A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis
Phase: PHASE2
Conditions: Atopic Dermatitis
Sponsor: Eli Lilly and Company

J2T-DM-KGAF Protocol (2) 
 
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy 
and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis 
 
NCT03443024 
 
Approval Date: 07-MAR-2018 

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 1 
Confidential 
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING 
TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN 
PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS  
Protocol Number 
DRM06-AD01 
Protocol Final Date 
27 November 2017 
Study Drug 
Lebrikizumab (DRM06) 
IND Number 
119866 
Sponsor
Dermira, Inc.
275 Middlefield Road 
Menlo Park, CA 94025 
USA 
Amendment (1) Date 
29 January 2018 
Amendment (2) Date 
07 March 2018 
CONFIDENTIAL INFORMATION 
The information contained herein is confidential and the proprietary property of Dermira. 
Any use or disclosure of such information without the prior written authorization of 
Dermira is expressly prohibited.  

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 2 
Confidential 
PROTOCOL AMENDMENT 2.0 (SUMMARY OF CHANGES) 
The changes in the table below are new changes being introduced to Amendment 2.0. Additions 
are noted in bold and strikethroughs are as made. Minor corrections/additions may not be 
included. 
Section 
Modified Text or Description  
Rationale 
6.5 Study-Drug 
Accountability 
The Investigator must keep an accurate record of the 
number of cartons received, the study drug 
dispensed/used, and those returned to the Sponsor or 
designee. The Sponsor will provide forms to facilitate 
inventory control. All study-drug accountability forms 
and treatment logs must be retained in the Investigator’s 
permanent study file, and these records must be 
available for inspection at any time by the Sponsor, its 
designees, or by regulatory agencies. 
The study monitor will perform drug accountability for all 
study drug at the site, and will assist in returning all 
used, unused, and expired study drug, to the 
Sponsor/designee, or verify study-drug destruction 
according to the study site’s standard operating 
procedure, if it is accepted by the Sponsor.designee. 
To accommodate 
sites with SOPs in 
place for 
destruction of 
unused study 
drug.  
6.7 Study-Drug 
Administration 
Study drug is to be administered to all patients in the 
clinic by designated and trained study personnel. Study 
drug should be prepared in advance and injected 
subcutaneously according to the following instructions:  
•
Remove study drug from refrigerated condition and
allow to warm to room temperature for 15 minutes
prior to administration. Study drug should be
administered within 4 hours.
•
Identify location for injections. Study drug may be
injected in the abdomen, upper arm, or thigh. All
injections administered at a single visit should be
given in the same area, but may be split up into
different areas for Week 0 and Week 2, which
have 4 injections/visit. Injection sites should be
≥10 cm from one another. If possible, injections
should not be administered at sites with active AD or
other skin lesions.
•
Inject study drug subcutaneously.
•
Record location of study injections in the eCRF.
•
Properly dispose of used syringe according to site
requirements. Syringe box must be kept for full drug
accountability.
Feedback from 
investigators 
indicated that 
patients may 
prefer not having 
4 injections given 
at the same site.  

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 3 
Confidential 
Section 
Modified Text or Description  
Rationale 
9.4. Laboratory 
Evaluations  
The inclusion of TB testing in Table 2 was not correct. 
It has been deleted from the table to make it consistent 
with the Schedule of Visits and Procedures in 
Appendix 1. 
TB testing was 
not intended to be 
performed for this 
study. This 
oversight is being 
corrected with this 
amendment. 
Appendix 1 
Add a checkbox for ECG assessment at Early 
termination visit 
It was 
inadvertently left 
out. 
Appendix 1  
Added collection of and procedure/therapy information. 
It was 
inadvertently left 
out. 

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 4 
Confidential 
PROTOCOL AMENDMENT 1.0 (SUMMARY OF CHANGES) 
The changes in the table below are new changes being introduced to Amendment 1.0. Additions 
are noted in bold and strikethroughs are as made. Minor corrections/additions may not be 
included. 
Section 
Modified Text or Description  
Rationale 
6.4. Study-Drug 
Unblinding 
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 will open the Code-Breaking Card 
received with the study-drug kit. The Code-Breaking 
Card should be stored in a secure, locked location 
at the site. The Investigator should have access to 
the Code-Breaking Card at all times (e.g., 24/7). is 
permitted to use the IWRS to obtain treatment 
assignment. The Investigator should consult with the 
Sponsor’s medical monitor prior to obtaining treatment 
assignment information. The Investigator must 
document (in the patient’s medical record) the date and 
time the blind was broken, the names of the personnel 
involved, and the reason that treatment assignment 
information was required. 
Because of the 
secondary 
packaging used 
for the kits in this 
study, the CRO 
was unable to 
accommodate 
use of an IWRS 
system. Instead, 
in the event of an 
unblinding, Code-
Breaking Cards 
will be used. 
6.7. Study-Drug 
Administration 
Study drug is to be administered to all patients in the 
clinic by designated and trained study personnel. Study 
drug should be prepared in advance and injected 
subcutaneously according to the following instructions:  
•
Remove study drug from refrigerated condition and
allow to warm to room temperature for 15 minutes
prior to administration. Study drug should be
administered within 4 hours.
•
Identify location for injections. Study drug may be
injected in the abdomen, upper arm, or thigh. All
injections administered at a single visit should be
given in the same area. Injection sites should be
≥10 cm from one another. If possible, injections
should not be administered at sites with active AD or
other skin lesions.
•
Inject study drug subcutaneously.
•
Record location of study injections in the eCRF.
•
Properly dispose of used syringe according to
site requirements. Syringe box must be kept for
full drug accountability.
Change of 
procedure. Sites 
will dispose of 
syringes instead 
of returning them 
to the carton. 
Study drug should 
not be left at room 
temperature for 
longer than 
4 hours.  

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 5 
Confidential 
Section 
Modified Text or Description  
Rationale 
7.2. Baseline Visit 
(Day 1) 
•
Confirm emollient use.
•
Re-assess and confirm patient eligibility
(Inclusion/Exclusion criteria).
•
Measure weight and vital signs.
•
Collect concomitant medication information.
•
Query for adverse events (AEs) since the last visit.
•
Collect a 12-lead ECG.
•
Draw blood samples for laboratory tests
(hematology and chemistry)
•
Draw a pre-dose blood sample for PK and anti-drug
antibody (ADA) testing.
•
Conduct urine for urinalysis and urine pregnancy
test (WOCBP only).
•
Dispense electronic tablet that will be used for
daily home recording of pruritus NRS, sleep-loss
NRS, and ADIQ.
•
Train patient on the use of the electronic tablet.
•
Review compliance report on the electronic tablet
for the daily assessments (pruritus NRS, sleep-loss
NRS, and ADIQ) and remind patient to continue
daily record.
•
Complete the following assessments:
−
Investigator’s Global Assessment (IGA)
−
Eczema Area and Severity Index (EASI)
−
Body Surface Area (BSA)
−
Patient Oriented Eczema Measure (POEM)
−
Dermatology Life Quality Index (DLQI)
−
Hospital Anxiety and Depression Scale (HADS)
•
Randomize the patient.
•
Administer study drug.
•
Instruct the patient to apply an emollient twice daily.
•
Schedule next visit.
Tablet will be 
dispensed at 
Baseline visit, not 
at Screening visit. 

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 6 
Confidential 
Section 
Modified Text or Description  
Rationale 
11.6. 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 applications, number of 
missed applications, and number and percentage of 
patients who are compliant. An application is 
considered the full set of injections (either 2 or 4 
depending on visit) specified by the protocol.  
A patient will be considered compliant with the dosing 
regimen if the patient received ≥75% of the expected 
number of applications while enrolled in the study. 
Clarification 
Appendix 1. 
Schedule of Visits 
and Procedures 
•
Changed D224 to D225
•
Noted that urine pregnancy test is for WOCBP
only
•
Added DLQI, HADS, and Global Assessment of
Change to Early-Termination visit.
Changes to 
reconcile the 
Schedule of Visits 
and Procedures 
with the Study 
Procedures 
Appendix 5. Body 
Surface Area 
(BSA) 
The BSA assessment estimates the extent of disease or 
skin involvement with respect to AD and is expressed 
as a percentage of total body surface.  
Determine BSA using the patient’s palm = 1% rule.  
The patient’s palm is measured from the wrist to the 
proximal interphalangeal (PIP) and thumb.  
Estimate the number of palms it takes to cover the 
affected AD area. Add up the number of palms to give a 
total estimate of the area covered in AD.  
Below are estimates when entire areas (anterior and 
posterior) are covered:  
Head and Neck = 10% (10 palms) 
Upper Extremities = 20% (20 palms) 
Trunk (axillae and groin) = 4030% (4030 palms) 
Lower extremities (buttocks) = 40% (40 palms) 
BSA scores 
adjusted to sum 
to 100%. 

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1- A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 7 
C o nfi d e nti al 
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, D O S E- R A N GI N G 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 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  
C R O P er s o n n el 
 
Pr o gr a m Dir e ct or 
 
 
 
 
S A E/ E m er g e n c y C o nt a ct I nf or m ati o n 
 
Sr. Vi c e Pr e si d e nt, Cli ni c al D e v el o p m e nt 
 
  
S p o n s or P er s o n n el  
 
 
 
 
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D

D er mir a, I nc. 
L e bri ki z u m a b 
S P O N S O R SI G N A T U R E P A G E 
D R M0 6- A D0 1 - A2 
A R A N D O M Z E D, D O U B L E- B L N D, P L A C E B O- C O N T R O L L E D, D O S E- R A N G N G T R A L T O 
E V A L U A T E T H E E F F C A C Y A N D S A F E T Y O F L E B R K Z U M A B N P A T E N T S W
T H 
M O D E R A T E- T O- S E V E R E A T O P C D E R M A T T S 
Pr ot o c ol N u m b er 
Pr ot o c ol Fi n al D at e 
A m e n d m e nt ( 1) D at e 
A m e n d m e nt ( 2) D at e 
D R M 0 6- A D 0 1 
2 7 N o v e m b er 2 0 1 7 
2 9 J a n u ar y 2 0 1 8 
0 7 M ar c h 2 0 1 8 
T h e si g n at ur e b el o w c o n stit ut e s a p pr o v al of t hi s pr ot o c ol.  c ertif y t h at  h a v e t h e a ut h orit y t o 
a p pr o v e t hi s pr ot o c ol o n b e h alf of t h e S p o n s or, D er mir a, 
n c. T h e st u d y will b e c o n d u ct e d i n 
a c c or d a n c e wit h t hi s pr ot o c ol a n d all a p pli c a bl e l a w s, r ul e s, a n d r e g ul ati o n s a n d nt er n ati o n al 
C o nf er e n c e o n H ar m o ni z ati o n G o o d Cli ni c al Pr a cti c e ( C H G C P), r e g ul ati o n s of t h e U nit e d 
St at e s ( U S) F o o d a n d Dr u g A d mi ni str ati o n ( F D A), a n d t h e et hi c al pri n ci pl e s 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 H el si n ki. 
A ut h ori z e d b y: 
S p o n s or Si g n at ur e 
 
S e ni or Vi c e Pr e si d e nt, Cli ni c al D e v el o p m e nt 
Pr ot o c ol: D R M0 6- A D0 1_ A 2 
P a g e 8
D at e 
P P D
Co nfi d e nti al 
P P D

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 9 
Confidential 
INVESTIGATOR SIGNATURE PAGE 
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) 

