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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443024
• Other study ID #: 17826
• Secondary ID: J2T-DM-KGAFDRM06
• Status: Completed
• Phase: Phase 2
• Start date: January 30, 2018
• Est. completion date: May 23, 2019

Study information

• Verified date: July 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: May 23, 2019
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-?, 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• Lebrikizumab
Sterile liquid solution administered subcutaneously.

Drug:
• Placebo
Solution administered subcutaneously.

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	Westlake Dermatology Clinical Research Center	Austin	Texas
United States	Meridian Clinical Research, LLC	Baton Rouge	Louisiana
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	ActivMed Practices & Research, Inc.	Beverly	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Total Vein and Skin	Boynton Beach	Florida
United States	Dermatology Trial Associates	Bryant	Arkansas
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	Piedmont Plastic Surgery and Dermatology	Charlotte	North Carolina
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Florida Academic Centers Research and Education, LLC	Coral Gables	Florida
United States	Menter Dermatology Research	Dallas	Texas
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Rivergate Dermatology Clinical Research Center	Goodlettsville	Tennessee
United States	The University of Texas Health	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Olympian Clinical Research	Largo	Florida
United States	JDR Dermatology Research	Las Vegas	Nevada
United States	Dermatology Research Associates	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Skin Sciences, PLLC	Louisville	Kentucky
United States	Marietta Dermatology Clinical Research, Inc.	Marietta	Georgia
United States	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Icahn School of Medicine	New York	New York
United States	Sadick Research Group, LLC.	New York	New York
United States	Schweiger Dermatology, PLLC	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Tory Sullivan, MD PA	North Miami Beach	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Kansas City Dermatology, PA	Overland Park	Kansas
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Oregon Medical Research Center	Portland	Oregon
United States	ActivMed Practices & Research, Inc.	Portsmouth	New Hampshire
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Stanford Medicine Outpatient Center-Medical Dermatology Clinic	Redwood City	California
United States	Dermatology and Skin Cancer Specialists, LLC	Rockville	Maryland
United States	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas
United States	Center for Dermatology and Laser Surgery	Sacramento	California
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	TCR Medical Corporation	San Diego	California
United States	UCSD Dermatology	San Diego	California
United States	Advanced Medical Research, PC	Sandy Springs	Georgia
United States	International Clinical Research - US, LLC	Sanford	Florida
United States	Clinical Science Institute	Santa Monica	California
United States	Clear Dermatology & Aesthetics Center	Scottsdale	Arizona
United States	Dermatology Associates of Seattle	Seattle	Washington
United States	Premier Clinical Research	Spokane	Washington
United States	DermResearchCenter of New York, Inc.	Stony Brook	New York
United States	Somerset Skin Centre	Troy	Michigan
United States	George Washington Medical Faculty Associates	Washington	District of Columbia
United States	Center for Clinical Studies, LTD. LLP	Webster	Texas
United States	Dundee Dermatology	West Dundee	Illinois
United States	Integrated Clinical Research, LLC	West Palm Beach	Florida
United States	Wilmington Dermatology Center	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Dermira, Inc. a wholly owned subsidiary of Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Eczema Area and Severity Index (EASI)	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.	Baseline, Week 16
Secondary	Percentage of Participants With a 75% Improvement From Baseline in EASI (EASI75) 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.	Week 16
Secondary	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)	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.	Week 16
Secondary	Percentage of Participants With EASI <7 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).	Week 16
Secondary	Percentage of Participants Achieving EASI50 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 = 50% improvement from baseline in the EASI score.	Week 16
Secondary	Percentage of Participants Achieving EASI90 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	Week 16
Secondary	Percent Change From Baseline in the Sleep Loss Scale Score	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.	Baseline, Week 16
Secondary	Percent Change From Baseline in Pruritus Numeric Rating Score (NRS)	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.	Baseline, Week 16
Secondary	Percentage of Participants With Pruritus NRS Change of =3 at 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.	Week 16
Secondary	Percentage of Participants With Pruritus NRS Change of =4 From Baseline to 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.	Week 16
Secondary	Change From Baseline in Body Surface Area (BSA) Involved With Atopic Dermatitis (AD)	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.	Baseline, Week 16
Secondary	Change From Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) Score	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.	Baseline, Week 16