A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03443024
• Collaborator: Dermira, Inc. (Industry)
• Enrollment: 280
• Locations: 58
• Arms: 4
• Actual Duration (Months): 15.7
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in participants with moderate-to-severe atopic dermatitis.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Biological: Lebrikizumab; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Jan 30, 2018
• Actual Primary Completion Date: Feb 7, 2019
• Actual Study Completion Date: May 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 125 milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W) 125 mg Lebrikizumab administered subcutaneously (SC) once Q4W. Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-milliliter (mL) of 125 mg/mL Lebrikizumab and 1-mL placebo). Week 2: Four 1-mL SC injections placebo. Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo. Weeks 6, 10, 14: Two 1-mL SC placebo.	Biological: Lebrikizumab; Sterile liquid solution administered subcutaneously.; Other Names: LY3650150 DRM06 ; Drug: Placebo; Solution administered subcutaneously.
Experimental: 250 mg Lebrikizumab - Q4W 250 mg Lebrikizumab administered SC once Q4W. Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 2: Four 1-mL SC injections of placebo. Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab). Weeks 6, 10, 14: Two 1-mL injections of placebo.	Biological: Lebrikizumab; Sterile liquid solution administered subcutaneously.; Other Names: LY3650150 DRM06 ; Drug: Placebo; Solution administered subcutaneously.
Experimental: 250 mg Lebrikizumab - Every 2 Weeks (Q2W) 250 mg Lebrikizumab administered SC once Q2W. Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab).	Biological: Lebrikizumab; Sterile liquid solution administered subcutaneously.; Other Names: LY3650150 DRM06 ; Drug: Placebo; Solution administered subcutaneously.
Placebo Comparator: Group 4 - Placebo Placebo administered SC once Q2W. Baseline and Week 2: Four 1-mL SC injections of placebo. Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo.	Drug: Placebo; Solution administered subcutaneously.

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in Eczema Area and Severity Index (EASI) [Baseline, Week 16]

   The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using analysis of covariance (ANCOVA) with the factor of treatment and the baseline EASI as covariate. Note: Missing values were imputed using Markov Chain Monte Carlo (MCMC) multiple imputation.

Secondary Outcome Measures

1. Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16 [Week 16]

   The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.

2. Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥2 Points From Baseline to Week 16 (5-point Scale) [Week 16]

   The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

3. Percentage of Participants With EASI <7 at Week 16 [Week 16]

   The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).

4. Percentage of Participants Achieving EASI50 at Week 16 [Week 16]

   The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score.

5. Percentage of Participants Achieving EASI90 at Week 16 [Week 16]

   The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score

6. Percent Change From Baseline in the Sleep Loss Scale Score [Baseline, Week 16]

   The Sleep Loss Scale is used by the participants to report the impact of itching on their sleep every night. Participants responded to the question to what extent did your itching interfere with your sleep last night. The scale ranged from 0 to 4, with 0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments were recorded daily by the participant using an electronic diary. Least Squares (LS) Means were calculated using ANCOVA with the factor of treatment and the baseline sleep-loss scale as covariates.

7. Percent Change From Baseline in Pruritus Numeric Rating Score (NRS) [Baseline, Week 16]

   The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Pruritus assessments were recorded daily by the participant using an electronic diary. LS Means were calculated using ANCOVA with the factor of treatments and the baseline pruritus NRS as covariates.

8. Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16 [Week 16]

   The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 3-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.

9. Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16 [Week 16]

   The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 4-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.

10. Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD) [Baseline, Week 16]

    The body surface area (BSA) affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.

11. Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score [Baseline, Week 16]

    The ADIQ is a 17-item questionnaire used to assess the participant's AD-specific health-related quality of life. Each item is rated on a 5-point scale from 0 to 4, with higher numbers indicating greater burden. 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 were recorded by the participant using an electronic diary and transferred to the clinical database.The ADIQ score is calculated by summing the score of each of the 14 questions resulting in a maximum of 56 and a minimum of 0, with higher scores indicating greater burden.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 .

• 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.

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).

