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NCT Number: NCT06046729

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

East Sydney Doctors, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eltrekibart

Drug

Administered SC

Other names: LY3041658

Placebo

Drug

Administered SC

Primary outcomes

  1. Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)

    Time frame: Week 16

Secondary outcomes

  1. Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules

    Time frame: Baseline, Week 16

  2. Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)

    Time frame: Baseline, Week 16

  3. Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart

    Time frame: Baseline through Week 16

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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