigator, study-site personnel, 
and the patient will be blinded to treatment assignment until the unblinded interim analysis to 
support regulatory submissions occurs (or when DRM06-AD18 study is unblinded for DRM06-
AD18 patients). The sponsor or designee could unblind a small team including but not limited to 
medical, statistics, data management, regulatory etc. to prepare for regulatory interactions, safety 
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updates, and disclosures if needed, while another team remains blinded to carry the day to day 
study work. After the interim database lock for the submission, patients will no longer receive 
placebo injections and will continue per assigned treatment group. 
The integrity of the clinical study will be maintained by observing the treatment blind. If 
knowledge of a patient’s treatment assignment is required for the patient’s clinical care and/or 
safety, the Investigator should consult with the Sponsor’s medical monitor prior to breaking the 
blind.  
5.5. 
Study Drug Administration  
Study drug will be administered to all patients in the clinic by designated and trained site staff 
from Baseline through the Week 4 visit and at all other scheduled clinic visits. Following the 
Week 4 visit, patients will be allowed to administer study drug at home. Sufficient study drug 
should be dispensed to cover at home administrations through the next study visit. 
5.5.1. 
Instructions for Administration in the Clinic  
Syringes should be at room temperature prior to injection (refer to the applicable Directions for 
Use provided by the sponsor). 
5.5.2. 
Instructions for Administration at Home  
Patients or caregivers will be instructed to self-administer study drug following the Week 4 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.  
Instructions for use with details of the injection procedures, as well as storage and handling of 
syringes, will be provided to the participant and/or their 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.  
Patients will enter the details about at-home injections in the diary provided.   
5.6. 
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 empty, used syringe cartons, 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. 
Acute severe infections can be treated with systemic antibiotics, use of which must be recorded 
in the eCRF. However, chronic treatment with systemic antibiotics is not permitted. 
Live or live attenuated vaccines are not permitted during the trial, but if taken, please contact 
sponsor or designee for additional guidance and hold study drug for 12 weeks post vaccination. 
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.  
See Section 6.3 for details on approved AD medications and timing of use.  
6.2. 
Moisturizers  
Non-medicated moisturizers are to be used during the study. Patients may continue to use her/his 
current over-the-counter moisturizer regimen, if approved by the Investigator.  
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6.3. 
Treatments for AD  
Intermittent use of topical rescue medications (e.g., TCS, TCIs and PDE4 inhibitors) for AD is 
permitted for the treatment of disease flares during the trial. 
Patients coming from the TCS combination trial DRM06-AD06 and still on TCS use at the end 
of the parent study, may taper or stop TCS use, as needed. If AD lesions return or a patient 
experiences a flare, TCS treatment may be resumed at the patient’s discretion. For patients 
coming from DRM06-AD06, TCS and TCI use will be recorded daily by the patient using an 
electronic diary, as indicated in the Schedule of Visits and Procedures (Appendix 1). 
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.  
The introduction of medications or therapies for other medical conditions known to affect AD 
(e.g., mycophenolate-mofetil, IFN-y, Janus kinase inhibitors, cyclosporine, azathioprine, 
methotrexate, phototherapy, or photochemotherapy) are not permitted during the study. Extended 
use of systemic corticosteroids for the treatment of AD are prohibited and require permanent 
discontinuation of Investigational Product. They may be used only for the treatment of an AE 
(for example, worsening of existing condition, such as asthma flare). If used for >30 days, 
sponsor approval is required for the patient to remain in the study. 
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.  
Patients requiring long-term systemic treatment for symptoms of AD (e.g., non-responders) must 
be discontinued from the study.  
Cannabinoid treatments for AD are prohibited. All medication used for AD must be recorded in 
the eCRF.  
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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. 
Baseline Visit (Day 1)  
Procedures for the Baseline Visit for study DRM06-AD07 are conducted as part of the study exit 
visit for the parent trial. Procedures are not duplicated but will be transferred electronically into 
the electronic data capture system where possible. 
 Obtain written informed consent/assent prior to performing any study procedures 
 Review Inclusion/Exclusion Criteria 
 Measure vital signs 
 Perform a complete physical examination 
 Collect height and weight 
 Review and record AEs 
 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) 
 Confirm moisturizer use and review compliance report on the eDiary, remind patient to 
record the following as indicated in Appendix 1: Pruritus, Sleep-Loss and Skin Pain NRS 
(daily), TCS/TCI use (daily), and POEM (weekly) 
 Draw blood samples for laboratory tests 
 Collect urine sample for urinalysis 
 Conduct urine pregnancy test (WOCBP only) 
 Instruct the patient to apply a moisturizer at least twice daily 
 Draw a pre-dose blood sample for PK and anti-drug antibody (ADA) testing 
 Administer study drug 
7.2. 
Week 2 (± 3 Days)  
 Complete the following assessments: IGA, BSA and EASI 
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 Measure vital signs 
 Confirm moisturizer use and review compliance report on the eDiary, remind patient to 
record the following as indicated in Appendix 1: Pruritus, Sleep-Loss and Skin Pain NRS 
(daily), TCS/TCI use (daily), and POEM (weekly)  
 Review and record AEs 
 Collect concomitant medication and procedure/therapy information 
 Conduct urine pregnancy test (WOCBP only) 
 Administer study drug 
7.3. 
Week 4 (± 3 Days)  
 Complete the following assessments: IGA, BSA and EASI 
 Measure vital signs 
 Confirm moisturizer use and review compliance report on the eDiary, remind patient to 
record the following as indicated in Appendix 1: Pruritus, Sleep-Loss and Skin Pain NRS 
(daily), TCS/TCI use (daily), and POEM (weekly) 
 Review and record AEs 
 Collect concomitant medication and procedure/therapy information 
 Conduct urine pregnancy test (WOCBP only) 
 Draw a pre-dose blood sample for PK and ADA testing  
 Administer study drug 
 Train the patient to self-administer study drug (if appropriate) 
 Dispense study drug through next visit 
 Remind patient to enter details about at home injections in the diary provided 
7.4. 
Week 16 (± 5 Days)  
 Complete the following assessments: IGA, BSA and EASI 
 Measure vital signs 
 Collect weight. In adolescents, also collect height  
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 Confirm moisturizer use and review compliance report on the eDiary, remind patient to 
record the following as indicated in Appendix 1: Pruritus, Sleep-Loss, and Skin Pain 
NRS (daily), TCS/TCI use (daily), and POEM (weekly) 
 Review and record AEs 
 Collect concomitant medication and procedure/therapy information 
 Draw blood sample for hormones in adolescents 
 Draw blood samples for laboratory tests 
 Collect urine sample for urinalysis 
 Conduct urine pregnancy test (WOCBP only) 
 Administer study drug 
 Review patient dosing diary and remind patient to enter details about at home injections 
in the diary provided 
 Dispense study drug through next visit 
7.5. 
Week 28 (± 5 Days)  
 Complete the following assessments: IGA, BSA and EASI 
 Measure vital signs 
 Collect weight. In adolescents, also collect height  
 Review and record AEs 
 Confirm moisturizer use and review compliance report on the eDiary, remind patient to 
record the following as indicated in Appendix 1: Pruritus, Sleep-Loss and Skin Pain NRS 
(daily), TCS/TCI use (daily), and POEM (weekly) 
 Collect concomitant medication and procedure/therapy information 
 Draw blood sample for hormones in adolescents 
 Draw blood samples for laboratory tests 
 Conduct urine pregnancy test (WOCBP only) 
 Draw a pre-dose blood sample for PK and ADA testing 
 Administer study drug 
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 Dispense study drug through next visit 
 Review patient dosing diary and remind patient to enter details about at home injections 
in the diary provided 
7.6. 
Week 40 (± 5 Days)  
 Complete the following assessments: IGA, BSA and EASI 
 Measure vital signs 
 Collect weight. In adolescents, also collect height  
 Confirm moisturizer use and review compliance report on the eDiary, remind patient to 
record the following as indicated in Appendix 1: Pruritus, Sleep-Loss and Skin Pain NRS 
(daily), TCS/TCI use (daily), and POEM (weekly) 
 Review and record AEs 
 Collect concomitant medication and procedure/therapy information 
 Draw blood sample for hormones in adolescents 
 Draw blood samples for laboratory tests 
 Collect urine sample for urinalysis  
 Conduct urine pregnancy test (WOCBP only) 
 Administer study drug 
 Dispense study drug through next visit 
 Review patient dosing diary and remind patient to enter details about at home injections 
in the diary provided 
7.7. 
Week 52 (± 5 Days)  
 Complete the following assessments: IGA, BSA and EASI 
 Perform a complete physical examination, including weight. In adolescents, also collect 
height.  
 Measure vital signs 
 Review and record AEs 
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 Confirm moisturizer use, review compliance report on the eDiary, and collect the eDiary 
device. 
 Collect concomitant medication and procedure/therapy information 
 Draw blood samples for laboratory tests 
 Draw a pre-dose blood sample for PK and anti-drug antibody (ADA) testing 
 Collect urine sample for urinalysis 
 Conduct urine pregnancy test (WOCBP only) 
 Administer study drug 
 Dispense study drug through next visit 
 Review patient dosing diary and remind patient to enter details about at home injections 
in the diary provided 
7.8. 
Week 64 (± 5 Days)  
 Collect POEM (in office collection) for patients coming from Study DRM06-AD04, 
DRM06-AD05, DRM06-AD06 and DRM06-AD18 
 Complete the following assessments: IGA, BSA, and EASI 
 Measure vital signs 
 Review and record AEs 
 Collect concomitant medication and procedure/therapy information 
 Conduct urine pregnancy test (WOCBP only) 
 Administer study drug 
 Dispense study drug through next visit 
 Review patient dosing diary and remind patient to enter details about at home injections 
in the diary provided 
 
