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ADorable-2: A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05735483
Collaborator
(none)
250
Enrollment
1
Arm
39.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Anticipated Study Start Date :
Mar 9, 2023
Anticipated Primary Completion Date :
Jun 26, 2026
Anticipated Study Completion Date :
Jun 26, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lebrikizumab + Placebo

Lebrikizumab will be given subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.

Drug: Lebrikizumab
Administered SC
Other Names:
  • LY3650150

    • Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) [Baseline through Week 52]

    Secondary Outcome Measures

    1. Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ [Baseline to Week 52]

    2. Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) from Baseline of Study KGBI by Visit in Study KGBJ [Baseline to Week 52]

    3. Percentage of Participants Achieving EASI-90 from Baseline of Study KGBI by Visit in Study KGBJ [Baseline to Week 52]

    4. Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ [Baseline to Week 52]

    5. Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score [Baseline, Week 52]

    6. Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD) [Baseline, Week 52]

    7. Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI [Baseline, Week 52]

    8. Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI [Baseline, Week 52]

    9. Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA) [Baseline, Week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI.

    • For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

    Exclusion Criteria:

    • Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.

    • Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.

    • Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)

    Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.

    • Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.

    Contacts and Locations

    Locations

    No locations specified.

    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

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05735483
    Other Study ID Numbers:
    • 18268
    • J2T-MC-KGBJ/DRM06-AD16
    • 2022-501478-21-00
    First Posted:
    Feb 21, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    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
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Feb 21, 2023