• Use of prescription moisturizers within 7 days of the baseline visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clear Dermatology & Aesthetics Center	Scottsdale	Arizona	United States	85255
2	Dermatology Trial Associates	Bryant	Arkansas	United States	72022
3	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas	United States	72758
4	Center for Dermatology Clinical Research, Inc.	Fremont	California	United States	94538
5	University of Southern California	Los Angeles	California	United States	90033
6	Dermatology Research Associates	Los Angeles	California	United States	90045
7	Stanford Medicine Outpatient Center-Medical Dermatology Clinic	Redwood City	California	United States	94063
8	Center for Dermatology and Laser Surgery	Sacramento	California	United States	95819
9	UCSD Dermatology	San Diego	California	United States	92122
10	TCR Medical Corporation	San Diego	California	United States	92123
11	Clinical Science Institute	Santa Monica	California	United States	90404
12	George Washington Medical Faculty Associates	Washington	District of Columbia	United States	20037
13	Total Vein and Skin	Boynton Beach	Florida	United States	33437
14	Florida Academic Centers Research and Education, LLC	Coral Gables	Florida	United States	33134
15	Olympian Clinical Research	Largo	Florida	United States	33770
16	Tory Sullivan, MD PA	North Miami Beach	Florida	United States	33162
17	International Clinical Research - US, LLC	Sanford	Florida	United States	32771
18	Integrated Clinical Research, LLC	West Palm Beach	Florida	United States	33406
19	Marietta Dermatology Clinical Research, Inc.	Marietta	Georgia	United States	30060
20	Advanced Medical Research, PC	Sandy Springs	Georgia	United States	30328
21	Dundee Dermatology	West Dundee	Illinois	United States	60118
22	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46256
23	The Indiana Clinical Trials Center	Plainfield	Indiana	United States	46168
24	Kansas City Dermatology, PA	Overland Park	Kansas	United States	66215
25	Skin Sciences, PLLC	Louisville	Kentucky	United States	40217
26	Meridian Clinical Research, LLC	Baton Rouge	Louisiana	United States	70808
27	Dermatology and Skin Cancer Specialists, LLC	Rockville	Maryland	United States	20850
28	ActivMed Practices & Research, Inc.	Beverly	Massachusetts	United States	01915
29	Tufts Medical Center	Boston	Massachusetts	United States	02111
30	Somerset Skin Centre	Troy	Michigan	United States	48084
31	JDR Dermatology Research	Las Vegas	Nevada	United States	89148
32	ActivMed Practices & Research, Inc.	Portsmouth	New Hampshire	United States	03801
33	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
34	Schweiger Dermatology, PLLC	New York	New York	United States	10022
35	Icahn School of Medicine	New York	New York	United States	10029
36	Sadick Research Group, LLC.	New York	New York	United States	10075
37	DermResearchCenter of New York, Inc.	Stony Brook	New York	United States	11790
38	Piedmont Plastic Surgery and Dermatology	Charlotte	North Carolina	United States	28277
39	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
40	Wilmington Dermatology Center	Wilmington	North Carolina	United States	28405
41	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
42	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
43	Oregon Medical Research Center	Portland	Oregon	United States	97223
44	Clinical Partners, LLC	Johnston	Rhode Island	United States	02919
45	Clinical Research Center of the Carolinas	Charleston	South Carolina	United States	29407
46	Rivergate Dermatology Clinical Research Center	Goodlettsville	Tennessee	United States	37072
47	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee	United States	37130
48	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215
49	Arlington Research Center, Inc.	Arlington	Texas	United States	76011
50	Westlake Dermatology Clinical Research Center	Austin	Texas	United States	78746
51	Bellaire Dermatology Associates	Bellaire	Texas	United States	77401
52	Menter Dermatology Research	Dallas	Texas	United States	75246
53	The University of Texas Health	Houston	Texas	United States	77030
54	Progressive Clinical Research, PA	San Antonio	Texas	United States	78213
55	Center for Clinical Studies, LTD. LLP	Webster	Texas	United States	77598
56	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23502
57	Dermatology Associates of Seattle	Seattle	Washington	United States	98101
58	Premier Clinical Research	Spokane	Washington	United States	99202

Sponsors and Collaborators

• Eli Lilly and Company
• Dermira, Inc.