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7.9. 
Week 76 (± 5 Days)  
 
 Collect POEM (in office collection) for patients coming from Study DRM06-AD04, 
DRM06-AD05, DRM06-AD06 and DRM06-AD18 
 Complete the following assessments: IGA, BSA, and EASI 
 Collect weight. In adolescents, also collect height  
 Measure vital signs 
 Review and record AEs 
 Collect concomitant medication and procedure/therapy information 
 Draw blood samples for laboratory tests 
 Draw a pre-dose blood sample for PK and anti-drug antibody (ADA) testing 
 Collect urine sample for urinalysis 
 Conduct urine pregnancy test (WOCBP only) 
 Administer study drug 
 Dispense study drug through next visit 
 Review patient dosing diary and remind patient to enter details about at home injections 
in the diary provided 
7.10. 
Week 88 (± 5 Days)  
 Collect POEM (in office collection) for patients coming from Study DRM06-AD04, 
DRM06-AD05, DRM06-AD06 and DRM06-AD18 
 Complete the following assessments: IGA, BSA, and EASI 
 Measure vital signs 
 Review and record AEs 
 Collect concomitant medication and procedure/therapy information 
 Conduct urine pregnancy test (WOCBP only) 
 Administer study drug 
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 Dispense study drug through next visit 
 Review patient dosing diary and remind patient to enter details about at home injections 
in the diary provided 
7.11. 
Week 100 / Early Termination (± 5 Days)  
 
