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

NCT06046729
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Phase
Phase 2
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Recruitment status
Completed
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Participants
352
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Lead sponsor
Eli Lilly and Company
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Start date
2023-10-23
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Number of sites
74
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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.
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Short title
A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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Official title
A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-08-17
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First posted
2023-09-21
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Registry last updated
2026-08-21
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Primary completion date
2025-09-30
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Start date
2023-10-23
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Actual participants
352
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Participants
352
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
74
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06046729
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ClinicalTrials.gov ID
NCT06046729
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

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

    Timeframe: Week 16

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

    Timeframe: Baseline, Week 16

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

    Timeframe: Baseline, Week 16

  3. Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart

    Timeframe: Baseline through Week 16

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Medical Dermatology SpecialistsPhoenix, United States
  • Saguaro Dermatology Associates, LLC - Probity - PPDSPhoenix, United States
  • Arkansas Research Trials, LLCNorth Little Rock, United States
  • Northwest Arkansas Clinical Trials CenterRogers, United States
  • First OC Dermatology Research IncFountain Valley, United States
  • Center For Dermatology Clinical Research, Inc.Fremont, United States
  • Dermatology Research AssociatesLos Angeles, United States
  • Dermatology Institute and Skin Care CenterSanta Monica, United States
  • University of ConnecticutFarmington, United States
  • Direct Helpers Research CenterHialeah, United States
  • University of MiamiMiami, United States
  • Skin Research of South FloridaMiami, United States
  • ForCare Clinical ResearchTampa, United States
  • Alliance Clinical Research of TampaTampa, United States
  • Olympian Clinical ResearchTampa, United States
  • Advanced Medical Research, PCSandy Springs, United States
  • NorthShore Medical Group Dermatology - SkokieSkokie, United States
  • Dawes Fretzin Clinical Research Group, LLCIndianapolis, United States
  • Equity Medical - Bowling GreenBowling Green, United States
  • Derm Research LLCLouisville, United States
  • Care Access-MarriottsvilleMarriottsville, United States
  • Beth Israel Deaconess Medical CenterBoston, United States
  • Revival Research Institute - TroyTroy, United States
  • Washington University School of MedicineSt Louis, United States
  • Skin Specialists, P.COmaha, United States

And 49 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • U1111-1292-6255
  • 2023-505608-43-00
  • I7P-MC-DSAF
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)