A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis
Phase: PHASE3
Conditions: Atopic Dermatitis
Sponsor: Eli Lilly and Company

 
 J2T-DM-KGAD-A1 Protocol  
 
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of 
Lebrikizumab When Used in Combination With Topical Corticosteroid Treatment in Patients 
With Moderate-to-Severe Atopic Dermatitis 
 
NCT04250337 
 
Approval Date: 13-May-2020 

St u d y Pr ot oc ol: D R M 0 6 -A D 0 6 -A 1/ J 2 T-D M -K G A D -A 1  
Le bri kiz u ma b  
Der mira, I nc.  FI N A L 1 3 Ma y 2 0 2 0  
C o nfi de ntial   
P a ge 1 
  
 
 
A R A N D O MI Z E D, D O U B L E -B LI N D, P L A C E B O -C O N T R O L L E D T RI A L T O E V A L U A T E 
T H E E F FI C A C Y A N D S A F E T Y O F L E B RI KI Z U M A B W H E N U S E D I N C O M BI N A TI O N 
WI T H T O PI C A L C O R TI C O S T E R OI D T R E A T M E N T 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 6 / J 2 T-D M -K G A D   
Pr ot oc ol Fi n al D ate  
2 6 N o ve m ber  2 0 1 9  
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 
1 1 9 8 6 6  
E u dr a C T N u m ber  
2 0 1 9 -0 0 4 3 0 0 -3 4  
S p o ns o r 
 
 
 
 
A me n d me nt ( 1) D ate  
1 3  M a y  2 0 2 0 –  FI N A L  
Me dic al M o nit or  
 
  
 
C O N FI D E N TI A L I N F O R M A TI O N  
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 D er mira. 
A n y us e 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 ori zati o n of 
Der mira is e x pressl y pr o hi bite d.  
 
P P D
P P D

St u d y Pr ot oc ol: D R M 0 6 -A D 0 6- Al /J 2T- D M- K G A D- AI 
Le b rl kiz u ma b 
S P O N S O R SI G N A T U R E P A G E 
R A N D O MI Z E D, D O U B L E- B L T N D, P L A C E B O- C O N T R O L L E D T RJ A L T O E V A L U A T E 
T H E E F FI C A C Y A N D S A F E T Y O F L E B RI KI Z U M A B W H E N U S E D I N C O M BI N A T I ON 
WI T H T O PI C A L C O R T I C O S T E R OID T R E A T M E N T I N P A TI E N T S WI T H M O D E R A T E -
T O - SE V E R E A T O PI C D E R M A TI TI S 
Pr ot oc ol N u m bel': 
D R M. 0 6- A D 0 6/ J 2 T- D M- K G A D 
Pr ot oc ol Fi n al D ate: 
2 6 N o ve m b e r 2 0 1 9 
A me n d me nt ( 1) D at e: 
1 3 M a y 2 0 2 0 
T h e si g n at ur e b el o w c o nsti ntt cs a p pr o v al of t his pr ot oc ol. I c ertif y th at I h a v e t h e a ut h orit y t o 
a p pr o v e t his pr ot oc ol o n b e h alf of t he S p o ns or, D er mir a, I n c. T h e st u d y will b e co n d u ct e d i n 
a c c or d a n c e wit h t his pr ot o c ol a n d all a p pli c a bl e l a ws. mi es, a nd r e g ul ati o ns a n d I nter nati o nal 
C o nf er e n c e o n H ar m o ni z ati o n G o o d Cl i nical Pr a cti c e (! C H G C P), r e g ul ati o ns of t he U nit e d 
St at es { U S) F o o d a n d Dr n g A d mi nistr ati o n ( F D A), a n d t h e et hi c al pri n ci pl es t h at h a v e t h eir 
ori gi n i n t h e D e cl ar ati o n of Helsi n ki. 
A ut h ori z e d b y: 
D er m ira, J n c. FI N A L l 3 Ma y 2 0 2 0 
C o nfi de nt ial 
P a g e 2 
P P D

Study Protocol: DRM06-AD06-A1/J2T-DM-KGAD-A1 
Lebrikizumab 
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INVESTIGATOR SIGNATURE PAGE 
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE 
THE EFFICACY AND SAFETY OF LEBRIKIZUMAB WHEN USED IN COMBINATION 
WITH TOPICAL CORTICOSTEROID TREATMENT IN PATIENTS WITH MODERATE-
TO-SEVERE ATOPIC DERMATITIS 
 
Protocol Number:  
DRM06-AD06/J2T-DM-KGAD 
 
Protocol Final Date: 
26 November 2019 
 
Amendment (1) Date:  13 MAY 2020  
I have read this protocol, including the appendices, and agree that it contains all necessary details 
for carrying out the study as described. I will conduct this protocol as outlined herein, according 
to the ethical principles that have their origin in the Declaration of Helsinki, International 
Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP) and applicable 
laws, rules and regulatory requirement(s) including those of the United States (US) Food and 
Drug Administration (FDA). 
I agree to obtain the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
approval of the protocol and informed consent prior to the start of the study. 
I agree to obtain formal written informed consent in accordance with applicable federal and local 
regulations and international guidelines from all patients prior to their entry into the study. 
I have received and reviewed the Investigator’s Brochure including the potential risks and side 
effects of the product and instructions for use. 
I agree to report to the Sponsor any adverse events that occur during the study in accordance 
with the ICH GCP guideline and the protocol. 
I agree to ensure that all associates, colleagues, and employees assisting me with the conduct of 
the study are informed of their responsibilities in meeting the above commitments and the 
commitments set forth in the Investigator’s Agreement. 
I agree to maintain adequate and accurate records and to make those records available for 
inspection in accordance with the ICH GCP guideline, and federal and local requirements. 
I understand that the study may be terminated, or enrollment suspended at any time by the 
Sponsor, with or without cause, or by me if it becomes necessary to protect the best interests of 
the study patients. 
 
_____________________________________ 
___________________________ 
Investigator’s Signature 
Date 
 
_____________________________________ 
Investigator’s Name (print) 

Study Protocol: DRM06-AD06-A1/J2T-DM-KGAD-A1 
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PROTOCOL AMENDMENT 1 (SUMMARY OF CHANGES) 
The table below summarizes new changes being introduced to Amendment 1. Minor 
corrections/additions may not be included. 
Protocol Section 
Description of Change 
Rationale 
Protocol Title 
page and 
Investigator 
signature page 
Added the DRM06-AD06 trial alias J2T-DM-KGAD. 
Added the Eli Lilly investigational product alias 
LY3650150 
References Eli Lilly 
and Company specific 
Protocol and 
Investigational Product 
alias 
Protocol 
Synopsis and 
Section 9.1.1  
Sample size adjusted to approximately 225 patients 
FDA recommendation 
to re-evaluate sample 
size 
Protocol 
Synopsis and 
inclusion 
criterion 1  
Adjusted upper age range for adolescents from 17 years  
to < 18 years. This change is made consistently 
throughout protocol where adolescent age range is 
referenced 
Reflects sponsor’s 
standard language for 
definition of minors 
Protocol 
Synopsis  
Updated description of study DRM06-AD07 from “open 
label safety study” to Long Term Extension. This 
change is made consistently throughout the protocol 
including in Figure 1, Study Schema 
Design of DRM06-AD-
07 protocol has been 
modified 
Protocol 
Synopsis and 
Section 3  
Added a clearer definition of the timing of the end of the 
study per EU Regulation 536-2014: Annex 1 D.17.o  
Added clearer definition of a patient being considered to 
have completed the study. 
Clarification per EU 
Regulation 536-2014: 
Annex 1 D.17.o 
Protocol 
Synopsis and 
Section 3.1  
Added clarifying phrases to duration of study definitions 
to distinguish between patients enrolling in the LTE and 
those not enrolling in the LTE. 
Clarification. 
Section 1.5 Study 
Conduct 
Statement 
Updated to include a statement that the clinical trial is to 
be conducted in compliance with the protocol, with the 
EU Regulation and with the principles of good clinical 
practice 
EU Regulation 536-
2014: Annex 1 D.17.a 
Section 2.3  
Changed secondary endpoint, “Proportion of patients 
with EASI-75, EASI-90 and EASI-50 by visit” 
Clarification 
Section 3  
Patients will be offered ‘the option to continue’ 
treatment 
Clarification 
Section 3.1 
Adjusted maximum total participation from 20 weeks to 
approximately 30 weeks. 
Clarification. Increase 
in duration of 
maximum participation 
reflects safety follow 
up visit at 12 weeks 
post study 

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Protocol Section 
Description of Change 
Rationale 
Section 4.1 
Inclusion 
Criterion 6 
Removed “or determination that topical treatments are 
otherwise medically inadvisable” 
Alignment with 
exclusion#20; TCS use 
required in study 
Section 4.1 
Inclusion 
Criterion 10 
Text has been modified to use the term highly effective 
contraceptive measures, as follows: 
“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.” 
Provides precision 
around definition of 
contraceptive measures 
Section 4.2 
Exclusion 
Criterion 3 
Removed brand name Eucrisa and updated text to refer 
to class of drugs “Phosphodiesterase-4 inhibitors such as 
crisaborole” 
Reflects variance in 
international 
registration of 
crisaborole 
Section 4.2 
Exclusion 
Criterion 5c 
Amended text from “Cell-depleting biologics“ to “B 
Cell-depleting biologics” 
Clarification 
Section 4.2 
Exclusion 
Criterion 20 
Added criterion 20, “Have had an important side effect 
to TCS (e.g., intolerance to treatment, hypersensitivity 
reactions, significant skin atrophy, and systemic 
effects), as assessed by the investigator or treating 
physician that would prevent further use.” 
Use of TCS is required 
in this study 
Section 5.2 and 
Section 5.3  
Removed reference to kits. 
Clarification 
Section 5.3 
Patient 
Randomization 
Text added “Patients will be assigned a unique identifier 
by the sponsor. Any patient records, datasets or tissue 
samples that are transferred to the sponsor will contain 
the identifier only; patient names or any information 
which would make the patient identifiable will not be 
transferred.” 
EU Regulation 536-
2014: Annex 1 D.17.al 
 
 
 
Section 5.5.1  
Removed details concerning administration at clinic.   
Added reference to Instructions for Use. 
Details provided in 
Instructions for Use. 

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Protocol Section 
Description of Change 
Rationale 
Section 6.1 
Permitted and 
Prohibited 
Treatments and 
Procedures 
Removed brand name Eucrisa and updated text to refer 
to class of drugs “Phosphodiesterase-4 inhibitors such as 
crisaborole” 
Added text detailing to treatment for AD with systemic 
corticosteroids. 
Reflects variance in 
international 
registration of 
crisaborole 
Clarification 
Section 6.2  
Removed text referencing sponsor providing moisturizer 
for use during the study. 
Removed text that non-medicated moisturizer should be 
used daily throughout study. 
Provider not providing. 
 
Clarification. 
Section 6.3  
Clarified how topical and systemic treatments for AD 
may be used in the trial.   
Clarification 
Section 6.3  
Text has been amended to clarify that mid-potency TCS, 
triamcinolone acetonide 0.1% is a cream and not an 
ointment 
Clarification regarding 
acceptable formulation 
of mid-potency TCS  
Section 6.4  
Removed text requiring patients who received systemic 
rescue medication to wait for a washout period before 
enrolling in the LTE. 
To prevent interruption 
of study drug between 
studies. 
Section 7.1  
 
 
And Schedule of 
Visits 
Appendix 1  
Added ‘review immunization record for adolescent 
patients’ at screening 
 
The requirement to perform TB screening serology 
(QuantiFERON – TB) has been removed from the 
screening visit  
To ensure PI reviews 
prior to inclusion in 
trial 
There is no scientific 
rational to believe 
patients exposed to 
Lebrikizumab are at 
higher risk to develop 
or reactivate TB. In 
countries where 
tuberculosis is a 
common disease and 
where required by 
regulatory authorities 
or ethics boards, a 
specific addendum will 
allow TB screening and 
management as per 
local guidelines 
Section 7.4 Week 
4 (± 3 Days) 
 
Added blood sample for PK 
Changed follow-up visit from phone call to onsite 
FDA recommendation 
to add this timepoint 
for PK 
ADA and PK collection 
Section 7.6 Week 
8 (± 3 Days) 
Added “except hormones” 
Clarification that 
hormones are not 
collected at Week 8 per 
Schedule of Visits 

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Protocol Section 
Description of Change 
Rationale 
Section 7.11  
Changed follow-up visit from phone call to onsite visit 
with blood draw for PK and ADA sample 
PK and ADA collection 
Section 8.1.2  
Added the requirement to collect immunization record 
(for adolescent patients) 
Reflects sponsors 
medical history 
standard for adolescent 
population 
Section 8.2  
Added, “The sponsor will administer training on the 
required efficacy assessments, detail on the specific 
instruments and training given are recorded in the study 
training materials.” 
Clarification. 
Section 8.4.3  
Added hormones (estradiol and testosterone) to 
laboratory parameters (for adolescents only) 
Assess sexual 
maturation 
Section 8.4.4.3  
Added examples of medical events. 
Clarification 
Section 8.4.4.4 
Reporting of 
SAEs 
Text added “Prompt notification by the investigator to 
the sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the 
safety of participants and the safety of a study 
intervention under clinical investigation are met. 
The sponsor has a legal responsibility to notify both the 
local regulatory authority and other regulatory agencies 
about the safety of a study intervention under clinical 
investigation. The sponsor will comply with country-
specific regulatory requirements relating to safety 
reporting to the regulatory authority, Institutional 
Review Boards (IRB)/Independent Ethics Committees 
(IEC), and investigators. 
An investigator who receives an investigator safety 
report describing a SAE or other specific safety 
information (e.g., summary or listing of SAEs) from the 
sponsor will review and then file it along with the 
[Investigator’s Brochure or state other documents] and 
will notify the IRB/IEC, if appropriate according to 
local requirements.” 
EU Regulation 536-
2014: Annex 1 D.20.c 
Section 8.4.5  
New Section added to cover the Product Complaint 
Handling Process 
Addition of Product 
Complaint Handling 
process 
Section 8.5  
Text changed from “Positive ADA results will be 
further evaluated for neutralizing antibodies” to 
“Positive ADA results may be further evaluated for 
neutralizing antibodies”. 
Allows flexibility in 
testing process 

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Protocol Section 
Description of Change 
Rationale 
Section 8.6.2  
Revised final sentence to read “Patients who 
discontinue study drug permanently during study 
participation must be scheduled for an Early 
Termination visit, except those receiving systemic 
rescue medication, as per the section 6.4” 
Changed reference from Section 5.4 to 6.4 
Clarification 
 
Clarification 
Section 9.1  
Removed, “No interim analyses are planned.” 
Added information on secondary endpoint analyses.  
 