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 10 
Confidential 
PROTOCOL SYNOPSIS 
Title: 
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial 
to Evaluate the Efficacy and Safety of Lebrikizumab in Patients with 
Moderate-to-Severe Atopic Dermatitis  
Protocol Number: 
DRM06-AD01 
Phase: 
2b 
Number of Sites: 
Approximately 60 in the United States 
Study Population: 
Patients with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic 
therapy.  
Sample Size: 
Approximately 275  
Study Objectives: 
•
To evaluate the safety and efficacy of lebrikizumab compared with placebo in patients
with moderate-to-severe AD.
•
To evaluate the dose-response of lebrikizumab in patients with moderate-to-severe AD.
Duration of Patient Participation: 
•
Screening: Maximum duration of 30 days;
•
Treatment period: Approximately 113 days
•
Post-treatment follow-up period: Approximately 111 days
•
Maximum total participation: Approximately 257 days
Study Treatment: 
Lebrikizumab, 125 mg/mL injectable delivered in a pre-filled syringe (PFS) 
Placebo, 0 mg/mL injectable delivered in a PFS 
Study Design: 
This is a randomized, double-blind, placebo-controlled, parallel-group study. Approximately 
275 patients with moderate-to-severe AD will be enrolled into this 32-week study. 
Patients will be seen every two weeks and receive all study drug injections in the clinic. Patients 
will be evaluated for safety and efficacy through Week 16 on study. A safety follow-up visit will 
occur at Week 24 and a follow-up phone call will occur at Week 32.  
Serum PK and anti-drug antibody (ADA) will be collected from all patients. PK samples will be 
collected at Baseline, Weeks 2, 4, 8, 12, 16, and 24. ADA samples will be collected at Baseline, 
Weeks 2, 4, 16, and 24. 
Patients will be randomized 3:3:3:2 to the following treatment groups. 
Treatment Group 1: Lebrikizumab, 125 mg every 4 weeks  
Baseline: Loading dose of 250 mg (2 injections of 1 mL of 125 mg/mL drug product and 
2 injections of 1-mL placebo) 
Week 2: Four 1-mL injections of placebo 

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 11 
Confidential 
Weeks 4, 8, 12: 125 mg (one 1-mL injection of 125 mg/mL drug product and one 1-mL injection 
of placebo) 
Weeks 6, 10, 14: Two 1-mL injections of placebo 
Treatment Group 2: Lebrikizumab, 250 mg every 4 weeks 
Baseline: Loading dose of 500 mg (four 1-mL injections of 125 mg/mL drug product) 
Week 2: Four 1-mL injections of placebo 
Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL drug product) 
Weeks 6, 10, 14: Two 1-mL injections of placebo 
Treatment Group 3: Lebrikizumab, 250 mg every 2 weeks 
Baseline and Week 2: Loading dose of 500 mg (four 1-mL injections of 125 mg/mL drug 
product) 
Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL injections of 125 mg/mL drug product) 
Treatment Group 4: Placebo every 2 weeks 
Baseline and Week 2: Four 1-mL injections of placebo 
Week 4, 6, 8, 10, 12, 14: Two 1-mL injections of placebo 
Key Inclusion Criteria: 
•
Male or female, 18 years or older.
•
Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year
before the screening visit (see Appendix 2)
•
Eczema Area and Severity Index (EASI) score ≥16 at the screening and the Baseline visit.
•
Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the
Baseline visit.
•
≥10% body surface area (BSA) of AD involvement at the screening and the Baseline visit.
Key Exclusion Criteria: 
•
Treatment with any of the following agents within 4 weeks prior to the Baseline visit:
•
Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,
cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine,
methotrexate, etc.)
•
Phototherapy and photochemotherapy (PUVA) for AD.
•
Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within
1 week prior to the Baseline visit.
•
Treatment with:
•
An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is
longer, prior to the Baseline visit.
•
Dupilumab within 3 months prior to Baseline visit.
•
Cell-depleting biologics, including rituximab, within 6 months prior to the Baseline visit.
•
Other biologics within 5 half-lives (if known) or 16 weeks prior to Baseline visit
(whichever is longer).

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 12 
Confidential 
•
Use of prescription moisturizers within 7 days of the Baseline visit.
Primary Endpoint: 
•
Percent change in Eczema Area and Severity Index (EASI) from Baseline to Week 16. 
Secondary Endpoints:
•
Proportion of patients with a 75% improvement from Baseline in EASI (EASI75) at 
         Week 16.
•
Proportion of patient with an IGA score of 0 (clear) or 1 (almost clear) and a reduction 
         ≥2 points from Baseline to Week 16 (5-point scale).
•
Proportion of patients with EASI <7 at Week 16.
•
Proportion of patients achieving EASI50 and EASI90 at Week 16.
•
Percent change in the sleep-loss numerical rating scale (NRS) score from Baseline to 
         Week 16.
•
Percent change in pruritus NRS score from Baseline to Week 16.
•
Proportion of patients with pruritus NRS change of ≥3 from Baseline to Week 16.
•
Proportion of patients with pruritus NRS change of ≥4 from Baseline to Week 16.
•
Change in Body Surface Area (BSA) involved with AD from Baseline to Week 16.
•
Change from Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) score. 

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 13 
Confidential 
TABLE OF CONTENTS 
PROTOCOL AMENDMENT 2.0 (SUMMARY OF CHANGES) .................................................... 2 
PROTOCOL AMENDMENT 1.0 (SUMMARY OF CHANGES) .................................................... 4 
SPONSOR SIGNATURE PAGE ................................................................................................... 8 
INVESTIGATOR SIGNATURE PAGE .......................................................................................... 9 
PROTOCOL SYNOPSIS ............................................................................................................ 10 
TABLE OF CONTENTS ............................................................................................................. 13 
LIST OF TABLES ....................................................................................................................... 15 
LIST OF APPENDICES .............................................................................................................. 15 
1 
BACKGROUND ........................................................................................................... 16 
1.1 
Atopic Dermatitis .......................................................................................................... 16 
1.2 
Lebrikizumab ................................................................................................................ 17 
1.3 
Study Rationale and Benefit-Risk Assessment ............................................................ 17 
1.3.1 
Scientific Rationale: Evidence of the Role of IL-13 in AD ............................................. 17 
1.3.2 
Summary of Clinical Development ............................................................................... 18 
1.3.2.1 
Efficacy ......................................................................................................................... 18 
1.3.2.2 
Safety ........................................................................................................................... 19 
1.4 
Rationale for Treatment Regimen ................................................................................ 19 
1.5 
Study Conduct Statement ............................................................................................ 20 
2 
STUDY OBJECTIVES ................................................................................................. 20 
3 
STUDY ENDPOINTS ................................................................................................... 20 
3.1 
Primary Endpoint: ......................................................................................................... 20 
3.2 
Secondary Endpoints: .................................................................................................. 20 
4 
STUDY DESIGN .......................................................................................................... 20 
4.1 
Duration of the Study ................................................................................................... 20 
4.2 
Study Population and Number of Patients ................................................................... 20 
5 
SELECTION OF PATIENTS ........................................................................................ 21 
5.1 
Inclusion Criteria .......................................................................................................... 21 
5.2 
Exclusion Criteria ......................................................................................................... 21 
6 
STUDY DRUG.............................................................................................................. 23 
6.1 
Study-Drug Formulation and Presentation ................................................................... 23 
6.2 
Study-Drug Supply and Labeling .................................................................................. 23 
6.3 
Study-Drug Storage...................................................................................................... 23 
6.4 
Study-Drug Unblinding ................................................................................................. 23 
6.5 
Study-Drug Accountability ............................................................................................ 23 
6.6 
Patient Randomization ................................................................................................. 24 
6.7 
Study-Drug Administration ........................................................................................... 25 
6.8 
Concomitant Medications and Procedures ................................................................... 25 
6.9 
Permitted and Prohibited Treatments and Procedures ................................................ 26 
6.10 
Rescue Therapy ........................................................................................................... 26 
7 
Study PROCEDURES ................................................................................................. 26 
7.1 
Screening Visit ............................................................................................................. 26 
7.2 
Baseline Visit (Day 1) ................................................................................................... 27 
7.3 
Visits on Day 15, Day 29, Day 43, Day 57, Day 71, Day 85 and Day 99 (+/- 3 Day) ... 27 
7.4 
Visit Day 113 (Week 16) (+/- 3 Day) (End-of-Treatment/Early-Termination Visit) ........ 28 
7.5 
Follow-Up Visit Day 141 (Week 20) (+/- 7 Days) ......................................................... 29 
7.6 
Follow-Up Visit Day 169 (Week 24) (+/- 7 Days) ......................................................... 29 

Dermira, Inc. 
Lebrikizumab 
DRM06-AD01-A2 
Protocol: DRM06-AD01_A2 
Page 14 
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7.7 
Follow-Up Visit Phone Call, Day 225 (Week 32) (+/- 7 Days) ...................................... 30 
7.8 
Unscheduled Visits ....................................................................................................... 30 
8 
DETAILS OF ASSESSMENTS .................................................................................... 30 
8.1 
Screening Assessments ............................................................................................... 30 
8.1.1 
Demographics .............................................................................................................. 30 
8.1.2 
Medical History ............................................................................................................. 30 
8.1.3 
Disease Specific Information ........................................................................................ 30 
8.2 
Assessment of Efficacy ................................................................................................ 30 
8.2.1 
AD Assessments .......................................................................................................... 30 
8.2.1.1 
Investigator Global Assessment (IGA) ......................................................................... 30 
8.2.1.2 
Eczema Area and Severity Index (EASI) ..................................................................... 31 
8.2.1.3 
Body Surface Area (BSA)............................................................................................. 31 
8.2.1.4 
Pruritus ......................................................................................................................... 31 
8.2.1.5 
Sleep-Loss ................................................................................................................... 31 
8.2.1.6 
Atopic Dermatitis Impact Questionnaire (ADIQ) ........................................................... 31 
8.2.1.7 
Patient Oriented Eczema Measure (POEM) ................................................................ 31 
8.2.1.8 
Dermatology Life Quality Index (DLQI) ........................................................................ 32 
8.2.1.9 
Hospital Anxiety and Depression Scale (HADS) .......................................................... 32 
8.2.1.10  Global Assessment of Change–AD .............................................................................. 32 
8.2.2 
PK and ADA Sampling ................................................................................................. 32 
9 
ASSESSMENT OF SAFETY ....................................................................................... 32 
9.1 
Assessment of Safety ................................................................................................... 32 
9.1.1 
Physical Examination ................................................................................................... 32 
9.1.2 
Vital Signs .................................................................................................................... 32 
9.1.3 
ECGs ............................................................................................................................ 33 
9.1.4 
Laboratory Evaluations................................................................................................. 33 
9.1.5 
Adverse Events (AEs) .................................................................................................. 34 
9.1.5.1 
Reporting ...................................................................................................................... 35 
9.1.6 
Serious Adverse Events (SAEs) ................................................................................... 35 
9.1.6.1 
Reporting of SAEs ........................................................................................................ 36 
9.1.7 
Adverse Events of Special Interest (AESI) ................................................................... 36 
9.1.8 
Pregnancy .................................................................................................................... 37 
10 
STUDY DISCONTINUATIONS .................................................................................... 37 
10.1 
Study Termination ........................................................................................................ 37 
10.2 
Early Termination of Study Patients ............................................................................. 37 
10.3 
Study-Drug Discontinuation.......................................................................................... 38 
11 
STATISTICAL CONSIDERATIONS ............................................................................ 38 
11.1 
General Statistical Methodology ................................................................................... 38 
11.2 
Populations Analyzed ................................................................................................... 39 
11.3 
Primary Efficacy ........................................................................................................... 40 
11.4 
Secondary Efficacy....................................................................................................... 40 
11.5 
PK Analysis .................................................................................................................. 40 
11.6 
Exposure and Compliance ........................................................................................... 40 
11.7 
Adverse Events ............................................................................................................ 40 
11.8 
Other Safety Data......................................................................................................... 41 
11.9 
Sample-Size Determination.......................................................................................... 41 
12 
ADMINISTRATION ...................................................................................................... 41 
12.1 
Compliance with the Protocol ....................................................................................... 41 
12.2 
Informed Consent Procedures ..................................................................................... 41 
12.3 
Study Documentation and the eCRF ............................................................................ 42 

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12.4 
Study Monitoring .......................................................................................................... 42 
12.5 
Retention of Study Documentation............................................................................... 43 
12.6 
Acronyms ..................................................................................................................... 43 
13 
REFERENCES ............................................................................................................. 45 
14 
APPENDICES .............................................................................................................. 48 
 