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Study Protocol - Mar 7, 2018
• Statistical Analysis Plan - Feb 25, 2019

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03443024
• Other Study ID Numbers: 17826; J2T-DM-KGAF; DRM06-AD01
• First Posted: Feb 22, 2018
• Last Update Posted: May 4, 2021
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eli Lilly and Company: Eczema
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

Participant Flow

Arm/Group Title	125 Milligrams (mg) Lebrikizumab - Every 4 Weeks (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab - Every 2 Weeks (Q2W)	Placebo
Arm/Group Description	125 milligrams (mg) Lebrikizumab administered subcutaneously (SC) once every Q4W. Baseline: Loading dose 250 mg Lebrikizumab SC (two injections SC 1-mL of 125 mg/mL Lebrikizumab and 1-mL placebo). Week 2: Four 1-mL SC injections placebo. Weeks 4, 8, 12: 125 mg SC Lebrikizumab and 1-mL SC placebo. Weeks 6, 10, 14: Two 1-mL SC placebo.	250 mg Lebrikizumab administered SC once every 4 weeks. Baseline: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 2: Four 1-mL SC injections of placebo. Weeks 4, 8, 12: 250 mg (two 1-mL injections of 125 mg/mL Lebrikizumab). Weeks 6, 10, 14: Two 1-mL injections of placebo.	250 mg Lebrikizumab administered SC once every 2 weeks. Baseline and Week 2: Loading dose of 500 mg (four 1-mL SC injections of 125 mg/mL Lebrikizumab). Week 4, 6, 8, 10, 12, 14: 250 mg (two 1-mL SC injections of 125 mg/mL Lebrikizumab).	Placebo administered SC once every 2 weeks. Baseline and Week 2: Four 1-mL SC injections of placebo. Week 4, 6, 8, 10, 12, 14: Two 1-mL SC injections of placebo.
Period Title: Overall Study
STARTED	73	80	75	52
Received at Least One Dose of Study Drug	73	80	75	52
COMPLETED	52	49	56	20
NOT COMPLETED	21	31	19	32

Baseline Characteristics

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo	Total
Arm/Group Description	125 mg Lebrikizumab administered SC once every 4 weeks.	250 mg Lebrikizumab administered SC once every 4 weeks.	250 mg Lebrikizumab administered SC once every 2 weeks.	Placebo administered SC once every 2 weeks.	Total of all reporting groups
Overall Participants	73	80	75	52	280
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.7 (16.54)	40.2 (17.88)	38.9 (17.36)	42.2 (18.21)	39.3 (17.48)
Sex: Female, Male (Count of Participants)
Female	46 63%	47 58.8%	49 65.3%	24 46.2%	166 59.3%
Male	27 37%	33 41.3%	26 34.7%	28 53.8%	114 40.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	14 19.2%	11 13.8%	12 16%	5 9.6%	42 15%
Not Hispanic or Latino	59 80.8%	69 86.3%	63 84%	47 90.4%	238 85%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.4%	1 1.3%	1 1.3%	0 0%	3 1.1%
Asian	8 11%	7 8.8%	6 8%	6 11.5%	27 9.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	26 35.6%	28 35%	23 30.7%	16 30.8%	93 33.2%
White	37 50.7%	42 52.5%	40 53.3%	26 50%	145 51.8%
More than one race	1 1.4%	2 2.5%	5 6.7%	4 7.7%	12 4.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	73 100%	80 100%	75 100%	52 100%	280 100%
Eczema Area and Severity Index (EASI) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	29.85 (13.517)	26.15 (10.135)	25.48 (11.206)	28.90 (11.790)	27.45 (11.764)

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Eczema Area and Severity Index (EASI)
Description	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). Least Square (LS) Means were calculated using analysis of covariance (ANCOVA) with the factor of treatment and the baseline EASI as covariate. Note: Missing values were imputed using Markov Chain Monte Carlo (MCMC) multiple imputation.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had Week 16 EASI data.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	73	80	75	52
Least Squares Mean (Standard Deviation) [percent change]	-62.34 (37.266)	-69.21 (38.282)	-72.09 (37.229)	-41.12 (59.496)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0165
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0022
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0005
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) at Week 16
Description	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	73	80	75	52
Number [percentage of participants]	43.3 59.3%	56.1 70.1%	60.6 80.8%	24.3 46.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0610
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0021
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0005
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

3. Secondary Outcome

Title	Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥2 Points From Baseline to Week 16 (5-point Scale)
Description	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	73	80	75	52
Number [percentage of participants]	26.6 36.4%	33.7 42.1%	44.6 59.5%	15.3 29.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1917
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0392
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0023
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

4. Secondary Outcome

Title	Percentage of Participants With EASI <7 at Week 16
Description	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	73	80	75	52
Number [percentage of participants]	42.2 57.8%	61.2 76.5%	61.8 82.4%	29.3 56.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2043
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0021
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0018
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