Included description of the calculation of the pruritus-
NRS weekly mean score. 
Revised text to reflect how patient data will be handled 
in the primary analysis with respect to rescue 
medication use.    
Details provided in new 
section, Section 9.14 
Clarification.  
Protocol consistency 
 
US regulatory 
recommendations 
regarding the statistical 
handling of data from 
patients who use rescue 
medication. 
Section 9.1.1  
Added that patients who are randomized and receive a 
dose of study drug will be included in the safety 
population. 
Clarification 
Section 9.4  
Revised text to describe how the primary analysis will 
be conducted with respect to patients who use rescue 
medication. 
US regulatory 
recommendations on 
handling missing data 
for efficacy endpoints. 
Section 9.4.1  
Revised text to clarify the differences between the 
primary method of handling missing data, multiple 
imputation using the Markov chain Monte Carlo method 
(MI MCMC) and use of this method as a sensitivity 
analysis   
Revisions to statistical 
section in response to 
FDA recommendations 
Section 9.4.2  
Added “the non-missing assessed values as collected for 
visits subsequent to rescue medication use will be used” 
Clarification in 
response to FDA  
Section 9.4.3   
Added Section, “In this set of sensitivity analysis, for 
patients who receive topical rescue medication (per 
Section 6.4), receive systemic rescue medication and 
any other missing values, set to non-response 
subsequent to this time through Week 16 for primary 
endpoint and the following secondary endpoints: EASI-
75, EASI-90, and Pruritus-NRS Improvement ≥4 points, 
all at Week 16.” 
Clarification on 
treatment of missing 
values in response to 
FDA letter  
Section 9.4.4  
Added “More details about missing value imputation 
analysis will be described in the SAP. 
Clarification 

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Protocol Section 
Description of Change 
Rationale 
Section 9.5  
Multiplicity considerations 
Clarification 
Section 9.6  
Previous Section 9.6 “Other endpoints” was deleted 
Revisions to statistical 
section in response to 
FDA recommendation 
Section 9.7  
Added “It is intended that data from this study will be 
combined with data from other studies to better 
characterize the PK of DRM06, 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” 
Clarification 
Section 9.11  
Added, “Growth monitoring of adolescents will be 
summarized.” 
Clarification  
Section 9.13 
Added Section 9.13 Interim Analyses. Described plan 
for interim analysis. 
Per ICH E9 
Section 10.2 
Informed 
Consent 
Procedures 
Text added to the section on informed consent “the 
patient’s medical records may be examined by Clinical 
Quality Assurance auditors or other authorized 
personnel appointed by the sponsor, by appropriate 
IRB/IEC members, and by inspectors from regulatory 
authorities. The ICF will also inform the patient that 
his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law; 
the ICF will describe the level of disclosure of data and 
seek appropriate consent from the patient for his/her 
data to be used in the manner described.” 
Provided detail on consent process for minors who reach 
majority during the study. 
EU Regulation 536-
2014: Annex 1 D.17.ak 
 
 
 
 
 
 
 
Clarification 
Section 10.4 
Study 
Documentation 
and the eCRF 
Text added “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” 
EU Regulation 536-
2014: Annex 1 
D.17.am 
Section 10.7 
Publication 
Policy  
New section added “In accordance with the sponsor’s 
publication policy the results of this study will be 
submitted for publication by a peer-reviewed journal” 
EU Regulation 536-
2014: Annex 1 D.17.ai 

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Protocol Section 
Description of Change 
Rationale 
Section 10.3  
Added new section to cover 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. 
Aligns document with 
sponsors policies and 
international 
regulations on data 
protection 
Appendix 1 . 
Schedule of 
Visits and 
Procedures 
Added ‘review of immunization record (for adolescents) 
at screening 
Added hormone lab collections (estradiol or 
testosterone) at screening and W16/ET 
Added blood sample for PK at Week 4 visit. 
Added blood sample for PK and ADA at safety 
follow-up visit 
Removed row for ‘phone call’ 
Added associated footnotes for certain assessments 
To ensure PI reviews 
prior to inclusion in 
trial 
Assess sexual 
maturation 
FDA recommendation 
to add this timepoint 
for PK 
Safety follow-up no 
longer via phone 
Clarification 

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Protocol Section 
Description of Change 
Rationale 
Appendices 3 
through 12 
These Appendices have been deleted as the instruments 
are provided in study related training materials. 
Sponsor training for 
efficacy assessments 
and use of validated 
instruments is provided 
and documentation is 
captured in training 
materials. 
 
 
 

Study Protocol: DRM06-AD06-A1/J2T-DM-KGAD-A1 
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PROTOCOL SYNOPSIS 
Title: 
A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The 
Efficacy and Safety of Lebrikizumab When Used In Combination with 
Topical Corticosteroid Treatment In Patients With Moderate-To-Severe 
Atopic Dermatitis 
Protocol 
Number: 
DRM06-AD06/ J2T-DM-KGAD 
Phase: 
3 
Number of Sites: Approximately 70 sites in North America (NA) and the European Union 
(EU) 
Study Population: 
Adults and adolescents (≥12 years to < 18 and weighing ≥40 kg) with moderate-to-severe 
atopic dermatitis (AD) who are candidates for systemic therapy.  
Sample Size: 
Approximately 225 patients with moderate to severe AD, including approximately 50 
adolescent patients. 
Study Objectives: 
To evaluate the safety and efficacy of lebrikizumab when used in combination with topical 
corticosteroid (TCS) treatment compared with placebo in patients with moderate to severe AD.  
Duration of Patient Participation: 
Screening: Maximum duration of 30 days 
Treatment Period: 16 weeks  
Safety Follow Up: 12 weeks 
Maximum total participation:  30 weeks  
Completion of Patient Participation: A patient is considered to have completed the study if 
he/she has completed the last scheduled visit: 
• For subjects continuing into LTE, upon completion of week 16 visit and rolling into 
LTE study 
• For subjects not continuing into LTE, when subject had either week 16 or ET visit, and 
safety follow up visit (12 weeks after last IP administration) 
Study Treatment: 
Lebrikizumab, 250 mg (2 mL injection of 125 mg/mL) 
Placebo, 2 mL injection  
Study Design: 
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks 
in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when 

Study Protocol: DRM06-AD06-A1/J2T-DM-KGAD-A1 
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Page 13 
used in combination with TCS treatment compared with placebo in combination with TCS 
treatment for moderate-to-severe AD.  
Eligible adult and adolescent patients (≥12 to <18 years and weighing ≥40 kg) with moderate-
to-severe AD for at least one year, defined according to the American Academy of 
Dermatology Consensus Criteria, an Eczema Area and Severity Index Score (EASI) of ≥16, an 
Investigator Global Assessment (IGA) score of ≥3 and a body surface area (BSA) of ≥10% will 
be enrolled.  
During the 16-week treatment period, approximately 225 patients will be stratified and 
randomized (2:1, active: placebo) to treatment with either 250 mg lebrikizumab (loading dose 
of 500 mg given at Baseline and Week 2) or placebo by subcutaneous (SC) injection every 2 
weeks (Q2W). All study drug injections will be administered in the clinic. TCS treatment will 
be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on 
treatment response.  
Efficacy will be measured through IGA, EASI, SCORing Atopic Dermatitis (SCORAD), BSA, 
Pruritus and Sleep-loss scores and, TCS/TCI use. 
Safety will be assessed in all patients by monitoring adverse events, serum chemistry, 
hematology and urinalysis laboratory testing, physical examination, pulse and blood pressure. 
Additionally, adolescents will be monitored for hormones. An independent Data Safety 
Monitoring Board will monitor patient safety by conducting formal reviews of accumulated 
safety data periodically throughout the trial. 
Quality of life and impact of disease will be assessed using the Patient Oriented Eczema 
Measure (POEM), Dermatology Life Quality Index/Children’s Dermatology Life Quality Index 
(DLQI/CDLQI), standardized instrument developed by the EuroQol Group (EQ-5D), and 
Patient-Reported Outcomes Measurement Information System (PROMIS®) Anxiety and 
Depression measures. Patients reporting comorbid asthma at study entry will complete the 
Asthma Control Questionnaire (ACQ-5). 
Serum samples will be collected for pharmacokinetic analysis and immunogenicity. 
After completion of the Week 16 visit, patients will be offered the option of continued 
treatment in a separate long-term extension study (DRM06-AD07). 
Patients who early terminate or choose not to enter the long-term extension study will undergo 
a safety follow-up visit approximately 12 weeks after the last study drug injection.  
A patient is considered to have completed the study if he/she has completed all required phases 
of the study including the last visit 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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Primary Endpoint(s): 
For FDA: 
The primary efficacy endpoint is the percentage of patients with an IGA score of 0 or 1 and a 
reduction ≥2-points from Baseline to Week 16. 
For EMA: 
Co-primary endpoints will be used as follows: 
• Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from 
Baseline to Week 16. 
• Percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) 
at Week 16 
 

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TABLE OF CONTENTS 
SPONSOR SIGNATURE PAGE ....................................................................................................2 
INVESTIGATOR SIGNATURE PAGE .........................................................................................3 
PROTOCOL AMENDMENT 1 (SUMMARY OF CHANGES) ....................................................4 
PROTOCOL SYNOPSIS ..............................................................................................................12 
TABLE OF CONTENTS ...............................................................................................................15 
LIST OF TABLES .........................................................................................................................18 
LIST OF FIGURES .......................................................................................................................19 
LIST OF APPENDICES ................................................................................................................19 
ACRONYMS .................................................................................................................................20 
1. 
BACKGROUND ........................................................................................................23 
1.1. 
Atopic Dermatitis ........................................................................................................23 
1.1.1. 
Epidemiology of Pediatric Atopic Dermatitis ............................................................23 
1.1.2. 
Clinical Manifestations ...............................................................................................23 
1.1.3. 
Treatment for AD .......................................................................................................24 
1.2. 
Lebrikizumab ..............................................................................................................24 
1.3. 
Study Rationale and Benefit-Risk Assessment ...........................................................25 
1.3.1. 
Scientific Rationale .....................................................................................................25 
1.3.1.1. 
Summary of Study GS29250 (TREBLE) ...................................................................25 
1.3.1.2. 
Summary of Study GS29735 (ARBAN) ....................................................................26 
1.3.1.3. 
Summary of Dose Ranging Study DRM06-AD01 .....................................................27 
1.3.1.4. 
Summary of DRM06-AD03 Phase 1 PK Study .........................................................28 
1.4. 
Rationale for Dose and Treatment Regimen ..............................................................28 
1.5. 
Study Conduct Statement ...........................................................................................29 
2. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................30 
2.1. 
Primary Endpoint(s) ....................................................................................................30 
2.2. 
Secondary Endpoints ..................................................................................................30 
2.3. 
Other Secondary Endpoints ........................................................................................31 
3. 
STUDY DESIGN .......................................................................................................32 
3.1. 
Duration of the Study ..................................................................................................33 
3.2. 
Study Population and Number of Patients ..................................................................33 
4. 
SELECTION OF PATIENTS.....................................................................................33 

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4.1. 
Inclusion Criteria ........................................................................................................33 
4.2. 
Exclusion Criteria .......................................................................................................34 
5. 
STUDY DRUG ...........................................................................................................36 
5.1. 
Investigational Medicinal Product ..............................................................................36 
5.2. 
Storage and Labeling ..................................................................................................36 
5.3. 
Patient Randomization ................................................................................................36 
5.4. 
Study Blinding ............................................................................................................37 
5.4.1. 
Unblinding Treatment Assignment.............................................................................37 
5.5. 
Study Drug Administration.........................................................................................37 
5.5.1. 
Instructions for Administration in the Clinic ..............................................................37 
5.6. 
Study Drug Accountability .........................................................................................37 
6. 
CONCOMITANT MEDICATIONS AND PROCEDURES ......................................38 
6.1. 
Permitted and Prohibited Treatments and Procedures ................................................38 
6.2. 
Moisturizers ................................................................................................................39 
6.3. 
Topical Treatment for AD ..........................................................................................39 
6.4. 
Rescue Treatment for Atopic Dermatitis ....................................................................39 
7. 
STUDY PROCEDURES ............................................................................................40 
7.1. 
Screening Visit ............................................................................................................40 
7.2. 
Baseline Visit (Day 1) ................................................................................................40 
7.3. 
Week 2 (± 3 Days) ......................................................................................................41 
7.4. 
Week 4 (± 3 Days) ......................................................................................................41 
7.5. 
Week 6 (± 3 Days) ......................................................................................................41 
7.6. 
Week 8 (± 3 Days) ......................................................................................................42 
7.7. 
Week 10 (± 3 Days) ....................................................................................................42 
7.8. 
Week 12 (± 3 Days) ....................................................................................................42 
7.9. 
Week 14 (± 3 Days) ....................................................................................................43 
7.10. 
Week 16 (± 3 Days) ....................................................................................................43 
7.11. 
Week 26 (± 3 Days) / Safety Follow-up .....................................................................43 
7.12. 
Early-Termination Visit ..............................................................................................44 
7.13. 
Unscheduled Visits .....................................................................................................44 
8. 
DETAILS OF ASSESSMENTS .................................................................................44 
8.1. 
Screening Assessments ...............................................................................................44 
8.1.1. 
Demographic Information ..........................................................................................44 

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8.1.2. 
Medical History ..........................................................................................................45 
8.2. 
Assessment of Efficacy ...............................................................................................45 
8.2.1. 
Investigator Global Assessment (IGA) .......................................................................45 
8.2.2. 
Eczema Area and Severity Index (EASI) ...................................................................45 
8.2.3. 
Body Surface Area (BSA) ..........................................................................................46 
8.2.4. 
SCORing Atopic Dermatitis (SCORAD) ...................................................................46 
8.2.5. 
Pruritus ........................................................................................................................46 
8.2.6. 
Sleep-Loss ...................................................................................................................46 
8.3. 
Patient Reported Outcomes and Health-Related Quality of Life ...............................46 
8.3.1. 
Patient Oriented Eczema Measure (POEM) ...............................................................47 
8.3.2. 
Dermatology Life Quality Index (DLQI) ...................................................................47 
8.3.3. 
EQ-5D .........................................................................................................................47 
8.3.4. 
PROMIS® (Patient-Reported Outcomes Measurement Information System): 
Anxiety and Depression ..............................................................................................47 
8.3.5. 
Asthma Control Questionnaire (ACQ-5) ....................................................................47 
8.4. 
Assessment of Safety ..................................................................................................48 
8.4.1. 
Physical Examination .................................................................................................48 
8.4.2. 
Vital Signs ..................................................................................................................48 
8.4.3. 
Laboratory Evaluations ...............................................................................................48 
8.4.4. 
Adverse Events ...........................................................................................................49 
8.4.4.1. 
Reporting ....................................................................................................................50 
8.4.4.2. 
Adverse Events of Special Interest (AESIs) ...............................................................50 
8.4.4.3. 
Serious Adverse Events (SAEs) .................................................................................51 
8.4.4.4. 
Reporting of SAEs ......................................................................................................51 
8.4.5. 
Product Complaints ....................................................................................................52 
8.4.6. 
Pregnancy ...................................................................................................................53 
8.4.7. 
Hypersensitivity Reactions .........................................................................................53 
8.5. 
PK and ADA Sampling ..............................................................................................54 
8.6. 
Study Termination ......................................................................................................54 
8.6.1. 
Early Termination of Study Patients...........................................................................54 
8.6.2. 
Study Drug Discontinuation .......................................................................................54 
8.7. 
Data Safety Monitoring Board ....................................................................................55 
9. 
STATISTICAL CONSIDERATIONS .......................................................................55 