LIST OF TABLES 
Table 1 
Dosing Schedule by Treatment Group ................................................................ 25 
Table 2 
Laboratory Parameters ........................................................................................ 34 
 
LIST OF APPENDICES 
Appendix 1. 
Schedule of Visits and Procedures...................................................................... 48 
Appendix 2. 
Hanifin/Rajka Diagnostic Criteria for Atopic Dermatitis ....................................... 50 
Appendix 3. 
Investigator Global Assessment (IGA) ................................................................ 51 
Appendix 4. 
Eczema Area and Severity Index (EASI)............................................................. 52 
Appendix 5. 
Body Surface Area (BSA) .................................................................................... 53 
Appendix 6. 
Pruritus Numeric Rating Scale (NRS) ................................................................. 54 
Appendix 7. 
Sleep-Loss .......................................................................................................... 55 
Appendix 8. 
Atopic Dermatitis Impact Questionnaire (ADIQ) .................................................. 56 
Appendix 9. 
Patient-Oriented Eczema Measure (POEM) ....................................................... 60 
Appendix 10.  Dermatology Life Quality Index (DLQI)................................................................ 61 
Appendix 11.  Hospital Anxiety and Depression Scale (HADS) ................................................. 63 
Appendix 12.  Global Assessment of Change‒AD ..................................................................... 64 
 
 
 

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1 
BACKGROUND 
1.1 
Atopic Dermatitis 
Atopic dermatitis (AD) is a relapsing and remitting inflammatory skin disorder that affects all age 
groups.1 It is chronic and incurable, and is characterized by skin-barrier disruption and immune 
dysregulation (largely mediated by type-2 helper T cells).1 Clinically, AD is characterized by 
xerosis, erythematous crusted eruption (dermatosis), lichenification, an impaired skin barrier, 
and intense pruritus.2 AD flares are frequently triggered by exposure to environmental factors, 
irritants, and allergens.3 
Although estimates of AD prevalence vary widely across different studies due to differences in 
data collection methodology, inconsistent age group assessment, and study periods, AD is one 
of the most common dermatologic diseases—15‒30% of children and 2‒10% of adults are 
affected, and prevalence appears to have increased over the past two to three decades.4 
There appears to be some geographic variability in prevalence. Prevalence in children has been 
estimated to be 5.9‒16.0% in Western Europe and 10.7% in the United States (US)5, 6 In adults, 
prevalence has been reported as 0.3‒2.0% in Europe, 4.9% in the United Kingdom (UK), and 
2.4‒6.0% in the US.7 With respect to disease severity, 14% of AD patients in the UK have 
moderate disease and 2% have severe disease.8 A recent US study measuring AD severity in 
children found that for 67% disease was mild, for 26% it was moderate, and for 7% it was 
severe.9 Approximately 85% of all cases of AD begin before age 5, with up to 70% of children 
having spontaneous remission before adolescence.2  
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.10 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.4 Depression, anxiety, and social dysfunction not only affect patients with AD, 
but also affect their caregivers.10 Compared with psoriasis, another common and debilitating 
skin disease, patients with AD have lower physical vitality, social functioning, role-emotional, 
and mental health scores.11 
The therapeutic approach to AD primarily consists of trigger avoidance, skin hydration with 
bathing, and use of emollients and anti-inflammatory therapies consisting predominantly of 
topical corticosteroids (TCS). In many patients, treatment with TCS provides some measure of 
symptomatic relief but does not adequately control the disease. 
In those patients who have persistent moderate-to-severe disease not responding adequately to 
TCS, guidelines outline several step-up therapeutic options.12, 13 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 U.S.), and its use is limited to patients 
≥16 years for a maximum treatment period of 8 weeks (Neoral®). Recently, the anti-IL-4R agent, 
dupilimab, was approved for the treatment of moderate-to-severe AD. Dupilimab’s mechanism 
of action is likely through inhibition of heterodimerization of the IL-4Rα/IL-13Rα1 complex, 
preventing IL-13 from initiating downstream signaling through the JAK/STAT pathway. 

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Protocol: DRM06-AD01_A2 
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1.2 
Lebrikizumab 
Lebrikizumab is a humanized monoclonal immunoglobulin (Ig) G4 antibody (huIgG4) with a 
mutation in the hinge region for increased 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 
IL-13 can still bind its receptor (IL-13 Rα1), but the receptor complex is not activated.  
Because lebrikizumab does not bind to IL-13 in mice, the most commonly used species for 
animal models of AD, it was not possible to perform in vivo lebrikizumab pharmacology or 
efficacy studies in an animal model of AD. However, several non-clinical studies in the literature 
demonstrate increased expression of IL-13 in affected skin, supporting the use of an anti-IL-13 
therapeutic for human AD.  
Two previous studies were conducted with lebrikizumab in patients with AD. They are described 
in Section 1.3.2. See the Lebrikizumab Investigator’s Brochure (IB) for additional details on 
lebrikizumab non-clinical and clinical studies. 
1.3 
Study Rationale and Benefit-Risk Assessment 
1.3.1 
Scientific Rationale: Evidence of the Role of IL-13 in AD 
AD is a T-helper type 2 (Th-2)-driven inflammatory disease. Several lines of evidence from 
published literature implicate IL-13 as a key component of AD pathobiology: 
• 
Genetic studies have shown that polymorphisms in the gene for IL-13,14, 15 and in the 
IL-4Rα receptor16 are associated with an increased risk for developing AD. 
• 
IL-13 can act on keratinocytes in the skin to downregulate their differentiation;17 and to 
induce T-cell chemoattractants that mediate T cell infiltration into AD lesions.18  
• 
Il-13 may induce IL-5 expression and eosinophil infiltration through the induction of 
eosinophil chemoattractants.19 
• 
IL-13 can reduce epithelial integrity through the downregulation of filaggrin, loricrin, and 
involucrin.20 
• 
IL-13 can mediate fibrosis through the induction of collagen production in fibroblasts.21 
• 
In an epi-cutaneous ovalbumin sensitization model of murine AD, topical anti-sense 
oligonucleotides targeting mouse IL-13 mRNA were shown to significantly reduce the 
production of IL-13 in the skin and in turn significantly reduce inflammation.22 
• 
Increased IL-13 has been reported in the serum of AD patients16 and several studies 
have reported an increase in IL-13 expressing T cells in the blood of AD patients.23-25  
• 
Increased expression of IL-13 in AD skin has been reported.26-31 
• 
Increased levels of IL-13 have been observed in AD skin lesions and reports suggest a 
relationship between IL-13 expression and the severity of disease.25 
• 
Clinical studies investigating agents with broadly acting anti-inflammatory activity 
demonstrated that reduced IL-13 expression was associated with clinical 
improvement.32-34 

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1- A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 1 8 
C o nfi d e nti al 
•   
Cli ni c al st u di e s wit h t w o m o n o cl o n al a nti b o di e s (tr al o ki n u m a b a n d d u pili m a b) t h at i n hi bit  
I L- 1 3 d e m o n str at e d cli ni c al b e n efit t o p atie nt s wit h A D. Tr al o ki n u m a b, a n a nti-I L- 1 3 
m o n o cl o n al a nti b o d y, w a s t e st e d i n c o m bi n ati o n wit h T C S.
3 5  D u pili m a b, a n a nti-I L 4 R 
a g e nt t h at i n hi bit s t h e a cti vit y of I L- 1 3 b y pr e v e nti n g h et er o di m eri z ati o n of t h e 
4 R α /I L- 1 3 Rα 1 c o m pl e x, w a s effi c a ci o u s a s a m o n ot h er a p y or i n c o m bi n ati o n wit h T C S. 3 6  
•   
D at a fr o m a P h a s e 2 a st u d y wit h l e bri ki z u m a b 
 d e m o n str at e d cli ni c al 
b e n efit i n p ati e nt s wit h A D. 
1. 3. 2 
S u m m ar y of Cli ni c al D e v el o p m e nt 
T w o cli ni c a l st u di e s of l ebri ki z u m a b i n A D h a v e b e e n p erf or m e d.  
•  
 
 
 
  
 
 
 
 t hr e e d o s e s. 
1. 3. 2. 1 
Effi c a c y 
C CI
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C CI
C CI

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1- A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 1 9 
C o nfi d e nti al 
•  
 
  
1. 3. 2. 2 
S af et y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. 4 
R ati o n al e f or Tr e at m e nt R e gi m e n 
C CI
 
 
  
 
 
 
 
 
 
 
 
 
 
 
C CI
C CI
C CI

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Protocol: DRM06-AD01_A2 
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1.5 
Study Conduct Statement 
This study will be conducted in compliance with the protocol, according to current United States 
federal regulations (21, Code of Federal Regulations [CFR] Parts 50, 56 and 312D) and the 
principles of International Conference on Harmonization (ICH) (ICH E6[R2]-June 2015) Good 
Clinical Practice (GCP), Food and Drug Administration (FDA) guidelines and the Declaration of 
Helsinki, 1964 (as amended in Edinburgh [2000]). 
2 
STUDY OBJECTIVES 
To evaluate the safety and efficacy of lebrikizumab compared with placebo in patients with 
moderate-to-severe AD. 
To evaluate the dose-response of lebrikizumab in patients with moderate-to-severe AD. 
3 
STUDY ENDPOINTS 
3.1 
Primary Endpoint: 
• 
Percent change in Eczema Area and Severity Index (EASI) from Baseline to Week 16. 
3.2 
Secondary Endpoints: 
• 
Proportion of patients with a 75% improvement from Baseline in EASI (EASI75) at 
Week 16. 
• 
Proportion of patient with an IGA score of 0 (clear) or 1 (almost clear) and a reduction 
≥2 points from Baseline to Week 16 (5-point scale, 0‒4).  
• 
Proportion of patients with EASI <7 at Week 16. 
• 
Proportion of patients achieving EASI50 and EASI90 at Week 16. 
• 
Percent change in the sleep-loss numerical rating scale (NRS) score from Baseline to 
Week 16. 
• 
Percent change in pruritus NRS score from Baseline to Week 16. 
• 
Proportion of patients with pruritus NRS change of ≥3 from Baseline to Week 16. 
• 
Proportion of patients with pruritus NRS change of ≥4 from Baseline to Week 16. 
• 
Change in Body Surface Area (BSA) involved with AD from Baseline to Week 16. 
• 
Change from Baseline in ADIQ score. 
4 
STUDY DESIGN 
4.1 
Duration of the Study 
The screening period will be no more than 30 days. The treatment period will be from Baseline 
to Week 16 (113 days). The follow-up period will last through Week 32. The maximum total 
participation is approximately 257 days. 
4.2 
Study Population and Number of Patients 
Approximately 275 patients, ≥18 years, will be enrolled. 

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Protocol: DRM06-AD01_A2 
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5 
SELECTION OF PATIENTS 
5.1 
Inclusion Criteria 
Patients must meet all the following criteria to be eligible for this study: 
1. Male or female, ≥18 years. 
2. Chronic AD as defined by Hanifin and Rajka (1980) 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 screening and the Baseline 
visits. 
4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the 
Baseline visits. 
5. ≥10% body surface area (BSA) of AD involvement at the screening and the Baseline 
visits. 
6. History of inadequate response to treatment with topical medications; or determination 
that topical treatments are otherwise medically inadvisable (e.g., because of important 
side effects or safety risks). 
7. Applied a stable dose of topical emollient (over-the-counter moisturizer) twice daily for 
≥7days prior to the Baseline visit.  
8. Willing and able to comply with all clinic visits and study-related procedures and 
questionnaires. 
9. Provide signed informed consent. 
5.2 
Exclusion Criteria 
Patients meeting any of the criteria below are not for this study: 
1. History of anaphylaxis. 
2. Participation in a prior lebrikizumab clinical study. 
3. 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. 
4. Treatment with TCS or TCI within 1 week prior to the Baseline visit. 
5. Treatment with biologics as follows: 
a. Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), 
whichever is longer, prior to the Baseline visit. 
b. Dupilimab within 3 months of Baseline visit. 
c. Cell-depleting biologics, including to rituximab, within 6 months prior to the Baseline 
visit. 
d. Biologics within 5 half-lives (if known) or 16 weeks prior to Baseline visit, whichever 
is longer. 

