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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04760314
Collaborator
(none)
280
Enrollment
37
Locations
3
Arms
22.6
Anticipated Duration (Months)
7.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jan 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lebrikizumab Regimen A + Topical Corticosteroid

Lebrikizumab Regimen A administered by subcutaneous (SC) injection in combination with topical corticosteroid

Drug: Lebrikizumab
Administered SC
Other Names:
  • LY3650150

    • Drug: Topical Corticosteroid
    Self-applied
    Experimental: Lebrikizumab Regimen B + Topical Corticosteroid

    Lebrikizumab Regimen B administered by SC injection in combination with topical corticosteroid

    Drug: Lebrikizumab
    Administered SC
    Other Names:
  • LY3650150

    • Drug: Topical Corticosteroid
    Self-applied
    Placebo Comparator: Placebo + Topical Corticosteroid

    Placebo administered by SC injection in combination with topical corticosteroid

    Drug: Placebo
    Administered SC

    Drug: Topical Corticosteroid
    Self-applied

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with an Investigators Global Assessment (IGA) score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16 [Baseline to Week 16]

      Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16

    2. Percentage of Participants achieving Eczema Area Severity Index-75 (EASI-75) (≥75% reduction in EASI score) from Baseline to Week 16 [Baseline to Week 16]

      Percentage of participants achieving EASI-75 (≥75% reduction in EASI score) from Baseline to Week 16

    Secondary Outcome Measures

    1. Percent Change in Eczema Area Severity Index (EASI) score from Baseline [Baseline to Week 16]

      Percent change in EASI score from Baseline

    2. Percentage of Participants achieving EASI-90 [Baseline to Week 16]

      Percentage of Participants achieving EASI-90

    3. Percentage of Participants with an Itch Numeric Rating Scale (NRS) Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction from Baseline [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

    4. Percentage of Participants with an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction from Baseline [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

    5. Percentage of Participants with an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction from Baseline [Baseline to Week 4]

      Percentage of Participants with an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction from Baseline

    6. Percentage of Participants with an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction from Baseline [Baseline to Week 16]

      Percentage of Participants with an Itch NRS Score of ≥4-points at Baseline Who Achieve A ≥4-point Reduction from Baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yanagihara dermatology clinic Ainokawa, Ichikawa-shi Chiba Japan 272-0143
    2 Kawashima Dermatology Clinic Ichikawa-shi Chiba Japan 272-0033
    3 Charme Clinique Matsudo Chiba Japan 270-2223
    4 Yasumoto Dermatology Clinic Chikushino-city Fukuoka Japan 818-0083
    5 Hino Dermatology Clinic Fukutsu Fukuoka Japan 811-3217
    6 Hiroshima University Hospital Hiroshima-shi Hiroshima-ken Japan 734-8551
    7 Takagi Dermatology Obihiro Hokkaido Japan 080-0013
    8 Kobayashi Skin Clinic Sapporo-shi Hokkaido Japan 060-0807
    9 Sapporo Skin Clinic Sapporo Hokkaido Japan 060-0063
    10 Dermatology Shimizu Clinic Kobe Hyogo Japan 657-0846
    11 Ibaraki Medical Center Inashiki-gun Ibaraki Japan 300-0395
    12 KAJI Dermatology Clinic Nonoichi-shi Ishikawa Japan 921-8801
    13 Kosugi Dermatology Clinic Kawasaki Kanagawa Japan 211-0063
    14 Queen's Square Dermatology and Allergology Nishi-ku, Yokohama-city Kanagawa Japan 220-6208
    15 Nomura Dermatology Clinic Yokohama-shi Kanagawa Japan 221-0825
    16 Noguchi Dermatology Kashima-machi, Kamimashiki-gun Kumamoto Japan 861-3101
    17 Jyouzanhihuka・Hinyoukika Clinic Kumamoto Shi Kumamoto Japan 860-0066
    18 Osaka Habikino Medical Center Habikino Osaka Japan 583-8588
    19 Mochida Dermatology Clinic Izumiotsu-shi Osaka Japan 595-0025
    20 Kume Clinic Sakai City Osaka Japan 593-8324
    21 Yoshikawa Dermatology Clinic Takatsuki Osaka Japan 569-0824
    22 Sanrui Dermatology Clinic Ohmiya-ku,Saitama-shi Saitama Japan 330-0854
    23 Dokkyo Medical University Hospital Shimotsuga-Gun Tochigi Japan 321 0293
    24 Akihabara Skin Clinic Chiyoda-ku Tokyo Japan 101-0021
    25 Sumire Dermatology Clinic Edogawa-ku Tokyo Japan 133-0057
    26 Maruyama Dermatology Clinic Koto-ku Tokyo Japan 136-0074
    27 Hamaguchi Skin Clinic Machida-shi Tokyo Japan 194-0013
    28 Mita Dermatology Clinic Minato-Ku Tokyo Japan 108-0014
    29 Tanpopo Dermatology Clinic Ota-ku Tokyo Japan 143-0023
    30 Yamate Dermatological Clinic Shinjuku Tokyo Japan 169-0075
    31 Yoshihara Dermatology Clinic Sumida-ku Tokyo Japan 130-0014
    32 Tachikawa Dermatology Clinic Tachikawa-shi Tokyo Japan 190-0023
    33 Shirasaki Clinic Takaoka-shi Toyama Japan 9330871
    34 Matsuda Tomoko Dermatological Clinic Fukuoka Japan 819-0167
    35 Kyoto Furitsu Medical University Hospital Kyoto-shi Japan 602 8566
    36 Osaka City University Hospital Osaka Japan 545-8586
    37 Goto Dermatology Clinic Osaka Japan 554-0021

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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 Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04760314
    Other Study ID Numbers:
    • 17953
    • J2T-JE-KGAL
    First Posted:
    Feb 18, 2021
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Eli Lilly and Company
    Corticosteroids
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Genetic Diseases, Inborn
    Skin Diseases, Genetic
    Dermatitis
    Skin Diseases

    Study Results

    No Results Posted as of Sep 5, 2021