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9.1. 
General Statistical Methodology ................................................................................55 
9.1.1. 
Populations Analyzed .................................................................................................56 
9.2. 
Primary Efficacy Analysis ..........................................................................................57 
9.3. 
Missing Data ...............................................................................................................57 
9.4. 
Sensitivity Analyses ....................................................................................................58 
9.4.1. 
All Missing Values MCMC Multiple Imputation ......................................................58 
9.4.2. 
Last Observation Carried Forward (LOCF) ...............................................................58 
9.4.3. 
Non-Response Imputation ..........................................................................................58 
9.4.4. 
Tipping Point Analysis ...............................................................................................59 
9.4.5. 
Subgroup Analyses .....................................................................................................59 
9.5. 
Multiplicity Considerations ........................................................................................59 
9.6. 
PK Analysis ................................................................................................................60 
9.7. 
Anti-Drug Antibody Data Analysis ............................................................................60 
9.8. 
Immunogenicity Data Analysis ..................................................................................60 
9.9. 
Exposure and Compliance ..........................................................................................60 
9.10. 
Adverse Events ...........................................................................................................60 
9.11. 
Other Safety Data .......................................................................................................61 
9.12. 
Sample-Size Determination ........................................................................................61 
9.13. 
Interim Analyses .........................................................................................................61 
10. 
ADMINISTRATION ..................................................................................................63 
10.1. 
Compliance with the Protocol ....................................................................................63 
10.2. 
Informed Consent Procedures.....................................................................................63 
10.3. 
Data Protection and Confidentiality ...........................................................................64 
10.4. 
Study Documentation and the eCRF ..........................................................................64 
10.5. 
Study Monitoring ........................................................................................................65 
10.6. 
Retention of Study Documentation ............................................................................65 
10.7. 
Publication Policy .......................................................................................................65 
11. 
REFERENCES ...........................................................................................................66 
12. 
APPENDICES ............................................................................................................69 
 
LIST OF TABLES 
Table 1: 
Secondary Endpoints .............................................................................................30 

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Table 2: 
Investigator Global Assessment (IGA) ..................................................................45 
Table 3: 
Laboratory Parameters ...........................................................................................49 
Table 4: 
Treatment Period Screening through Week 16 and Safety Follow-Up .................69 
 
LIST OF FIGURES 
Figure 1: 
Study Schema.........................................................................................................33 
LIST OF APPENDICES 
Appendix 1. 
Schedule of Visits and Procedures .........................................................................69 
Appendix 2. 
American Academy of Dermatology Consensus Criteria for Chronic 
Atopic Dermatitis ...................................................................................................71 
 

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ACRONYMS 
Acronym 
Term 
ACQ-5 
Asthma Control Questionnaire 
AD 
atopic dermatitis 
ADA 
anti-drug antibody 
AE 
adverse event 
AESI 
adverse event of special interest 
ALT 
alanine amino-transferase 
ANCOVA 
analysis of covariance 
AST 
aspartate amino-transferase 
AUC 
area under the curve 
BP 
blood pressure 
BSA 
body surface area 
BUN 
blood urea nitrogen 
C 
Celsius  
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Sciences 
Cmax 
maximum (or peak) serum concentration 
DLQI/CDLQI 
Dermatology Life Quality Index/Children’s Dermatology Life Quality Index 
DSMB 
Data Safety Monitoring Board 
EASI 
Eczema Area and Severity Index 
EASI-50 
50% reduction in EASI from Baseline to Week 16  
EASI-75 
75% reduction in EASI from Baseline to Week 16  
eCRF 
electronic case report form 
EDC 
electronic data capture 
EMA 
European Medicines Agency 
EQ-5D 
standardized instrument developed by the EuroQol Group 
ET 
early termination 
EU 
European Union 
F 
Fahrenheit 
FDA 
Food and Drug Administration 
FLG 
filaggrin 
GCP 
good clinical practice 

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Acronym 
Term 
GGT 
gamma-glutamyl transferase 
HCT 
hematocrit 
HGB 
hemoglobin 
HIV 
human immunodeficiency virus 
ICF 
informed consent form 
ICH 
International Conference on Harmonization  
IEC 
independent ethics committee 
IFN 
interferon 
Ig 
immunoglobin  
IGA 
Investigator Global Assessment 
IL 
interleukin 
IRB 
institutional review board 
ITT 
intent-to-treat 
IV 
intravenous 
LDH 
Lactic dehydrogenase  
LOCF 
last observation carried forward 
LOR 
loricrin 
LTE 
long-term extension 
MCH 
mean corpuscular hemoglobin 
MCHC 
mean corpuscular hemoglobin concentration 
MCMC 
Markov chain Monte Carlo 
MCV 
mean corpuscular volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
NRS 
numerical rating scale 
PFS-NSD 
pre-filled syringe with a pre-assembled needle safety device 
PIP 
proximal interphalangeal 
PK 
pharmacokinetics 
POEM 
Patient Oriented Eczema Measure 
PP 
per protocol 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
PUVA 
psoralen (P) and ultraviolet A (UVA) therapy 
Q2W 
every 2 weeks 

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Acronym 
Term 
Q4W 
every 4 weeks 
QoL 
quality of life 
RBC 
red blood cells 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SC 
subcutaneous 
SCORAD 
SCORing Atopic Dermatitis 
SD 
standard deviation 
SOC 
system organ class 
TB 
tuberculosis 
TCI 
topical calcineurin inhibitor 
TCS 
topical corticosteroid 
TEAE 
treatment-emergent adverse event 
Td 
Tetanus, Diphtheria 
TSLP 
thymic stromal lymphopoietin 
US 
United States 
USP 
United States Pharmacopeia 
VAS 
visual analog scale 
WBC 
white blood cells 
WHO 
World Health Organization 
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 
[TSLP]) and inflammation. Type 2 cytokines increase epidermal thickening, sensitization, 
inflammation, pruritus and decrease the expression of antimicrobial peptides and the barrier 
proteins FLG, LOR, and involucrin. IL-13 in particular can reduce epithelial integrity and barrier 
function through downregulation of FLG, LOR, and involucrin (Kim 2008) and can act on 
keratinocytes in the skin to downregulate their differentiation (Howell 2008). IL-13 also induces 
T-cell chemoattractants that mediate T-cell infiltration into AD lesions (Purwar 2006) and may 
also induce IL-5 expression and eosinophil infiltration through the induction of eosinophil 
chemoattractants (Esche 2004). Increased expression of IL-13 has consistently been reported in 
AD skin lesions and is associated with disease severity (Choy 2012; Hamid 1996; Jeong 2003; 
La Grutta 2005; Neis 2006; Suarez-Farinas 2013; Tazawa 2004). The ubiquitous presence of 
IL-13 in the skin of patients with AD supports the evaluation of anti-IL-13 therapies in patients 
with AD.  
1.1.1. 
Epidemiology of Pediatric Atopic Dermatitis 
AD is one of the most common chronic medical diseases—15‒30% of children and 2‒10% of 
adults are affected, and the prevalence appears to have increased over the past two to three 
decades (Williams 2008), with some geographic variability. With respect to disease severity, 
about 67% of AD pediatric patients have mild disease, 14 to 26% have moderate disease and 2 to 
7% have severe disease (Silverberg 2017). Approximately 85% of all cases of AD begin before 
age 5, with up to 70% of children having spontaneous remission before adolescence 
(Bieber 2008; Hua 2014; Illi 2004).  
1.1.2. 
Clinical Manifestations 
Clinically, AD is characterized by xerosis, erythematous crusted eruption (dermatosis), 
lichenification and intense pruritus (Bieber 2008), which along with the distribution, chronicity 
and history of skin lesions, form the basis for making the diagnosis AD. Flares are frequently 

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triggered by exposure to environmental factors, irritants, and allergens (Bieber 2009). Several 
clinical patterns, with differing distributions of skin lesions in distinct age groups, have been 
noted (Weidinger 2016; Weidinger 2018). 
The infantile stage (up to 2 years of age) is characterized by eczema that is usually localized to 
the face, scalp, and extensor aspects of the arms and legs. The lesions are characterized by 
pruritic, red, eczematous plaques, erythema, papules, vesicles, excoriations, oozing, and 
formation of crusts.  
The adult stage (from puberty onwards) is less predictable. Affected patients may have had only 
a few outbreaks since infancy, or they may have had a chronic, relapsing course. Lesions 
frequently localize to the face and neck (head-and neck dermatitis), as well in the flexures of the 
elbows and knees, and a considerable portion of patients (around 30%) develop atopic hand 
eczema, which may interfere with workplace activities. Like affected children, adolescents and 
adults commonly have lichenification of the flexures and have facial dermatitis. 
Patients with AD have a high disease burden and their quality of life (QoL) is significantly 
affected. In one study, AD was shown to have a greater negative effect on patient mental health 
than diabetes and hypertension (Zuberbier 2006). Patients with moderate-to-severe AD have a 
higher prevalence of social dysfunction and sleep impairment, which are directly related to the 
severity of the disease (Williams 2008). Depression, anxiety, and social dysfunction not only 
affect patients with AD, but also affect their caregivers (Zuberbier 2006). Compared with 
psoriasis, another common and debilitating skin disease, patients with AD have lower physical 
vitality, social functioning, role-emotional, and mental health scores (Kiebert 2002).  
1.1.3. 
Treatment for AD 
The therapeutic approach to AD consists primarily of trigger avoidance, skin hydration with 
bathing, and use of moisturizers and anti-inflammatory therapies consisting predominantly of 
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, the anti-IL-4R monoclonal antibody, dupilumab, was approved for the treatment of 
adult and adolescent patients with moderate-to-severe AD. In spite of these treatments, AD 
remains a major societal burden and a significant unmet medical need.  
1.2. 
Lebrikizumab 
Lebrikizumab is a humanized monoclonal immunoglobulin (Ig) G4 antibody (huIgG4) with a 
mutation in the hinge region that increases stability. Lebrikizumab binds specifically to soluble 
human interleukin (IL)-13 with high affinity, and potently inhibits IL-13 signaling through the 
IL-4Rα/IL-13Rα1 complex. Because lebrikizumab binds to IL-13 in a non-receptor binding 
domain (i.e., a portion of the molecule not involved in binding to its receptor), antibody-bound 

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IL-13 can still bind its receptor (IL-13Rα1), 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 SCORAD-50 and adjusted mean change from baseline to Week 
12. 
Safety Results 
• Injection-site reactions occurred infrequently (1.3% all lebrikizumab treated vs. 1.9% 
placebo); all events were non-serious, lasted a median of 1 to 3 days, and did not lead to 
treatment discontinuation or interruption. 
• Herpes viral infections and zoster occurred infrequently, but only among lebrikizumab-
treated patients (6 of 156 [3.8%]); all events were non-serious, and none led to treatment 
discontinuation or dose interruption of lebrikizumab. 
• Eosinophil-associated adverse events (AEs) were reported infrequently, but only occurred 
among lebrikizumab-treated patients (3.2%); however, all events were non-serious, did 

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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%. 
• 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 
• Adverse events 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%). 

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• 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 Q4W (with a loading dose of 500 mg); 75 to lebrikizumab 250 mg Q2W (with a loading 
dose of 500 mg given at baseline and Week 2); 52 to placebo Q2W.  
Efficacy Results 
• Statistically significantly greater proportions of patients in each of the lebrikizumab 
250 mg Q4W and 250 mg Q2W groups achieved EASI-50, EASI-75, or EASI-90 at 
Week 16 than the placebo group.  
• A statistically significantly greater proportion of patients in each of the lebrikizumab 
250 mg Q4W and 250 mg Q2W groups had both an IGA score of 0 or 1 and a ≥ 2-point 
improvement in IGA score at Week 16 than the placebo group.  
• The lebrikizumab 250 mg Q2W group had a statistically significantly greater proportion 
of patients who achieved a ≥ 4-point improvement in pruritus NRS compared with the 
placebo group. 
• Positive changes in pruritus correlated with positive changes in sleep; the lebrikizumab 
250 mg Q4W and 250 mg Q2W groups had statistically significant percent reductions in 
sleep loss due to itching compared with placebo (p=0.0459 and p=0.0062, respectively). 
Safety Results 
• The incidences of conjunctivitis (2.6% all lebrikizumab groups, 0 placebo), herpes 
infections (2.2% all lebrikizumab groups, 0 placebo), and herpes zoster (0.9% all 
lebrikizumab groups, 0 placebo) were relatively low. 
• Three patients (1.3%) in the lebrikizumab groups and 2 patients (3.8%) in the placebo 
group had an SAE. Those reported in the lebrikizumab groups were severe chest pain 
(1 patient in the 250 mg Q2W group), femur fracture of moderate severity (1 patient in 
the 125 mg Q4W group), and panic attack of moderate severity (1 patient in the 250 mg 
Q2W group). Those reported in the placebo group were severe chronic obstructive 

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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.  
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) SC injections and 20 subjects received one 2-mL (250 mg) SC injection. The 
primary objective was to compare the PK (AUC, Cmax) of the 2 lebrikizumab dosing regimens. 
Blood samples were collected prior to dosing and on Days 2, 4, 6, 8, 11, 15, 29, 43, 57, 71, 85 
and 99 for PK and Day 29, 43, 57, 71, 85 and 99 for anti-drug antibodies (ADA).  
Pharmacokinetic Results 
For each AUC comparison (i.e., AUClast, AUCinf, and AUC0-57d) geometric mean ratios were 
close to 1 with 90% CIs within the range of 80% to 125%, except for AUCinf, which was just 
above the upper bound, with a value of 132%. The Cmax geometric mean ratio was 0.89 with a 
90% CI of 73%–108%.  
Conclusions 
Both the AUC and Cmax results indicated similar overall exposure between the 2 lebrikizumab 
dosing regimens evaluated in this study, i.e., two 1-mL (125 mg) SC injections versus one 2-mL 
(250 mg) SC injection. Data from this study support the use of the 2-mL (250 mg) pre-filled 
syringe with a pre-assembled needle safety device (PFS-NSD) in the Phase 3 pivotal trials. 
1.4. 
Rationale for Dose and Treatment Regimen 
The dosing regimen of 500 mg loading dose at baseline and Week 2, followed by 250 mg Q2W 
lebrikizumab was selected, based on an evaluation of safety, efficacy and PK data from the 
DRM06-AD01 and DRM06-AD03 trials (see above).  

