A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
4 other identifiers
interventional
352
6 countries
74
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2023
Typical duration for phase_2
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedOctober 16, 2025
October 1, 2025
1.9 years
September 14, 2023
October 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
Week 16
Secondary Outcomes (3)
Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules
Baseline, Week 16
Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS)
Baseline, Week 16
Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart
Baseline through Week 16
Study Arms (4)
Eltrekibart Dose 1
EXPERIMENTALEltrekibart will be given subcutaneously (SC).
Eltrekibart Dose 2
EXPERIMENTALEltrekibart will be given SC.
Eltrekibart Dose 3
EXPERIMENTALEltrekibart will be given SC.
Placebo
PLACEBO COMPARATORPlacebo will be given.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Medical Dermatology Specialists
Phoenix, Arizona, 85006, United States
Saguaro Dermatology Associates, LLC - Probity - PPDS
Phoenix, Arizona, 85008, United States
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117, United States
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758, United States
First OC Dermatology Research Inc
Fountain Valley, California, 92708, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Dermatology Institute and Skin Care Center
Santa Monica, California, 90404, United States
University of Connecticut
Farmington, Connecticut, 06032, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
University of Miami
Miami, Florida, 33125, United States
Skin Research of South Florida
Miami, Florida, 33173-1407, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Alliance Clinical Research of Tampa
Tampa, Florida, 33615, United States
Olympian Clinical Research
Tampa, Florida, 33615, United States
Advanced Medical Research, PC
Sandy Springs, Georgia, 30328, United States
NorthShore Medical Group Dermatology - Skokie
Skokie, Illinois, 60077-1049, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, 42104, United States
Derm Research LLC
Louisville, Kentucky, 40217, United States
Care Access-Marriottsville
Marriottsville, Maryland, 21104, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Revival Research Institute - Troy
Troy, Michigan, 48084, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Skin Specialists, P.C
Omaha, Nebraska, 68144, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, 03801, United States
Darst Dermatology
Charlotte, North Carolina, 28277-8014, United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28277, United States
Duke University Medical Center
Durham, North Carolina, 27710-3038, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124, United States
DermDox Centers for Dermatology
Camp Hill, Pennsylvania, 17011, United States
DermDox Dermatology Centers
Sugarloaf, Pennsylvania, 18249, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Columbia Dermatology & Aesthetics
Columbia, South Carolina, 29212-8623, United States
International Clinical Research - Tennessee (IC Research)
Murfreesboro, Tennessee, 37130, United States
Advanced Research Experts
Nashville, Tennessee, 37211, United States
Modern Research Associates
Dallas, Texas, 75231, United States
North Texas Clinical Research
Frisco, Texas, 75034, United States
Jordan Valley Dermatology Center
South Jordan, Utah, 84095, United States
Dermatology Specialists of Spokane
Spokane, Washington, 99202-1332, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
East Sydney Doctors
Darlinghurst, New South Wales, 2010, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Sinclair Dermatology - East Melbourne
East Melbourne, Victoria, 3002, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fremantle Dermatology
Fremantle, Western Australia, 6160, Australia
Holdsworth House Medical Practice
Sydney, 2010, Australia
Beacon Dermatology
Calgary, Alberta, T3E 0B2, Canada
Alberta Dermasurgery Centre
Edmonton, Alberta, T6G 1C3, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, R3M 3Z4, Canada
Brunswick Dermatology Center
Fredericton, New Brunswick, E3B 1G9, Canada
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1, Canada
DermEffects - Probity - PPDS
London, Ontario, N6H 5L5, Canada
Center de Recherche St Louis
Québec, Quebec, G1W 4R4, Canada
Hautklinik Erlangen
Erlangen, Bavaria, 91054, Germany
Hautarztpraxis Mahlow
Blankenfelde-Mahlow, Brandenburg, 15827, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60596, Germany
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital
Bochum, North Rhine-Westphalia, 44791, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, Westfalen, 48149, Germany
Hautzentrum Friedrichshain - Dermatologie
Berlin, 10247, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20251, Germany
Hospital of Venereal and Skin Diseases A.Syggros
Athens, Attica, 16121, Greece
University General Hospital of Heraklion Loc. 1
Heraklion, Irakleío, 711 10, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, 56429, Greece
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
Wroclaw, Lower Silesian Voivodeship, 50-566, Poland
Wro Medica
Wroclaw, Lower Silesian Voivodeship, 51-685, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, Masovian Voivodeship, 02-507, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Klinika Badawcza Centrum Badan Klinicznych Wojciech Brzezicki
Malbork, Pomeranian Voivodeship, 82-200, Poland
Centrum Medyczne Pratia Katowice
Katowice, Silesian Voivodeship, 40-081, Poland
Dermoklinika-Centrum Medyczne s.c
Lodz, Łódź Voivodeship, 90-436, Poland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2023
First Posted
September 21, 2023
Study Start
October 23, 2023
Primary Completion
September 30, 2025
Study Completion (Estimated)
August 1, 2026
Last Updated
October 16, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.