Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— ADvocate2  

Official title:

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178967
• Other study ID #: 17802
• Secondary ID: 2019-002933-12J2
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2019
• Est. completion date: April 28, 2022

Study information

• Verified date: April 2023
• 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 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: April 28, 2022
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male or female adults and adolescents (=12 years and =40 kg)
• Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for =1 year before the screening visit
• Eczema Area and Severity Index (EASI) score =16 at the baseline visit
• Investigator Global Assessment (IGA) score =3 (scale of 0 to 4) at the baseline visit
• =10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
• History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable

Exclusion Criteria:

• Prior treatment with dupilumab or tralokinumab
• Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
• 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-?, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
• Phototherapy and photochemotherapy (PUVA) for AD
• Treatment with the following prior to the baseline visit:
• An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
• Cell-depleting biologics, including to rituximab, within 6 months of baseline
• Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer
• Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study
• Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma
• Evidence of active acute or chronic hepatitis
• History of human immunodeficiency virus (HIV) infection or positive HIV serology
• 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
• 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

Locations

Country	Name	City	State
Bulgaria	DCC Sveti Georgi	Plovdiv
Bulgaria	Alexandrovska University Hospital	Sofia
Bulgaria	Diagnostic and Consultation Center 14	Sofia
Bulgaria	Euro Derma clinic	Sofia
Bulgaria	Medical centre Alitera-Med EOOD	Sofia
Bulgaria	Military Medical Academy	Sofia
Canada	Simcoderm Medical & Surgical Dermatology Centre	Barrie	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	North York Research Inc.	North York	Ontario
Canada	Ottawa Allergy Research Corp	Ottawa	Ontario
Canada	Dr. Chih-ho Hong Medical Inc.	Surrey	British Columbia
Canada	K. Papp Clinical Research	Waterloo	Ontario
Germany	licca Fachklinik	Augsburg	Bayern
Germany	Praxis Dr. Michael Dietlen	Augsburg
Germany	Fachklinik Bad Bentheim	Bad Bentheim	Nordrhein-Westfalen
Germany	Charité Universitätsmedizin Berlin Campus Buch	Berlin
Germany	ISA GmbH	Berlin
Germany	Praxis für Ganzheitliche Dermatologie im Ärztehaus	Berlin
Germany	Hautzentrum im Jahrhunderthaus	Bochum	Nordrhein-Westfalen
Germany	Elbe Klinikum Buxtehude	Buxtehude	Niedersachsen
Germany	Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH	Darmstadt	Hessen
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt am Main	Hessen
Germany	Derma-Study-Center Friedrichshafen GmbH	Friedrichshafen	Baden-Württemberg
Germany	TFS Trial Form Support GmbH	Hamburg
Germany	Universitätsklinikum Hamburg	Hamburg
Germany	Studienzentrum Dr.Beate Schwarz	Langenau	Baden-Württemberg
Germany	SIBAmed Studienzentrum GmbH & Co. KG	Leipzig	Saxony
Germany	Universität Leipzig - Universitätsklinikum	Leipzig	Sachsen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	Universitätsklinikum Münster	Münster	Nordrhein-Westfalen
Germany	Klinische Forschung Osnabrück	Osnabrück	Niedersachsen
Germany	Hautarztpraxis am Löwenmarkt	Stuttgart	Baden-Württemberg
Mexico	Derma Norte del Bajío, S.C.	Aguascalientes
Mexico	Clinica De Enfermedades Cronicas y Procedimientos Especiales	Morelia	Michoacan Morelia
Singapore	Kk Women'S and Childrens Hospital	Singapore
Singapore	National Skin Centre NSC	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Taiwan	Kaohsiung Medical University Chung-Ho Institutional Review B	Kaohsiung
Taiwan	Taipei Medical University- Shuang Ho Hospital	New Taipei City
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Niaosong Dist	Kaohsiung City
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	China Medical University Hospital	Taichung City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital - Linkou	Taoyuan City
Ukraine	Municipal Healthcare Institution Kharkiv City Dermatoverenologic Dispensary N2	Kharkiv
Ukraine	Rivne Regional Dermatology and Venereology Dispensary	Rivne
Ukraine	Treatment-diagnostic center PE "Asclepius"	Uzhhorod
Ukraine	Community Institution Zaporizhzhya Regional Dermatovenereology Clinical Hospital of Zaporizhzhya Regional Council	Zaporizhzhya
United States	Georgia Pollens Clinical Research Centers, Inc	Albany	Georgia
United States	Arlington Research Center, Inc	Arlington	Texas
United States	Bakersfield Dermatology and Skin Cancer Medical Group	Bakersfield	California
United States	Meridian Clinical Research	Baton Rouge	Louisiana
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	ActivMed Practices and Research	Beverly	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Dermatology & Laser Center of Charleston	Charleston	South Carolina
United States	OnSite Clinical Solutions	Charlotte	North Carolina
United States	Clarkston Skin Research	Clarkston	Michigan