St u d y Pr ot oc ol: D R M 0 6 -A D 0 6 -A 1/ J 2 T-D M -K G A D -A 1  
Le bri kiz u ma b  
Der mira, I nc.  FI N A L 1 3 Ma y 2 0 2 0  
C o nfi de ntial   
P a ge 2 9  
T he D R M 0 6- A D 0 3 P K st u d y c o n d u cte d i n healt h y a d ults de m o nstrat e d t hat a si n gle S C i njecti o n 
of 2 - m L ( 2 5 0 m g) of le bri kiz u ma b deli vere d c o m para ble le v els of le bri kiz u ma b as di d t w o 1-m L 
( 1 2 5 m g) S C i njecti o ns. T his si m ulate d t he c o n diti o ns u n der w hic h st u d y dr u g will be  
a d mi nistere d i n  P hase 3, f urt her s u p port i n g t he d ose a n d treat me nt re gi me n f or P hase 3 trials, 
le bri kiz u ma b 2 5 0 m g Q 2 W wit h a l oa di n g d ose of 5 0 0 m g gi ve n at Bas eli ne a n d Wee k 2.   
A d olesce nt P atie nts  
I n t his P hase 3 st u dy, a d olesce nt patie nts  (≥1 2  t o < 1 8 years  w ei g hi n g  ≥4 0  k g ), will be i ncl u de d 
a n d will recei v e t he sa me d oses of le bri kiz u ma b descri be d a b o ve f or a d ults. T he j ustificati o n  f or 
t his a p pr oac h is as f oll o ws:  
B ot h a d ults a n d a d oles ce nt patie nts ha ve si milar disease c h aracteristics, t y pifie d b y pr o mi ne nt 
T y pe 2 s ki n i nfla m mati o n a n d si milar cli nical ma nifestati o ns. I n a d diti o n, b ot h gr o u ps te n d t o 
ha ve si milar efficac y o utc o mes i n res p o nse t o t hera pies, i ncl u di n g d u pil u m a b ( Si m ps o n 2 0 1 8 ; 
Treister 2 0 1 9 ). P har mac o ki netic m o deli n g a n d si m ulati o ns of le bri kiz u ma b d osi n g ( p o p ulati o n 
P K m o deli n g of p o ole d d ata fr o m 2 2 5 9 a d ult ast h ma patie nts a n d a s u bse q ue nt e xter nal p osteri or 
pre dicti ve c h ec k wit h le bri kiz u ma b P K data fr o m t he D R M 0 6- A D 0 1 trial i n a d ult A D pati e nts) 
re veal e d si milar ki netics f or a d ults a n d a d oles ce nt patie nts, 1 2 t o < 1 8 years of a ge.  Th e ma xi mal 
e x p os ures are pr e dicte d t o be 
r i n a d olesce nt patie nts t ha n i n a d ults f or a n y 
gi ve n d os e d ue t o t he l o wer a d oles ce nt w ei g ht ra n ges  a n d le bri kiz u ma b e x p os ure de pe n de nce o n 
wei g ht;  h o w e ver, t he s af et y pr ofile i n a d olesce nt patie nts, base d o n t he e x p os ure-res p o nse 
relati o ns hi p a nal ysis a n d  o n partial e xtra p olati o n, is c o m para ble t o t hat  o bser ve d i n a d ults.  
1. 5.  
St u d y C o n d uct St ate me nt  
 
T his  st u d y will be c o n d u cte d i n acc or da n ce wit h t he pr ot oc ol a n d wit h t he f oll o wi n g: 
•  C o nse ns us et hical pri nci ples deri ve d fr o m i nter nati o nal g ui deli nes 
i ncl u di n g t he D eclar ati o n of Helsi n ki a n d C o u ncil f or I nter n ati o nal 
Or ga nizati o ns of Me dical Scie nces ( CI O M S ) I nter nati o nal Et hical 
G ui deli nes 
•  A p plica ble I C H G o o d Cli nical Practice ( G C P) G ui deli nes  
•  A p plica ble la ws a n d re g ulati o ns 
T he pr ot oc ol, pr ot oc ol a me n d me nts, I C F, I n vesti gat or Br o c h ure, a n d ot her rele v a nt d oc u me nts 
(e. g., a d vertise me nts) m ust be s u b mitte d t o a n I R B/I E C b y t he i n vesti gat or a n d re vie w e d a n d 
a p pr o ve d b y t he I R B/I E C bef ore t he st u d y is i nitiate d. 
A n y a me n d me nts t o t he pr ot oc ol will re q uire I R B/I E C a p pr o val bef ore i m ple me ntati o n of 
c ha n ges ma d e t o t he st u d y desi g n, e x ce pt f or c ha n ges n ecess ar y t o eli mi nat e a n i m me diate 
hazar d t o st u d y partici pa nts. 
T he i n vesti gat or will be r es p o nsi ble f or t he f oll o wi n g: 
•  Pr o vi di n g writte n s u m maries of t he stat us of t he st u d y t o t he I R B/I E C 
a n n uall y or m ore fre q u e ntl y i n acc or da n ce wit h t h e re q uire me nts, p olicies, a n d 
pr oce d ur es esta blis he d b y t he I R B/I E C 
•  N otif yi n g t he I R B/I E C of S A Es  [a n d/ or U A D Es] or ot her si g nifica nt safet y 
fi n di n gs as r e q uire d b y I R B/I E C pr oce d ures 
C CI

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• Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 
536/2014 for clinical studies (if applicable), and all other applicable local 
regulations 
Investigator sites are compensated for participation in the study as detailed in the clinical trial 
agreement. 
 
2. 
STUDY OBJECTIVES AND ENDPOINTS 
To evaluate the safety and efficacy of lebrikizumab when used in combination with TCS 
treatment compared with placebo, in patients with moderate-to-severe AD. 
2.1. 
Primary Endpoint(s) 
For FDA: 
The primary efficacy endpoint is the percentage of patients with an IGA score of 0 or 1 and a 
reduction ≥2-points from Baseline to Week 16. 
For EMA: 
Co-primary endpoints will be used as follows: 
• Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from 
Baseline to Week 16. 
• Percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) 
at Week 16  
2.2. 
Secondary Endpoints 
Table 1: 
Secondary Endpoints  
FDA 
EMA 
• 
Percentage of patients achieving EASI-75 
(≥75% reduction from Baseline in EASI 
score) at Week 16  
• 
Percentage of patients achieving EASI-90 
(≥90% reduction from Baseline in EASI 
score) at Week 16 
• 
Percentage change in Pruritus Numerical 
Rating Scale (NRS) score from Baseline to 
Week 16 
• 
Percentage of patients with a Pruritus NRS 
of ≥4-points at Baseline who achieve a ≥4-
point reduction from Baseline to Week 16 
• 
Percentage change in EASI score from 
Baseline to Week 16 
• 
Percentage of patients achieving EASI-90 
(≥90% reduction from Baseline in EASI 
score) at Week 16 
• 
Percentage change in Pruritus Numerical 
Rating Scale (NRS) score from Baseline to 
Week 16 
• 
Percentage of patients with a Pruritus NRS 
of ≥4-points at Baseline who achieve a ≥4-
point reduction from Baseline to Week 16 
• 
Percentage of patients with a Pruritus NRS 
of ≥5-points at Baseline who achieve a ≥4-
point reduction from Baseline to Week 16 
• 
Percentage change in EASI score from 
Baseline to Week 16 

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FDA 
EMA 
• 
Change from Baseline to Week 16 in 
percent BSA 
• 
Percentage of patients achieving EASI-90 at 
Week 4 
• 
Percentage change in Sleep-loss score from 
Baseline to Week 16 
• 
Change from Baseline in Sleep-loss score at 
Week 16 
• 
Percentage of patients with a Pruritus NRS 
of ≥4-points at Baseline who achieve a ≥4-
point reduction from Baseline to Week 4 
• 
Percentage of patients with a Pruritus NRS 
of ≥4-points at Baseline who achieve a ≥4-
point reduction from Baseline to Week 2 
• 
Percentage of patients with a Pruritus NRS 
of ≥4-points at Baseline who achieve a ≥4-
point reduction from Baseline to Week 1 
• 
Proportion of TCS / TCI-free days from 
Baseline to Week 16 
• 
Percentage of patients achieving EASI-90 at 
Week 4 
• 
Change from baseline in DLQI at Week 16 
• 
Percentage of patients achieving ≥4-point 
improvement in DLQI from baseline to 
Week 16 
• 
Percentage change in Sleep-loss score from 
Baseline to Week 16 
• 
Change from Baseline in Sleep-loss score at 
Week 16 
• 
Proportion of TCS / TCI-free days from 
Baseline to Week 16 
 
• 
Time (days) to TCS / TCI-free use from 
Baseline to Week 16 
• 
Percentage of patients with a Pruritus NRS 
of ≥4-points at Baseline who achieve a ≥4-
point reduction from Baseline to Weeks 1, 2 
and 4 
 
• 
Time (days) to TCS / TCI-free use from 
Baseline to Week 16 
• 
Percentage of patients with a Pruritus NRS 
of ≥5-points at Baseline who achieve a ≥4-
point reduction from Baseline to Weeks 1, 2 
and 4 
2.3. 
Other Secondary Endpoints 
• Proportion of patients with EASI-75, EASI-90 and EASI-50 by visit 
• Proportion of patients with IGA Score of 0 or 1 and a reduction ≥2 points from Baseline 
by visit 
• Percentage change from Baseline in EASI Score by visit 
• Percentage change from Baseline in Pruritus NRS by visit 
• Percentage of patients with Pruritus NRS change of ≥4 from Baseline by visit 
• Percentage of patients with a Pruritus NRS score of ≥4 points at Baseline who achieve a 
≥4-point reduction from Baseline by visit 
• Change from Baseline in Sleep-Loss score by visit 
• Change from Baseline in DLQI/CDLQI by visit 
• Change from Baseline in EQ5D by visit 
• Change from Baseline in POEM by visit 
• Change from Baseline in PROMIS Anxiety measure by visit 

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• Change from Baseline in PROMIS Depression measure by visit 
• Change in ACQ-5 score from Baseline to Week 16 in patients who have self-reported 
comorbid asthma 
• Percentage change from Baseline to Week 16 in SCORAD 
3. 
STUDY DESIGN 
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks 
in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used 
in combination with TCS treatment compared with placebo in combination with TCS treatment 
for moderate-to-severe AD (Figure 1).  
Eligible adult and adolescent patients (≥12 to <18 years and weighing ≥40 kg) with moderate-to-
severe AD for at least one year, defined according to the American Academy of Dermatology 
Consensus Criteria, an EASI of ≥16, an IGA score of ≥3 and a BSA of ≥10% will be enrolled.  
During the 16-week treatment period, approximately 225 patients will be stratified and 
randomized 2:1 to treatment with either 250 mg lebrikizumab (loading dose of 500 mg given at 
Baseline and Week 2) or placebo by subcutaneous (SC) injection every 2 weeks (Q2W). All 
study drug injections will be administered in the clinic. TCS will be initiated at Baseline in all 
patients and may be tapered or stopped, as needed, based on treatment response.  
Efficacy will be measured through IGA, EASI, SCORAD, BSA, Pruritus and Sleep-loss scores 
and, TCS/TCI use. 
Safety will be assessed by monitoring adverse events, serum chemistry, hematology and 
urinalysis laboratory testing, physical examination, pulse and blood pressure. An independent 
Data Safety Monitoring Board will monitor patient safety by conducting formal reviews of 
accumulated safety data periodically throughout the trial. 
Quality of life and impact of disease will be assessed using the POEM, DLQI/CDLQI, EQ-5D, 
and PROMIS® Anxiety and Depression measures. Patients reporting comorbid asthma at study 
entry will complete the ACQ-5. 
Serum samples will be collected for pharmacokinetic analysis and immunogenicity. 
After completion of the Week 16 visit, patients will be offered the option to continue treatment 
in a separate long-term extension study (DRM06-AD07). 
Patients who early terminate or choose not to enter the long-term extension study will receive a 
safety follow-up approximately 12 weeks after the last study drug injection. 
Completion of Patient Participation: A patient is considered to have completed the study if 
he/she has completed the last scheduled visit: 
• For subjects continuing into LTE, upon completion of week 16 visit and rolling into LTE 
study 
• For subjects not continuing into LTE, when subject had either week 16 or ET visit, and 
safety follow up visit (12 weeks after last IP administration) 

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The end of the study is defined as the date of the last visit of the last patient in the study shown in 
the Schedule of Visits and Procedures. 
 
Figure 1: 
Study Schema 
 
 
3.1. 
Duration of the Study 
The total duration of a patient’s participation in this study, if enrolling in the LTE, will be 
approximately 20 weeks (Screening: maximum duration of 30 days; Treatment Period: 16 
weeks).  
The total duration of a patient’s participation in this study if not enrolling in the long-term 
extension will be approximately 30 weeks (Screening: maximum duration of 30 days; Treatment 
Period: 16 weeks; Post-Treatment Follow-up: 12 weeks from last dose).  
3.2. 
Study Population and Number of Patients 
Approximately 225 patients with moderate to severe atopic dermatitis, including approximately 
50 adolescent patients (≥12 to <18 years, weighing ≥40 kg). 
4. 
SELECTION OF PATIENTS 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
4.1. 
Inclusion Criteria 
Patients must meet all the following criteria to be eligible for this study: 
1. Adults and adolescents (≥12 to <18 years of age and weighing ≥40 kg). 
2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that 
has been present for ≥1 year before the screening visit (see Appendix 2). 
3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit  
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit 
(see Section 8.2.1). 
5. ≥10% body surface area (BSA) of AD involvement at the baseline visit 

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6. History of inadequate response to treatment with topical medications. 
7. Applied a stable dose of non-medicated topical moisturizer at least twice daily for 
≥7 days prior to the baseline visit. 
8. Completed electronic diary entries for pruritus and sleep-loss for a minimum of 4 of 
7 days preceding randomization. 
9. Willing and able to comply with all clinic visits and study-related procedures and 
questionnaires. 
10. 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, 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. 
11. Male patients must agree to use an effective barrier method of contraception during the 
study and for a minimum of 18 weeks following the last dose of study drug if sexually 
active with a female of child bearing potential.  
12. Provided signed informed consent/assent as described in Section 10.15.  
4.2. 
Exclusion Criteria 
Patients meeting any of the criteria below will be excluded from this study: 
1. Participation in a prior lebrikizumab clinical study. 
2. History of anaphylaxis as defined by the Sampson criteria (Sampson 2006). 
3. Treatment with topical corticosteroids, calcineurin inhibitors or Phosphodiesterase-4 
inhibitors such as crisaborole within 1 week prior to the baseline visit. 
4. Treatment with any of the following agents within 4 weeks prior to the baseline visit: 
a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, 
cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, 
methotrexate, etc.) 
b. Phototherapy and photochemotherapy (PUVA) for AD. 

