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

NCT ID: NCT04760314

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2023-02-01

Brief 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.

Conditions

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lebrikizumab 250 mg Every 4 weeks (Q4W)

Participants received 500 mg of Lebrikizumab (2 x 250 mg) subcutaneous (SC) injections as a loading dose at Baseline followed by 250 mg of Lebrikizumab administered SC Q4W from Week 4 until Week 12, in combination with topical corticosteroid. Week 16 responders entered maintenance period and continued with the same treatment. Week 16 non responders entered Escape Arm and received Lebrikizumab 250 mg Q2W until Week 68.

Group Type: EXPERIMENTAL

Lebrikizumab

Intervention Type: DRUG

Administered SC

Topical Corticosteroid

Intervention Type: DRUG

Self-applied

Lebrikizumab 250 mg Every 2 weeks (Q2W)

Participants received 500 mg of Lebrikizumab (2 x 250 mg) SC injections as a loading dose at Baseline and Week 2 followed by 250 mg of Lebrikizumab administered SC Q2W from Week 4 until Week 14, in combination with topical corticosteroid. Week 16 responders entered maintenance period and were randomly allocated to receive 250 mg lebrikizumab Q2W or 250 mg lebrikizumab Q4W, in a 1:1 ratio. Week 16 non responders entered Escape Arm and received Lebrikizumab 250 mg Q2W until Week 68.

Group Type: EXPERIMENTAL

Lebrikizumab

Intervention Type: DRUG

Administered SC

Topical Corticosteroid

Intervention Type: DRUG

Self-applied

Placebo

Participants received two SC injections of Placebo as a loading dose at Baseline in combination with topical corticosteroid and Week 2 followed by a single injection Q2W from Week 4 until Week 14. Week 16 responders entered maintenance period and continued with the same treatment. Week 16 non responders entered Escape Arm and received Lebrikizumab 250 mg Q2W until Week 68.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

Topical Corticosteroid

Intervention Type: DRUG

Self-applied

Interventions

Lebrikizumab

Administered SC

Intervention Type: DRUG

Placebo

Administered SC

Intervention Type: DRUG

Topical Corticosteroid

Self-applied

Intervention Type: DRUG

Other Intervention Names

LY3650150

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Yanagihara dermatology clinic

Ainokawa, Ichikawa-shi, Chiba, Japan

Kawashima Dermatology Clinic

Ichikawa-shi, Chiba, Japan

Charme Clinique

Matsudo, Chiba, Japan

Yasumoto Dermatology Clinic

Chikushino-shi, Fukuoka, Japan

Hino Dermatology Clinic

Fukutsu, Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Takagi Dermatology

Obihiro, Hokkaido, Japan

Sapporo Skin Clinic

Sapporo, Hokkaido, Japan

Kobayashi Skin Clinic

Sapporo, Hokkaido, Japan

Dermatology Shimizu Clinic

Kobe, Hyōgo, Japan

Ibaraki Medical Center

Inashiki-gun, Ibaraki, Japan

KAJI Dermatology Clinic

Nonoichi-shi, Ishikawa-ken, Japan

Kosugi Dermatology Clinic

Kawasaki, Kanagawa, Japan

Queen's Square Dermatology and Allergology

Nishi-ku, Yokohama-city, Kanagawa, Japan

Nomura Dermatology Clinic

Yokohama, Kanagawa, Japan

Noguchi Dermatology

Kashima-machi, Kamimashiki-gun, Kumamoto, Japan

Jyouzanhihuka・Hinyoukika Clinic

Kumamoto, Kumamoto, Japan

Osaka Habikino Medical Center

Habikino, Osaka, Japan

Mochida Dermatology Clinic

Izumiotsu-shi, Osaka, Japan

Kume Clinic

Sakai, Osaka, Japan

Yoshikawa Dermatology Clinic

Takatsuki, Osaka, Japan

Sanrui Dermatology Clinic

Ohmiya-ku,Saitama-shi, Saitama, Japan

Dokkyo Medical University Hospital

Shimotsuga-Gun, Tochigi, Japan

Akihabara Skin Clinic

Chiyoda-ku, Tokyo, Japan

Sumire Dermatology Clinic

Edogawa-ku, Tokyo, Japan

Maruyama Dermatology Clinic

Koto-ku, Tokyo, Japan

Hamaguchi Skin Clinic

Machida-shi, Tokyo, Japan

Mita Dermatology Clinic

Minato-Ku, Tokyo, Japan

Tanpopo Dermatology Clinic

Ōta-ku, Tokyo, 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

Matsuda Tomoko Dermatological Clinic

Fukuoka, , Japan

Kyoto Furitsu Medical University Hospital

Kyoto, , Japan

Osaka City University Hospital

Osaka, , Japan

Goto Dermatology Clinic

Osaka, , Japan

Countries

Japan

References

Katoh N, Tanaka A, Takahashi H, Shimizu R, Kataoka Y, Torisu-Itakura H, Morisaki Y, Yamamoto C, Igawa K. Long-term management of moderate-to-severe atopic dermatitis with lebrikizumab and concomitant topical corticosteroids: a 68-week randomized double-blind placebo-controlled phase III trial in Japan (ADhere-J). Br J Dermatol. 2025 Mar 18;192(4):597-610. doi: 10.1093/bjd/ljae394.

Reference Type: DERIVED

PMID: 39442013 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lillytrialguide.com/en-US/trial/6Snw910hnAdavPQabysPCL

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

Other Identifiers

J2T-JE-KGAL

Identifier Type: OTHER

Identifier Source: secondary_id

17953

Identifier Type: -

Identifier Source: org_study_id