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A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06046729
Collaborator
(none)
350
Enrollment
4
Arms
32.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase 2bPhase 2b
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Anticipated Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Jul 20, 2025
Anticipated Study Completion Date :
Jun 23, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eltrekibart Dose 1

Eltrekibart will be given subcutaneously (SC).

Drug: Eltrekibart
Administered SC
Other Names:
  • LY3041658

    		•
    Experimental: Eltrekibart Dose 2

    Eltrekibart will be given SC.

    Drug: Eltrekibart
    Administered SC
    Other Names:
  • LY3041658

    		•
    Experimental: Eltrekibart Dose 3

    Eltrekibart will be given SC.

    Drug: Eltrekibart
    Administered SC
    Other Names:
  • LY3041658

    		•
    Placebo Comparator: Placebo

    Placebo will be given.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Week 16]

    Secondary Outcome Measures

    1. Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules [Baseline, Week 16]

    2. Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS) [Baseline, Week 16]

    3. Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart [Baseline through Week 16]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have a diagnosis of HS for at least 12 months.

    • Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.

    • Have an (abscess plus inflammatory nodule) count of at least 5.

    • Agree to use topical antiseptics daily.

    • Had an inadequate response or intolerance to a 28-day course of oral antibiotics.

    Exclusion Criteria:

    • Have more than 20 draining fistulae.

    • Have had surgical treatment for HS in the last 4 weeks before randomization.

    • Have an active skin disease or condition, that could interfere with the assessment of HS.

    • Have a current or recent acute, active infection.

    • Are immunocompromised.

    • Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.

    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:
    NCT06046729
    Other Study ID Numbers:
    • 18518
    • I7P-MC-DSAF
    • 2023-505608-43-00
    • U1111-1292-6255
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 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:
    Hidradenitis Suppurativa
    Hidradenitis

    Study Results

    No Results Posted as of Sep 21, 2023