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5. Treatment with the following prior to the baseline visit: 
a. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is 
longer. 
b. Dupilumab within 8 weeks. 
c. B Cell-depleting biologics, including rituximab, within 6 months. 
d. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer. 
6. Use of prescription moisturizers within 7 days of the baseline visit.  
7. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the 
screening visit. 
8. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or 
planned during the study. 
9. Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., 
co-morbid severe uncontrolled asthma (defined by an ACQ-5 score ≥1.5 or a history of 
≥ 2 asthma exacerbations within the last 12 months requiring systemic [oral and/or 
parenteral] corticosteroid treatment or hospitalization for > 24 hours). 
10. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, 
antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or 
superficial skin infections within 1 week before the baseline visit.  
NOTE: patients may be rescreened after infection resolves. 
11. Evidence of active acute or chronic hepatitis (as defined by the Department of Health & 
Human Services Centers for Disease Control and Prevention) or known liver cirrhosis.  
12. Diagnosed active endoparasitic infections or at high risk of these infections. 
13. Known or suspected history of immunosuppression, including history of invasive 
opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis, 
coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or 
unusually frequent, recurrent, or prolonged infections, per the Investigator’s judgment. 
14. History of human immunodeficiency virus (HIV) infection or positive HIV serology at 
screening. 
15. In the Investigator’s opinion, any clinically significant laboratory results from the 
chemistry, hematology or urinalysis tests obtained at the screening visit. 
16. Presence of skin comorbidities that may interfere with study assessments. 
17. History of malignancy, including mycosis fungoides, within 5 years before the screening 
visit, except completely treated in situ carcinoma of the cervix, completely treated and 
resolved non-metastatic squamous or basal cell carcinoma of the skin. 
18. Severe concomitant illness(es) that in the Investigator’s judgment would adversely affect 
the patient’s participation in the study. Any other medical or psychological condition that 
in the opinion of the Investigator may suggest a new and/or insufficiently understood 
disease, may present an unreasonable risk to the study patient because of his/her 

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participation in this clinical trial, may make patient’s participation unreliable, or may 
interfere with study assessments.  
19. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed 
during the study. 
20. Have had an important side effect to TCS (e.g., intolerance to treatment, hypersensitivity 
reactions, significant skin atrophy, and systemic effects), as assessed by the investigator 
or treating physician that would prevent further use. 
5. 
STUDY DRUG  
5.1. 
Investigational Medicinal Product  
Lebrikizumab is a sterile liquid solution containing 125 mg/mL lebrikizumab, histidine acetate, 
sucrose, polysorbate 20, and sterile water for injection, USP, pH 5.4‒6.0. Placebo solution is 
identical in appearance and content to the active solution except for lebrikizumab. All study drug 
(lebrikizumab and placebo) will be supplied as a sterile pre-filled syringe with a pre-assembled 
needle safety device (PFS-NSD). Each pre-filled syringe is intended for a single 2 mL dose 
(250 mg) administered subcutaneously (SC). 
5.2. 
Storage and Labeling 
Study drug is to be stored under refrigerated conditions (2‒8°C) and protected from excessive 
light and heat. Study drug should not be frozen, shaken or stored at room temperature. 
Temperature excursions outside of 2‒8°C must be reported to the Sponsor or the designee. 
Each PFS-NSD will be packaged in a carton. A medication numbering system will be used in 
labeling blinded study drug. Lists linking medication numbers with product lot numbers will be 
maintained by the group responsible for study drug packaging. In order to maintain the study 
blind, these lists will not be accessible to individuals involved in study conduct. 
Medication numbers will be assigned to a patient in the electronic data capture system based on 
the study randomization schema. 
5.3. 
Patient Randomization 
Patients will be assigned a unique identifier by the sponsor. Any patient records, datasets or 
tissue samples that are transferred to the sponsor will contain the identifier only; patient names or 
any information which would make the patient identifiable will not be transferred. All patients 
will be randomly allocated to receive the study treatment using an electronic data capture system 
(an electronic randomization and trial supply management system) at the Baseline visit. The 
allocation to treatment will be prospectively stratified by geographic region (US versus EU 
versus rest of world), age (adolescent patients 12 to <18 years versus adults ≥18 years) and 
disease severity (IGA 3 versus 4). At the Baseline visit (Day 1), once a patient is considered 
eligible to participate in the study, demographic and stratification information will be entered 
into the EDC to receive a medication number assigning the appropriate treatment to a patient. 
Patients will be randomized 2:1 to one of the following treatment groups: 

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• Lebrikizumab 250mg Q2W: 500mg lebrikizumab administered at Baseline and Week 2 
(loading dose) and 250mg given every two weeks (Q2W) through Week 14. TCS 
treatment initiated at Baseline and applied PRN. 
• Placebo 4mLs (two PFS-NSD) administered at Baseline and Week 2 and 2mLs given 
Q2W through Week 14. TCS treatment initiated at Baseline and applied PRN.  
5.4. 
Study Blinding 
The Sponsor or designee, the Investigator, study-site personnel, and the patient will be blinded to 
treatment assignment. 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.  
5.4.1. 
Unblinding Treatment Assignment  
Unblinding the treatment assignment of a patient may only be performed in emergencies where 
knowledge of the patient’s treatment assignment is essential for management of the patient’s 
medical care. Unblinding the treatment assignment by the investigator under any other 
circumstances will be considered a protocol violation. The investigator should make every effort 
to contact the Sponsor or designee prior to unblinding a patient’s treatment assignment. In the 
event of any unblinding, emergency or accidental, the sponsor must be notified within 1 business 
day.  
Unblinding will occur using the EDC. The Investigator must record the date and time the blind 
was broken, the names of the personnel involved, and the reason that treatment assignment 
information was required. The date and time that the Sponsor or designee was notified will also 
be recorded. 
5.5. 
Study Drug Administration 
Study drug will be administered to all patients in the clinic by designated and trained site staff.  
5.5.1. 
Instructions for Administration in the Clinic 
Syringes should be at room temperature prior to injection (refer to the applicable Instructions for 
Use provided by the sponsor). 
5.6. 
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 used, unused, and expired materials, to the Sponsor/designees, or destroy it 
according to the study site’s standard operating procedure, if accepted by the Sponsor. 

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6. 
CONCOMITANT MEDICATIONS AND PROCEDURES 
All medications (including over-the-counter drugs, vitamins, and antacids) and over-the-counter 
emollient(s) taken/used at screening and throughout the study must be recorded. Patients should 
be instructed to consult with the Investigator prior to initiating any new medication (either self-
administered non-prescription drugs or prescription therapy prescribed by another physician) 
while participating in the study. The Investigator is expected to examine the acceptability of all 
concomitant medications, topical preparations, and dietary supplements taken by patients 
participating in the trial. 
• Medication entries should be specific to product name (if a combination drug product) 
and spelled correctly.  
• The brand and specific product name for any over-the-counter emollient(s) should be 
noted and spelled correctly. 
• Information on the dose, unit, frequency, route of administration, start date, 
discontinuation date, indication, and reason for use will be recorded.  
• The use of any concomitant medication must relate to an AE listed on the AE electronic 
case report form (eCRF) or the patient's medical history unless it is a supplement or used 
as preventative care. 
6.1. 
Permitted and Prohibited Treatments and Procedures 
The use of concomitant medications for other medical conditions (e.g., hypertension, diabetes, 
acute infections) is permitted during this study. Inhaled corticosteroids and bronchodilators to 
control asthma are permitted. 
The introduction of medications or therapies for other medical conditions known to affect AD 
(e.g. systemic corticosteroids, mycophenolate-mofetil, IFN-y, Janus kinase inhibitors, TCI, 
cyclosporine, azathioprine, methotrexate, phototherapy, or photochemotherapy, 
phosphodiesterase-4 inhibitors such as crisaborole) are not permitted during the study. The use of 
systemic corticosteroids for the treatment of AD is prohibited and requires permanent 
discontinuation of Investigational Product. If used for treatment of AEs (for example, worsening 
of existing condition, such as asthma exacerbation), it will be treated as rescue medication as per 
the Section 6.4 .  
Acute 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.  
The use of a tanning booth/parlor is not permitted during the trial. 
Cannabinoid treatments for AD are prohibited. 
Planned or anticipated major medical procedures or surgeries should be avoided during the trial.  
See Section 6.4 for details on approved rescue medications and timing of use.  

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6.2. 
Moisturizers 
Non-medicated moisturizers are to be used during the study. The patient may continue her/his 
current over-the-counter moisturizer regimen, if approved by the Investigator.  
6.3. 
Topical Treatment for Atopic Dermatitis  
All patients will be instructed to use TCS for AD symptoms starting at the Baseline visit (Day 1). 
Patients 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.  
Low-potency TCS or topical calcineurin inhibitors (TCI) may be used for sensitive areas only, 
i.e., face, neck, intertriginous and genital areas.  
A mid-potency TCS, triamcinolone acetonide 0.1% cream, and a low-potency TCS, 
hydrocortisone 1% cream (for use on sensitive skin areas) will be provided by the Sponsor or 
clinical site for use in this trial. Patients are to be instructed to return all used and unused TCS 
medication (tubes) to the study site for accountability purposes.  
The Investigator must keep an accurate record of the number of tubes received, dispensed/used, 
and those returned to the Sponsor or designee. The Sponsor or designee will provide forms to 
facilitate inventory control. All 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 accountability for all TCS tubes at the site, and will assist in 
returning all used, unused, and expired materials, to the Sponsor/designees, or destroy it 
according to the study site’s standard operating procedure, if accepted by the Sponsor. 
All TCS and TCI use will be recorded daily by the patient using an electronic diary.  
6.4. 
Rescue Treatment for Atopic Dermatitis 
The goal of this Phase 3 study is to demonstrate the efficacy and safety of lebrikizumab when 
used in combination with TCS for AD. However, add on rescue therapies may be needed, if the 
patient experiences clinical worsening of symptoms that are intolerable.  
If medically necessary (i.e., to control intolerable AD symptoms), high potency TCS or systemic 
treatments (e.g., oral corticosteroids, phototherapy, cyclosporin, etc.) may be used. Study drug 
must be discontinued for patients receiving systemic rescue treatment. Patients should continue 
to attend all study visits and be assessed for safety and efficacy according to the schedule of 
events, even if rescue medication is initiated.  
Patients using topical or systemic rescue medication who complete the study through Week 16 
will be eligible to continue to a separate long-term extension study after the Week 16 visit has 
been completed.  
All rescue treatment usage must be captured 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. 
Screening Visit 
The purpose of the screening visit/period is to ensure that appropriate patients are entered into 
the study and that they remain stable during the pre-treatment period.  
• Obtain written informed consent/assent prior to performing any study procedures 
• Review Inclusion/Exclusion Criteria 
• Measure vital signs 
• Review immunization record for adolescent patients 
• Perform a complete physical examination, including height and weight 
• Collect concomitant medication and procedure/therapy information 
• Complete the following assessments: IGA, BSA, and EASI 
• Draw blood samples for laboratory tests, including serum pregnancy  
• Collect urine sample for urinalysis 
• Complete medical history/review of systems 
• Collect demographic information 
• Instruct the patient to apply a moisturizer at least twice daily 
• Assign eDiary and instruct the patient on the completion of the following assessments: 
Pruritus and Sleep-Loss (daily), and POEM (weekly). Instruct patient to record TCS/TCI 
use daily.  
7.2. 
Baseline Visit (Day 1)  
• Administer the DLQI/CDLQI and EQ-5D 
• Administer the PROMIS (Patient-Reported Outcomes Measurement Information System) 
Anxiety and Depression measures 
• Collect the ACQ-5 assessment for patients with comorbid asthma 
• Update medical history/review of systems and concomitant medication and 
procedure/therapy information 
• Measure vital signs 
• Complete the following assessments: IGA, BSA, EASI and SCORAD 
• Review compliance report on the eDiary and confirm moisturizer use 
• Draw a pre-dose blood sample for PK and anti-drug antibody (ADA) testing 

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• Conduct urine pregnancy test (WOCBP only) 
• Re-assess and confirm patient eligibility (Inclusion/Exclusion criteria) 
• Randomize the patient, receive kit assignment and administer study drug 
• Remind patient to record the following in their eDiary: Pruritus and Sleep-Loss (daily), 
TCS/TCI use (daily) and POEM (weekly) 
7.3. 
Week 2 (± 3 Days) 
• Measure vital signs 
• Complete the following assessments: IGA, BSA and EASI 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Administer study drug 
• Review compliance report on the eDiary, confirm moisturizer use and remind patient to 
record the following in their eDiary: Pruritus and Sleep-Loss (daily), TCS/TCI use (daily) 
and POEM (weekly) 
7.4. 
Week 4 (± 3 Days) 
• Administer the DLQI/CDLQI 
• Measure vital signs 
• Complete the following assessments: IGA, BSA and EASI 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Draw a pre-dose blood sample for PK and ADA testing  
• Conduct urine pregnancy test (WOCBP only) 
• Administer study drug 
• Review compliance report on the eDiary, confirm moisturizer use and remind patient to 
record the following in their eDiary: Pruritus and Sleep-Loss (daily), TCS/TCI use (daily) 
and POEM (weekly) 
7.5. 
Week 6 (± 3 Days) 
• Measure vital signs 
• Complete the following assessments: IGA, BSA, and EASI 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Administer study drug 

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• Review compliance report on the eDiary, confirm moisturizer use and remind patient to 
record the following in their eDiary: Pruritus and Sleep-Loss (daily), TCS/TCI use (daily) 
and POEM (weekly) 
7.6. 
Week 8 (± 3 Days) 
• Administer the DLQI/CDLQI 
• Measure vital signs 
• Complete the following assessments: IGA, BSA and EASI 
• Draw blood samples for laboratory tests, except hormones 
• Collect a urine sample for urinalysis 
• Conduct urine pregnancy test (WOCBP only) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Administer study drug 
• Review compliance report on the eDiary, confirm moisturizer use and remind patient to 
record the following in their eDiary: Pruritus and Sleep-Loss (daily), TCS/TCI use (daily) 
and POEM (weekly) 
7.7. 
Week 10 (± 3 Days) 
• Measure vital signs 
• Complete the following assessments: IGA, BSA, EASI 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Administer study drug 
• Review compliance report on the eDiary, confirm moisturizer use and remind patient to 
record the following in their eDiary: Pruritus and Sleep-Loss (daily), TCS/TCI use (daily) 
and POEM (weekly) 
7.8. 
Week 12 (± 3 Days) 
• Administer the DLQI/CDLQI 
• Measure vital signs 
• Complete the following assessments: IGA, BSA and EASI 
• Conduct urine pregnancy test (WOCBP only) 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Administer study drug 

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• Review compliance report on the eDiary, confirm moisturizer use and remind patient to 
record the following in their eDiary: Pruritus and Sleep-Loss (daily), TCS/TCI use (daily) 
and POEM (weekly) 
7.9. 
Week 14 (± 3 Days) 
• Measure vital signs 
• Complete the following assessments: IGA, BSA and EASI 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Administer study drug  
• Review compliance report on the eDiary, confirm moisturizer use and remind patient to 
record the following in their eDiary: Pruritus and Sleep-Loss (daily), TCS/TCI use (daily) 
and POEM (weekly) 
7.10. 
Week 16 (± 3 Days)  
• Administer the DLQI/CDLQI, and EQ-5D 
• Administer the PROMIS measures 
• Collect ACQ-5 for patients with comorbid asthma 
• Measure vital signs 
• Complete the following assessments: IGA, BSA, EASI and SCORAD 
• Collect a urine sample for urinalysis 
• Conduct urine pregnancy test (WOCBP only) 
• Draw blood samples for laboratory tests, PK and ADA testing 
• Perform a complete physical examination, including height and weight 
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Review compliance report on the eDiary 
• Collect eDiary  
7.11. 
Week 26 (± 3 Days) / Safety Follow-up  
This visit is only applicable to patients who terminate early from the study or do not enroll in the 
long-term extension study, DRM06-AD07. Patients will undergo a safety follow-up visit  
approximately 12 weeks after the last study drug injection. 
• Review and record AEs and concomitant medications and procedures that were ongoing 
at study termination 
• Draw blood samples for PK and ADA testing. 

