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

October 15, 2025 updated by: Eli Lilly and Company

A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia, 2010
        • Holdsworth House Medical Practice
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • East Sydney Doctors
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Sinclair Dermatology - East Melbourne
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Dermatology
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • Beacon Dermatology
      • Edmonton, Alberta, Canada, T6G 1C3
        • Alberta Dermasurgery Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Brunswick Dermatology Center
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Simcoderm Medical & Surgical Dermatology Centre
      • London, Ontario, Canada, N6H 5L5
        • DermEffects - Probity - PPDS
    • Quebec
      • Québec, Quebec, Canada, G1W 4R4
        • Center de Recherche St Louis
  • Germany
      • Berlin, Germany, 10247
        • Hautzentrum Friedrichshain - Dermatologie
      • Hamburg, Germany, 20251
        • Universitaetsklinikum Hamburg-Eppendorf
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Hautklinik Erlangen
    • Brandenburg
      • Blankenfelde-Mahlow, Brandenburg, Germany, 15827
        • Hautarztpraxis Mahlow
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60596
        • Universitätsklinikum Frankfurt
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44791
        • Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitätsklinikum Bonn
    • Westfalen
      • Münster, Westfalen, Germany, 48149
        • Universitätsklinikum Münster - Albert Schweitzer Campus
  • Greece
    • Attica
      • Athens, Attica, Greece, 16121
        • Hospital of Venereal and Skin Diseases A.Syggros
    • Irakleío
      • Heraklion, Irakleío, Greece, 711 10
        • University General Hospital of Heraklion Loc. 1
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 56429
        • Papageorgiou General Hospital of Thessaloniki
  • Poland
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-566
        • Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
      • Wroclaw, Lower Silesian Voivodeship, Poland, 51-685
        • Wro Medica
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Malbork, Pomeranian Voivodeship, Poland, 82-200
        • Klinika Badawcza Centrum Badan Klinicznych Wojciech Brzezicki
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-081
        • Centrum Medyczne Pratia Katowice
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-436
        • Dermoklinika-Centrum Medyczne s.c
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Medical Dermatology Specialists
      • Phoenix, Arizona, United States, 85008
        • Saguaro Dermatology Associates, LLC - Probity - PPDS
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Research Trials, LLC
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Clinical Trials Center
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology Research Inc
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc.
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Santa Monica, California, United States, 90404
        • Dermatology Institute and Skin Care Center
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • University of Connecticut
    • Florida
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Research Center
      • Miami, Florida, United States, 33125
        • University of Miami
      • Miami, Florida, United States, 33173-1407
        • Skin Research of South Florida
      • Tampa, Florida, United States, 33613-1244
        • ForCare Clinical Research
      • Tampa, Florida, United States, 33615
        • Alliance Clinical Research of Tampa
      • Tampa, Florida, United States, 33615
        • Olympian Clinical Research
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Advanced Medical Research, PC
    • Illinois
      • Skokie, Illinois, United States, 60077-1049
        • NorthShore Medical Group Dermatology - Skokie
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Equity Medical - Bowling Green
      • Louisville, Kentucky, United States, 40217
        • Derm Research LLC
    • Maryland
      • Marriottsville, Maryland, United States, 21104
        • Care Access-Marriottsville
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Troy, Michigan, United States, 48084
        • Revival Research Institute - Troy
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, P.C
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices & Research, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Dermatology Specialists of Charlotte
      • Charlotte, North Carolina, United States, 28277-8014
        • Darst Dermatology
      • Durham, North Carolina, United States, 27710-3038
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Mayfield Heights, Ohio, United States, 44124
        • Apex Clinical Research Center
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • DermDox Centers for Dermatology
      • Sugarloaf, Pennsylvania, United States, 18249
        • DermDox Dermatology Centers
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29212-8623
        • Columbia Dermatology & Aesthetics
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • International Clinical Research - Tennessee (IC Research)
      • Nashville, Tennessee, United States, 37211
        • Advanced Research Experts
    • Texas
      • Dallas, Texas, United States, 75231
        • Modern Research Associates
      • Frisco, Texas, United States, 75034
        • North Texas Clinical Research
    • Utah
      • South Jordan, Utah, United States, 84095
        • Jordan Valley Dermatology Center
    • Washington
      • Spokane, Washington, United States, 99202-1332
        • Dermatology Specialists of Spokane
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Time Frame: Week 16
Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
Time Frame: Baseline, Week 16
Baseline, Week 16
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)
Time Frame: Baseline, Week 16
Baseline, Week 16
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart
Time Frame: Baseline through Week 16
Baseline through Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2023

Primary Completion (Actual)

September 30, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Estimated)

October 16, 2025

Last Update Submitted That Met QC Criteria

October 15, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18518
  • I7P-MC-DSAF (Other Identifier: Eli Lilly and Company)
  • 2023-505608-43-00 (Other Identifier: EU Trial Number)
  • U1111-1292-6255 (Other Identifier: UTN Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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