5. Secondary Outcome

Title	Percentage of Participants Achieving EASI50 at Week 16
Description	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 50% improvement from baseline in the EASI score.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	73	80	75	52
Number [percentage of participants]	66.4 91%	77.0 96.3%	81.0 108%	45.8 88.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0554
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0037
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0008
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

6. Secondary Outcome

Title	Percentage of Participants Achieving EASI90 at Week 16
Description	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	73	80	75	52
Number [percentage of participants]	26.1 35.8%	36.1 45.1%	44.0 58.7%	11.4 21.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0800
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0062
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

7. Secondary Outcome

Title	Percent Change From Baseline in the Sleep Loss Scale Score
Description	The Sleep Loss Scale is used by the participants to report the impact of itching on their sleep every night. Participants responded to the question to what extent did your itching interfere with your sleep last night. The scale ranged from 0 to 4, with 0 (not at all) to 4 (unable to sleep at all). Higher scores indicated a greater impact and worse outcome. Assessments were recorded daily by the participant using an electronic diary. Least Squares (LS) Means were calculated using ANCOVA with the factor of treatment and the baseline sleep-loss scale as covariates.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had Week 16 Sleep Loss Scale score.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	38	33	38	14
Least Squares Mean (Standard Deviation) [percent change]	-48.68 (50.692)	-53.03 (50.662)	-64.69 (50.692)	-20.24 (51.066)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0773
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0459
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0062
	Comments
	Method	ANCOVA
	Comments

8. Secondary Outcome

Title	Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)
Description	The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Pruritus assessments were recorded daily by the participant using an electronic diary. LS Means were calculated using ANCOVA with the factor of treatments and the baseline pruritus NRS as covariates.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received least one dose of study drug and had Week 16 Pruritus NRS score.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	55	56	50	22
Least Squares Mean (Standard Deviation) [percent change]	-35.94 (55.553)	-49.60 (55.555)	-60.63 (55.564)	4.26 (55.610)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0047
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

9. Secondary Outcome

Title	Percentage of Participants With Pruritus NRS Change of ≥3 at Week 16
Description	The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 3-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had a >=3 point improvement from Baseline in Week 16 Pruritus NRS score.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	55	57	50	22
Number [percentage of participants]	50.9 69.7%	64.9 81.1%	76.0 101.3%	45.5 87.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6674
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1166
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0119
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

10. Secondary Outcome

Title	Percentage of Participants With Pruritus NRS Change of ≥4 From Baseline to Week 16
Description	The Pruritus NRS is an 11-point scale used by participants to assess their worst itch severity over the past 24 hours, with 0 indicating no itch and 10 indicating worst itch imaginable. Assessments were recorded daily by the participant using an electronic diary. The percentage of participants who are dichotomized to success (pruritus NRS greater than or equal to 4-point improvement) at Week 16 will be analyzed using a Cochran-Mantel-Haenszel (CMH) test.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had a >=4 point improvement from Baseline in Week 16 Pruritus NRS score.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	55	57	50	22
Number [percentage of participants]	41.8 57.3%	47.4 59.3%	70.0 93.3%	27.3 52.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2371
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1067
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0008
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

11. Secondary Outcome

Title	Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)
Description	The body surface area (BSA) affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had Week 16 BSA data.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	59	62	59	24
Mean (Standard Deviation) [percentage of BSA]	-19.6 (19.08)	-24.9 (20.08)	-24.3 (21.00)	-17.4 (20.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4631
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0368
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0232
	Comments
	Method	ANCOVA
	Comments

12. Secondary Outcome

Title	Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score
Description	The ADIQ is a 17-item questionnaire used to assess the participant's AD-specific health-related quality of life. Each item is rated on a 5-point scale from 0 to 4, with higher numbers indicating greater burden. 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 were recorded by the participant using an electronic diary and transferred to the clinical database.The ADIQ score is calculated by summing the score of each of the 14 questions resulting in a maximum of 56 and a minimum of 0, with higher scores indicating greater burden.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had evaluable Week 16 ADIQ data.