 Collect POEM (in office collection) for patients coming from Study DRM06-AD04, 
DRM06-AD05, DRM06-AD06 and DRM06-AD18 
 Complete the following assessments: IGA, BSA, and EASI 
 Perform a complete physical examination, including weight. In adolescents, also collect 
height  
 Measure vital signs 
 Review and record AEs 
 Collect concomitant medication and procedure/therapy information 
 Draw blood samples for laboratory tests 
 Draw a blood sample for PK and anti-drug antibody (ADA) testing 
 Collect urine sample for urinalysis 
 Conduct urine pregnancy test (WOCBP only) 
 Review patient dosing diary. 
7.12. 
Safety Follow-up (± 5 Days)  
Patients who complete the study or terminate early from this study will return for safety 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 sample for PK and anti-drug antibody (ADA) testing 
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7.13. 
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  
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8. 
DETAILS OF ASSESSMENTS  
8.1. 
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.  
8.1.1. 
Investigator Global Assessment (IGA)  
The IGA is an instrument used to globally rate the severity of the patient’s AD and is based on a 
5-point scale ranging from 0 (clear) to 4 (severe). The IGA score is selected using the descriptors 
below 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.  
8.1.2. 
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.  
8.1.3. 
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. 
8.1.4. 
Pruritus  
Pruritus will continue to be assessed by all patients who evaluated pruritus as part of their parent 
trial participation using the same patient reported outcome instrument, the Pruritus Numerical 
Rating Scale (NRS). The Pruritus NRS is an 11-point scale used by patients to rate their worst 
itch severity over the past 24 hours with 0 indicating “No itch” and 10 indicating “Worst itch 
imaginable.” Assessments will be recorded daily by the patient using an electronic diary through 
Week 52. Data will be transferred to the clinical database. 
8.1.5. 
Sleep-Loss  
Sleep-loss due to pruritus will continue to be assessed by all patients who evaluated sleep-loss as 
part of their parent trial participation using the same patient reported outcome instrument. 
Patients rate their sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. 
Assessments will be recorded daily by the patient using an electronic diary through Week 52. 
Data will be transferred to the clinical database. 
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8.1.6. 
Patient Oriented Eczema Measure (POEM)  
POEM will continue to be assessed by all patients who completed a POEM assessment as part of 
their parent trial participation using the same patient reported outcome instrument. The POEM is 
a 7-item, validated, questionnaire used by the patient to assess disease symptoms over the last 
week. Patients are asked to respond to questions on skin dryness, itching, flaking, cracking, sleep 
loss, bleeding and weeping. All answers carry equal weight with a total possible score from 0 to 
28 (answers scored as: No days=0; 1‒ 2 days = 1; 3-4 days = 2; 5‒6 days = 3; everyday = 4). 
A high score is indicative of a poor quality of life. POEM responses will be captured using an 
electronic diary through Week 52, then captured at site visits starting at Week 64, and transferred 
into the clinical database. 
8.1.7. 
Skin Pain Numeric Rating Scale (NRS)  
Skin Pain NRS (Newton et al. 2019) is a patient-administered, validated, 11-point horizontal 
scale anchored at 0 and 10, with 0 representing “no pain” and 10 representing “worst pain 
imaginable.” Overall severity of a patient’s skin pain is indicated by selecting the number that 
best describes the worst level of skin pain in the past 24 hours.  
Skin Pain NRS will only be collected for patients continuing from DRM06-AD18. Participants 
will record the Skin Pain NRS assessments daily using an electronic diary at home through Week 
52, as indicated in the Schedule of Visits and Procedures (Appendix 1).  
8.2. 
ASSESSMENT OF SAFETY  
8.2.1. 
Physical Examination  
A complete physical examination will be conducted at baseline and at end-of-treatment and will 
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.  
At other study visits, a symptom-directed physical examination may be conducted at the 
discretion of the Investigator.  
8.2.2. 
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. 
8.2.3. 
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, standard urine testing, urine pregnancy test for women who are not post-menopausal 
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or surgically sterile and estradiol or testosterone testing in adolescents. Blood and urine will be 
collected from each patient as specified in the Schedule of Visits and Procedures or as clinically 
indicated. Any laboratory re-testing, if needed, should be conducted using the central laboratory. 
Laboratory data will be transferred to the clinical database. 
All laboratory tests with values considered clinically significantly abnormal during participation 
in the study or within 28 days after the last dose of study intervention should be repeated until 
the values return to normal or baseline or are no longer considered clinically significant by the 
investigator or medical monitor. 
 If such values do not return to normal or baseline within a period of time judged 
reasonable by the investigator, the etiology should be identified and the sponsor 
notified. 
 All protocol-required laboratory assessments must be conducted in accordance 
with the laboratory manual and Appendix 1. 
If laboratory values from non-protocol-specified laboratory assessments performed at the 
institution’s local laboratory require a change in participant management or are 
considered clinically significant by the investigator (e.g., SAE or AE or dose 
modification), then the clinically significant results will be reported as an AE in the AE 
section of the eCRF. 
Blinding of laboratory test results 
Laboratory results that could unblind the study will not be reported to investigative sites or other 
blinded personnel. 
 
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Table 1: 
Laboratory Parameters  
Hematology 
Chemistry 
Urine 
Hormones 
Serology 
CBC with 
differential: 
Hematocrit  
Hemoglobin  
Red blood cells  
White blood cells  
Mean corpuscular 
hemoglobin  
MCH 
concentration  
Mean corpuscular 
volume 
RBC morphology 
Platelet count 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
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 
pH 
Specific gravity 
Protein 
Glucose 
Ketones 
Bilirubin 
Blood 
Nitrite 
Urobilinogen 
Leukocyte esterase  
 