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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 before the Baseline visit. 
9. 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. 
10. 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. 
11. History of human immunodeficiency virus (HIV) infection or positive HIV serology at 
screening. 
12. Positive with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or 
hepatitis C antibody at the screening visit. 
13. In the Investigator’s opinion, any clinically significant laboratory results from the 
chemistry, hematology or urinalysis tests obtained at the screening visit. 
14. Presence of skin comorbidities that may interfere with study assessments. 
15. History of malignancy 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. 
16. 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 
(including relevant laboratory abnormalities at screening) that in the opinion of the 
Investigator may suggest a new and/or insufficiently understood disease, may present 
an unreasonable risk to the study patient because of his/her participation in this clinical 
trial, may make patient’s participation unreliable, or may interfere with study 
assessments. Pregnant or breastfeeding women, or women planning to become 
pregnant or breastfeed during the study. 
17. Women of reproductive potential* who are sexually active and unwilling to use adequate 
birth control. Adequate birth control is defined as agreement to consistently practice an 
effective and accepted method of contraception† throughout the duration of the study 
and for 120 days after last dose of study drug. 
*The following are considered women who are NOT of reproductive potential: Menopausal 
women, defined as ≥12 consecutive months without menses (if in question, a follicle 
stimulating hormone level of ≥25 mU/mL); Women surgically sterilized (history of 
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). 
†Includes abstinence, oral/implant/injectable/transdermal hormonal contraceptives, 
intrauterine device, double-barrier contraception (i.e., condom+diaphragm), same sex 
partner, or a male partner with vasectomy. 

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1- A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 2 3 
C o nfi d e nti al 
6 
S T U D Y D R U G  
6. 1 
St u d y- Dr u g F or m ul ati o n a n d Pr e s e nt ati o n  
T h e st u d y dr u g u s e d i n t hi s tri al will b e l e bri ki z u m a b a n d pl a c e b o. L e bri ki z u m a b i s a st eril e li q ui d 
s ol uti o n c o nt ai ni n g 1 2 5 m g/ m L l e bri ki z u m a b, 
 
 Pl a c e b o s ol uti o n i s i d e nti c al i n a p p e ar a n c e a n d 
c o nt e nt t o t h e a cti v e s ol uti o n wit h t h e e x c e pti o n of l e bri ki z u m a b. All st u d y dr u g will b e s u p pli e d 
a s a st eril e pr e-fill e d s yri n g e wit h a pr e- a s s e m bl e d n e e dl e s af et y d e vi c e.  
E a c h pr efill e d s yri n g e i s i nt e n d e d f or a si n gl e- d o s e s u b c ut a n e o u s ( S C) a d mi ni str ati o n o nl y. 
6. 2 
St u d y- Dr u g S u p pl y a n d L a b eli n g 
All st u d y dr u g will b e s u p pli e d a s a st eril e pr e-fil le d s yri n g e ( P F S) wit h a pr e- a s s e m bl e d n e e dl e 
s af et y d e vi c e. E a c h P F S will b e p a c k a g e d i n a s yri n g e- b o x. 
Pr e-fill e d s yri n g e s will b e l a b el e d a n d will c o nt ai n t h e pr e- pri nt e d m e di c ati o n n u m b er ( M E D N O), 
al o n g wit h st u d y dr u g st or a g e i n str u cti o n s. T h e s yri n g e- b o x l a b el will al s o c o nt ai n t h e 
c orr e s p o n di n g pr e- pri nt e d M E D N O a n d u s e b y d at e, al o n g wit h st u d y- dr u g st or a g e i n str u cti o n s. 
I n a d diti o n, t h e s yri n g e- b o x l a b el will c o nt ai n a writ e-i n s p a c e f or t h e p ati e nt n u m b er, 
i n v e sti g at or n u m b er a n d a d mi ni str ati o n d at e. All l a b el s will st at e “li mit e d b y U. S. l a w t o 
i n v e sti g ati o n al u s e”. 
S yri n g e s a n d s yri n g e b o x e s will b e p a c k a g e d i n a s e c o n d ar y kit a n d l a b el e d wit h a Kit N u m b er. 
Kit N u m b er s will b e a s si g n e d t o a p ati e nt i n t h e i nt er a cti v e w e b r e s p o n s e s y st e m (I W R S) b a s e d 
o n t h e st u d y r a n d o mi z ati o n s c h e m a.  
6. 3 
St u d y- Dr u g St or a g e 
St u d y dr u g i s t o b e st or e d u n d er r efri g er at e d c o n diti o n s ( 2 ‒ 8° C) a n d pr ot e ct e d fr o m e x c e s si v e 
li g ht a n d h eat. St u d y dr u g s h o ul d n ot b e fr o z e n, s h a k e n, or st or e d at r o o m t e m p er at ur e. 
T e m p er at ur e e x c ur si o n s o ut si d e of 2 ‒ 8° C m u st b e r e p ort e d t o t h e S p o n s or or t h e d e si g n e e. 
6. 4 
St u d y- Dr u g U n bli n di n g 
T h e S p o n s or or d e si g n e e, t h e I n v e sti g at or, st u d y- sit e p er s o n n el, a n d t h e p ati e nt will b e bli n d e d 
t o tr e at m e nt a s si g n m e nt. T h e i nt e grit y of t h e cli ni c al st u d y will b e m ai nt ai n e d b y o b s er vi n g t h e 
tr e at m e nt bli n d. If k n o wl e d g e of a p ati e nt’ s tr e atm e nt a s si g n m e nt i s r e q uir e d f or t h e p ati e nt’ s 
cli ni c al c ar e a n d/ or s af et y, t h e I n v e sti g at or will o p e n t h e C o d e Br e a ki n g C ar d r e c ei v e d wit h t h e 
st u d y- dr u g kit. T h e C o d e- Br e a ki n g C ar d s h o ul d b e st or e d i n a s e c ur e, l o c k e d l o c ati o n at t h e 
sit e. T h e I n v e sti g at or s h o ul d h a v e a c c e s s t o t h e C o d e- Br e a ki n g C ar d at all ti m e s ( e. g., 2 4/ 7). 
T h e I n v e sti g at or s h o ul d c o n s ult wit h t h e S p o n s or’ s m e di c al m o nit or pri or t o o bt ai ni n g tr e at m e nt 
a s si g n m e nt i nf or m ati o n. T h e I n v e sti g at or m u st d o c u m e nt (i n t h e p ati e nt’ s m e di c al r e c or d) t h e 
d at e a n d ti m e t h e bli n d w a s br o k e n, t h e n a m e s of t h e p er s o n n el i n v ol v e d, a n d t h e r e a s o n t h at 
tr e at m e nt a s si g n m e nt i nf or m ati o n w a s r e q uir e d. 
6. 5 
St u d y- Dr u g A c c o u nt a bilit y 
C CI
T h e I n v e sti g at or m u st k e e p a n a c c ur at e r e c or d of t h e n u m b er of c art o n s r e c ei v e d, t h e st u d y 
dr u g di s p e n s e d/ u s e d, a n d t h o s e r et ur n e d t o t h e S p o n s or or d e si g n e e. T h e S p o n s or will pr o vi d e 
f or m s t o f a cilit at e i n v e nt or y c o ntr ol. All st u d y- dr u g a c c o u nt a bilit y f or m s a n d tr e at m e nt l o g s m u st 
b e r et ai n e d i n t h e I n v e sti g at or’ s p er m a n e nt st u d y fil e, a n d t h e s e r e c or d s m u st b e a v ail a bl e f or 
i n s p e cti o n at a n y ti m e b y t h e S p o n s or, it s d e si g n e e s, or b y r e g ul at or y a g e n ci e s. 

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The study monitor will perform drug accountability for all study drug at the site, and will assist in 
returning all used, unused, and expired study drug, to the Sponsor/designees, or destroy it 
according to the study site’s standard operating procedure, if accepted by the Sponsor.  
6.6 
Patient Randomization 
All patients will be randomized to study treatment using an IWRS. Study randomization will 
occur across study sites. After written informed consent has been obtained, all patients will 
receive a six-digit screening number (XXX-XXX = site number-patient number), assigned in 
EDC (via iMedidata Rave in sequential order), which will be assigned by the site. Sites should 
assign the patient numbers in the order that they are screened and enter patients in EDC in the 
same order. Following completion of the screening period, and after all patient eligibility 
requirements are confirmed on Day 1 (Baseline), the patient’s screening number will be entered 
in the IWRS, and the patient will be assigned a patient study-drug kit. One kit will provide all the 
study drug for that patient based on the assigned treatment group.  
Patients will be randomized 3:3:3:2 to one of the following treatment groups. The dosing 
schedule by treatment group is shown in Table 1. 
Treatment Group 1: Lebrikizumab, 125 mg every 4 weeks  
Baseline: Loading dose of 250 mg (two injections of 1 mL of 125 mg/mL drug product and 
two injections of 1 mL placebo);  
Week 2: Four 1-mL injections of placebo 
Weeks 4, 8, 12: 125 mg (one 1-mL injection of 125 mg/mL drug product and one 1-mL 
injection of placebo) 
Week 6, 10, 14: Two 1-mL injections of placebo 
Treatment Group 2: Lebrikizumab, 250 mg every 4 weeks  
Baseline: Loading dose of 500 mg (four 1-mL injections of 125 mg/mL drug product) 
Week 2: Four 1-mL injections of placebo 
Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL drug product);  
Week 6, 10, 14: Two 1-mL injections of placebo 
Treatment Group 3: Lebrikizumab, 250 mg every 2 weeks 
Baseline and Week 2: Loading dose of 500 mg (four 1-mL injections of 125 mg/mL drug 
product) 
Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL injections of 125 mg/mL drug product) 
Treatment Group 4: Placebo every 2 weeks 
Baseline and Week 2: Placebo (four 1-mL injections of placebo) 
Week 4, 6, 8, 10, 12, 14: Two 1-mL injections of placebo 

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Table 1 
Dosing Schedule by Treatment Group 
Group 
Baseline 
Week 2 
Week 4 
Week 6 
Week 8 
Week 10 
Week 12 
Week 14 
1 
250 mg 
Placebo 
125 mg 
Placebo 
125 mg 
Placebo 
125 mg 
Placebo 
2 
500 mg 
Placebo 
250 mg 
Placebo 
250 mg 
Placebo 
250 mg 
Placebo 
3 
500 mg 
500 mg 
250 mg 
250 mg 
250 mg 
250 mg 
250 mg 
250 mg 
4 
Placebo 
Placebo 
Placebo 
Placebo 
Placebo 
Placebo 
Placebo 
Placebo 
6.7 
Study-Drug Administration 
Study drug is to be administered to all patients in the clinic by designated and trained study 
personnel. Study drug should be prepared in advance and injected subcutaneously according to 
the following instructions:  
• 
Remove study drug from refrigerated condition and allow to warm to room temperature 
for 15 minutes prior to administration. Study drug should be administered within 4 hours.  
• 
Identify location for injections. Study drug may be injected in the abdomen, upper arm, 
or thigh. All injections administered at a single visit should be given in the same area, but 
may be split up into different areas for Week 0 and Week 2, which have 4 injections/visit. 
Injection sites should be ≥10 cm from one another. If possible, injections should not be 
administered at sites with active AD or other skin lesions. 
• 
Inject study drug subcutaneously. 
• 
Record location of study injections in the eCRF.  
• 
Properly dispose of used syringe according to site requirements. Syringe box must be 
kept for full drug accountability.  
6.8 
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.  
The sponsor will provide the patient with an over-the-counter emollient. The patient may 
continue her/his current over-the-counter emollient regimen, if approved by the Investigator. 
All medications and treatments taken for AD prior to screening will be recorded separately on an 
AD medication-history eCRF.  
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.  