Arm/Group Title	125 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q4W)	250 mg Lebrikizumab (Q2W)	Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q4W.	250 mg Lebrikizumab administered SC once Q2W.	Placebo administered SC once Q2W.
Measure Participants	38	33	35	17
Mean (Standard Deviation) [score on a scale]	-14.2 (12.74)	-18.8 (12.03)	-18.6 (12.63)	-11.0 (13.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	125 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4729
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q4W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0282
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	250 mg Lebrikizumab (Q2W), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0506
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	Baseline up to 271 days
Adverse Event Reporting Description	All participant who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Arm/Group Title	125 mg Lebrikizumab (Q4W)		250 mg Lebrikizumab (Q4W)		250 mg Lebrikizumab (Q2W)		Placebo
Arm/Group Description	125 mg Lebrikizumab administered SC once Q4W.		250 mg Lebrikizumab administered SC once Q4W.		250 mg Lebrikizumab administered SC once Q2W.		Placebo administered SC once Q2W.
All Cause Mortality
	125 mg Lebrikizumab (Q4W)		250 mg Lebrikizumab (Q4W)		250 mg Lebrikizumab (Q2W)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/73 (0%)		0/80 (0%)		0/75 (0%)		0/52 (0%)
Serious Adverse Events
	125 mg Lebrikizumab (Q4W)		250 mg Lebrikizumab (Q4W)		250 mg Lebrikizumab (Q2W)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/73 (2.7%)		0/80 (0%)		2/75 (2.7%)		2/52 (3.8%)
Gastrointestinal disorders
Hernial eventration	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
General disorders
Chest pain	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Oedema peripheral	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Injury, poisoning and procedural complications
Periprosthetic fracture	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Psychiatric disorders
Panic attack	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Pulmonary embolism	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Other (Not Including Serious) Adverse Events
	125 mg Lebrikizumab (Q4W)		250 mg Lebrikizumab (Q4W)		250 mg Lebrikizumab (Q2W)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/73 (56.2%)		39/80 (48.8%)		45/75 (60%)		24/52 (46.2%)
Blood and lymphatic system disorders
Anaemia	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Leukocytosis	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Leukopenia	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Neutropenia	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Neutrophilia	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Normocytic anaemia	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Polycythaemia	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Cardiac disorders
Arteriosclerosis coronary artery	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Bradycardia	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Tachycardia	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Ear and labyrinth disorders
Cerumen impaction	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Endocrine disorders
Goitre	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Eye disorders
Chalazion	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Conjunctivitis allergic	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Dry eye	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	2/52 (3.8%)	2
Eye irritation	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Eye pruritus	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Glaucoma	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Lacrimation increased	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Vitreous detachment	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Gastrointestinal disorders
Abdominal pain	2/73 (2.7%)	2	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Abdominal pain upper	0/73 (0%)	0	0/80 (0%)	0	2/75 (2.7%)	2	0/52 (0%)	0
Constipation	1/73 (1.4%)	1	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Diarrhoea	0/73 (0%)	0	3/80 (3.8%)	3	1/75 (1.3%)	1	0/52 (0%)	0
Food poisoning	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Gastritis	0/73 (0%)	0	0/80 (0%)	0	2/75 (2.7%)	2	0/52 (0%)	0
Gastrooesophageal reflux disease	1/73 (1.4%)	1	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Nausea	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Toothache	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Vomiting	1/73 (1.4%)	1	2/80 (2.5%)	2	0/75 (0%)	0	0/52 (0%)	0
General disorders
Application site rash	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Chest pain	1/73 (1.4%)	1	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Cyst	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Cyst rupture	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Face oedema	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Fatigue	0/73 (0%)	0	4/80 (5%)	4	0/75 (0%)	0	0/52 (0%)	0
Injection site dermatitis	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Injection site erythema	0/73 (0%)	0	2/80 (2.5%)	2	3/75 (4%)	6	1/52 (1.9%)	1
Injection site oedema	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Injection site pain	0/73 (0%)	0	3/80 (3.8%)	8	4/75 (5.3%)	20	1/52 (1.9%)	1