At All Visits 
(WOCBP only): 
Urine beta human 
chorionic 
gonadotropin 
Estradiol 
(adolescent females 
only)a 
Testosterone 
(adolescent males 
only)a 
HBV DNAb 
a Stop hormone tests when the patient reaches 18 years of age 
b Only for participants who are anti-HBc reactive and anti-HBs nonreactive at parent study screening. 
8.2.4. 
Adverse Events  
AEs 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. 
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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 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). 
8.2.4.1. 
Reporting  
AEs that are ongoing at the exit visit of the parent trial will be carried over and followed. New 
AEs occurring from the time of consent to the end of study will be reported in the AE section of 
the eCRF. All AEs 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 8.2.4.3. Unless a diagnosis is available, 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. (Section 8.2.4.3) 
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 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.  
8.2.4.2. 
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. Additional data will be collected for AESIs 
in the eCRF. Patient records must include any follow-up information regarding these AESIs.  
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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. The investigator or designee may 
discuss discontinuation of study drug or dose changes with the Sponsor or designee prior to 
implementation. 
8.2.4.3. 
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. 
8.2.4.4. 
Reporting of SAEs  
All SAEs, as defined in Section 8.2.4.3, 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 an SAE form. 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 
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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. 
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 
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it along with the Investigator’s Brochure and will notify the IRB/IEC, if appropriate, according 
to local requirements. 
8.2.5. 
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. 
8.2.6. 
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.  
8.2.7. 
Hepatic Safety Monitoring  
Close hepatic monitoring 
The laboratory tests listed in Appendix 2, including ALT, AST, ALP,TBL, direct bilirubin, GGT, 
and CK should be repeated within 48 to 72 hours, to confirm the abnormality and to determine 
whether it is increasing or decreasing, if these conditions occur: 
If a participant with baseline...  
has the following elevations: 
ALT or AST <1.5 times ULN 
ALT or AST ≥3 times ULN 
ALP <1.5 times ULN 
ALP ≥2 times ULN 
TBL <1.5 times ULN 
TBL ≥2 times ULN 
ALT or AST ≥1.5 times ULN 
ALT or AST ≥2 times baseline 
ALP ≥1.5 times ULN 
ALP ≥2 times baseline 
TBL ≥1.5 times ULN  
TBL ≥1.5 times baseline (except for patients with 
Gilbert’s syndrome) 
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If the abnormality persists or worsens, clinical and laboratory monitoring and evaluation for the 
possible causes of the abnormal liver tests should be initiated by the investigator in consultation 
with the sponsor’s designated medical monitor. At a minimum, this evaluation should include a 
physical examination and a thorough medical history, including symptoms, recent illnesses (for 
example, heart failure, systemic infection, hypotension, or seizures), recent travel, history of 
concomitant medications (including over-the-counter), herbal and dietary supplements, history of 
alcohol drinking, and other substance abuse. 
Initially, monitoring of symptoms and hepatic biochemical tests should be done at a frequency of 
one to three times weekly, based on the participant’s clinical condition and hepatic biochemical 
tests. Subsequently, the frequency of monitoring may be lowered to once every 1 to 2 weeks, if 
the participant’s clinical condition and lab results stabilize. Monitoring of ALT, AST, ALP, and 
TBL should continue until levels normalize or return to approximate baseline levels. 
Comprehensive hepatic evaluation 
A comprehensive evaluation should be performed to search for possible causes of liver injury if 
these conditions occur: 
If a participant with baseline... 
has the following elevations: 
ALT or AST <1.5 times ULN 
ALT or AST ≥3 times ULN with hepatic signs or symptoms*, or  
ALT or AST ≥5 times ULN 
ALP <1.5 times ULN 
ALP ≥3 times ULN 
TBL <1.5 times ULN 
TBL ≥2 times ULN 
ALT or AST ≥1.5 times ULN 
ALT or AST ≥2 times baseline with hepatic signs or symptoms*, or 
ALT or AST ≥3 times baseline 
ALP ≥1.5 times ULN 
ALP ≥2 times baseline 
TBL ≥1.5 times ULN  
TBL ≥2 times baseline, except for patients with Gilbert’s syndrome 
*Hepatic signs or symptoms are severe fatigue, nausea, vomiting, right upper quadrant abdominal pain, 
fever, and/or rash. 
At a minimum, this evaluation should include a physical examination and a thorough medical 
history, as outlined above, as well as tests for prothrombin-time/INR (PT-INR); viral hepatitis A, 
B, C, and E; tests for autoimmune hepatitis; and an abdominal imaging study, for example, 
ultrasound or CT scan. 
Based on the participant’s history and initial results, further testing should be considered in 
consultation with the sponsor’s designated medical monitor, including tests for hepatitis D virus, 
cytomegalovirus, Epstein-Barr virus, acetaminophen levels, acetaminophen protein adducts, 
urine toxicology screen, Wilson’s disease, blood alcohol levels, urinary ethyl glucuronide, and 
serum phosphatidylethanol. 
Based on the circumstances and the investigator’s assessment of the participant’s clinical 
condition, the investigator should consider referring the participant for a 
hepatologist/gastroenterologist consultation, magnetic resonance cholangiopancreatography, 
endoscopic retrograde cholangiopancreatography, cardiac echocardiogram, or a liver biopsy. 
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8.2.7.1. 
Additional Hepatic Data Collection in Participants Who have Abnormal Liver 
Tests during the Study  
Additional hepatic safety data collection (hepatic safety eCRF) should be performed for 
participants who meet one or more of the following conditions: 
 Elevation of serum ALT to ≥5 times ULN on two or more consecutive blood tests, if 
baseline ALT is <1.5 times ULN 
o In participants with baseline ALT ≥1.5 times ULN, the threshold is ALT ≥3 times 
baseline on two or more consecutive blood tests 
 Elevation of TBL to ≥2 times ULN, if baseline TBL is <1.5 times ULN (except for cases 
of known Gilbert’s syndrome) 
o In participants with baseline TBL ≥1.5 times ULN, the threshold should be 
TBL ≥2 times baseline 
 Elevation of serum ALP to ≥2 times ULN on two or more consecutive blood tests, if 
baseline ALP <1.5 times ULN 
o In participants with baseline ALP ≥1.5 times ULN, the threshold is ALP ≥2 times 
baseline on two or more consecutive blood tests 
 Hepatic event considered to be an SAE, and 
 Discontinuation of study drug due to a hepatic event. 
Note that the interval between the two consecutive blood tests should be at least 2 days. 
8.2.7.2. 
Hepatitis B Testing and Monitoring  
HBV DNA results that are reported as positive or as detecting HBV DNA, but HBV DNA is 
below the level of quantification: the sponsor’s designated medical monitor should be contacted 
regarding the study status of the participant. HBV DNA testing is to be repeated as soon as is 
feasible. If HBV DNA is confirmed as positive, the participant must be permanently 
discontinued from study drug. 
The participant is to be referred to, evaluated, and managed by a specialist physician with 
expertise in evaluation and management of viral hepatitis prior to discontinuation of any 
immunomodulatory and/or immunosuppressive therapy, including study drug. Timing of 
discontinuation from study drug relative to the initiation of any antiviral treatment for hepatitis is 
to be based on the recommendation of the consulting specialist physician, in conjunction with the 
investigator, and aligned with medical guidelines and standard of care. 
8.2.7.3. 
Hepatitis C Testing and Monitoring  
If HCV RNA is detected during the study, the study drug will be permanently discontinued and 
the participant should receive appropriate follow-up medical care. 
8.2.8. 
Infections and Opportunistic Infections  
Completion of the Infection eCRF is required for each infection (with the exception of the 
common cold) reported as an AE or SAE. The sponsor will identify infections considered to be 
opportunistic based on the article by Winthrop et al. (2015). 
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8.2.9. 
Product Complaints  
A product complaint is any written, electronic, or oral communication that alleges a deficiency 
related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a 
Lilly product after it is released for distribution. When the ability to use the product safely is 
impacted, the following are also considered as product complaints:  
 deficiencies in labeling information, and 
 use errors for device or combination products due to ergonomic design elements of the 
product. 
Sponsor collects product complaints on investigational products and drug delivery systems used 
in clinical studies to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
Complaints are also collected on comparators and other materials supplied, as required and 
instructed for the study. 
Participants will be instructed to contact the investigator as soon as possible if they have a 
complaint or problem with the study drug or drug delivery system, so that the situation can be 
assessed. 
Product complaints will be reported by the investigator to the sponsor per instructions provided 
on the study-specific Product Complaint Form.  
All complaints associated with CT material and/or investigational device supplied by Lilly need 
to be reported within 24 hours of receipt of the complaint (see pharmacy manual). Updated 
product complaints information should be reported as soon as possible upon site awareness using 
the originally completed Product Complaint Form with all changes signed and dated by the 
investigator.  
8.3. 
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. The procedural instructions will be provided in a 
separate PK and Serum Antibody Sampling manual. 
8.4. 
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 
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All data available for the patient at the time of study discontinuation must be recorded in the 
patient’s records and the eCRF. 
8.4.1. 
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. 
 Not achieving an EASI-50, from parent study baseline, by Week 16, maintaining an 
EASI-50 response, or not achieving clinical benefit based on PI discretion should be 
terminated from this study. 
 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. 
 Enrollment in any other clinical study involving an investigational product or enrollment 
in any other type of medical research judged not to be scientifically or medically 
compatible with this study. 
 Patients requiring long-term systemic treatment for symptoms of AD (e.g., non-
responders). 
 Serious protocol violation, persistent non-compliance or requirement for medication or 
procedure prohibited by the protocol. 
 Lost to follow-up  
o 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. 
Patients who are terminated early from the study will have an Early Termination visit 
(Section 7.7) scheduled as soon as possible. All information, including the reason for early 
termination will be recorded in the patient’s study records and in the eCRF.  
8.4.2. 
Discontinuation of Inadvertently Enrolled Patients  
If the sponsor or investigator identify a participant who did not meet enrollment criteria and was 
inadvertently enrolled, then the participant should be discontinued from the study unless there 
are extenuating circumstances that make it medically necessary for the participant to continue on 
study drug. If the investigator and the sponsor-designated medical monitor agree it is medically 
appropriate to continue, the investigator must obtain documented approval from the sponsor 
designated medical monitor to allow the inadvertently enrolled participant to continue in the 
study.  
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8.4.3. 
Study Drug Discontinuation  
8.4.3.1. 
Temporary Study Drug Discontinuation  