United States	Dermatology and Skin Surgery Center	Exton	Pennsylvania
United States	Clinical Physiology Associates, Clinical Study Center	Fort Myers	Florida
United States	Innovate Research, LLC	Fort Worth	Texas
United States	Center For Dermatology Clinical Research, Inc.	Fremont	California
United States	Woodward Centre	Fresno	California
United States	Associated Skin Care Specialists	Fridley	Minnesota
United States	Palmetto Clinical Trial Services	Greenville	South Carolina
United States	DermDOX	Hazleton	Pennsylvania
United States	Direct Helpers Medical Center	Hialeah	Florida
United States	The Community Research of South Florida	Hialeah	Florida
United States	Solutions Through Advanced Research, Inc.	Jacksonville	Florida
United States	Forest Hills Dermatology Group	Kew Gardens	New York
United States	Dermatology Research Associates	Los Angeles	California
United States	LA Universal Research Center, INC	Los Angeles	California
United States	Marietta Dermatology Clinical Research	Marietta	Georgia
United States	University of Utah MidValley Dematology	Murray	Utah
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Kansas City Dermatology, PA	Overland Park	Kansas
United States	Austin Institute for Clinical Research	Pflugerville	Texas
United States	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	Central Dermatology PC	Saint Louis	Missouri
United States	University Clinical Trials, Inc.	San Diego	California
United States	San Luis Dermatology & Laser Clinic	San Luis Obispo	California
United States	Advanced Medical Research	Sandy Springs	Georgia
United States	Investigate MD	Scottsdale	Arizona
United States	Dermatology Associates	Seattle	Washington
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	Peak Research LLC	Upper Saint Clair	Pennsylvania
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,  Bulgaria,  Canada,  Germany,  Mexico,  Singapore,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an Investigator 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 atopic dermatitis (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 in EASI Score) From Baseline to Week 16	The EASI assesses objective physician estimates of 2 dimensions of AD - 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-75 responder is defined as a participant who achieves a = 75% reduction from baseline in the EASI score.	Baseline to Week 16
Secondary	Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 2	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 2
Secondary	Percentage of Participants With an IGA Score of 0 or 1 and a Reduction =2 Points From Baseline to Week 4	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 4
Secondary	Percentage of Participants With an 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
Secondary	Percentage of Participants Achieving EASI-90 (=90% Reduction in EASI Score) From Baseline to Week 16	The EASI assesses objective physician estimates of 2 dimensions of AD - 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-90 responder is defined as a participant who achieves a = 90% reduction from baseline in the EASI score.	Baseline to Week 16
Secondary	Percentage 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 of covariance (ANCOVA) model with treatment and randomization strata (region, disease severity, age) as fixed factors and baseline value as covariate.	Baseline, Week 16
Secondary	Percentage of Participants With a Pruritus NRS Score of =4-points at Baseline Who Achieve a =4-point Reduction in Pruritus 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."	Baseline to Week 16
Secondary	Percentage of Participants With a Pruritus NRS Score of =5-points at Baseline Who Achieve a =4-point Reduction in Pruritus 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."	Baseline to Week 16
Secondary	Percentage Change in EASI Score From Baseline to Week 16	The EASI assesses objective physician estimates of 2 dimensions of AD - 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, stratification factors of geographic region, age group, baseline IGA score (IGA 3 versus 4) as fixed factors baseline value as covariate.	Baseline, Week 16
Secondary	Change From Baseline in Percent Body Surface Area (BSA) at Week 16	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 From Baseline to Week 4	The EASI assesses objective physician estimates of 2 dimensions of AD - 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-90 responder is defined as a participant who achieves a = 90% reduction from baseline in the EASI score.	Baseline to Week 4
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 Achieving =4-point Improvement in DLQI From Baseline to 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.	Baseline to Week 16
Secondary	Percentage of Participants With a DLQI Total Score of =4-point at Baseline Achieving =4-point Improvement in DLQI From Baseline to 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.	Baseline to Week 16
Secondary	Percentage 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.	Baseline, Week 16
Secondary	Percentage of Participants With a Sleep-loss Score =2 Points at Baseline Who Achieve a =2 Points Reduction 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.	Baseline to Week 16
Secondary	Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1	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 1