Injection site pruritus	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Injection site rash	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Injection site reaction	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Injection site swelling	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Malaise	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Mass	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Oedema peripheral	0/73 (0%)	0	2/80 (2.5%)	2	1/75 (1.3%)	1	1/52 (1.9%)	1
Pain	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Peripheral swelling	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Pyrexia	0/73 (0%)	0	1/80 (1.3%)	1	2/75 (2.7%)	2	1/52 (1.9%)	1
Immune system disorders
Seasonal allergy	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Infections and infestations
Alveolar osteitis	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Bacterial vaginosis	2/46 (4.3%)	3	0/47 (0%)	0	0/49 (0%)	0	0/24 (0%)	0
Bacterial vulvovaginitis	0/46 (0%)	0	1/47 (2.1%)	1	0/49 (0%)	0	0/24 (0%)	0
Body tinea	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Bronchitis	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Cellulitis	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	2/52 (3.8%)	2
Cellulitis staphylococcal	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Chlamydial infection	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Conjunctivitis	1/73 (1.4%)	1	1/80 (1.3%)	1	2/75 (2.7%)	2	0/52 (0%)	0
Conjunctivitis bacterial	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Ear infection	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Eczema herpeticum	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Folliculitis	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	1/52 (1.9%)	1
Fungal skin infection	1/73 (1.4%)	1	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Gastroenteritis	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Gastroenteritis viral	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Genital herpes	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Herpes simplex	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Herpes zoster	0/73 (0%)	0	2/80 (2.5%)	2	1/75 (1.3%)	1	0/52 (0%)	0
Impetigo	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Influenza	1/73 (1.4%)	1	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Injection site infection	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Lower respiratory tract infection	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Nasopharyngitis	4/73 (5.5%)	5	2/80 (2.5%)	3	9/75 (12%)	11	2/52 (3.8%)	2
Oral herpes	1/73 (1.4%)	1	2/80 (2.5%)	2	1/75 (1.3%)	1	0/52 (0%)	0
Otitis media	1/73 (1.4%)	1	0/80 (0%)	0	1/75 (1.3%)	2	1/52 (1.9%)	1
Pharyngitis	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Pharyngitis streptococcal	0/73 (0%)	0	2/80 (2.5%)	2	2/75 (2.7%)	2	0/52 (0%)	0
Rash pustular	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	4	0/52 (0%)	0
Respiratory tract infection viral	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Sinusitis	1/73 (1.4%)	1	2/80 (2.5%)	2	1/75 (1.3%)	1	1/52 (1.9%)	1
Skin infection	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Staphylococcal infection	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Tinea cruris	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Tonsillitis	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Tooth abscess	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Tooth infection	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Upper respiratory tract infection	6/73 (8.2%)	7	9/80 (11.3%)	10	2/75 (2.7%)	3	3/52 (5.8%)	3
Urinary tract infection	2/73 (2.7%)	2	1/80 (1.3%)	1	0/75 (0%)	0	1/52 (1.9%)	1
Viral tonsillitis	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Viral upper respiratory tract infection	1/73 (1.4%)	2	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Vulvovaginal candidiasis	1/46 (2.2%)	2	0/47 (0%)	0	0/49 (0%)	0	0/24 (0%)	0
Vulvovaginal mycotic infection	0/46 (0%)	0	1/47 (2.1%)	1	1/49 (2%)	1	0/24 (0%)	0
Vulvovaginitis gonococcal	0/46 (0%)	0	0/47 (0%)	0	0/49 (0%)	0	1/24 (4.2%)	1
Injury, poisoning and procedural complications
Arthropod bite	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Contusion	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Fall	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Ligament sprain	1/73 (1.4%)	1	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Post procedural haematoma	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Skin abrasion	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Sunburn	1/73 (1.4%)	2	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Investigations
Alanine aminotransferase increased	1/73 (1.4%)	1	2/80 (2.5%)	2	2/75 (2.7%)	2	0/52 (0%)	0
Aspartate aminotransferase increased	0/73 (0%)	0	1/80 (1.3%)	1	2/75 (2.7%)	2	0/52 (0%)	0
Bilirubin conjugated increased	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Blood bilirubin increased	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Blood lactate dehydrogenase increased	1/73 (1.4%)	1	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Blood potassium increased	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Blood pressure increased	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Cardiac murmur	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Gamma-glutamyltransferase increased	1/73 (1.4%)	1	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Haematocrit decreased	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Haematocrit increased	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Haemoglobin decreased	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Haemoglobin increased	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Hepatic enzyme increased	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Neutrophil count increased	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Protein urine present	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Urine leukocyte esterase positive	2/73 (2.7%)	2	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Weight increased	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Metabolism and nutrition disorders