Some possible reasons for temporarily withholding the study drug include, but are not limited to: 
 HBV DNA results that are reported as positive, or as detecting HBV DNA, but HBV 
DNA is below the level of quantification: the sponsor’s designated medical monitor 
should be contacted regarding study status of the participant. HBV DNA testing is to be 
repeated as soon as is feasible. If HBV DNA is confirmed as positive, the participant 
must be permanently discontinued from study drug. 
 Hepatic event or liver test abnormality: the study drug should be withheld and additional 
testing performed following consultation with the Lilly-designated medical monitor, if 
the results of repeat tests following elevated ALT, ALP, or TBL include one of the 
following: 
o ALT 3 times ULN and TBL <2 times ULN 
o ALP 2 times ULN and TBL <2 times ULN 
o TBL 2 times ULN without increase from baseline in ALT or AST or ALP. 
8.4.3.2. 
Permanent Study Drug Discontinuation  
If HCV RNA is detected during the study, the study drug will be permanently discontinued, and 
the participant should receive appropriate follow-up medical care. 
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 
 The participant develops any of the following conditions during the study: 
o Malignancy, except for successfully treated basal or squamous cell skin 
carcinoma 
o Serious or opportunistic infection that in the opinion of the investigator merits 
the study drug being discontinued. Such infections may include, but are not 
limited to: 
▪ HIV infection/acquired immune deficiency syndrome 
▪ active TB infection or untreated latent TB infection 
▪ HCV RNA positive 
▪ HBV DNA positive 
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NOTE: the HBV DNA result is to be confirmed if initial positive test 
result is positive but below the level of quantification. The participant is to 
be referred to, evaluated, and managed by a specialist physician with 
expertise in evaluation and management of viral hepatitis prior to 
discontinuation of any immunomodulatory and/or immunosuppressive 
therapy, including study drug. Timing of discontinuation from study drug 
relative to the initiation of any antiviral treatment for hepatitis is to be 
based on the recommendation of the consulting specialist physician, in 
conjunction with the investigator, and aligned with medical guidelines and 
standard of care. 
Participants who are discontinued from the study drug due to a hepatic event or liver test 
abnormality should have additional hepatic safety data collected via eCRF. Discontinuation of 
the study drug for abnormal liver tests should be considered by the investigator when a 
participant meets one of the following conditions after consultation with the sponsor-designated 
medical monitor:  
 ALT or AST ≥8 times ULN 
 ALT or AST ≥5 times ULN for more than 2 weeks 
 ALT or AST ≥3 times ULN and TBL ≥2 times ULN or international normalized ratio 
(INR) ≥1.5 
 ALT or AST ≥3 times ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant abdominal pain or tenderness, fever, and/or rash 
 ALP ≥3 times ULN 
 ALP ≥2.5 times ULN and TBL ≥2 times ULN, or 
 ALP ≥2.5 times ULN with the appearance of fatigue, nausea, vomiting, right upper 
quadrant abdominal pain or tenderness, fever, and/or rash 
Patients who discontinue study drug permanently during study participation must be scheduled 
for an Early Termination visit. 
8.5. 
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 that is blinded by treatment group; if 
requested, the DSMB may have access to the treatment allocation code or any other requested 
data for the purposes of a risk-benefit assessment.  
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. 
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9. 
STATISTICAL CONSIDERATIONS  
9.1. 
General Statistical Methodology  
All statistical processing will be performed using SAS® unless otherwise stated. This study is a 
blinded study until the parent studies have had database lock and dosing for those studies is no 
longer blinded. An unblinded interim will be performed to support regulatory submissions when 
the parent studies have completed the treatment periods. Additional interim analyses may also be 
performed for regulatory interactions, safety updates, and disclosures. 
Descriptive statistics will be used to provide an overview of the efficacy and safety results. For 
categorical parameters, the number and percentage of patients in each category will be presented. 
For continuous parameters, descriptive statistics will include n (number of patients), mean, 
standard deviation, median, minimum and maximum. 
The Pruritus-NRS weekly mean will be calculated as follows: The mean of each patient’s 
baseline and post-baseline Pruritus-NRS scores will be computed for each week based on the 
previous 7 days. The weekly mean will be calculated if a patient has responses for Pruritus-NRS 
on at least 4 of the 7 days of the week. If the patient has 3 or fewer Pruritus-NRS responses, the 
mean value for that item will be considered missing. All Pruritus-NRS efficacy endpoint 
analyses will be conducted on the weekly mean. 
All safety data from this study will be used as part of integrated summaries, combining with data 
from the parent studies. For the purposes of the CSR for Study DRM06-AD07, a listing and 
summary of SAEs and AEs leading to permanent discontinuation of study drug will be created. 
Demographic data will be summarized by treatment group using descriptive statistics.  
The number of patients in each analysis set will be summarized. Reasons for study withdrawal 
and treatment withdrawal during the study will be summarized using frequencies and 
percentages by treatment group. 
A statistical analysis plan, describing all statistical analyses will be provided as a separate 
document. 
9.1.1. 
Populations Analyzed  
All entered patients are those who have signed informed consent. This population will be used 
for tables and/or listings of disposition that include screen failures and inclusion or exclusion 
criteria. 
The ITT population consists of all patients assigned to treatment, even if the patient does not take 
the assigned treatment, does not receive the correct treatment, or otherwise does not follow the 
protocol. The modified ITT (mITT) population is the ITT population excluding all patients from 
sites with critical GCP noncompliance findings related to participant eligibility. mITT population 
will be used to summarize patient disposition, demographics, and efficacy analyses, plus to list 
patient data. 
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All patients who receive at least one confirmed dose of lebrikizumab will be included in the 
Safety Population. The modified Safety (mSafety) population is the Safety population excluding 
all patients from sites with critical GCP noncompliance findings related to participant eligibility. 
Demographics, extent of exposure, treatment compliance, prior or concomitant medication use, 
adverse event, and immunogenicity safety analyses will be performed using the mSafety 
Population. A sub-group analysis of safety in patients under 18 years of age (adolescents) will be 
conducted as appropriate. 
The number of patients included in the mSafety population will be summarized. 
9.1.2. 
Baseline Definition  
The baseline used for efficacy and immunogenicity endpoints is the parent study baseline.  
9.2. 
EFFICACY ASSESSMENTS  
The following efficacy assessments will be summarized at each visit, compared to parent study 
baseline: 
 Proportion of patients with Investigator’s Global Assessment (IGA) score = 0 or 1 at each 
visit 
 Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75% reduction 
in EASI scores) at each visit  
 Change and percent change in EASI score at each visit 
 Proportion of patients with EASI-50 and EASI-90 scores at each visit  
 Percentage of patients who achieve a ≥4-point reduction in the Pruritus NRS score at 
prespecified time points (for studies in which these data were collected) 
 Percentage change in Pruritus NRS score at prespecified time points (for studies in which 
these data were collected)  
 Percentage change in Skin Pain NRS score at prespecified time points (for studies in 
which these data were collected) 
 Change in sleep-loss at prespecified time points (for studies in which these data were 
collected)  
 Change in POEM scores at prespecified time points through the end of study (for studies 
in which these data were collected)  
 Change in BSA at prespecified time points through the end of study 
 Proportion of patients requiring AD concomitant treatment 
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9.3. 
Exposure and Compliance  
Exposure to lebrikizumab from the patient’s parent study and from study KGAA will be 
combined for reporting the extent of exposure. The extent of exposure to study drug in each 
treatment group will be summarized by total number of days of exposure, total number of 
injections, number of missed injections, and study drug total dose. 
The number and percentage of patients who are compliant will be summarized. The treatment 
compliance calculation is defined as the percentage of the total number of injections 
administered out of the expected number of injections. 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. 
9.4. 
Adverse Events  
The primary endpoint of study DRM06-AD07 is the proportion of patients discontinued from 
study treatment due to adverse events through the last treatment visit. This proportion will be 
calculated on the Safety Population from Day 1 to Week 100. For interim analysis, the 
calculation will be based on all data before interim DBL. 
All AEs occurring during the study will be recorded and coded using the Medical Dictionary for 
Regulatory Activities (MedDRA) dictionary.  
SAEs and AEs leading to permanent discontinuation of study drug will be summarized by 
system organ class and preferred term in the Safety Population. All SAEs as well as AEs that led 
to permanent discontinuation of study drug will be listed by patient. 
The data from all studies will be pooled by treatment, 250 mg lebrikizumab Q2W, 250 mg 
lebrikizumab Q4W, and 250 mg lebrikizumab overall. 
The AE data from this study will also be used as part of integrated safety assessments and 
ongoing safety review through study end. 
9.5. 
Other Safety Data  
The vital signs and laboratory data from this study will be used as part of integrated safety 
assessments and ongoing safety review through study end.  
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. 
9.6. 
Sample-Size Determination  
Sample size is based on the number of patients who completed studies DRM06-AD04, 
DRM06-AD05, DRM06-AD06, DRM06-AD17, and DRM06-AD18 who choose to participate in 
the study who meet all inclusion and exclusion criteria. It is estimated that approximately 900 
patients may enroll from the parent studies.  
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9.7. 
Pharmacokinetics Analysis  
Plasma concentration data will be tabulated and summarized, such as geometric mean, arithmetic 
mean, minimum, maximum, SD, and coefficient of variation, by treatment group for each visit at 
which samples were taken. 
It is intended that data from this study will be combined with data from other studies to better 
characterize the PK of lebrikizumab, as well as to explore the relationship between exposure and 
efficacy and/or safety outcomes. Further details on PK and PK/PD analyses will be provided in 
the PK/PD analysis plan. The results of these analyses will be described in a separate PK/PD 
report.  
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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.  
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. 
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 in order to continue participating. 
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.  
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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. 
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. 
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 is 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 this 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. 
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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 
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. 
Publication Policy  
In accordance with the sponsor’s publication policy the results of this study will be submitted for 
publication by a peer-reviewed journal. 
 