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• 
The use of any concomitant medication must relate to an AE listed on the AE eCRF or 
the patient's medical history unless it is a supplement or used as preventative care.  
6.9 
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 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, TCS 
(except when given for rescue therapy), TCI, cyclosporine, azathioprine, methotrexate, 
phototherapy, or photochemotherapy) are not permitted during the study and during the interval 
prior to entry into the study as defined in the exclusion criteria. In addition, the use of a tanning 
booth/parlor is not permitted during the trial. 
Planned or anticipated major medication procedures or surgeries should be avoided during the 
trial.  
6.10 
Rescue Therapy 
Patients requiring rescue therapy should consider the addition of TCS prior to considering 
systemic treatment. Any patient who requires TCS treatment may stay in the study and should 
continue the TCS for as brief a period as possible. Any patient requiring systemic therapy to 
treat their AD during the study will be discontinued from the study and the end of study visit 
assessment should be completed per Schedule of Visits and Procedures. TCS use must be 
recorded on the concomitant medications eCRF, indicated as “AD therapy”. 
7 
STUDY PROCEDURES  
The required procedures for each study visit are outlined in the study Schedule of Visits and 
Procedures. 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 prior to performing any study procedures.  
• 
Review Inclusion/Exclusion Criteria. 
• 
Collect demographic information. 
• 
Complete medical history/review of systems. 
• 
Collect concomitant-medication and procedure/therapy information. 
• 
Perform a complete physical examination, including height and weight.  
• 
Measure vital signs. 
• 
Draw blood samples for laboratory tests, including serum pregnancy test (screening visit 
only). 
• 
Collect urine sample for urinalysis.  
• 
Complete the following assessments: 

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− 
Investigator’s Global Assessment (IGA) 
− 
Eczema Area and Severity Index (EASI) 
− 
Body Surface Area (BSA) 
• 
Instruct the patient to apply an emollient twice daily.  
• 
Schedule next visit.  
7.2 
Baseline Visit (Day 1)  
• 
Confirm emollient use. 
• 
Re-assess and confirm patient eligibility (Inclusion/Exclusion criteria). 
• 
Measure weight and vital signs. 
• 
Collect concomitant medication and procedure/therapy information. 
• 
Query for adverse events (AEs) since the last visit. 
• 
Collect a 12-lead ECG. 
• 
Draw blood samples for laboratory tests (hematology and chemistry) 
• 
Draw a pre-dose blood sample for PK and anti-drug antibody (ADA) testing. 
• 
Conduct urine for urinalysis and urine pregnancy test (WOCBP only). 
• 
Dispense electronic tablet that will be used for home recording of pruritus NRS and 
sleep-loss NRS (daily), and ADIQ (weekly). 
• 
Train patient on the use of the electronic tablet. 
• 
Review compliance report on the electronic tablet for the assessments (pruritus NRS, 
sleep-loss NRS, and ADIQ) and remind patient to record daily. 
• 
Complete the following assessments: 
− 
Investigator’s Global Assessment (IGA) 
− 
Eczema Area and Severity Index (EASI) 
− 
Body Surface Area (BSA) 
− 
Patient Oriented Eczema Measure (POEM)  
− 
Dermatology Life Quality Index (DLQI) 
− 
Hospital Anxiety and Depression Scale (HADS). 
• 
Randomize the patient.  
• 
Administer study drug. 
• 
Instruct the patient to apply an emollient twice daily. 
• 
Schedule next visit.  
7.3 
Visits on Day 15, Day 29, Day 43, Day 57, Day 71, Day 85 and Day 99 (+/- 3 Day) 
• 
Confirm emollient use. 

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• 
Measure vital signs. 
• 
Collect concomitant-medication information. 
• 
Review and record AEs. 
• 
Review compliance report on the electronic tablet for the daily assessments (pruritus 
NRS, sleep-loss NRS, and ADIQ) and remind patient to continue daily record.  
• 
At Day 29, 57, and 85, draw blood samples for laboratory tests, and collect urine for 
urinalysis and pregnancy test (WOCBP only). 
• 
At Day 29, 57, and 85, complete the following assessments: 
− 
Investigator’s Global Assessment (IGA) 
− 
Eczema Area and Severity Index (EASI) 
− 
Body Surface Area (BSA) 
• 
At Day 57 complete the following assessments: 
− 
Dermatology Life-Quality Index (DLQI) 
− 
Hospital Anxiety and Depression Scale (HADS). 
• 
At Day 15, 29, 57, and 85, collect blood samples for PK (see Section 8.2.2 for 
instructions). 
• 
At Day 15 and 29, collect a pre-dose blood sample for ADA testing (see Section 8.2.2 
for instructions). 
• 
Administer study drug. 
• 
Remind the patient to apply an emollient twice daily. 
• 
Remind the patient to use the tablet daily. 
• 
Schedule next visit.  
7.4 
Visit Day 113 (Week 16) (+/- 3 Day) (End-of-Treatment/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 patient’s records and the eCRF.  
• 
Confirm emollient use. 
• 
Perform a complete physical examination, including weight. 
• 
Measure vital signs. 
• 
Collect concomitant medication and procedure/therapy information. 
• 
Review and record AEs. 
• 
Collect a 12-lead ECG. 
• 
Draw blood samples for laboratory tests (hematology and chemistry). 
• 
Draw a blood sample for PK and ADA testing. 
• 
Collect urine for urinalysis and urine pregnancy test (WOCBP only). 

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• 
Review compliance report on the electronic tablet for the daily assessments (pruritus 
NRS, including a global impression of change for itching; sleep-loss NRS; and ADIQ). 
• 
Collect electronic tablets and download any remaining data on device. 
• 
Complete the following assessments: 
− 
Investigator’s Global Assessment (IGA) 
− 
Eczema Area and Severity Index (EASI) 
− 
Body Surface Area (BSA) 
− 
Patient-Oriented Eczema Measure (POEM)  
− 
Dermatology Life Quality Index (DLQI) 
− 
Hospital Anxiety and Depression Scale (HADS) 
− 
Global Assessment of Change for AD. 
• 
Remind the patient to apply an emollient twice daily. 
• 
Schedule next visit. 
7.5 
Follow-Up Visit Day 141 (Week 20) (+/- 7 Days) 
• 
Measure vital signs. 
• 
Collect concomitant medication and procedure/therapy information. 
• 
Review and record AEs. 
• 
Complete the following assessments: 
− 
Investigator’s Global Assessment (IGA) 
− 
Eczema Area and Severity Index (EASI) 
• 
Remind the patient to apply an emollient twice daily 
• 
Schedule next visit. 
7.6 
Follow-Up Visit Day 169 (Week 24) (+/- 7 Days) 
• 
Measure vital signs. 
• 
Collect concomitant medication and procedure/therapy information. 
• 
Review and record AEs. 
• 
Draw blood samples for laboratory tests (hematology and chemistry) 
• 
Draw blood sample for PK and ADA testing. 
• 
Collect urine for urinalysis and urine pregnancy test (WOCBP only). 
• 
Complete the following assessments: 
− 
Investigator’s Global Assessment (IGA) 
− 
Body Surface Area (BSA). 
− 
Eczema Area and Severity Index (EASI) 

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• 
Remind the patient to apply an emollient twice daily  
• 
Add reminder to schedule a FU visit phone call. 
7.7 
Follow-Up Visit Phone Call, Day 225 (Week 32) (+/- 7 Days) 
• 
Review and record AEs. 
7.8 
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): 
• 
Measure vital signs. 
• 
Collect concomitant medication and procedure/therapy information. 
• 
Review and record AEs. 
8 
DETAILS OF ASSESSMENTS 
8.1 
Screening Assessments  
8.1.1 
Demographics 
At the screening visit, demographic information including age, gender, race and ethnicity will be 
collected and recorded in the eCRF for each patient.  
8.1.2 
Medical History 
A complete medical history will be collected as part of the screening assessment and include all 
clinically relevant past or coexisting medical conditions or surgeries. Extensive information on 
the patient’s atopic dermatitis, asthma, and allergies will be collected as part of the medical 
history. The medical history will be updated prior to treatment on Baseline/Day 1 should new 
findings be present since the screening visit. Findings will be recorded in the eCRF. 
8.1.3 
Disease Specific Information 
Information on the patient’s atopic dermatitis will be collected as part of the screening 
assessment and include the date of onset of atopic dermatitis, anatomical areas affected by 
atopic dermatitis, and past treatments for atopic dermatitis. Information will be recorded in the 
eCRF.  
8.2 
Assessment of Efficacy 
8.2.1 
AD Assessments 
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. 
Individuals will be trained and certified by the Sponsor prior to conducting any assessments. 
8.2.1.1 
Investigator Global Assessment (IGA) 
The IGA (Appendix 3) is an instrument used to globally rate the severity of the patient’s AD and 
is based on a 5-point scale ranging from 0 (clear) to 4 (severe). The IGA must be conducted 
prior to conducting the EASI assessment.  

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A grade of 0 to 4 will be assessed by the Investigator or designee. Assessors must be trained 
and certified by the Sponsor prior to conducting this assessment. Assessments will be recorded 
in the eCRF. 
8.2.1.2 
Eczema Area and Severity Index (EASI) 
The EASI (Appendix 4) is used to assess the severity and extent of AD; it is a composite index 
with scores ranging from 0 to 72, with the higher values indicating more severe and or extensive 
disease. A grade of 0 to 72 will be assessed by the Investigator or designee.  
Assessors must be trained and certified by the Sponsor prior to conducting this assessment. 
Assessments will be recorded in the eCRF. 
8.2.1.3 
Body Surface Area (BSA) 
The BSA (Appendix 5) assessment estimates the extent of disease or skin involvement with 
respect to AD and is expressed as a percentage of total body surface. BSA will be determined 
by the Investigator or designee using the patient palm = 1% rule. 
Assessments will be recorded in the eCRF. Assessors must be trained and certified by the 
Sponsor prior to conducting this assessment. 
8.2.1.4 
Pruritus 
Pruritus will be assessed by the patient using a Pruritus Numeric Rating Scale (NRS) 
(Appendix 6). The Pruritus NRS is an 11-point scale used by patients to assess their worst itch 
severity over the past 24 hours with 0 indicating “No itch” and 10 indicating “Worst itch 
imaginable”. At Week 16, a global impression of change for itching question will be requested. 
Assessments will be recorded daily by the patient using an electronic diary and transferred into 
the clinical database. 
8.2.1.5 
Sleep-Loss 
Quality of sleep will be assessed by the patient using a sleep-loss question (Appendix 7) over 
the past 24 hours.  
Assessments will be recorded daily by the patient using an electronic diary and transferred into 
the clinical database. 
8.2.1.6 
Atopic Dermatitis Impact Questionnaire (ADIQ)  
The ADIQ (Appendix 8) is a 17-item questionnaire used to assess the patients’ AD-specific 
health-related QoL. The questionnaire assesses AD’s impact on emotions, energy, activities of 
daily living, and social activities. The ADIQ has a recall specification of 7 days.  
Assessments will be recorded by the patient using an electronic diary and transferred into the 
clinical database. 
8.2.1.7 
Patient Oriented Eczema Measure (POEM) 
The POEM (Appendix 9) is a 7-item questionnaire used by the patient to assess the severity of 
the patient’s eczema over the last week. All seven answers carry equal weight and are scored 
as: No days=0; 1‒ 2 days =1; 3‒4 days=2; 5‒6 days=3; everyday=4. 
The POEM is completed by the patient in the clinic. Assessments will be recorded in the eCRF. 