Secondary	Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2	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 2
Secondary	Percentage of Participants With a Pruritus NRS Score of =4 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4	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 4
Secondary	Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 1	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 1
Secondary	Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 2	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 2
Secondary	Percentage of Participants With a Pruritus NRS Score of =5 Points at Baseline Who Achieve a =4-point Reduction From Baseline to Week 4	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 4
Secondary	Percentage Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16	SCORAD is validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on visual analog scale (VAS), where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.	Baseline, Week 16
Secondary	Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)	C-trough was the concentration of study drug in the blood immediately before the next dose was administered. Trough serum concentration of Lebrikizumab was assessed at predose week 52.	Predose at Week 52
Secondary	Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continue to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)	The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent, i.e., percentage of skin 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-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).; The EASI-75 responder is defined as a participant who achieves a = 75% reduction from baseline in the EASI score.	Baseline to Week 52
Secondary	Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a =2-point Improvement From Baseline at Week 16 Who Continue to Exhibit an IGA 0 or 1 and a =2-point Improvement From Baseline at Week 52	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 52
Secondary	Percentage of Participants From Those With a Pruritus NRS of =4-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52	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 52
Secondary	Percentage of Participants From Those With a Pruritus NRS of =5-points at Baseline Re-randomized Having Achieved =4-point Reduction From Baseline at Week 16 Who Continue to Exhibit =4-point Reduction From Baseline at Week 52	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 52
Secondary	Percentage Change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) From Baseline at Week 52	SCORAD is a validated tool for assessing the extent and intensity of AD, it consists of 3 components: A=extent of AD as a percentage of each defined body area and reported as sum of all areas, with maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using following scale: none=0, mild=1, moderate=2, or severe=3 for maximum of 18 total points. C=subjective assessment of itch and sleeplessness recorded by participant on VAS, where 0=no itch/no sleeplessness and 10=worst imaginable itch/sleeplessness with maximum score of 20. SCORAD total score is calculated: A/5+7*B/2+ C to give total score range of 0 to 103, where 0=no disease to 103=severe disease. LS Mean was calculated using ANCOVA model with treatment group and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.	Baseline, Week 52
Secondary	Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index	The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a is a 2-part questionnaire which measure health status of the participant. The first component (Health state) is a descriptive system of the respondent's health 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. A higher score indicates better health state.; LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.	Baseline, Week 16
Secondary	Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (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 and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.	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-Adolescents	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 (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.	Baseline, Week 16
Secondary	Change From Baseline in 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. 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 (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.	Baseline, Week 16
Secondary	Change From Baseline in PROMIS Depression at Week 16- Adolescents	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 (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.	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. 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 (mean = 50 and a standard deviation = 10) with higher scores representing greater anxiety. LS Mean was calculated using the ANCOVA model with treatment and stratification factors of geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.	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 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher scores indicate lower asthma control.; LS Mean was calculated using ANCOVA with treatment, geographic region, age group, baseline IGA (3 versus 4) score as fixed factors and baseline value as covariate.	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

•   Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate2)