Decreased appetite	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Hypercholesterolaemia	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Hyperkalaemia	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	2/73 (2.7%)	2	2/80 (2.5%)	2	0/75 (0%)	0	2/52 (3.8%)	2
Back pain	3/73 (4.1%)	3	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Bursitis	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Muscle spasms	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Musculoskeletal pain	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Myalgia	1/73 (1.4%)	1	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Neck pain	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Osteoarthritis	0/73 (0%)	0	2/80 (2.5%)	2	1/75 (1.3%)	1	0/52 (0%)	0
Pain in extremity	0/73 (0%)	0	0/80 (0%)	0	2/75 (2.7%)	2	0/52 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Lipoma	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Seborrhoeic keratosis	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Skin papilloma	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Thyroid adenoma	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	2	0/52 (0%)	0
Nervous system disorders
Auditory nerve disorder	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Dizziness	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Headache	3/73 (4.1%)	3	1/80 (1.3%)	1	4/75 (5.3%)	4	3/52 (5.8%)	4
Hypoaesthesia	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Migraine	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Paraesthesia	1/73 (1.4%)	1	2/80 (2.5%)	2	0/75 (0%)	0	0/52 (0%)	0
Restless legs syndrome	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Syncope	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Trigeminal neuralgia	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy	0/46 (0%)	0	0/47 (0%)	0	0/49 (0%)	0	1/24 (4.2%)	1
Psychiatric disorders
Anxiety	3/73 (4.1%)	3	0/80 (0%)	0	2/75 (2.7%)	3	0/52 (0%)	0
Depression	1/73 (1.4%)	2	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Suicidal ideation	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Renal and urinary disorders
Bilirubinuria	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Nephrolithiasis	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Pollakiuria	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Reproductive system and breast disorders
Gynaecomastia	0/46 (0%)	0	0/47 (0%)	0	1/49 (2%)	1	0/24 (0%)	0
Menorrhagia	0/46 (0%)	0	0/47 (0%)	0	1/49 (2%)	1	0/24 (0%)	0
Pelvic pain	0/73 (0%)	0	1/80 (1.3%)	2	1/75 (1.3%)	1	0/52 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	1/73 (1.4%)	2	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Cough	2/73 (2.7%)	2	0/80 (0%)	0	2/75 (2.7%)	2	0/52 (0%)	0
Lower respiratory tract congestion	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Nasal congestion	1/73 (1.4%)	1	1/80 (1.3%)	2	1/75 (1.3%)	1	0/52 (0%)	0
Oropharyngeal pain	2/73 (2.7%)	2	1/80 (1.3%)	1	2/75 (2.7%)	2	0/52 (0%)	0
Paranasal sinus discomfort	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Rhinitis allergic	1/73 (1.4%)	1	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Sinus congestion	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Upper respiratory tract congestion	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	0/52 (0%)	0
Upper-airway cough syndrome	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Skin and subcutaneous tissue disorders
Actinic keratosis	0/73 (0%)	0	1/80 (1.3%)	1	1/75 (1.3%)	1	0/52 (0%)	0
Alopecia	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Dermatitis	1/73 (1.4%)	1	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Dermatitis allergic	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	2	0/52 (0%)	0
Dermatitis atopic	2/73 (2.7%)	2	2/80 (2.5%)	3	0/75 (0%)	0	3/52 (5.8%)	3
Dermatitis contact	0/73 (0%)	0	1/80 (1.3%)	1	3/75 (4%)	3	0/52 (0%)	0
Dermatitis exfoliative	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	2	0/52 (0%)	0
Eczema	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Erythema	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Hypersensitivity vasculitis	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Milia	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Pain of skin	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Papule	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Photosensitivity reaction	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Pruritus	1/73 (1.4%)	1	1/80 (1.3%)	1	2/75 (2.7%)	2	0/52 (0%)	0
Pruritus generalised	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Rash	0/73 (0%)	0	2/80 (2.5%)	2	0/75 (0%)	0	0/52 (0%)	0
Rosacea	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Skin exfoliation	0/73 (0%)	0	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Skin fragility	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Skin irritation	0/73 (0%)	0	1/80 (1.3%)	1	0/75 (0%)	0	0/52 (0%)	0
Stasis dermatitis	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1
Vascular disorders
Hypertension	2/73 (2.7%)	2	0/80 (0%)	0	1/75 (1.3%)	1	0/52 (0%)	0
Hypertensive crisis	0/73 (0%)	0	0/80 (0%)	0	0/75 (0%)	0	1/52 (1.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.