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8.2.1.8 
Dermatology Life Quality Index (DLQI) 
The DLQI (Appendix 10) is a 10-question instrument used to measure 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).  
The DLQI is completed by the patient in the study clinic. Assessments will be recorded in the 
eCRF. 
8.2.1.9 
Hospital Anxiety and Depression Scale (HADS) 
The HADS (Appendix 11) assesses anxiety and depression in a non-psychiatric population. 
The HADS has two subscales (depression and anxiety), both with 7 questions.  
Responses are based on the relative frequency of symptoms over the past week, using a 
four-point scale ranging from 0 (not at all) to 3 (very often indeed).  
HADS is completed by the patient in the clinic. Assessments will be recorded in the eCRF. 
8.2.1.10 
Global Assessment of Change–AD 
The Global Assessment of Change for AD (Appendix 12) will be one question asked at Week 16 
and the Early-Termination visit. The value of the question is to capture the patient’s impression 
of overall change in their AD.  
This will be completed by the patient in the clinic. Assessments will be recorded in the eCRF 
8.2.2 
PK and ADA Sampling 
Serum PK and ADA samples on Day 1, 15, 29, 57 (PK only), 85 (PK only), 113, and 169 will be 
taken predose. PK and ADA samples will be collected from all patients including those assigned 
to the placebo group to maintain the blinding of the treatment assignment. Positive ADA results 
will be further evaluated for antidrug antibodies. The procedural instructions will be provided in a 
separate PK and Serum Antibody Sampling manual. 
9 
ASSESSMENT OF SAFETY 
9.1 
Assessment of Safety 
9.1.1 
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 be recorded 
as part of the screening physical exam and only the patient’s weight will be recorded with the 
Baseline and the week 16 physical examination. Findings will be recorded in the eCRF.  
At subsequent study visits, a symptom-directed physical examination may be conducted.  
9.1.2 
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, 

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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. 
9.1.3 
ECGs 
12-lead ECG measurements will be obtained in all patients. The patient should rest quietly for at 
least 5 minutes in a supine position prior to ECG collection. The ECG should be obtained either 
prior to the time of blood collection, or at least 15 minutes afterwards. The medical monitor may 
be consulted if needed for interpretation of ECGs. 
All study sites will be supplied with standardized, validated, digital, 12-lead ECG machine 
(12-lead at 25 mm/sec reporting rhythm, ventricular rate, the RR interval, the PR interval, QRS 
duration, QT and QTcF intervals) capable of recording, storing, printing, and producing high 
resolution 12-lead ECG data. Study sites will be trained on the use of the equipment prior to 
study start.  
Machine-read ECG recordings will be collected and analyzed centrally. Data will be transferred 
electronically to the database. 
9.1.4 
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 of child-bearing 
potential (WOCBP). Blood and urine will be collected from each patient as specified in the 
Schedule of Visits and Procedures or as clinically indicated. Laboratory samples are to be 
shipped on the same day as collected. Laboratory test results will be provided to the sites 
through a web-based reporting system. Alert values will be emailed to the site. Laboratory data 
will be transferred to the clinical database from the central laboratory database.  
Screening laboratory test results must be reviewed by the Investigator prior to patient 
enrollment. Patients will fail screening for clinically significant laboratory values. However, at the 
discretion of the Investigator, screening laboratory tests may be repeated one time to confirm 
out-of-range results or clinical significance. Specific laboratory tests are listed in Table 2.  
The central laboratory should be used for all laboratory testing required for a patient during 
study participation, including laboratory testing needed for unscheduled visits. Clinically 
significant laboratory results must be entered as a diagnosis on the AE eCRF rather than as an 
individual test result. Patients with clinically significant laboratory test results will be evaluated, 
treated and followed at the discretion of the Investigator until the value returns to clinically 
acceptable levels. 
Throughout the study, all laboratory results should be reviewed and signed by the Investigator 
within 48 hours of receipt of the report (whenever possible). 

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Table 2 
Laboratory Parameters 
Hematology 
Chemistry 
Urine 
• 
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) 
9.1.5 
Adverse Events (AEs) 
An AE is defined as any untoward medical occurrence associated with the use of a study drug 
in humans, whether considered drug related. An AE can, therefore, be any unfavorable and 
unintended sign (including clinically significant abnormal laboratory finding), symptom or 
disease temporally associated with the use of the study drug, whether related to the 
investigational product.  
AEs will be monitored throughout the study. Patients will be instructed to inform the Investigator 
and/or study staff of any AEs. At each visit, patients will be asked about AEs in a non-specific 
manner using open-ended questions so as not to bias the response (e.g., How have you been 
since the last visit?). Specific inquiry regarding reported AEs will be conducted when applicable. 
All AEs will be documented and recorded in the patient’s eCRF. 
Any patient who has an AE (serious or non-serious) will be evaluated by the Investigator and 
treated and followed until the symptom(s) return to normal or to clinically acceptable levels, as 
judged by the Investigator. A physician, either at clinical site, or at a nearby hospital emergency 
room, will administer treatment for any serious AEs (SAEs), if necessary. When appropriate, 
medical tests and examinations will be performed to document resolution of event(s). 

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9.1.5.1 
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 recorded 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 9.1.6. Unless a diagnosis is available, signs and symptoms must 
be reported as individual AEs in the eCRF; a diagnosis is preferred.  
The severity of an AE will be designated as mild, moderate or severe. The term “severe” is used 
to describe the intensity of an AE; the event itself, however, may be of relatively minor clinical 
significance (e.g., ‘severe’ upper respiratory infection). Severity is not the same as “serious”. 
Seriousness of AEs is based on the outcome/action of an AE. (See Section 9.1.6.) 
The relationship of the AE to the study treatment should be determined by the Investigator and 
will be based on the following two definitions: 
Not related: The AE is judged to not be associated with the study drug, and is attributable to 
another cause. 
Related: A causal relationship between the AE and the study drug is a reasonable 
possibility, i.e., there is evidence (e.g., dechallenge/rechallenge) or other clinical arguments 
to suggest a causal relationship between the AE and study treatment.  
9.1.6 
Serious Adverse Events (SAEs) 
An SAE is defined as any untoward medical occurrence that,  
• 
Results in death 
• 
Is in the opinion of the Investigator immediately life threatening (i.e., the patient is at 
immediate risk of death; it does not include a reaction that, had it occurred in a more 
severe form, might have caused death) 
• 
Requires inpatient hospitalization or results in prolongation of an existing hospitalization 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
• 
Is an important medical event that may not be immediately life-threatening, result in 
death, or require hospitalization, but based on appropriate medical judgment, it 
jeopardizes the patient, or may require medical or surgical intervention to prevent one of 
the outcomes listed. 
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. 

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9.1.6.1 Reporting of SAEs 
All SAEs, as defined in Section 9.1.6, regardless of causal relationship, must be reported to the 
Sponsor or designee within 24 hours of the Investigator becoming aware of the event. As soon 
as the Investigator becomes aware of an AE that meets the criteria for an SAE, the SAE should 
be documented to the extent that information is available.  
SAEs will be recorded from the time of informed consent/assent until the end of the study. 
If, in the opinion of the Investigator, an SAE occurring outside the specified time window  
(i.e., following patient completion or terminations of the study) is deemed to be drug-related, the 
event should be reported with 24 hours. 
SAEs must be recorded on an SAE form. The minimum information required for SAE reporting 
includes the identity of the 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: 
• 
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. 
9.1.7 
Adverse Events of Special Interest (AESI) 
AESIs in this study include: 
• 
Anaphylactic reactions or acute allergic reactions that require immediate treatment  
• 
Malignancies (excluding non-melanoma skin cancers). 

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All AESIs must be reported to the sponsor and designee within 24 hours of identification.  
9.1.8 
Pregnancy 
In the instance that a patient becomes pregnant during participation in the study, the patient 
must be withdrawn from study drug but may continue study participation. The Investigator must 
perform medical assessments as clinically indicated and continue to follow the patient for 
≥4 weeks after delivery, at a minimum. Details for both the mother and baby must be obtained. 
Although pregnancy is not itself an AE or SAE, maternal/fetal complications or abnormalities will 
be recorded as AEs or SAEs, as appropriate.  
The Investigator must complete a study-specific Pregnancy Form upon confirmation of a 
pregnancy. Pregnancy reporting forms will be provided to the site. 
10 
STUDY DISCONTINUATIONS 
10.1 
Study Termination 
The Sponsor has the right to terminate or to stop 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. Should this be necessary, patients 
should be scheduled for an Early-termination visit (Section 7.4).  
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 
If the study is terminated by the Sponsor, all data available for the patient at the time of 
discontinuation must be recorded in the patient’s records and the eCRF. 
10.2 
Early Termination of Study Patients 
The Investigator will make every reasonable effort 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 study will have an Early-Termination visit scheduled 
(Section 7.4) as soon as possible. All information, including the reason for early discontinuation 
will be recorded in the patient’s study records and in the eCRF.  
Before a patient can be terminated early due to loss of follow-up, the Investigator must show 
documented attempts to contact the patient regarding study participation on two separate 
occasions (telephone contact) followed by a certified letter of contact.  

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Prior to discontinuing a patient from study participation, the Investigator will discuss his/her 
intentions with the Sponsor Medical Monitor or designee.  
10.3 
Study-Drug Discontinuation 
Study drug must be discontinued for patients who experience the following: 
• 
Inter-current illness that would, in the judgment of the Investigator, affect assessments of 
clinical status to a significant degree 
• 
Treatment related AEs that are clinically significant, deemed persistent, in the judgment 
of the Investigator 
• 
Unacceptable toxicity 
• 
Pregnancy 
Patients who discontinue study drug permanently during study participation must be scheduled 
for an Early-termination visit (Section 7.4).  
11 
STATISTICAL CONSIDERATIONS 
11.1 
General Statistical Methodology 
All statistical processing will be performed using SAS® unless otherwise stated. No interim 
analyses are planned.  
Except where noted, all statistical tests will be two-sided and will be performed at the 0.05 level 
of significance. The inclusion of p-values in the efficacy analyses is to assist in characterizing 
the therapeutic efficacy of the active medication. No adjustments will be made for multiple 
comparisons for the efficacy analyses. The primary analysis will be performed when all patients 
have completed the treatment phase at Week 16. The final time-course data analysis will be 
performed when all patients have finished Week 32. 
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. The denominator for percentage will be based on the number of patients appropriate 
for the analysis. For continuous parameters, descriptive statistics will include the number of 
patients (n), mean, standard deviation (SD), median, and range. Appropriate inferential statistics 
will be used for the primary and secondary efficacy variables. 
For the primary efficacy variable, the primary method of handling missing efficacy data will be 
the method of MCMC multiple imputation. This method does not rely on the assumption of data 
missing at random. Additionally, 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 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 a 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 EASI75 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. 
For the EASI assessment, a total of 4 seeds are required to impute the EASI score for the four 
treatment groups. Those 4 random seeds have been pre-specified by using a random number 
generator: 
Lebrikizumab, 125 mg every 4 weeks: seed = 1083679005 
Lebrikizumab, 250 mg every 4 weeks: seed = 1346533179 
Lebrikizumab, 250 mg every 2 weeks: seed = 297484487  
Placebo every 2 weeks: seed = 424603513  
 
For the IGA assessment, a total of 4 seeds are required to impute the IGA score for the four 
treatment groups. Those 4 random seeds have been pre-specified by using a random number 
generator: 
Lebrikizumab, 125 mg every 4 weeks: seed = 1975600090 
Lebrikizumab, 250 mg every 4 weeks: seed = 1260832817 
Lebrikizumab, 250 mg every 2 weeks: seed = 2036512379 
Placebo every 2 weeks: seed = 202520365 
Sensitivity analyses on some of the secondary efficacy variables will be performed as follows: 
• 
Non-response imputation (NRI) will be used to impute missing values. Specifically, 
any patient with a missing IGA (or EASI75) value at Week 16 will be treated as a 
non-responder for analysis purposes. 
• 
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 determine whether the results are 
directly comparable. 
• 
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. 
A statistical analysis plan (SAP) describing all statistical analyses will be provided as a separate 
document. The SAP will be finalized prior to unblinding of the treatment groups. 
11.2 
Populations Analyzed 
Patients will be randomized in a 3:3:3:2 ratio to each treatment group. There will be 
approximately 75 patients for groups with study drug, and 50 patients for the placebo group.  
Efficacy analyses will be performed using the modified intent-to-treat (mITT) population and the 
per-protocol (PP) population. The mITT population will include all patients who were randomized 
and received study drug. The PP population will include all patients in the safety population who 
completed 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). 
Safety analyses will be performed using the safety population. All patients who are randomized 
and receive ≥1 dose of study drug will be included in the safety population.  

