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

Dermatitis, Atopic Clinical Trial

— ADhere-J  

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 Japanese Patients With Moderate-to-Severe Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04760314
• Other study ID #: 17953
• Secondary ID: J2T-JE-KGAL
• Status: Completed
• Phase: Phase 3
• Start date: March 10, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: July 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in combination with a topical corticosteroids in Japanese participants with atopic dermatitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: February 1, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Have chronic Atopic Dermatitis (AD) that has been present for =1 year before the screening.

• Have moderate-to-severe AD, including all of the following:

• EASI score =16 at the baseline

• IGA score =3 (scale of 0 to 4) at the baseline

• AD involvement on =10% of Body Surface Area (BSA) at the baseline

• Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:

• Inability to achieve good disease control, defined as mild disease or better (for example, IGA =2) after use of at least a medium-potency topical corticosteroids (TCS) for at least 4 weeks, or for the maximum duration recommended by the product prescribing information (for example, 14 days for super-potent TCS), whichever is shorter. Topical corticosteroids may be used with or without Topical calcineurin inhibitors (TCI) and/or topical Janus Kinase (JAK) inhibitors.

• Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, methotrexate (MTX), azathioprine, and mycophenolate mofetil (MMF), will also be considered as surrogates for having inadequate response to topical therapy.

• Body weight =40 kilogram (kg)

Exclusion Criteria:

• Have a history of anaphylaxis

• Have uncontrolled chronic disease that might require bursts of oral corticosteroids for example, comorbid severe uncontrolled asthma within the past 12 months requiring systemic corticosteroid treatment or hospitalization for >24 hours at baseline.

• Have an active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline or superficial skin infections within 1 week before the baseline.

• Evidence of acute or chronic hepatitis or known liver cirrhosis.

• Have a history of pneumocystis pneumonia (PCP) or a positive beta-D-glucan test at screening and a confirmed diagnosis of PCP.

• Have a history of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.

• Have presence of skin comorbidities (for example, sclerosis, psoriasis, or lupus erythematosus) that may interfere with study assessments.

• Have presence of significant uncontrolled neuropsychiatric disorder.

• Have been exposed to a live vaccine within 12 weeks prior to baseline or are expected to need/receive a live vaccine during the study or up to 125 days after the last dose of study drug.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Genetic Diseases, Inborn
• Skin Diseases
• Skin Diseases, Genetic

Intervention

Drug:
• Lebrikizumab
Administered SC
• Placebo
Administered SC
• Topical Corticosteroid
Self-applied

Locations

Country	Name	City	State
Japan	Yanagihara dermatology clinic	Ainokawa, Ichikawa-shi	Chiba
Japan	Yasumoto Dermatology Clinic	Chikushino-city	Fukuoka
Japan	Akihabara Skin Clinic	Chiyoda-ku	Tokyo
Japan	Sumire Dermatology Clinic	Edogawa-ku	Tokyo
Japan	Matsuda Tomoko Dermatological Clinic	Fukuoka
Japan	Hino Dermatology Clinic	Fukutsu	Fukuoka
Japan	Osaka Habikino Medical Center	Habikino	Osaka
Japan	Hiroshima University Hospital	Hiroshima-shi	Hiroshima-ken
Japan	Kawashima Dermatology Clinic	Ichikawa-shi	Chiba
Japan	Ibaraki Medical Center	Inashiki-gun	Ibaraki
Japan	Mochida Dermatology Clinic	Izumiotsu-shi	Osaka
Japan	Noguchi Dermatology	Kashima-machi, Kamimashiki-gun	Kumamoto
Japan	Kosugi Dermatology Clinic	Kawasaki	Kanagawa
Japan	Dermatology Shimizu Clinic	Kobe	Hyogo
Japan	Maruyama Dermatology Clinic	Koto-ku	Tokyo
Japan	Jyouzanhihuka·Hinyoukika Clinic	Kumamoto Shi	Kumamoto
Japan	Kyoto Furitsu Medical University Hospital	Kyoto-shi
Japan	Hamaguchi Skin Clinic	Machida-shi	Tokyo
Japan	Charme Clinique	Matsudo	Chiba
Japan	Mita Dermatology Clinic	Minato-Ku	Tokyo
Japan	Queen's Square Dermatology and Allergology	Nishi-ku, Yokohama-city	Kanagawa
Japan	KAJI Dermatology Clinic	Nonoichi-shi	Ishikawa
Japan	Takagi Dermatology	Obihiro	Hokkaido
Japan	Sanrui Dermatology Clinic	Ohmiya-ku,Saitama-shi	Saitama
Japan	Goto Dermatology Clinic	Osaka
Japan	Osaka City University Hospital	Osaka
Japan	Tanpopo Dermatology Clinic	Ota-ku	Tokyo
Japan	Kume Clinic	Sakai City	Osaka
Japan	Sapporo Skin Clinic	Sapporo	Hokkaido
Japan	Kobayashi Skin Clinic	Sapporo-shi	Hokkaido
Japan	Dokkyo Medical University Hospital	Shimotsuga-Gun	Tochigi
Japan	Yamate Dermatological Clinic	Shinjuku	Tokyo
Japan	Yoshihara Dermatology Clinic	Sumida-ku	Tokyo
Japan	Tachikawa Dermatology Clinic	Tachikawa-shi	Tokyo
Japan	Shirasaki Clinic	Takaoka-shi	Toyama
Japan	Yoshikawa Dermatology Clinic	Takatsuki	Osaka
Japan	Nomura Dermatology Clinic	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With an Investigators 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 Severity Index-75 (EASI-75) (=75% Reduction in EASI Score) at Week 16	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - 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% improvement from baseline in the EASI score.	Week 16
Secondary	Percent Change in Eczema Area Severity Index (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).; Least Square (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 to Week 16
Secondary	Percentage of Participants Achieving EASI-90 at 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.	Week 16
Secondary	Percentage of Participants With an Itch Numeric Rating Scale (NRS) Score of =4-points at Baseline Who Achieve A =4-point Reduction From Baseline to Week 1	The Itch Numeric Rating Scale (NRS) is a 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 an Itch NRS Score of =4-points at Baseline Who Achieve A =4-point Reduction From Baseline to Week 2	The Itch Numeric Rating Scale (NRS) is a 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 an Itch NRS Score of =4-points at Baseline Who Achieve A =4-point Reduction From Baseline to Week 4	The Itch Numeric Rating Scale (NRS) is a 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 an Itch NRS Score of =4-points at Baseline Who Achieve A =4-point Reduction From Baseline to Week 16	The Itch Numeric Rating Scale (NRS) is a 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

External Links

•   A Study of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroids in Japanese Participants With Moderate-to-Severe Atopic Dermatitis (ADhere-J)