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

NCT ID: NCT06046729

Last Updated: 2025-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hidradenitis Suppurativa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 2b
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Eltrekibart Dose 1

Eltrekibart will be given subcutaneously (SC).

Group Type EXPERIMENTAL

Eltrekibart

Intervention Type DRUG

Administered SC

Eltrekibart Dose 2

Eltrekibart will be given SC.

Group Type EXPERIMENTAL

Eltrekibart

Intervention Type DRUG

Administered SC

Eltrekibart Dose 3

Eltrekibart will be given SC.

Group Type EXPERIMENTAL

Eltrekibart

Intervention Type DRUG

Administered SC

Placebo

Placebo will be given.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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Eltrekibart

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3041658

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Medical Dermatology Specialists

Phoenix, Arizona, United States

Site Status

Saguaro Dermatology Associates, LLC - Probity - PPDS

Phoenix, Arizona, United States

Site Status

Arkansas Research Trials, LLC

North Little Rock, Arkansas, United States

Site Status

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, United States

Site Status

First OC Dermatology Research Inc

Fountain Valley, California, United States

Site Status

Center For Dermatology Clinical Research, Inc.

Fremont, California, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Dermatology Institute and Skin Care Center

Santa Monica, California, United States

Site Status

University of Connecticut

Farmington, Connecticut, United States

Site Status

Direct Helpers Research Center

Hialeah, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Skin Research of South Florida

Miami, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status

Alliance Clinical Research of Tampa

Tampa, Florida, United States

Site Status

Olympian Clinical Research

Tampa, Florida, United States

Site Status

Advanced Medical Research, PC

Sandy Springs, Georgia, United States

Site Status

NorthShore Medical Group Dermatology - Skokie

Skokie, Illinois, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

Equity Medical - Bowling Green

Bowling Green, Kentucky, United States

Site Status

Derm Research LLC

Louisville, Kentucky, United States

Site Status

Care Access-Marriottsville

Marriottsville, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Revival Research Institute - Troy

Troy, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Skin Specialists, P.C

Omaha, Nebraska, United States

Site Status

ActivMed Practices & Research, Inc.

Portsmouth, New Hampshire, United States

Site Status

Darst Dermatology

Charlotte, North Carolina, United States

Site Status

Dermatology Specialists of Charlotte

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Apex Clinical Research Center

Mayfield Heights, Ohio, United States

Site Status

DermDox Centers for Dermatology

Camp Hill, Pennsylvania, United States

Site Status

DermDox Dermatology Centers

Sugarloaf, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Columbia Dermatology & Aesthetics

Columbia, South Carolina, United States

Site Status

International Clinical Research - Tennessee (IC Research)

Murfreesboro, Tennessee, United States

Site Status

Advanced Research Experts

Nashville, Tennessee, United States

Site Status

Modern Research Associates

Dallas, Texas, United States

Site Status

North Texas Clinical Research

Frisco, Texas, United States

Site Status

Jordan Valley Dermatology Center

South Jordan, Utah, United States

Site Status

Dermatology Specialists of Spokane

Spokane, Washington, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

East Sydney Doctors

Darlinghurst, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Site Status

Sinclair Dermatology - East Melbourne

East Melbourne, Victoria, Australia

Site Status

Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Fremantle Dermatology

Fremantle, Western Australia, Australia

Site Status

Holdsworth House Medical Practice

Sydney, , Australia

Site Status

Beacon Dermatology

Calgary, Alberta, Canada

Site Status

Alberta Dermasurgery Centre

Edmonton, Alberta, Canada

Site Status

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, Canada

Site Status

Brunswick Dermatology Center

Fredericton, New Brunswick, Canada

Site Status

Simcoderm Medical & Surgical Dermatology Centre

Barrie, Ontario, Canada

Site Status

DermEffects - Probity - PPDS

London, Ontario, Canada

Site Status

Center de Recherche St Louis

Québec, Quebec, Canada

Site Status

Hautklinik Erlangen

Erlangen, Bavaria, Germany

Site Status

Hautarztpraxis Mahlow

Blankenfelde-Mahlow, Brandenburg, Germany

Site Status

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital

Bochum, North Rhine-Westphalia, Germany

Site Status

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, Westfalen, Germany

Site Status

Hautzentrum Friedrichshain - Dermatologie

Berlin, , Germany

Site Status

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Hospital of Venereal and Skin Diseases A.Syggros

Athens, Attica, Greece

Site Status

University General Hospital of Heraklion Loc. 1

Heraklion, Irakleío, Greece

Site Status

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Thessaloníki, Greece

Site Status

Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Wro Medica

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

Warsaw, Masovian Voivodeship, Poland

Site Status

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Klinika Badawcza Centrum Badan Klinicznych Wojciech Brzezicki

Malbork, Pomeranian Voivodeship, Poland

Site Status

Centrum Medyczne Pratia Katowice

Katowice, Silesian Voivodeship, Poland

Site Status

Dermoklinika-Centrum Medyczne s.c

Lodz, Łódź Voivodeship, Poland

Site Status

Countries

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United States Australia Canada Germany Greece Poland

Related Links

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https://trials.lilly.com/en-US/trial/424355

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

Other Identifiers

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I7P-MC-DSAF

Identifier Type: OTHER

Identifier Source: secondary_id

2023-505608-43-00

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1292-6255

Identifier Type: OTHER

Identifier Source: secondary_id

18518

Identifier Type: -

Identifier Source: org_study_id

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