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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. 
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. 
Newton L, DeLozier AM, Griffiths PC, et al. Exploring content and psychometric validity of 
newly developed assessment tools for itch and skin pain in atopic dermatitis. J Patient Rep 
Outcomes. 2019(16);3(1):42. https://doi.org/10.1186/s41687-019-0128-z 
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. 
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. 
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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. 
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. 
Winthrop KL, Novosad SA, Baddley JW, et al. Opportunistic infections and biologic therapies in 
immune-mediated inflammatory diseases: consensus recommendations for infection reporting 
during clinical trials and postmarketing surveillance. Ann Rheum Dis. 2015;74(12):2107–2116. 
https://doi.org/10.1136/annrheumdis-2015-207841 
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  
Table 2: 
Schedule of Visits and Procedures: Baseline Through End of Study  
Study Procedure 
 
Week (W) 
Baseline1 
W2 
W4 
W16 
W28 
W40 
W52 
W64 
W76 
W88 
W100/
ET 
12W 
Post-Dose 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Visit Window 
- 
±3d 
±3d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
Enrollment 
 
Informed Consent/Assent 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
Safety 
 
Physical Exam  
X 
 
 
 
 
 
X 
 
 
 
X 
 
Height and Weight 
X 
 
 
X6 
X6 
X6 
X6 
 
X6 
 
X6 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications/Procedures 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Hematology, Chemistry 
X 
 
 
X 
X 
X 
X 
 
X 
 
X 
 
HBV DNA7 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Estradiol or Testosterone2 
X 
 
 
X 
X 
X 
X 
 
X 
 
X 
 
Urinalysis 
X 
 
 
X 
 
X 
X 
 
X 
 
X 
 
Pregnancy Testing11 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Efficacy 
 