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7.12. 
Early-Termination Visit 
Patients who discontinue the study early for any reason should have these assessments performed 
at their early-termination visit. The reason for early termination must be recorded in the eCRF 
(see Section 8.6.1).  
• Administer the DLQI/CDLQI, and EQ5D 
• Administer the PROMIS measures 
• Collect the ACQ-5 assessment for patients with comorbid asthma 
• Measure vital signs 
• Complete the following assessments: IGA, BSA, EASI and SCORAD 
• Draw blood samples for laboratory tests, PK and ADA testing 
• Collect a urine sample for urinalysis 
• Conduct urine pregnancy test (WOCBP only) 
• Perform a complete physical examination, including height and weight.  
• Review and record AEs and update concomitant medication and procedure/therapy 
information 
• Review compliance report on the eDiary and collect eDiary 
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 AD, complete the following 
assessments: IGA, BSA and EASI  
8. 
DETAILS OF ASSESSMENTS 
8.1. 
Screening Assessments  
8.1.1. 
Demographic Information 
Patient age, gender at birth, ethnicity and race will be collected. Race and ethnicity information 
will only be used to support sub-group analyses assessing phenotype with treatment response. 
The collection of a patient’s race and ethnicity is particularly important, given recent descriptions 
of disease heterogeneity in AD, with diverse phenotypes and endotypes described based on age, 
disease chronicity, ethnicity, genetics, IgE status, and underlying molecular mechanisms 
(Czarnowicki 2019). 

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8.1.2. 
Medical History 
A complete medical history will be collected and include immunization record (for adolescent 
patients), clinically relevant medical conditions or surgeries, including more specific information 
on a history of conjunctivitis and herpes infection/zoster. Information on the patient’s AD and 
comorbidities (past history of asthma, allergic rhinitis, food allergies, alopecia) will be collected 
and include the date of onset, extent of involvement and past treatments for AD and 
comorbidities.  
8.2. 
Assessment of Efficacy 
Each patient’s AD will be assessed as specified in the Schedule of Visits and Procedures. 
Whenever possible, the same assessor should perform all assessments on a given patient over the 
course of the study. The sponsor will administer training on the required efficacy assessments, 
detail on the specific instruments and training given are recorded in the study training materials. 
8.2.1. 
Investigator Global Assessment  
The IGA is a static assessment and rates the severity of the patient’s AD. The IGA is comprised 
of a 5-point scale ranging from 0 (clear) to 4 (severe) and a score is selected using descriptors 
that best describe the overall appearance of the lesions at a given time point. It is not necessary 
that all characteristics under Morphological Description be present. Assessors must be trained 
and certified by the Sponsor prior to conducting this assessment. The IGA must be conducted 
prior to conducting the EASI and BSA assessments. A single assessor should be assigned to each 
individual patient for as many visits as possible, to avoid inter-assessor variability in scoring. 
Table 2: 
Investigator Global Assessment  
Score 
Grade 
Definition 
0 
Clear 
Minor, residual discoloration; no erythema or induration/papulation; no 
oozing/crusting; no edema. 
1 
Almost Clear 
Trace, faint pink erythema with barely perceptible induration/papulation 
and no oozing/crusting; no edema. 
2 
Mild 
Faint-pink erythema with papulation and edema perceptible upon palpation 
and no oozing/crusting; minimal induration. 
3 
Moderate 
Pink-red erythema with definite edema of skin papules and plaques; there 
may be some oozing/crusting; palpable induration. 
4 
Severe 
Deep/bright red erythema with significant swelling and obvious raised 
borders of papules and plaques with oozing/crusting; significant induration.  
8.2.2. 
Eczema Area and Severity Index  
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. 
Assessors must be trained and certified by the Sponsor prior to conducting this assessment.  

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8.2.3. 
Body Surface Area  
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. Body surface area 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. 
8.2.4. 
SCORing Atopic Dermatitis  
SCORing Atopic Dermatitis is a validated clinical tool for assessing the extent and intensity of 
atopic dermatitis. There are 3 components to the assessment:  
• The extent of AD is assessed as a percentage of each defined body area and reported as 
the sum of all areas, with a maximum score of 100% (assigned as “A” in the overall 
SCORAD calculation). 
• The severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, 
excoriation, skin thickening/lichenification, dryness) is assessed using the following 
scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points, 
assigned as “B” in the overall SCORAD calculation). 
• Subjective assessment of itch and of sleeplessness is recorded for each symptom by the 
patient or relative on a VAS, where 0 is no itch (or sleeplessness) and 10 is the worst 
imaginable itch (or sleeplessness), with a maximum possible score of 20 (assigned as “C” 
in the overall SCORAD calculation).  
The SCORAD is calculated as: A/5 + 7B/2 + C where the maximum is 103.  
8.2.5. 
Pruritus 
Pruritus will be assessed by the patient using a 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. Data will be transferred to the 
clinical database. 
8.2.6. 
Sleep-Loss 
Sleep-loss due to pruritus will be assessed by the patient. 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. Data will be transferred to the clinical database. 
8.3. 
Patient Reported Outcomes and Health-Related Quality of Life 
Patient reported outcome and quality of life measures should all be completed prior to other 
study assessments.  

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8.3.1. 
Patient Oriented Eczema Measure  
The POEM is a 7-item, validated, questionnaire used by the patient to assess disease symptoms 
over the last week. The patient is asked to respond to 7 questions on skin dryness, itching, 
flaking, cracking, sleep loss, bleeding and weeping. All 7 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 and transferred into the clinical database. 
8.3.2. 
Dermatology Life Quality Index  
The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the 
quality of life of an affected person. The 10 questions cover the following topics: symptoms, 
embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close 
relationships, sex, and treatment, over the previous week. Questions are scored from 0 to 3, 
giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) 
to 30 (meaning maximum impact on quality of life). A high score is indicative of a poor quality 
of life. Patients ≤16 years will complete the Children’s Dermatology Life Quality Index 
(CDLQI) and should continue to complete the CDLQI for the duration of the study. 
DLQI/CDLQI is completed by the patient in the study clinic. 
8.3.3. 
EQ-5D 
EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and 
anxiety/depression. The EQ VAS records the patient’s self-rated health on a vertical visual 
analogue scale. The scores on these five dimensions can be presented as a health profile or can 
be converted to a single summary index number (utility) reflecting preferability compared to 
other health profiles. EQ-5D is completed by the patient in the study clinic. 
8.3.4. 
Patient-Reported Outcomes Measurement Information System: Anxiety and 
Depression 
Patient-Reported Outcomes Measurement Information System is a set of person-centered 
measures that evaluates and monitors physical, mental, and social health in adults and children. 
Pediatric and tools for anxiety and depression. Patients ≤17 years will complete pediatric 
versions for the duration of the study. The PROMIS measures will be completed by the patient in 
the study clinic. 
8.3.5. 
Asthma Control Questionnaire  
Patients who report comorbid asthma prior to enrollment will complete the ACQ-5) in addition 
to other patient reported outcomes in this trial. The ACQ-5 has been shown to reliably measure 
asthma control and distinguish patients with well-controlled asthma (score ≤0.75 points) from 
those with uncontrolled asthma (score ≥1.5 points). It consists of 5 questions that are scored on a 
7-point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of 
all questions; a lower score represents better asthma control. ACQ-5 is completed by the patient 
in the study clinic. 

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8.4. 
Assessment of Safety 
8.4.1. 
Physical Examination 
A complete physical examination will be conducted at screening and cover general appearance, 
dermatological, head, ears, eyes, nose, throat, respiratory, cardiovascular, abdominal, 
neurological, musculoskeletal, and lymphatic body systems. Height and weight will also be 
recorded. At subsequent study visits, a symptom-directed physical examination may be 
conducted at the discretion of the Investigator. Findings will be recorded as medical history or 
AE in the eCRF. 
8.4.2. 
Vital Signs 
Vital signs, including body temperature, respiratory rate (breath per minute), pulse (beats per 
minute), and blood pressure (mmHg), will be obtained with the patient in the seated position, 
after sitting for at least 5 minutes. Any abnormal findings which are new or worsened in severity 
and clinically significant, in the opinion of the Investigator, will be recorded as an AE. Vital sign 
measurements will be recorded in the eCRF. 
8.4.3. 
Laboratory Evaluations  
Laboratory tests will be analyzed using a central laboratory and include hematology with 
differential, serology, a standard chemistry panel (including liver-function tests), total 
cholesterol, standard urine testing, and urine pregnancy test for women who are not post-
menopausal or surgically sterile. Blood and urine will be collected from each patient as specified 
in the Schedule of Visits and Procedures or as clinically indicated. Laboratory data will be 
transferred to the clinical database. 

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Table 3: 
Laboratory Parameters 
Hematology 
Chemistry 
Urine 
Hormones 
CBC with differential: 
Hematocrit (HCT) 
Hemoglobin (HGB) 
Red blood cells (RBC) 
White blood cells 
(WBC) 
Mean corpuscular 
hemoglobin (MCH) 
MCH concentration 
(MCHC) 
Mean corpuscular 
volume (MCV) 
RBC morphology 
Platelet count 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
 
Screening Only:  
HIV Antibody (HIV Ab) 
Hepatitis B Antibody 
(HBcAb) 
Hepatitis B Antigen 
(HBsAg) 
Hepatitis C Antibody 
(Hep C Ab) 
 
Sodium 
Potassium 
Chloride  
Calcium 
Phosphorus 
Bicarbonate 
Uric Acid 
Blood urea nitrogen 
(BUN) 
Creatinine 
Total Protein 
Albumin 
Aspartate 
aminotransferase (AST) 
Alanine aminotransferase 
(ALT) 
Lactic dehydrogenase 
(LDH) 
Gamma-glutamyl 
transpeptidase (GGT) 
Alkaline phosphatase 
Bilirubin (total and direct) 
Total cholesterol 
Non-fasting glucose 
 
For All Female Patients 
(WOCBP) At Screening: 
Serum beta human 
chorionic gonadotropin (β-
hCG) 
pH 
Specific gravity 
Protein 
Glucose 
Ketones 
Bilirubin 
Blood 
Nitrite 
Urobilinogen 
Leukocyte esterase  
 
At All Visits Except 
Screening (WOCBP 
only): 
Urine beta human 
chorionic gonadotropin 
(β-hCG) 
Estradiol (for adolescent 
females only) 
Testosterone (for 
adolescent males only) 
8.4.4. 
Adverse Events  
Adverse events will be monitored throughout the study. Patients will be instructed to inform the 
Investigator and/or study staff of any AEs. At each visit, patients will be asked about AEs in a 
non-specific manner using open-ended questions so as not to bias the response (e.g., How have 
you been since the last visit?). Specific inquiry regarding reported AEs will be conducted when 
applicable. All AEs will be documented and recorded in the patient’s eCRF. 
Any patient who has an AE (serious or non-serious) will be evaluated by the Investigator and 
treated and followed until the symptom(s) return to normal or to clinically acceptable levels, as 
judged by the Investigator. A physician, either at the clinical site, or at a nearby hospital 
emergency room, will administer treatment for any serious AEs (SAEs), if necessary. When 

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

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

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• 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 an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
intervention under clinical investigation are met. 
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 an SAE or other specific 
safety information (e.g., summary or listing of SAEs) from the sponsor will review and then file 
it along with the Investigator’s Brochure and will notify the IRB/IEC, if appropriate according to 
local requirements. 
8.4.5. 
Product Complaints  
 
A product complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, durability, reliability, safety, effectiveness or performance of a 
trial intervention. The sponsor collects product complaints on investigational products and drug 
delivery systems used in clinical studies in order to ensure the safety of study participants, 
monitor quality, and to facilitate process and product improvements. Participants will be 
instructed to contact the investigator as soon as possible if he or she has a complaint or problem 
with the investigational product or drug delivery system so that the situation can be assessed. 