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11.3 
Primary Efficacy 
The following primary endpoint will be analyzed: 
• 
Percent change in Eczema Area and Severity Index (EASI) from Baseline to Week 16. 
11.4 
Secondary Efficacy 
The following secondary endpoints will be analyzed: 
• 
Proportion of patients with a 75% improvement from Baseline in EASI (EASI75) at 
Week 16. 
• 
Proportion of patient with an IGA score of 0 (clear) or 1 (almost clear) and a reduction 
≥2 points from Baseline to Week 16.  
• 
Proportion of patients with EASI <7 at Week 16. 
• 
Proportion of patients achieving EASI50 and EASI90 at Week 16. 
• 
Percent change in sleep-loss numerical rating scale (NRS) score from Baseline to 
Week 16. 
• 
Percent change in pruritus numerical rating scale (NRS) score from Baseline to 
Week 16. 
• 
Proportion of patients with pruritus NRS change of ≥3 from Baseline to Week 16. 
• 
Proportion of patients with pruritus NRS change of ≥4 from Baseline to Week 16. 
• 
Change in Body Surface Area (BSA) involved with AD from Baseline to Week 16. 
11.5 
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. 
The planned PK analysis will be included in a separate Pharmacokinetic Analysis Plan. 
11.6 
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 applications, number of missed applications, and 
number and percentage of patients who are compliant. An application is considered the full set 
of injections (either 2 or 4 depending on visit) specified by the protocol.  
A patient will be considered compliant with the dosing regimen if the patient received ≥75% of 
the expected number of applications while enrolled in the study. 
11.7 
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 application. 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. 

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Three sets of AE tabulations are anticipated, one for the treatment period, one for the post-
treatment (follow-up) period, and one for the combined treatment and post treatment period. 
The denominator used for the treatment period will correspond to the number of patients in the 
safety population. Data will also be corrected for exposure and reported per 100 patient-years. 
11.8 
Other Safety Data 
Laboratory data will be presented in a by patient listing. Any clinically significant laboratory 
abnormalities will be captured as AEs. Changes from Baseline in safety laboratory values will be 
summarized by treatment group at each follow-up evaluation during the treatment period using 
descriptive statistics or frequency tables as applicable. Tables and listings will be in SAS format. 
Additionally, changes from Baseline in safety laboratory values will be summarized using shift 
tables according to normal ranges.  
ECGs and 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. 
11.9 
Sample-Size Determination 
The sample size for this study was based mainly on clinical considerations. 
12 
ADMINISTRATION 
12.1 
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. 
12.2 
Informed Consent Procedures 
The Informed Consent Form (ICF) will include all elements required by ICH/GCP and applicable 
regulatory requirements, and will adhere to GCP and to the ethical principles that have their 
origin in the Declaration of Helsinki. The consent form will also include a statement that the 
Sponsor and regulatory authorities have direct access to patient records.  
Prior to the beginning of the study, the Investigator will have the IRB/IEC’s written opinion 
(approval/favorable) of the written informed consent form and any other information to be 
provided to the patients. 
The Investigator must provide the patient or legally acceptable representative with a copy of the 
consent form and written information about the study in the language in which the patient is 
most proficient. The language must be non-technical and easily understood. The Investigator 
should allow time necessary for patient or patient's legally acceptable representative to inquire 
about the details of the study, then informed consent must be signed and personally dated by 
the patient or the patient's legally acceptable representative, by the Investigator and by the 

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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. 
12.3 
Study Documentation and the eCRF 
This protocol is to be signed by the investigator responsible for the conduct of this study at the 
study site. A copy of the signed protocol signature page is to be provided to the Sponsor and 
retained in the study site’s Regulatory Binder.  
The Investigator is responsible for ensuring that all study data is accurately recorded on the 
eCRFs or other study data collection tools. All eCRF entries must be supported by the patient’s 
medical records or source notes. The Investigator must ensure that study observations and 
findings are legible and recorded accurately and completely. 
Original reports, traces and films must be reviewed, signed and dated, and retained by the 
Investigator for future reference.  
The Investigator is expected to promptly review all study data recorded in the patient’s source 
records. Completed eCRFs must be promptly reviewed, signed, and dated by the Investigator or 
Sub-Investigator at the end of the study. Corrections to data entered into the eCRF will be 
handled through an electronic query. Corrections to patients’ medical or source records should 
be legible, initialed and dated. At the end of the study, an electronic copy of the investigator’s 
eCRFs will be provided to the Investigator. The Investigator is to retain this data. The 
Investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on eCRFs. Refer to Section 12.5 regarding 
retention requirements. 
An Investigator is required to prepare and maintain adequate and accurate case histories 
designed to record all observations and other data pertinent to the investigation for each patient 
treated with the study drug or entered as a control in the investigation. Data reported on the 
eCRFs that are derived from source documents must be consistent with the source documents 
or the discrepancies must be explained.  
12.4 
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 

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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. 
12.5 
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. 
12.6 
Acronyms 
The acronyms listed below are a non-exhaustive list of those commonly used in Dermira study 
documents. Not all acronyms listed below are used within this document. 
Acronym 
Term 
ADIQ 
Atopic dermatitis impact questionnaire 
AE 
Adverse event(s) 
ALT 
Alanine amino-transferase 
ASIQ 
AD-specific health-related QoL 
AST 
Aspartate amino-transferase 
AD 
Atopic dermatitis 
BP 
blood pressure 
BUN 
Blood urea nitrogen 
C 
Celsius  
CFR 
Code of federal regulations 
eCRF 
Electronic case report form 
CRO 
Clinical research organization 
EASI 
Eczema area of severity index 
ET 
Early termination 
F 
Fahrenheit 
FDA 
Food and Drug Administration 
GCP 
Good clinical practice 

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Acronym 
Term 
GGT 
Gamma-glutamyl transferase 
GLP 
Good laboratory practice 
HCT 
Hematocrit 
HGB 
Hemoglobin 
IB 
Investigator's brochure 
ICF 
Informed consent form 
ICH 
International Conference on Harmonization  
IEC 
Independent ethics committee 
IRB 
Institutional review board 
ITT 
Intent-to-treat 
IUD 
Intrauterine device 
IV 
Intravenous 
IWRS 
Interactive web response system 
MCH 
Mean corpuscular hemoglobin 
MCHC 
Mean corpuscular hemoglobin concentration 
MCV 
Mean corpuscular volume 
MedDRA 
Medical Dictionary for Regulatory Activities 
PDK 
phosphoinositide-dependent kinase 
PK 
Pharmacokinetics 
PP 
Per protocol 
QoL 
Quality of life 
Q4W 
Every 4 weeks 
RBC 
Red blood cells 
SAE 
Serious adverse event(s) 
SC 
Subcutaneous 
SCORAD 
Severity scoring of atopic dermatitis 
SOC 
System organ class 
TCS 
Topical corticosteroids 
TCI 
Topical calcineurin inhibitors 
Th-2 
T-helper type 2 
TEAE 
Treatment-emergent adverse events 
US 
United States 
VAS 
Visual analog scale 
WBC 
White blood cells 
WHO 
World Health Organization 
WOCBP 
Women of childbearing potential 

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with IL-4 and IL-13 in atopic and allergic contact dermatitis. J Allergy Clin Immunol. 
118:930-7. 
32. Khattri, S, Shemer A, Rozenblit M, et al. 2014. Cyclosporine in patients with atopic 
dermatitis modulates activated inflammatory pathways and reverses epidermal pathology. J 
Allergy Clin Immunol. 133:1626-34. 
33. Bunikowski, R, Staab D, Kussebi F, et al. 2001. Low-dose cyclosporin A microemulsion in 
children with severe atopic dermatitis: clinical and immunological effects. Pediatr Allergy 
Immunol. 12:216-23. 
34. Tintle, S, Shemer A, Suarez-Farinas M, et al. 2011. Reversal of atopic dermatitis with 
narrow-band UVB phototherapy and biomarkers for therapeutic response. J Allergy Clin 
Immunol. 128:583-93 e1-4. 
35. Wollenberg, A, Howell MD, Guttman-Yassky E, et al., editors. A Phase 2b Dose-Ranging 
Efficacy and Safety Study of Tralokinumab in Adult Patients with Moderate to Severe 
Atopic Dermatitis (AD). AAD 2017 2017; Orlando, FL. 

Dermira, Inc. 
Lebrikizumab 
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36. Simpson, EL, Bieber T, Guttman-Yassky E, et al. 2016. Two Phase 3 Trials of Dupilumab 
versus Placebo in Atopic Dermatitis. The New England journal of medicine. 375:2335-48. 
 

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14 
APPENDICES 
Appendix 1. 
Schedule of Visits and Procedures  
Study Procedure Screening
Baseline
Treatment Period 
Visit (V) 
Week (W) 
Day (D) 
Visit Window (d) 
V1 
V2 
V3 
V4 
V5 
V6 
V7 
V8 
-30 to -7 
W0 
D1 
W2
W4 
W6 
W8 
W10 
W12 
D15
D29 
D43 
D57 
D71 
D85 
±3d 
±3d 
±3d 
±3d 
±3d 
±3d 
Screening/Baseline: 
Informed Consent 
X 
 
 
 
 
 
 
 
Inclusion/Exclusion 
X 
X 
 
 
 
 
 
 
Medical History/ Demographics 
X 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
Safety: 
Weight 
X 
X 
 
 
 
 
 
 
Height 
X 
 
 
 
 
 
 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
Physical Examination 
X 
 
 
 
 
 
 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
Procedure/Therapy 
X 
X 
X 
X 
X 
X 
X 
X 
12-Lead ECG 
 
X 
 
 
 
 
 
 
Laboratory Testing: 
HIV Ab, HBsAg, HBcAb, Hep C 
Ab 
X 
 
 
 
 
 
 
 
Hematology, Chemistry 
X 
X 
 
X 
 
X 
 
X 
Urinalysis 
X 
X 
 
X 
 
X 
 
X 
Pregnancy Test (WOCBP only) 
Serum 
Urine 
 
Urine 
 
Urine 
 
Urine 
Efficacy: 
IGA 
X 
X 
 
X 
 
X 
 
X 
EASI 
X 
X 
 
X 
 
X 
 
X 
BSA 
X 
X 
 
X 
 
X 
 
X 
Pruritus (daily)a 
 
X 
X 
X 
X 
X 
X 
X 
Sleep-loss (daily) a 
 
X 
X 
X 
X 
X 
X 
X 
ADIQa 
 
X 
X 
X 
X 
X 
X 
X 
POEM  
 
X 
 
 
 
 
 
 
DLQI 
 
X 
 
 
 
X 
 
 
HADS 
 
X 
 
 
 
X 
 
 
PK/Drug Concentration and Anti-Drug Antibody (ADA) Samplesc:
PK Sample 
 
X 
X 
X 
 
X 
 
X 
ADA Sample 
 
X 
X 
X 
 
 
 
 
Treatment: 
Administer Study Drug 
 
X 
X 
X 
X 
X 
X 
X 
Reminders: 
Apply emollient twice daily 
 
X 
X 
X 
X 
X 
X 
X 
Use electronic tablet daily 
 
X 
X 
X 
X 
X 
X 
X 

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Schedule of Visits and Procedures (cont’d) 
Study Procedure 
Treatment 
Period 
Follow-up/EOS 
Unscheduled 
Visitb 
Early 
Terminationb
Visit (V) 
V9 
V10 
V11 
V12 
V13 Phone 
Call 
 
 
Week (W) 
W14 
W16 
W20 
W24 
W32 
 
 
Day (D) 
D99 
D113 
D141 
D169 
D225 
 
 
Visit Window (d) 
±3d 
±3d 
±7d 
±7d 
±7d 
 
 
Safety: 
Weight 
 
X 
 
 
 
 
X 
Vital Signs 
X 
X 
X 
X 
 
X 
X 
Physical Examination 
 
X 
 
 
 
 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medication 
X 
X 
X 
X 
 
X 
X 
Procedure/Therapy 
X 
X 
X 
X 
 
X 
X 
12-Lead ECG 
 
X 
 
 
 
 
X 
Laboratory Testing: 
Hematology, Chemistry 
 
X 
 
X 
 
 
X 
Urinalysis 
 
X 
 
X 
 
 
X 
Pregnancy Test 
(WOCBP only) 
 
Urine 
 
Urine 
 
 
Urine 
Efficacy: 
IGA 
 
X 
X 
X 
 
 
X 
EASI 
 
X 
X 
X 
 
 
X 
BSA 
 
X 
X 
X 
 
 
X 
Pruritus (daily) a 
X 
X 
 
 
 
 
X 
Sleep-loss (daily) a 
X 
X 
 
 
 
 
X 
ADIQ a 
X 
X 
 
 
 
 
X 
POEM 
 
X 
 
 
 
 
X 
DLQI 
 
X 
 
 
 
 
X 
HADS 
 
X 
 
 
 
 
X 
Global Assessment of 
Change–AD 
 
X 
 
 
 
 
X 
PK/Drug Concentration and Anti-Drug Antibody (ADA) Samplesc:
PK Sample  
 
X 
 
X 
 
 
 
ADA Sample 
 
X 
 
X 
 
 
 
Treatment: 
Administer Study Drug 
X 
 
 
 
 
 
 
Reminders: 
Apply emollient twice 
daily 
X 
X 
X 
X 
 
 
 
Use electronic tablet 
daily 
X 
 
 
 
 
 
 
a Pruritus NRS, sleep-loss NRS, and ADIQ are completed on an electronic tablet issued to the patient at 
the Baseline visit. 
b If applicable. 
c PK and ADA samples taken pre-dose on dosing days (There is no dosing at the Week 16 and Week 24 
visits). 

