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

NCT04760314 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 17953J2T-JE-KGAL
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 37

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

Keywords

Corticosteroids

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Percent Change in Eczema Area Severity Index (EASI) Score From Baseline to Week 16

  Baseline to Week 16

• Percentage of Participants Achieving EASI-90 at Week 16

  Week 16

• 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

  Baseline to Week 1

• Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 2

  Baseline to Week 2

• Percentage of Participants With an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction From Baseline to Week 4

  Baseline to Week 4

Study Arms (3)

Lebrikizumab 250 mg Every 4 weeks (Q4W)

EXPERIMENTAL

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.

Drug: Lebrikizumab; Drug: Topical Corticosteroid

Lebrikizumab 250 mg Every 2 weeks (Q2W)

EXPERIMENTAL

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.

Drug: Lebrikizumab; Drug: Topical Corticosteroid

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Topical Corticosteroid

Interventions

Lebrikizumab DRUG

Administered SC

Also known as: LY3650150

Lebrikizumab 250 mg Every 2 weeks (Q2W); Lebrikizumab 250 mg Every 4 weeks (Q4W)

Placebo DRUG

Administered SC

Placebo

Topical Corticosteroid DRUG

Self-applied

Lebrikizumab 250 mg Every 2 weeks (Q2W); Lebrikizumab 250 mg Every 4 weeks (Q4W); Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (37)

Yanagihara dermatology clinic

Ainokawa, Ichikawa-shi, Chiba, 272-0143, Japan

Location

Kawashima Dermatology Clinic

Ichikawa-shi, Chiba, 272-0033, Japan

Location

Charme Clinique

Matsudo, Chiba, 270-2223, Japan

Location

Yasumoto Dermatology Clinic

Chikushino-shi, Fukuoka, 818-0083, Japan

Location

Hino Dermatology Clinic

Fukutsu, Fukuoka, 811-3217, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

Location

Takagi Dermatology

Obihiro, Hokkaido, 080-0013, Japan

Location

Sapporo Skin Clinic

Sapporo, Hokkaido, 060-0063, Japan

Location

Kobayashi Skin Clinic

Sapporo, Hokkaido, 060-0807, Japan

Location

Dermatology Shimizu Clinic

Kobe, Hyōgo, 657-0846, Japan

Location

Ibaraki Medical Center

Inashiki-gun, Ibaraki, 300-0395, Japan

Location

KAJI Dermatology Clinic

Nonoichi-shi, Ishikawa-ken, 921-8801, Japan

Location

Kosugi Dermatology Clinic

Kawasaki, Kanagawa, 211-0063, Japan

Location

Queen's Square Dermatology and Allergology

Nishi-ku, Yokohama-city, Kanagawa, 220-6208, Japan

Location

Nomura Dermatology Clinic

Yokohama, Kanagawa, 221-0825, Japan

Location

Noguchi Dermatology

Kashima-machi, Kamimashiki-gun, Kumamoto, 861-3101, Japan

Location

Jyouzanhihuka・Hinyoukika Clinic

Kumamoto, Kumamoto, 860-0066, Japan

Location

Osaka Habikino Medical Center

Habikino, Osaka, 583-8588, Japan

Location

Mochida Dermatology Clinic

Izumiotsu-shi, Osaka, 595-0025, Japan

Location

Kume Clinic

Sakai, Osaka, 593-8324, Japan

Location

Yoshikawa Dermatology Clinic

Takatsuki, Osaka, 569-0824, Japan

Location

Sanrui Dermatology Clinic

Ohmiya-ku,Saitama-shi, Saitama, 330-0854, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga-Gun, Tochigi, 321 0293, Japan

Location

Akihabara Skin Clinic

Chiyoda-ku, Tokyo, 101-0021, Japan

Location

Sumire Dermatology Clinic

Edogawa-ku, Tokyo, 133-0057, Japan

Location

Maruyama Dermatology Clinic

Koto-ku, Tokyo, 136-0074, Japan

Location

Hamaguchi Skin Clinic

Machida-shi, Tokyo, 194-0013, Japan

Location

Mita Dermatology Clinic

Minato-Ku, Tokyo, 108-0014, Japan

Location

Tanpopo Dermatology Clinic

Ōta-ku, Tokyo, 143-0023, Japan

Location

Yamate Dermatological Clinic

Shinjuku, Tokyo, 169-0075, Japan

Location

Yoshihara Dermatology Clinic

Sumida-ku, Tokyo, 130-0014, Japan

Location

Tachikawa Dermatology Clinic

Tachikawa-shi, Tokyo, 190-0023, Japan

Location

Shirasaki Clinic

Takaoka-shi, Toyama, 9330871, Japan

Location

Matsuda Tomoko Dermatological Clinic

Fukuoka, 819-0167, Japan

Location

Kyoto Furitsu Medical University Hospital

Kyoto, 602 8566, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

Goto Dermatology Clinic

Osaka, 554-0021, Japan

Location

Related Publications (1)

• 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.

  PMID: 39442013 DERIVED

Related Links

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

MeSH Terms

Conditions

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

Interventions

lebrikizumab; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 18, 2021
• Study Start: March 10, 2021
• Primary Completion: July 31, 2022
• Study Completion: February 1, 2023
• Last Updated: August 23, 2023
• Results First Posted: August 23, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

JP (37)