Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.

Atopic Dermatitis Clinical Trial

— ADhere  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250337
• Other study ID #: 17803
• Secondary ID: 2019-004300-34J2
• Status: Completed
• Phase: Phase 3
• Start date: February 3, 2020
• Est. completion date: September 16, 2021

Study information

• Verified date: May 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: September 16, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Male or female adult and adolescents (=12 years to <18 years, and weighing =40 kg).

2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before the screening visit.

3. Eczema Area and Severity Index (EASI) score =16 at the baseline visit.

4. Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit

5. =10% body surface area (BSA) of AD involvement at the baseline visit.

6. History of inadequate response to treatment with topical medications.

Exclusion Criteria:

1. Participation in a prior lebrikizumab clinical study.

2. Treatment with the following prior to the baseline visit:

1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.

2. Dupilumab within 8 weeks.

3. B-cell-depleting biologics, including to rituximab, within 6 months.

4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.

3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.

4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.

5. Evidence of active acute or chronic hepatitis

6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.

7. History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.

8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• Lebrikizumab
Subcutaneous injection

Other:
• Placebo
Subcutaneous injection
• Topical Corticosteroid
Topical Corticosteroid

Locations

Country	Name	City	State
Canada	International Dermatology Research	Montreal	Quebec
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	CARe Clinic	Red Deer	Alberta
Canada	Dr. Chih-ho Hong Medical Inc.	Surrey	British Columbia
Canada	Enverus Medical Research	Surrey	British Columbia
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
Germany	Praxis für Ganzheitliche Dermatologie im Ärztehaus	Berlin
Germany	Elbe Klinikum Buxtehude	Buxtehude	Lower Saxony
Germany	Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Klinik und Poliklinik fuer	Dresden	Saxony
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt am Main	Hessen
Germany	TFS Trial Form Support GmbH	Hamburg
Poland	Clinica Vitae Sp. z o.o.	Gdansk	Woj. Pomorskie
Poland	COPERNICUS Podmiot Leczniczy sp. z o.o.	Gdansk	Pomorskie
Poland	Gabinet Dermatlogiczny. Beata Krecisz	Kielce	Swietokrzyskie
Poland	Labderm s.c.	Ossy	Slaskie
Poland	Kliniczny Szpital Wojewodzki nr. 1 Klinika Dermatologii	Rzeszow	Podkarpackie
Poland	Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.	Tarnow	Malopolska
Poland	Centralny Szpital Kliniczny MSWiA	Warszawa
Poland	Clinical Research Group Sp. z o.o.	Warszawa
Poland	DermMEDICA Sp. z o.o.	Wroclaw	Dolnoslaskie
United States	Orange County Research Institute	Anaheim	California
United States	Fivenson Dermatology	Ann Arbor	Michigan
United States	Arlington Research Center, Inc	Arlington	Texas
United States	Bakersfield Dermatology and Skin Cancer Medical Group	Bakersfield	California
United States	ActivMed Practices and Research	Beverly	Massachusetts
United States	Wallace Medical Group, Inc.	Beverly Hills	California
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	OnSite Clinical Solutions	Charlotte	North Carolina
United States	Clarkston Skin Research	Clarkston	Michigan
United States	St. Francis Medical Institute	Clearwater	Florida
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	First OC Dermatology	Fountain Valley	California
United States	Center For Dermatology Clinical Research, Inc.	Fremont	California
United States	University of Florida - Gainesville	Gainesville	Florida
United States	Direct Helpers Medical Center	Hialeah	Florida
United States	The Community Research of South Florida	Hialeah	Florida
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	California Allergy and Asthma Medical Group + Research Center	Los Angeles	California
United States	Dermatology Research Associates	Los Angeles	California
United States	Keck School of Medicine University of Southern California	Los Angeles	California
United States	LA Universal Research Center, INC	Los Angeles	California
United States	GSI Clinical Research, LLC	Margate	Florida
United States	Clinical Research Institute	Medford	Oregon
United States	Vitae Research Center, LLC	Miami	Florida
United States	Well Pharma Medical Research Corp.	Miami	Florida
United States	Sadick Research Group	New York	New York
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	OHSU Center for Health and Healing	Portland	Oregon
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	ALLCUTIS Research	Portsmouth	New Hampshire
United States	Beacon Clinical Research LLC	Quincy	Massachusetts
United States	Dermatology and Skin Cancer Specialists	Rockville	Maryland
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	ACRC Studies	San Diego	California
United States	University Clinical Trials, Inc.	San Diego	California
United States	Advanced Medical Research	Sandy Springs	Georgia
United States	Southern California Dermatology, Inc.	Santa Ana	California
United States	Investigate MD	Scottsdale	Arizona
United States	ForCare Clinical Research	Tampa	Florida
United States	Foxhall Dermatology	Washington	District of Columbia
United States	Wilmington Dermatology Center	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Dermira, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction =2-points From Baseline to 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.	Baseline to Week 16
Primary	Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (=75% Reduction From Baseline in EASI Score) at 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.	Baseline to Week 16
Secondary	Percentage of Participants Achieving EASI-90 (=90% Reduction From Baseline in EASI Score) at 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.	Baseline to Week 16
Secondary	Percent Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable." Least Squares (LS) Mean was calculated using analysis covariance (ANCOVA) model includes treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score as fixed factors.	Baseline, Week 16
Secondary	Percentage of Participants With a Pruritus NRS of =4-Points at Baseline Who Achieve a =4-Point Reduction From Baseline to Week 16	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."	Baseline to Week 16
Secondary	Percentage of Participants With a Pruritus NRS of =5-points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 16	Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."	Baseline to Week 16
Secondary	Percent Change in EASI Score From Baseline at 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).; LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors.	Baseline, Week 16
Secondary	Change From Baseline to Week 16 in Percent Body Surface Area (BSA)	The 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.	Baseline, Week 16
Secondary	Percentage of Participants Achieving EASI-90 at Week 4	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.	Baseline to Week 4