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Time Period for Detecting Product Complaints 
●    Product complaints that result in an adverse event will be detected, documented, 
and reported to the sponsor during all periods of the study in which the drug is 
used. 
●    If the investigator learns of any product complaint at any time after a participant 
has been discharged from the study, and such incident is considered reasonably 
related to a drug provided for the study, the investigator will promptly notify the 
sponsor. 
Prompt Reporting of Product Complaints to Sponsor 
●    Product complaints will be reported to the sponsor within 24 hours after the 
investigator becomes aware of the complaint. 
●    The Product Complaint Form will be sent to the sponsor. 
Follow-up of Product Complaints 
●    Follow-up applies to all participants, including those who discontinue study 
intervention. 
●    The investigator is responsible for ensuring that follow-up includes any 
supplemental investigations as indicated to elucidate the nature and/or causality of 
the product complaint. 
●    New or updated information will be recorded on the originally completed form with all 
changes signed and dated by the investigator and submitted to the sponsor 
8.4.6. 
Pregnancy 
The Investigator must 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. 
8.4.7. 
Hypersensitivity Reactions 
Patients experiencing any hypersensitivity reaction should receive appropriate symptomatic 
medical care, as needed. Patients should be instructed to inform the site if a hypersensitivity 
reaction occurs. At the next study visit, a blood sample must be collected for immunogenicity 
analysis. The Sponsor or designee should be immediately consulted, particularly if the 

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hypersensitivity reaction might be attributed to the study drug, and particularly if the reaction is 
severe, for discussions about discontinuing the study medication. 
8.5. 
PK and ADA Sampling 
Serum PK and ADA samples will be collected in all patients. Positive ADA results may be 
further evaluated for neutralizing antibodies. The procedural instructions will be provided in a 
separate PK and Serum Antibody Sampling manual. 
8.6. 
Study Termination 
The Sponsor has the right to terminate the study at any time. Should the study be terminated, the 
decision and reason will be communicated in writing by the Sponsor to the Investigator and 
request that all patients be discontinued. Patients should be scheduled for an Early Termination 
visit. The entire study will be stopped if: 
• Evidence has emerged that, in the collective opinion of the Investigators at each site with 
the concurrence of the Sponsor, or the sole opinion of the Sponsor, continuation of the 
study is unnecessary or unethical 
• The stated objectives of the study are achieved 
• The Sponsor discontinues the development of the study drug 
All data available for the patient at the time of study discontinuation must be recorded in the 
patient’s records and the eCRF. 
8.6.1. 
Early Termination of Study Patients 
The Investigator will make reasonable efforts to keep each patient in the study. However, 
patients may terminate or be terminated early from the study for the following reasons: 
• Voluntarily withdrawal of consent to participate in the study participation, at any time 
• Adverse event, laboratory abnormality or inter-current illness which, in the opinion of the 
Investigator, indicates that continued treatment and/or participation in the study is not in 
the best interest of the patient 
• Serious protocol violation, persistent non-compliance or requirement for medication or 
procedure prohibited by the protocol 
• Lost to follow-up 
Patients who are terminated early from the study will have an Early Termination visit scheduled 
as soon as possible (see Section 7.12). All information, including the reason for early termination 
will be recorded in the patient’s study records and in the eCRF.  
Two attempts of contact (e.g., telephone contact) followed by a certified letter of contact to the 
patient must be documented in a patient’s study records for all patients who are believed to be 
lost to follow-up.  
8.6.2. 
Study Drug Discontinuation 
Study drug must be discontinued for patients who experience the following: 

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• Inter-current illness that would, in the judgment of the Investigator, affect assessments of 
clinical status to a significant degree 
• Treatment-related AEs that are clinically significant, deemed persistent, in the judgment 
of the Investigator 
• Unacceptable toxicity 
• Pregnancy 
• Use of systemic rescue medication as outlined in Section 6.4  
Patients who discontinue study drug permanently during study participation must be scheduled 
for an Early Termination visit except those receiving systemic rescue medication, as per the 
Section 6.4 . 
8.7. 
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 DMC charter. 
9. 
STATISTICAL CONSIDERATIONS 
9.1. 
General Statistical Methodology 
All statistical processing will be performed using SAS® unless otherwise stated. Except where 
noted, all statistical tests will be two-sided and will be performed at the 0.05 level of 
significance. 
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 number of subjects (n), 
mean, standard deviation (SD), median, minimum and maximum. Appropriate inferential 
statistics will be used for the primary and secondary efficacy variables. For dichotomous 
variables, the CMH analysis will be used. For continuous variables, an analysis of covariance 
(ANCOVA) will be used with factors of treatment and randomization strata and relevant baseline 
value. More details will be specified in the statistical analysis plan (SAP). 
 
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 

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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. The Sleep-Loss weekly mean will be calculated 
similar to the Pruritus-NRS weekly mean.  All Sleep-Loss efficacy endpoint analyses will be 
conducted on the weekly mean. 
The primary method of handling missing efficacy data will be as follows for both binary and 
continuous endpoints: for patients who receive rescue medication (Section 6.4 for definition of 
rescue medication), use systemic corticosteroids or withdraw from the study due to lack of 
efficacy, set to the patient’s baseline value subsequent to this time through Week 16. Markov 
chain Monte Carlo (MCMC) multiple imputation will be used to handle the remaining missing 
data. MCMC multiple imputation for all missing values, Last Observation Carried Forward 
(LOCF) and Tipping Point analysis will be used for sensitivity analyses. 
Demographic data will be summarized by treatment group using descriptive statistics. Patients’ 
baseline characteristics related to efficacy analyses will be compared with descriptive statistics 
among treatment groups to ensure comparable results. 
The number of patients in each analysis set will be summarized. Reasons for study withdrawal 
during the blinded study will be summarized using frequencies and percentages by treatment 
group. 
An SAP, describing all statistical analyses will be provided as a separate document. The SAP 
will be finalized prior to unblinding of the study treatments. 
9.1.1. 
Populations Analyzed 
Approximately 225 patients (including approximately 50 adolescent patients [≥12 to <18 years 
of age and weighing ≥40 kg]) will be randomized to lebrikizumab 250 mg Q2W or placebo 
treatment groups in a 2:1 ratio. Efficacy analyses will be performed using the intent-to-treat 
(ITT) population and the per-protocol (PP) population. Safety analyses will be performed using 
the safety population. 
All patients who are randomized will be included in the ITT population. 
All patients who are randomized and receive at least one confirmed dose of study drug will be 
included in the safety population. 
The PP population will include all patients in the ITT population who complete the Week 16 
evaluation without any significant protocol violations (i.e., any patient or Investigator activity 
that could have possibly interfered with the therapeutic administration of the treatment or the 
precise evaluation of treatment efficacy). The PP population will include patients in the safety 
population who do not meet any of the following criteria: 
• Violated the inclusion/exclusion criteria; 
• Used an interfering concomitant medication (see Section 6.1 for definitions of interfering 
concomitant medications) or underwent a prohibited procedure; 
• Did not attend the Week 16 visit; 
• Missed more than one post-baseline study visit prior to Week 16; 

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• Have not been compliant with the dosing regimen (i.e., patients must receive at least 75% 
of the expected injections of study medication during participation in the study); 
• Out of visit window at the Week 16 visit by more than ±4 day. 
Patients that discontinue from the study due to an adverse event related to study treatment or 
documented lack of treatment effect will be included in the PP population. Prior to breaking the 
blind, other additional criteria may be added to the list to accommodate for unforeseen events 
that occurred during the conduct of the trial that result in noteworthy study protocol violations. 
9.2. 
Primary Efficacy Analysis 
For FDA: 
The primary endpoint is the percentage of patients with an IGA 0 or 1 and a reduction ≥2-points 
from Baseline to Week 16 and will be analyzed using the Cochran-Mantel-Haenszel test adjusted 
by randomization strata (region, disease severity, age).  
For EMA: 
Both co-primary endpoints: 
• Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2 points from baseline 
to Week 16, and 
• Percentage of patients achieving EASI-75 (≥75% reduction from baseline in EASI score) at 
Week 16 
will be analyzed using the Cochran-Mantel-Haenszel test adjusted by randomization strata 
(region, disease severity, age).  
9.3. 
Missing Data 
The primary method of handling missing efficacy data will be as follows for both binary and 
continuous endpoints: for patients who receive topical rescue medication (per Section 6.4), 
receive systemic rescue medication or withdraw from the study due to lack of efficacy, set to the 
patient’s baseline value subsequent to this time through Week 16. MCMC multiple imputation 
will be used to handle the remaining missing data. Imputation will be conducted within each 
treatment group independently so the pattern of missing observations in one treatment group 
cannot influence missing value estimations in another. For each imputation process, 25 datasets 
with imputations will be calculated. Each complete data set will be analyzed with the specified 
analysis. The results from these analyses will be combined into a single inference using SAS 
PROC MIANALYZE. 
For binary responses related to EASI and IGA, the binary response variables will be calculated 
based on the multiply imputed datasets that have been created. Because the MCMC algorithm is 
based on the multivariate normal model, imputed values for IGA will not generally be one of the 
discrete values used in IGA scoring (0, 1, 2, 3, or 4). Therefore, to derive the binary IGA 
response variable, standard rounding rules will be applied to the imputed values. For example, if 
a patient has an IGA score imputed as 1.4 (and assuming a Baseline IGA score of 3), the imputed 
value would be rounded down to 1, and the minimum change from Baseline of 2 would have 
been met. This patient would be considered a responder. 

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For derivation of an EASI-75 response, no rounding will be performed. The imputed Week 16 
EASI value will be compared directly to the observed Baseline EASI value to determine whether 
a reduction of at least 75% was achieved. 
Imputation of continuous data will parallel that of binary variables.  
A total of 4 random seeds will be needed to impute IGA for the two treatment groups. The two 
seeds have been pre-specified by a random-number generator: 
• IGA: Lebrikizumab 250 mg Q2W: Seed = 970309630 
• IGA: Placebo Q2W: Seed = 1477266806 
A total of 2 random seeds will be needed to impute Pruritus NRS for the two treatment groups. 
The two seeds have been pre-specified by a random-number generator: 
• NRS: Lebrikizumab 250 mg Q2W: Seed = 1611917356 
• NRS: Placebo Q2W: Seed = 1087836192 
A total of 2 random seeds will be needed to impute EASI for the two treatment groups. Those 
2 random seeds have been pre-specified by using a random number generator: 
• EASI: Lebrikizumab 250 mg Q2W: Seed = 353985587  
• EASI: Placebo Q2W: Seed = 1828572477 
9.4. 
Sensitivity Analyses 
9.4.1. 
All Missing Values MCMC Multiple Imputation 
In this set of sensitivity analysis, the non-missing assessed values as collected for visits 
subsequent to rescue medication use will be used. Otherwise, missing values will be imputed 
using MCMC multiple imputation for the primary endpoint of an IGA 0 or 1 and a ≥2-point 
reduction from Baseline to Week 16 and the following secondary endpoints: EASI-75, EASI-90 
and Pruritus-NRS Improvement ≥4 points, all at Week 16.  
 
9.4.2. 
Last Observation Carried Forward (LOCF) 
In this set of sensitivity analysis, the non-missing assessed values as collected for visits 
subsequent to rescue medication use will be used. Otherwise, missing values will be imputed 
using LOCF for the primary endpoint of an IGA 0 or 1 and a ≥2-point reduction from Baseline to 
Week 16 and the following secondary endpoints: EASI-75, EASI-90 and Pruritus-NRS 
Improvement ≥4 points, all at Week 16.  
9.4.3. 
Non-Response Imputation 
In this set of sensitivity analysis, for patients who receive topical rescue medication (per 
Section 6.4 ), receive systemic rescue medication and any other missing values, set to non-
response subsequent to this time through Week 16 for primary endpoint and the following 
secondary endpoints: EASI-75, EASI-90, and Pruritus-NRS Improvement ≥4 points, all at Week 
16. 

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9.4.4. 
Tipping Point Analysis 
Assuming the primary analyses results of endpoints are statistically significant, in this set of 
sensitivity analysis, assumptions on missing data due to rescue medication and study 
discontinuation will be varied to investigate if there will be any tipping points. To assess the 
impact of rescue medication and missing data due to dropout, the rates of response and non-
response (including rescue medication use and dropout) will be varied to assess the response 
rates that tip significant differences to non-significance. The primary endpoint of an IGA 0 or 1 
and a ≥2-point reduction from Baseline to Week 16 and the following secondary endpoints: 
EASI-75, EASI-90 and Pruritus-NRS improvement ≥4-points, all at Week 16 will be assessed 
using the tipping point analysis. 
More details about missing value imputation analysis will be described in the SAP. 
9.4.5. 
Subgroup Analyses 
Subgroup analyses will be conducted for the ITT populations for the following subgroups: 
Adolescents (Age 12 to <18 years) vs. Adults (Age ≥18 years), sex, race, baseline IGA score 
(3 or 4), region (US, Europe, Rest of the World). Subgroup analysis will be conducted on the 
primary endpoint of IGA (0,1), EASI-75, EASI-90 and percent of patients with pruritus 
improvement ≥4 points, all at Week 16. 
Sensitivity analyses will be addressed in a full statistical analysis plan.  
9.5. 
Multiplicity Considerations 
 
The prespecified graphical multiple testing approach (Bretz et al. 2011) will be implemented to 
control the overall Type I error rate at 2-sided alpha of 0.05 for superiority tests for the 
hypotheses for the primary and major secondary endpoints.  The graphical approach is a closed 
testing procedure; hence it strongly controls the family-wise error rate across all endpoints 
(Alosh et al. 2014).  The major secondary endpoints will be pre-specified in the SAP prior to the 
first unblinded analysis. 
 
FDA objectives: 
The graphical testing scheme will test IGA (0,1) first before proceeding to test the major 
secondary endpoints.  Details of the specific graphical testing scheme (including testing order, 
interrelationships, Type I error allocation for the major secondary endpoints, and the associated 
propagation) will be pre-specified in the SAPs prior to first unblinded efficacy analysis. 
 
EMA objectives: 
The Week 16 endpoints of IGA (0,1) and EASI-75 represent a primary endpoint family.  The 
graphical testing scheme will sequentially test IGA (0,1) first, followed by EASI-75 before 
proceeding to test the major secondary endpoints.  Details of the specific graphical testing 
scheme (including testing order, interrelationships, Type I error allocation for the major 
secondary endpoints, and the associated propagation) will be pre-specified in the SAPs prior to 
first unblinded efficacy analysis. 

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9.6. 
PK Analysis 
Plasma concentration data will be tabulated and summarized (geometric mean, arithmetic mean, 
minimum, maximum, SD, and % coefficient of variation) by treatment group for each visit at 
which samples were taken. 
It is intended that data from this study will be combined with data from other studies to better 
characterize the PK of DRM06, 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. 
9.7. 
Anti-Drug Antibody Data Analysis 
The ADA variables will be analyzed using descriptive statistics. Drug concentration data will be 
examined and the influence of ADAs on individual concentration-time profiles will be evaluated. 
Assessment of impact of ADA on safety and efficacy may be provided. 
It is intended that data from this study will be combined with data from other studies to better 
characterize the PK of DRM06, 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 
9.8. 
Immunogenicity Data Analysis 
Listings and appropriate summary statistics will be provided for immunogenicity data. 
9.9. 
Exposure and Compliance 
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 
number and percentage of patients who are compliant. An injection is considered the full set of 
injections specified by the protocol for a given treatment.  
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. 
9.10. 
Adverse Events 
All AEs occurring during the study will be recorded and coded using the MedDRA dictionary. 
Treatment-emergent AEs (TEAEs) are defined as AEs with an onset date on or after the date of 
the first injection of study drug. TEAEs will be summarized by treatment group, including the 
number of patients reporting an event, system organ class, preferred term, severity, relationship 
to study drug, and seriousness for the safety population. All serious AEs as well as AEs that led 
to study discontinuation will be listed by patient. 
AE tabulations will be summarized and presented. The denominator used for the treatment 
period will correspond to the number of patients in the safety population.  