IGA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
BSA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
EASI 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
eDiary: Pruritus, Sleep-loss, POEM3 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
eDiary: TCS/TCI use3 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
eDiary: Skin Pain NRS8 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
eDiary return (patient to site)9 
 
 
 
 
 
 
X 
 
 
 
 
 
POEM (in office collection only)3 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
PK and Immunogenicity 
 
Pre-dose PK 
X 
 
X 
 
X 
 
X 
 
X 
 
X10 
X10 
Pre-dose ADA4 
X 
 
X 
 
X 
 
X 
 
X 
 
X10 
X10 
Study Treatment 
 
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Study Procedure 
 
Week (W) 
Baseline1 
W2 
W4 
W16 
W28 
W40 
W52 
W64 
W76 
W88 
W100/
ET 
12W 
Post-Dose 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Visit Window 
- 
±3d 
±3d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
±5d 
Study Drug Administration5 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
  
Dispense Study Drug5 
  
 
X 
X 
X 
X 
X 
X 
X 
X 
 
  
 
 
 
 
 
1 Baseline procedures are conducted as part of parent study exit visit. 
2 Collect estradiol in adolescent females only and testosterone in adolescent males only. Stop hormone tests when the patient reaches 18 years of age. 
3 
Daily pruritus and sleep-loss and weekly/in-office POEM only collected for patients participating in DRM06-AD04, DRM06-AD05, DRM06-AD06, and DRM06-AD18. TCS/TCI data only collected for patients participating in 
DRM06-AD06.  In-office POEM should be completed prior to any other study assessments.   
4 
nAB testing conducted for positive treatment-emergent ADA responses. Additional immunogenicity sample collected for any patient experiencing a hypersensitivity reaction during study. 
5  Study drug administered Q2W including those patients on Q4W regimen. Patients instructed on study drug administration for at home dosing following Week 4. Sufficient drug is dispensed to cover injections through next visit. 
6 
Collect height in adolescents only at these visits. Collect weight in all patients. 
7 Only for participants who are anti-HBc reactive and anti-HBs nonreactive at screening (Section 8.2.3). 
8 Daily Skin Pain NRS only collected for patients participating in DRM06-AD18. 
9 Collect eDiary from patients participating in DRM06-AD04, DRM06-AD05, DRM06-AD06, and DRM06-AD18.   
10 PK and ADA are random collections at Week 100 and the Safety Follow-up. 
11 Urine pregnancy tests for women of childbearing potential (Section 8.2.3). 
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APPENDIX 2. LIVER SAFETY: SUGGESTED ACTIONS AND 
FOLLOW-UP ASSESSMENTS  
Hepatic evaluation testing 
See Section 8.2.3 for guidance on appropriate test selection. 
The Lilly-designated central laboratory must complete the analysis of all selected testing except 
for microbiology testing. 
Local testing may be performed in addition to central testing when necessary for immediate 
participant management. 
Results will be reported if a validated test or calculation is available. 
Hematology 
Clinical Chemistry 
Hemoglobin 
Total bilirubin 
Hematocrit 
Direct bilirubin 
Erythrocytes (RBCs - red blood cells) 
Alkaline phosphatase (ALP) 
Leukocytes (WBCs - white blood cells) 
Alanine aminotransferase (ALT) 
Differential: 
Aspartate aminotransferase (AST) 
Neutrophils, segmented 
Gamma-glutamyl transferase (GGT) 
Lymphocytes 
Creatine kinase (CK) 
Monocytes 
Other Chemistry 
Basophils 
Acetaminophen 
Eosinophils 
Acetaminophen protein adducts 
Platelets 
Alkaline phosphatase isoenzymes 
Cell morphology (RBC and WBC) 
Ceruloplasmin 
Coagulation 
Copper 
Ethyl alcohol (EtOH) 
Prothrombin-time/International normalized ratio(PT-
INR) 
Haptoglobin 
Serology 
Immunoglobulin A (IgA; quantitative) 
Hepatitis A virus (HAV) testing: 
Immunoglobulin G (IgG; quantitative) 
HAV total antibody 
Immunoglobulin M (IgM; quantitative) 
HAV IgM antibody 
Phosphatidylethanol (PEth) 
Hepatitis B virus (HBV) testing: 
Urine Chemistry 
Hepatitis B surface antigen (HBsAg) 
Drug screen 
Hepatitis B surface antibody (anti-HBs) 
Ethyl glucuronide (EtG) 
Hepatitis B core total antibody (anti-HBc) 
Other Serology 
Hepatitis B core IgM antibody 
Anti-nuclear antibody (ANA) 
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Hematology 
Clinical Chemistry 
Hepatitis B core IgG antibody 
Anti-smooth muscle antibody (ASMA)a 
HBV DNAd 
Anti-actin antibodyb 
Hepatitis C virus (HCV) testing: 
Epstein-Barr virus (EBV) testing: 
HCV antibody 
EBV antibody 
HCV RNAd 
EBV DNAd 
Hepatitis D virus (HDV) testing: 
Cytomegalovirus (CMV) testing: 
HDV antibody 
CMV antibody 
Hepatitis E virus (HEV) testing: 
CMV DNAd 
HEV IgG antibody 
Herpes simplex virus (HSV) testing: 
HEV IgM antibody 
HSV (Type 1 and 2) antibody  
HEV RNAd 
HSV (Type 1 and 2) DNAd 
Microbiologyc 
Liver kidney microsomal type 1 (LKM-1) antibody 
Culture: 
 
Blood 
 
Urine 
 
 
a Not required if anti-actin antibody is tested. 
b Not required if ASMA is tested. 
c Assayed ONLY by investigator-designated local laboratory; no central testing available. 
d Reflex/confirmation dependent on regulatory requirements, testing availability, or both. 
 