Secondary	Percent Change in Sleep-loss Score From Baseline to Week 16	Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.; .	Baseline, Week 16
Secondary	Change From Baseline in Sleep-loss Score at Week 16	Sleep Loss due to interference of itch will be assessed by the participant. Participants rate their interference of itch on sleep based on a 5-point Likert scale [0 (not at all) to 4 (unable to sleep at all)]. Higher scores indicated a greater impact and worse outcome. Assessments will be recorded daily by the participant using an electronic diary. LS Mean was calculated using ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.; APD: All randomized participants, even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.	Baseline, Week 16
Secondary	Percentage of Participants With a Pruritus NRS of =4-points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4	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.	Baseline to Week 4
Secondary	Percentage of Participants With a Pruritus NRS of =4-points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2	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.	Baseline to Week 2
Secondary	Percentage of Participants With a Pruritus NRS of =4-points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1	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.	Baseline to Week 1
Secondary	Percentage of Participants With a Pruritus NRS of =5-points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4	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.	Baseline to Week 4
Secondary	Percentage of Participants With a Pruritus NRS of =5-points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2	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.	Baseline to Week 2
Secondary	Percentage of Participants With a Pruritus NRS of =5-points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1	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.	Baseline to Week 1
Secondary	Percentage of Topical Corticosteroid (TCS)/Topical Calcineurin Inhibitors (TCI) Free Days From Baseline to Week 16	Number of the total TCS/TCI free days divided by total number of days during the treatment period. The mixed model repeated measures (MMRM) includes treatment, visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score.	Baseline to Week 16
Secondary	Median Time (Days) to TCS/TCI-free Use From Baseline to Week 16	Days from first study drug injection to the day participant stopped using all TCS/TCI (if a participant started and stopped using low or midpotency TCS/TCI multiple times, use the last stop date as the stop date for this participant).	Baseline to Week 16
Secondary	Percent Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16	The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.; LS Mean was calculated using the ANCOVA model with treatment group, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.; LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16
Secondary	Percentage of Participants With a DLQI Score =4 Points at Baseline Who Achieve a =4 Points	The DLQI is a 10-item, validated questionnaire used to assess the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, over the previous week. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". Questions are scored from 0 to 3, giving a possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.; LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline to Week 16
Secondary	Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Health State Index	The EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state.; LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16
Secondary	Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 Visual Analog Score (VAS)	The EQ-5D-5L is a 2-part measurement. The second part is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16
Secondary	Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16	POEM is a 7-item, validated, questionnaire used by the participant to assess disease symptoms over the last week. The participant is asked to respond to 7 questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding and weeping. All 7 answers carry equal weight with a total possible score from 0 to 28 (answers scored as: No days=0; 1- 2 days = 1; 3-4 days = 2; 5-6 days = 3; everyday = 4). A high score is indicative of a poor quality of life. POEM responses will be captured using an electronic diary and transferred into the clinical database. LS Mean was calculated using MMRM model using treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit as covariates, geographic region, age group, baseline IGA (3 versus 4) score as fixed.	Baseline, Week 16
Secondary	Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 - Adults	PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16
Secondary	Change From Baseline in PROMIS Depression at Week 16 - Adults	PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS measures will be completed by the participant in the study clinic. PROMIS depression has 8 questions on Emotion Distress-Depression. Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16
Secondary	Change From Baseline in PROMIS Anxiety at Week 16 - Pediatrics	PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants =17 years will complete pediatric versions for the duration of the study. PROMIS anxiety has 8 questions on Emotion Distress-Anxiety (or Pediatric Anxiety Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16
Secondary	Change From Baseline in PROMIS Depression at Week 16 - Pediatrics	PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Participants =17 years will complete pediatric versions for the duration of the study. PROMIS depression has 8 questions on Emotion Distress-Depression (or Pediatric Depressive Symptom). Each question has 5 response options with values from 1 to 5. Total raw scores were converted to T-scores with higher scores indicating greater severity of symptoms. LS Mean was calculated using the ANCOVA model with treatment, baseline value, and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16
Secondary	Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma	The ACQ-5 has been shown to reliably measure asthma control and distinguish participants with well-controlled asthma (score =0.75 points) from those with uncontrolled asthma (score =1.5 points). It consists of 5 questions that are scored on a 7- point Likert scale with a recall period of 1 week. The total ACQ-5 score is the mean score of all questions; a lower score represents better asthma control.; LS Mean was calculated using ANCOVA with treatment, baseline value, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16
Secondary	Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16	The CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. The scoring of each question is: Very much =3; Quite a lot = 2; Only a little = 1; Not at all = 0. CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).; LS Mean was calculated using MMRM model which includes treatment, baseline value, visit, the interaction of the baseline value-by-visit as covariates, the interaction of treatment by-visit, geographic region, age group, and baseline IGA (3 versus 4) score as fixed factors.	Baseline, Week 16

External Links

•   Related Info
•   Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis. (ADhere)