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9.11. 
Other Safety Data 
Laboratory data will be presented in a by patient listing. Any clinically significant laboratory 
abnormalities will be captured as AEs. Changes from Baseline in safety laboratory values will be 
summarized by treatment group at each follow-up evaluation during the treatment period using 
descriptive statistics or frequency tables as applicable. Tables and listings will be in SAS format. 
Additionally, changes from Baseline in safety laboratory values will be summarized using shift 
tables according to normal ranges.  
Vital signs will be presented by treatment group as absolute values and changes from Baseline 
using descriptive statistics. 
Medical histories will be coded using the MedDRA dictionary and presented in a by-patient 
listing. Concomitant medications will be coded using the WHO-Drug dictionary. Concomitant 
medications will be summarized by treatment, drug class, and preferred term. Physical 
examination data will be presented in a by-patient listing. Growth monitoring of adolescents will 
be summarized. 
9.12. 
Sample-Size Determination 
For FDA 
Approximately 225 patients will be randomized at a 2:1 ratio to lebrikizumab or placebo (150 
patients:75 patients).  The assumed IGA score of 0 or 1 at Week 16 response rates are 38% for 
lebrikizumab 250 mg Q2W and 13% for placebo.  The assumption for lebrikizumab is based on 
the DRM06-AD01 Phase 2b study, the proportion of patients who achieved an IGA score of 0 or 
1 at Week 16 using the rescue medication non-response sensitivity analysis, adjusting for the 
allowed use of TCS/TCI.  The placebo response rates are based on the review of historical TCS 
clinical studies in atopic dermatitis (Simpson et al. 2016). This study has power >95% for testing 
superiority of lebrikizumab to placebo based on a two-sided Fisher’s exact test with alpha of 
0.05. 
For EMA: 
Approximately 225 patients will be randomized at a 2:1 ratio to lebrikizumab or placebo (150 
patients:75 patients).  The assumed IGA score of 0 or 1 at Week 16 response rates are 38% for 
lebrikizumab 250 mg Q2W and 13% for placebo.  The assumed EASI75 response rate at Week 
16 response rates are 58% for lebrikizumab 250 mg Q2W and 20% for placebo.  The 
assumptions for lebrikizumab are based on the DRM06-AD01 Phase 2b study, the proportion of 
patients who achieved an IGA score of 0 or 1 and proportion of patients who achieved EASI75 
response at Week 16 using the rescue medication non-response sensitivity analysis, adjusting for 
the allowed use of TCS/TCI.  The placebo response rates are based on the review of historical 
TCS clinical studies in atopic dermatitis (Simpson et al. 2016). This study has power >95% for 
testing superiority of lebrikizumab to placebo based on a two-sided Fisher’s exact test with alpha 
of 0.05.  
9.13. 
Interim Analyses 
A database lock and unblinding will occur, and the analysis will be performed at the time (that is, 
a cut-off date) the last patient completes Week 16 or the early termination visit from the 
study.  This database lock will include all data collected by the cut-off date.  This analysis will be 

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treated as the primary analysis because all primary and major secondary study objectives will be 
assessed at this time. A final database lock will then be conducted after all patients have 
completed the follow-up period of Study AD06. 
 
 

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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 and that the patient’s 
medical records may be examined by Clinical Quality Assurance auditors or other authorized 
personnel appointed by the sponsor, by appropriate IRB/IEC members, and by inspectors from 
regulatory authorities. The ICF will also inform the patient that his/her personal study-related 
data will be used by the sponsor in accordance with local data protection law; the ICF will 
describe the level of disclosure of data and seek appropriate consent from the patient for his/her 
data to be used in the manner described. 
Prior to the beginning of the study, the Investigator will have the IRB/IEC’s written opinion 
(approval/favorable) of the written informed consent form and any other information to be 
provided to the patients. 
The Investigator must provide the patient or legally acceptable representative with a copy of the 
consent form and written information about the study in the language in which the patient is most 
proficient. The language must be non-technical and easily understood. The Investigator should 
allow time necessary for patient or patient's legally acceptable representative to inquire about the 
details of the study, then informed consent must be signed and personally dated by the patient or 
the patient's legally acceptable representative, by the Investigator and/or by the person who 
conducted the informed consent discussion. The patient or legally acceptable representative 
should receive a copy of the signed informed consent and any other written information provided 
to study patients prior to patient's participation in the study. 
The informed consent and any other information provided to patients or the patient's legally 
acceptable representative, should be revised whenever important new information becomes 
available that is relevant to the patient's consent, and should receive IRB/IEC approval/ favorable 
opinion prior to use. The Investigator, or a person designated by the Investigator should fully 
inform the patient or the patient's legally acceptable representative of all pertinent aspects of the 
study and of any new information relevant to the patient's willingness to continue participation in 
the study. This communication to the patient should be documented in the source note.  
During a patient's participation in the study, any updates to the consent form or to the written 
information will be provided to the patient in writing. 

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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. 
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 electronic Case Repot Form 
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. 
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 

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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.  
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. 
10.5. 
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 
Alosh M, Bretz F, Huque M. Advanced multiplicity adjustment methods in clinical trials. Stat 
Med. 2014;33(4):693-713 
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. 
Bretz F, Posch M, Glimm E, Klinglmueller F, Maurer W, Rohmeyer K. Graphical approaches for 
multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests. 
Biom J. 2011;53(6):894-913. 
Choy DF, Hsu DK, Seshasayee D, et al. Comparative transcriptomic analyses of atopic 
dermatitis and psoriasis reveal shared neutrophilic inflammation. J Allergy Clin Immunol. 
2012;130(6):1335-1343. 
Czarnowicki T, He H, Krueger JG, Guttman-Yassky E. Atopic dermatitis endotypes and 
implications for targeted therapeutics. J Allergy Clin Immunol. 2019;143(1):1-11. 
Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic 
dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad 
Dermatol. 2014;70(2):338-351.  
Esche C, de Benedetto A, Beck LA. Keratinocytes in atopic dermatitis: inflammatory signals. 
Curr Allergy Asthma Rep. 2004;4(4):276-284. 
Flohr C, Irvine AD. Systemic therapies for severe atopic dermatitis in children and adults. 
J Allergy Clin Immunol. 2013;132(3):774-774.e6. 
Hamid Q, Naseer T, Minshall EM, Song YL, Boguniewicz M, Leung DY. In vivo expression of 
IL-12 and IL-13 in atopic dermatitis. J Allergy Clin Immunol. 1996;98(1):225-231. 
He JQ, Chan-Yeung M, Becker AB, et al. Genetic variants of the IL13 and IL4 genes and atopic 
diseases in at-risk children. Genes Immun. 2003;4(5):385-389. 
Howell MD, Fairchild HR, Kim BE, et al. Th2 cytokines act on S100/A11 to downregulate 
keratinocyte differentiation. J Invest Dermatol. 2008;128(9):2248-2258. 
Hua TC, Hwang CY, Chen YJ et al. The natural course of early-onset atopic dermatitis in 
Taiwan: a population-based cohort study. Br J Dermatol. 2014;170(1):130-135.  
Hummelshoj T, Bodtger U, Datta P, et al. Association between an interleukin-13 promoter 
polymorphism and atopy. Eur J Immunogenet. 2003;30(5):355-359. 
Illi S, von Mutius E, Lau S, et al. The natural course of atopic dermatitis from birth to age 
7 years and the association with asthma. J Allergy Clin Immunol. 2004;113(5):925-931. 

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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. 
Kim BE, Leung DY, Boguniewicz M, Howell MD. Loricrin and involucrin expression is down-
regulated by Th2 cytokines through STAT-6. Clin Immunol. 2008;126(3):332-337. 
La Grutta S, Richiusa P, Pizzolanti G, et al. CD4(+)IL-13(+) cells in peripheral blood well 
correlates with the severity of atopic dermatitis in children. Allergy. 2005;60(3):391-395. 
Neis MM, Peters B, Dreuw A, et al. Enhanced expression levels of IL-31 correlate with IL-4 and 
IL-13 in atopic and allergic contact dermatitis. J Allergy Clin Immunol. 2006;118(4):930-
937. 
Novak N, Kruse S, Kraft S, et al. Dichotomic nature of atopic dermatitis reflected by combined 
analysis of monocyte immunophenotyping and single nucleotide polymorphisms of the 
interleukin-4/interleukin-13 receptor gene: the dichotomy of extrinsic and intrinsic atopic 
dermatitis. J Invest Dermatol. 2002;119(4):870-875. 
Purwar R, Werfel T, Wittmann M. IL-13-stimulated human keratinocytes preferentially attract 
CD4+CCR4+ T cells: possible role in atopic dermatitis. J Invest Dermatol. 
2006;126(5):1043-1051. 
Sampson HA, Munoz-Furlong A, Campbell RL, et al. Second symposium on the definition and 
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Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin 
Immunol. 2006;117(2):391-397. 
Silverberg JI. Public Health Burden and Epidemiology of Atopic Dermatitis. Dermatol Clin. 
2017;35(3):283-289. 
Simon D, Wollenberg A, Renz H, Simon HU. Atopic Dermatitis: Collegium Internationale 
Allergologicum (CIA) Update 2019. Int Arch Allergy Immunol. 2019;178(3):207-218. 
Simpson E, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo 
in atopic dermatitis. N Engl J Med. 2016; 375:2335-2348 
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. 

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Treister AD, Lio PA. Long-term off-label dupilumab in pediatric atopic dermatitis: A case series. 
Pediatr Dermatol. 2019;36(1):85-88.  
Van Bever HP, Llanora G. Features of childhood atopic dermatitis. Asian Pac J Allergy 
Immunol. 2011;29(1):15-24. 
Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine AD. Atopic dermatitis. Nat Rev Dis 
Primers. 2018;4(1):1. 
Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122. 
Werfel T, Allam JP, Biedermann T, et al. Cellular and molecular immunologic mechanisms in 
patients with atopic dermatitis. J Allergy Clin Immunol. 2016;138(2):336-349. 
Williams H, Stewart A, von Mutius E, et al. Is eczema really on the increase worldwide? 
J Allergy Clin Immunol. 2008;121(4):947-954.e15. 
Zuberbier, T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic 
dermatitis. J Allergy Clin Immunol. 2006;118(1):226-232. 
 

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12. 
APPENDICES 
APPENDIX 1. SCHEDULE OF VISITS AND PROCEDURES 
Table 4: 
Treatment Period Screening through Week 16 and Safety Follow-Up 
Study Procedure 
Screening 
Baseline 
Treatment Period 
Safety 
F/U1 
Day (D); Week (W) 
D-30 to -7 
D1 
W2 
W4 
W6 
W8 
W10 
W12 
W14 
W16 / ET 
W26 
Visit Window 
 
 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
Informed Consent/Assent 
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
X 
X 
 
 
 
 
 
 
 
 
 
Med History/Demographics 
X 
X 
 
 
 
 
 
 
 
 
 
Review of immunization record (for 
adolescents) 
X 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
Safety 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Physical Exam, Weight/Height 
X 
 
 
 
 
 
 
 
 
X 
 
Adverse Events 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Con Meds/Procedures 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Laboratory Testing  
 
HIV, Hepatitis 
X 
 
 
 
 
 
 
 
 
 
 
Hematology, Chemistry  
X 
 
 
 
 
X 
 
 
 
X 
 
Estradiol or Testosterone2 
X 
 
 
 
 
 
 
 
 
X 
 
Urinalysis  
X 
 
 
 
 
X 
 
 
 
X 
 
Pregnancy Test  
Serum 
Urine 
 
Urine 
 
Urine 
 
Urine 
 
Urine 
 
Pre-dose PK 
 
X 
 
X 
 
 
 
 
 
X 
X 

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Study Procedure 
Screening 
Baseline 
Treatment Period 
Safety 
F/U1 
Pre-dose ADA3 
 
X 
 
X 
 
 
 
 
 
X 
X 
Table 4: 
Treatment Period Screening through Week 16 and Safety Follow-Up (Continued) 
Study Procedure 
Screening 
Baseline 
Treatment Period 
Safety F/U1 
Day (D); Week (W) 
D-30 to -7 
D1 
W2 
W4 
W6 
W8 
W10 
W12 
W14 
W16 / ET 
W26 
Visit Window 
 
 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
Efficacy 
 
IGA; EASI; BSA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
SCORAD 
 
X 
 
 
 
 
 
 
 
X 
 
E-Diary: Pruritus, Sleep- loss, (daily) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
E-Diary: POEM (weekly) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Patient Reported Outcomes / Quality of Life 
 
DLQI/CDLQI*  
 
X 
 
X 
 
X 
 
X 
 
X 
 
EQ-5D*  
 
X 
 
 
 
 
 
 
 
X 
 
ACQ-5* 
 
X 
 
 
 
 
 
 
 
X 
 
PROMIS Anxiety and Depression Measures* 
 
X 
 
 
 
 
 
 
 
X 
 
Treatment 
 
 
Administer study drug 
 
Loading dose 
Loading dose 
X 
X 
X 
X 
X 
X 
 
 
1 For patients terminating early or not rolling into the long term extension study, a safety follow-up will occur 12 weeks after last dose of study medication. 
2 Collect estradiol in adolescent female participants only. Collect testosterone in adolescent male participants only. 
3 nAB testing conducted for positive treatment-emergent ADA responses. Additional immunogenicity sample collected for any patient experiencing a 
hypersensitivity reaction during study. 
*Patient reported outcomes and quality of life measures should all be completed prior to other study assessments. 

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APPENDIX 2. AMERICAN ACADEMY OF DERMATOLOGY 
CONSENSUS CRITERIA FOR CHRONIC ATOPIC 
DERMATITIS 
Atopic dermatitis: Diagnosis recommendations 
Patients with presumed atopic dermatitis should have their diagnosis based on the criteria 
summarized below. On occasion, skin biopsy specimens or other tests (such as serum 
immunoglobulin E, potassium hydroxide preparation, patch testing, and/or genetic testing) may 
be helpful to rule out other or associated skin conditions.  
Level of Evidence: III Strength of Recommendation: C 
Essential features — must be present: 
• Pruritus  
• Eczema (acute, subacute, chronic) 
• Typical morphology and age specific patterns* 
• Chronic or relapsing history 
*Patterns include: 
1. Facial, neck, and extensor involvement in infants and children 
2. Current or previous flexural lesions in any age group 
3. Sparing of the groin and axillary regions 
Important features — seen in most cases, adding support to the diagnosis: 
• Early age of onset 
• Atopy 
• Personal and/or family history 
• Immunoglobulin E reactivity 
• Xerosis 
Associated features — These clinical associations help to suggest the diagnosis of atopic 
dermatitis but are too nonspecific to be used for defining or detecting atopic dermatitis for 
research and epidemiologic studies: 
• Atypical vascular responses (eg facial pallor, white dermographism, delayed blanch 
response) 
• Keratosis pilaris/ pityriasis alba/ hyperlinear palms/ icthyosis 
• Ocular/periorbital changes 

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• Perifollicular accentuation/ lichenification/ prurigo lesions 
Exclusionary conditions — It should be noted that a diagnosis of atopic dermatitis depends on 
excluding conditions, such as: 
• Scabies 
• Seborrheic dermatitis 
• Contact dermatitis (irritant or allergic) 
• Icthyoses 
• Cutaneous T-cell lymphoma 
• Psoriasis  
• Photosensitivity dermatoses 
• Immune deficiency diseases 
• Erythroderma of other causes 
adapted from Eichenfield 2014.