 
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APPENDIX 3. PROTOCOL AMENDMENT (1) HISTORY  
The table below summarizes new changes being introduced to Amendment 1. Minor corrections 
or additions may not be included. 
Protocol Section 
Description of Change 
Rationale 
Title Page  
Sponsor Signature Page 
Updated medical monitor and 
contact information 
Change in personnel 
Protocol Synopsis 
3 Study Design 
3.1 Duration of the Study 
Added 48 weeks of treatment 
To gain additional safety data 
on long-term exposures 
Protocol Synopsis 
3 Study Design 
4.1 Inclusion Criteria 
Modified Study Design and 
inclusion criterion 1: “…in a 
Dermira- or Lilly-sponsored 
lebrikizumab study…” 
Correction 
Protocol Synopsis 
3 Study Design 
5.3 Study Drug Assignment 
Added text for the 
monotherapy trials, AD04 
and AD05, “…until 
unblinding (see Section 5.4), 
except for patients from an 
escape arm, who will receive 
open-label study drug” 
Clarification 
Protocol Synopsis 
3 Study Design 
5.3 Study Drug Assignment 
Added language describing 
the treatment assignment for 
patients who received rescue 
treatment in DRM06-AD06 
Added language to clarify 
blinding plan for patients 
from DRM06-AD06 
Clarification 
Protocol Synopsis 
3 Study Design 
5.3 Study Drug Assignment 
 
Clarified treatment group for 
patients coming from 
DRM06-AD17 and the 
escape arm (DRM06-AD04 
and DRM06-AD05), “…will 
continue to receive open label 
250 mg…” 
Clarification 
Protocol Synopsis 
3 Study Design 
“Patients not achieving an 
EASI-50 (from parent study 
baseline) by Week 16, or 
maintaining an EASI-50 
response, or not achieving 
clinical benefit based on PI 
discretion should be 
terminated from this study” 
Clarification 
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Rationale 
Protocol Synopsis 
Modified language on interim 
analyses: “An unblinded 
interim analysis will be 
performed to support 
regulatory submissions when 
the parent studies have 
completed the treatment 
periods” 
Need to maintain blinding up 
to regulatory submission 
1.3.1.3 Summary of Dose 
Ranging Study 
DRM06-AD01 
Updated safety results 
Update 
4.1 Inclusion Criteria 
Updated contraception 
requirements (criterion 3) 
Female language added as 
clarification for allowable 
contraceptive methods 
4.1 Inclusion Criteria 
Removed male contraception 
requirements (criterion 4) 
Male language modifications 
supported by available 
toxicology data 
5.4 Study Blinding 
“For trials where blinding to 
treatment will be maintained, 
the Investigator, study-site 
personnel, and the patient will 
be blinded to treatment 
assignment until the parent 
studies have had database 
lock and dosing for those 
studies are no longer blinded 
the unblinded interim analysis 
to support regulatory 
submissions occurs” 
Added “After the interim 
database lock for the 
submission, patients will no 
longer receive placebo 
injections and will continue 
per assigned treatment group” 
Clarification of study drug 
administration after 
unblinding 
5.5.2 Instructions for 
Administration at Home 
Updated how patients will 
receive instructions for use  
Correction 
6.3 Treatments for AD 
Modified example language 
for permitted topical rescue 
medications: “low- and mid-
potency TCS, TCI’s and 
PDE4 inhibitors…” 
Clarification 
7.1 Baseline Visit (Day 1) 
“…will be transferred 
electronically into the 
Clarification 
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Rationale 
electronic data capture system 
where possible” 
7 Study Procedures (7.1 
through 7.13) 
Appendix 1 Schedule of 
Visits and Procedures 
Added 48 weeks of treatment 
(4 additional visits) 
Added Informed 
Consent/Assent at Baseline 
Added HBV DNA 
Added hematology, 
chemistry, and urinalysis to 
additional visits 
Added dosing diary through 
Week 100 
Added Skin Pain NRS for 
patients continuing from 
DRM06-AD18, through 
Week 52 
To obtain additional 
long-term safety data 
Informed Consent/Assent 
added for clarification 
8.1.4 Pruritus 
8.1.5 Sleep-Loss 
“Assessments will be 
recorded daily by the patient 
using an electronic diary 
through Week 52” 
Reduce patient burden for 
additional 48 weeks added 
8.1.6 Patient Oriented 
Eczema Measure (POEM) 
“POEM responses will be 
captured using an electronic 
diary through Week 52, then 
captured at site visits starting 
at Week 64…” 
Reduce patient burden for 
additional 48 weeks added 
8.1.7 Skin Pain Numeric 
Rating Scale (NRS) 
Added subsection 
Added for patients continuing 
from DRM06-AD18 
8.2.3 Laboratory Evaluations 
Added instructions for 
clinically significantly 
abnormal laboratory values 
and blinding of laboratory 
test results 
Clarification 
8.2.7 Hepatic Safety 
Monitoring 
Added section and 
subsections 
To provide detailed guidance 
for hepatic safety monitoring 
and hepatitis safety 
instructions 
8.4.1 Early Termination of 
Study Patients 
8.4.2 Discontinuation of 
Inadvertently Enrolled 
Patients 
Added reasons for which a 
patient may terminate or be 
terminated early from the 
study, including 
 not achieving clinical 
benefit 
 enrollment in another 
medically 
Clarification 
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Protocol Section 
Description of Change 
Rationale 
incompatible clinical 
study 
 requiring long-term 
systemic treatment for 
symptoms of AD (that 
is, non-responders), 
and 
 inadvertent enrollment 
8.4.3 Study Drug 
Discontinuation 
8.4.3.1 Temporary Study 
Drug Discontinuation 
8.4.3.2 Permanent Study 
Drug Discontinuation 
Added subsections 
To provide instructions for 
withholding study drug when 
warranted for patient safety 
9.1 General Statistical 
Methodology 
Added language to describe 
use of safety data 
Clarification 
9.1 General Statistical 
Methodology 
“Reasons for study 
withdrawal and treatment 
withdrawal during the study 
will be summarized…” 
Clarification 
9.1.1 Populations Analyzed 
Updated subsection to further 
describe populations analyzed 
Clarification 
9.1.2 Baseline Definition 
Added subsection 
Clarification 
9.2 Efficacy Assessments 
Added and modified language 
to clarify how assessments 
will be performed 
Clarification 
9.3 Exposure and Compliance Added and modified language 
to clarify extent of exposure 
reporting and treatment 
compliance definition  
Clarification 
9.4 Adverse Events 
Added language describing 
the primary endpoint and how 
SAEs and AEs will be 
analyzed 
Clarification 
9.5 Other Safety Data 
Modified description of vital 
signs and laboratory data 
Details will be provided in 
the SAP 
9.6 Sample-Size 
Determination 
Added estimate for sample 
size 
Clarification 
9.7 Pharmacokinetics 
Analysis 
Added section 
To provide details on PK 
analysis 
Appendix 2 Liver Safety: 
Suggested Actions and 
Follow-up Assessments 
Added appendix 
To provide detailed guidance 
for liver safety actions and 
follow-up information 
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Description of Change 
Rationale 
Throughout protocol 
Added DRM06-AD18 as 
parent study 
Clarification 
 
Approved on 14 Dec 2022 GMT

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