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Appendix 2. 
Hanifin/Rajka Diagnostic Criteria for Atopic Dermatitis 
From: Hanifin JM and Rajka G. Diagnostic features of atopic dermatitis. Acta Derm Venereol 
(Stockholm) 1980; Suppl 92:44−7. 
To establish a diagnosis of atopic dermatitis the patient requires the presence of at least 
3 “basic features” and 3 or more minor features listed below. 
Basic Features 
Must have three or more basic features: 
• Pruritus 
• Typical morphology and distribution  
• Flexural lichenification or linearity in adults 
• Chronic or chronically-relapsing dermatitis 
• Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis) 
Minor Features 
Plus, three or more minor features: 
• Xerosis 
• Ichthyosis, palmar hyperlinearity, or keratosis pilaris 
• Immediate (type 1) skin-test reactivity 
• Elevated serum IgE 
• Early age of onset 
• Tendency toward cutaneous infections (especially Staph. aureus and Herpes 
simplex)/impaired cell-mediated immunity 
• Tendency toward non-specific hand or foot dermatitis 
• Nipple eczema 
• Cheilitis 
• Recurrent conjunctivitis 
• Dennie-Morgan infraorbital fold 
• Keratoconus 
• Anterior subcapsular cataracts 
• Orbital darkening 
• Facial pallor/facial erythema 
• Pityriasis alba 
• Anterior neck folds 
• Itch when sweating 
• Intolerance to wool and lipid solvents 
• Perifollicular accentuation 
• Food intolerance 
• Course influenced by environmental or emotional factors 
• White dermographism/delayed blanch 

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Appendix 3. 
Investigator Global Assessment (IGA) 
For IGA scoring, the Investigator should evaluate the patient's extent and severity of AD at a 
macroscopic level; i.e., without focusing on specific components of AD, which will be quantitated 
in the EASI score. In doing so, the investigator will use the table below to provide the IGA score. 
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.  
 

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1 _ A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 5 2 
C o nfi d e nti al 
A p p e n di x 4. 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  T a k e a n a v er a g e of t h e s e v erit y a cr o s s t h e i n v ol v e d ar e a. 
  H alf p oi nt s ( 1. 5 a n d 2. 5) m a y b e u s e d. 0. 5 i s n ot 
p er mitt e d. If a si g n i s pr e s e nt it s h o ul d b e at l e a st mil d.  
 P al p ati o n m a y b e u s ef ul i n a s s e s si n g e d e m a/ p a p ul ati o n 
a s w ell a s li c h e nifi c ati o n.
C CI
 

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Appendix 5. 
Body Surface Area (BSA) 
The BSA assessment estimates the extent of disease or skin involvement with respect to AD 
and is expressed as a percentage of total body surface.  
Determine BSA using the patient’s palm = 1% rule.  
The patient’s palm is measured from the wrist to the proximal interphalangeal (PIP) and thumb.  
Estimate the number of palms it takes to cover the affected AD area. Add up the number of 
palms to give a total estimate of the area covered in AD.  
Below are estimates when entire areas (anterior and posterior) are covered: 
Head and Neck = 10% (10 palms) 
Upper Extremities = 20% (20 palms) 
Trunk (axillae and groin) = 30% (30 palms) 
Lower extremities (buttocks) = 40% (40 palms) 
TOTAL BSA = 100% (100 palms) 
Additional rules: 
1. When many small lesions are present, try to put several together to make one patient 
palm. 
2. Only include the edge of current lesions, not areas that have cleared. 
3. Double check to see if area derived matches eyeball method. 

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1 _ A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 5 4 
C o nfi d e nti al 
A p p e n di x 6. 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C CI
C CI

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1 _ A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 5 5 
C o nfi d e nti al 
A p p e n di x 7. 
 
C CI
 
 
 
 
 
 
 

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1 _ A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 5 6 
C o nfi d e nti al 
A p p e n di x 8. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C CI

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1 _ A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 5 7 
C o nfi d e nti al 
5.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7. 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C CI
C CI
C CI
C CI

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1 _ A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 5 8 
C o nfi d e nti al 
9. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 0. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
C CI
C CI
C CI
C CI

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1 _ A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 5 9 
C o nfi d e nti al 
1 3.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 4. 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
C CI
C CI

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Appendix 9. 
Patient-Oriented Eczema Measure (POEM) 
Please circle one response for each of the seven questions below about your eczema. 
Please leave blank any questions you feel unable to answer.  
1. Over the last week, on how many days has your skin been itchy because of your 
eczema?  
No days 
1‒2 days 
3‒4 days 
5‒6 days 
Every day 
 
 
2. Over the last week, on how many nights has your sleep been disturbed because of 
your eczema?  
No days 
1‒2 days 
3‒4 days 
5‒6 days 
Every day 
 
 
3. Over the last week, on how many days has your skin been bleeding because of your 
eczema?  
No days 
1‒2 days 
3‒4 days 
5‒6 days 
Every day 
 
 
4. Over the last week, on how many days has your skin been weeping or oozing clear 
fluid because of your eczema?  
No days 
1‒2 days 
3‒4 days 
5‒6 days 
Every day 
 
 
5. Over the last week, on how many days has your skin been cracked because of your 
eczema?  
No days 
1‒2 days 
3‒4 days 
5‒6 days 
Every day 
 
 
6. Over the last week, on how many days has your skin been flaking off because of your 
eczema?  
No days 
1‒2 days 
3‒4 days 
5‒6 days 
Every day 
 
 
7. Over the last week, on how many days has your skin felt dry or rough because of 
your eczema? 
No days 
1‒2 days 
3‒4 days 
5‒6 days 
Every day 
 
 
Total POEM Score (Maximum 28): __________ 

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Appendix 10. 
Dermatology Life Quality Index (DLQI) 
The aim of this questionnaire is to measure how much your skin problem has affected your life 
OVER THE LAST WEEK. Please tick (X) one box for each question. 
1. 
Over the last week, how itchy, sore, painful or 
stinging has your skin been? 
2. 
Over the last week, how embarrassed or self 
conscious have you been because of your skin? 
3. 
Over the last week, how much has your skin 
interfered with you going shopping or looking after 
your home or garden? 
4. 
Over the last week, how much has your skin 
influenced the clothes you wear? 
5. 
Over the last week, how much has your skin 
affected any social or leisure activities? 
6. 
Over the last week, how much has your skin made it 
difficult for you to do any sport? 
7. 
Over the last week, has your skin prevented you 
from working or studying? 
If "No", over the last week how much has your skin 
been a problem at work or studying? 
8. 
Over the last week, how much has your skin 
created problems with your partner or any of your 
close friends or relatives? 
9. 
Over the last week, how much has your skin caused 
any sexual difficulties? 
10. Over the last week, how much of a problem has 
the treatment for your skin been, for example by 
making your home messy, or by taking up time? 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Yes 
No 
 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
Very much 
A lot 
A little 
Not at all 
 
 
 
 
 
 
 
 
Not relevant  
 
 
 
 Not relevant  
 
 
 
 Not relevant  
 
 
 
 Not relevant  
 
 
 
 Not relevant  
 
 
 
 
 
 
 
 
 
Not relevant  
 
 
 
 
Not relevant  
 
 
 
 Not relevant  
 
 
 Please check you have answered EVERY question. Thank you. 

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DERMATOLOGY LIFE QUALITY INDEX (DLQI) – INSTRUCTIONS FOR USE 
The Dermatology Life Quality Index questionnaire is designed for use in adults, i.e. patients over 
the age of 16. It is self-explanatory and can be simply handed to the patient who is asked to fill it 
in without the need for detailed explanation. It is usually completed in one or two minutes. 
SCORING 
The scoring of each question is as follows: 
Very much 
Scored 3 
A lot 
Scored 2 
A little 
Scored 1 
Not at all 
Scored 0 
Not relevant 
Scored 0 
Question 7, ‘prevented work or studying’ Scored 3 
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 
and a minimum of 0. The higher the score, the more quality of life is impaired. 
HOW TO INTERPRET MEANING OF DLQI SCORES 
0–1 
No effect at all on 
patient's life 
2–5 
Small effect on 
patient's life 
6–10 
Moderate effect on 
patient's life 
11–20 
Very large effect on 
patient's life 
21–30 
Extremely large effect on patient's life 
REFERENCES 
Finlay AY and Khan GK. Dermatology Life Quality Index (DLQI): a simple practical 
measure for routine clinical use. Clin Exp Dermatol 1994; 19:210-216. 
Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality 
Index 1994-2007: a comprehensive review of validation data and clinical results. 
Br J Dermatol 2008; 159:997-1035. 
Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY. Translating the science of 
quality of life into practice: What do dermatology life quality index scores mean? 
J Invest Dermatol 2005; 125:659-64. 
There is more information about the DLQI, including over 85 translations, at 
www.dermatology.org.uk. The DLQI is copyright but may be used without seeking 
permission by clinicians for routine clinical purposes. For other purposes, please 
contact the copyright owners. 
 
 

D er mir a, I n c. 
L e bri ki z u m a b 
D R M 0 6- A D 0 1 _ A 2 
Pr ot o c ol: D R M 0 6- A D 0 1 _ A 2 
P a g e 6 3 
C o nfi d e nti al 
A p p e n di x 1 1. 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
  
  
 
 
  
 
 
  
 
 
  
 
  
 
  
 
 
  
 
 
  
 
 
 
 
 
 
  
 
 
  
 
  
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
  
  
 
 
  
 
 
  
 
 
  
 
 
 
  
 
 
  
 
  
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
  
 
 
 
  
 
 
  
 
 
  
 
 
  
 
  
  
 
 
  
 
 
  
 
 
  
 
  
  
 
 
 
  
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
   
 
 
  
 
 
  
 
  
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
  
  
 
 
  
 
 
  
 
 
  
 
  
  
 
 
  
 
 
  
 
 
  
 
 
 
  
 
  
  
 
  
  
 
  
  
 
 
  
 
  
  
 
 
  
 
 
  
 
 
  
  
C CI
  
 
 
C
C
I

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Protocol: DRM06-AD01_A2 
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Appendix 12. 
Global Assessment of Change‒AD 
The following question will be asked at Week 16: 
Overall, compared to the start of the study, how would you rate your atopic dermatitis symptoms 
over the past week? 
1 = Much better 
2 = Moderately better 
3 = A little better 
4 = No difference 
5 = A little worse 
6 = Moderately worse 
7 = Much worse