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

April 15, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

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 Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Australia
      • Sydney, Australia, 2010
        • Recruiting
        • Holdsworth House Medical Practice
        • Principal Investigator:
          • John Frew
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • East Sydney Doctors
        • Principal Investigator:
          • David Baker
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Principal Investigator:
          • Pablo Fernandez-Penas
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Hospital
        • Principal Investigator:
          • Leith Banney
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Not yet recruiting
        • Fremantle Dermatology
        • Principal Investigator:
          • Kurt Gebauer
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E 0B2
        • Not yet recruiting
        • Beacon Dermatology
        • Principal Investigator:
          • Susan Poelman
      • Edmonton, Alberta, Canada, T6G 1C3
        • Not yet recruiting
        • Alberta DermaSurgery Centre
        • Principal Investigator:
          • Jaggi Rao
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Not yet recruiting
        • Wiseman Dermatology Research Inc.
        • Principal Investigator:
          • Marni Wiseman
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 1G9
        • Not yet recruiting
        • Brunswick Dermatology Center
        • Principal Investigator:
          • Irina Turchin
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Not yet recruiting
        • Simcoderm Medical & Surgical Dermatology Centre
        • Principal Investigator:
          • Maryam Shayesteh Alam
      • London, Ontario, Canada, N6H 5L5
        • Not yet recruiting
        • DermEffects - Probity - PPDS
        • Principal Investigator:
          • Loo Wei Jing
    • Quebec
      • Quebec City, Quebec, Canada, G1W 4R4
        • Not yet recruiting
        • Center de Recherche St Louis
        • Principal Investigator:
          • Virginia Kelly
  • Germany
      • Berlin, Germany, 10247
        • Not yet recruiting
        • Hautzentrum Friedrichshain - Dermatologie
        • Principal Investigator:
          • Jens Rossbacher
        • Contact:
          • Phone Number: 491706993886
      • Hamburg, Germany, 20251
        • Not yet recruiting
        • Universitaetsklinikum Hamburg-Eppendorf
        • Principal Investigator:
          • Matthias Augustin
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Not yet recruiting
        • Hautklinik Erlangen
        • Principal Investigator:
          • Michael Sticherling
    • Brandenburg
      • Blankenfelde-Mahlow, Brandenburg, Germany, 15827
        • Not yet recruiting
        • Hautarztpraxis Mahlow
        • Principal Investigator:
          • Michael Sebastian
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60596
        • Not yet recruiting
        • Universitatsklinikum Frankfurt
        • Principal Investigator:
          • Andreas Pinter
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • Not yet recruiting
        • Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital
        • Principal Investigator:
          • Falk Bechara
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • Not yet recruiting
        • Universitätsklinikum Bonn
        • Principal Investigator:
          • Jorg Wenzel
    • Westfalen
      • Muenster, Westfalen, Germany, 48149
        • Not yet recruiting
        • Universitätsklinikum Münster - Albert Schweitzer Campus
        • Principal Investigator:
          • Nina Magnolo
  • Greece
      • Heraklion, Greece, 711 10
        • Not yet recruiting
        • University General Hospital of Heraklion
        • Principal Investigator:
          • Konstantinos Krasagakis
    • Attiki
      • Athens, Attiki, Greece, 16121
        • Not yet recruiting
        • Hospital of Venereal and Skin Diseases A.Syggros
        • Principal Investigator:
          • Alexander Stratigos
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 56429
        • Not yet recruiting
        • Papageorgiou General Hospital of Thessaloniki
        • Principal Investigator:
          • Elisavet Lazaridou
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 51-685
        • Not yet recruiting
        • Wro Medica
        • Principal Investigator:
          • Wojciech Baran
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-507
        • Not yet recruiting
        • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
        • Principal Investigator:
          • Irena Walecka Herniczek
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-214
        • Not yet recruiting
        • Uniwersyteckie Centrum Kliniczne
        • Principal Investigator:
          • Roman Nowicki
      • Malbork, Pomorskie, Poland, 82-200
        • Not yet recruiting
        • Klinika Badawcza Centrum Badan Klinicznych Wojciech Brzezicki
        • Principal Investigator:
          • Anna Sobieszek-Kundro
    • Śląskie
      • Katowice, Śląskie, Poland, 40-081
        • Not yet recruiting
        • Centrum Medyczne Pratia Katowice
        • Principal Investigator:
          • Kamila Placzek
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Medical Dermatology Specialists
        • Principal Investigator:
          • Lindsay Ackerman
      • Phoenix, Arizona, United States, 85008
        • Not yet recruiting
        • Saguaro Dermatology Associates, LLC - Probity - PPDS
        • Contact:
          • Phone Number: 602-610-4247
        • Principal Investigator:
          • Dathan Hamann
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Recruiting
        • Arkansas Research Trials, LLC
        • Principal Investigator:
          • Scott Dinehart
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Northwest Arkansas Clinical Trials Center
        • Principal Investigator:
          • Cheryl Hull
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • First OC Dermatology Research Inc
        • Principal Investigator:
          • Vivian Laquer
      • Fremont, California, United States, 94538
        • Recruiting
        • Center for Dermatology Clinical Research, Inc.
        • Principal Investigator:
          • Sunil Dhawan
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates
        • Principal Investigator:
          • Howard Sofen
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Dermatology Institute and Skin Care Center
        • Principal Investigator:
          • Paul Yamauchi
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Not yet recruiting
        • University of Connecticut
        • Principal Investigator:
          • Jun Lu
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Florida Academic Dermatology Centers
        • Principal Investigator:
          • Francisco Kerdel
      • Hialeah, Florida, United States, 33012
        • Not yet recruiting
        • Direct Helpers Research Center
        • Principal Investigator:
          • Frank Don
      • Margate, Florida, United States, 33063
        • Recruiting
        • GSI Clinical Research, LLC
        • Principal Investigator:
          • Brad Glick
      • Miami, Florida, United States, 33125
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Hadar Lev-Tov
      • Miami, Florida, United States, 33173-1407
        • Recruiting
        • Skin Research of South Florida
        • Principal Investigator:
          • Giovanna Ciocca
      • Saint Petersburg, Florida, United States, 33709
        • Recruiting
        • Olympian Clinical Research
        • Principal Investigator:
          • Matthew Zook
      • Tampa, Florida, United States, 33613-1244
        • Recruiting
        • Forcare Clinical Research
        • Principal Investigator:
          • Seth Forman
      • Tampa, Florida, United States, 33615
        • Recruiting
        • Alliance Clinical Research of Tampa Loc. 1
        • Principal Investigator:
          • Luis Fernandez Menendez
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Recruiting
        • Advanced Medical Research, PC
        • Principal Investigator:
          • Jamie Weisman
    • Illinois
      • Skokie, Illinois, United States, 60077-1049
        • Not yet recruiting
        • NorthShore Medical Group Dermatology - Skokie
        • Principal Investigator:
          • Shannon Ewing
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Dawes Fretzin Clinical Research Group, LLC
        • Principal Investigator:
          • Scott Fretzin
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Not yet recruiting
        • Derm Research LLC
        • Principal Investigator:
          • Leon Kircik
        • Contact:
          • Phone Number: 502-456-2783
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Alexa Kimball
    • Michigan
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute - Troy
        • Principal Investigator:
          • Ali Moiin
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Milan Anadkat
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Skin Specialists, P.C
        • Principal Investigator:
          • Joel Schlessinger
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Recruiting
        • ActivMed Practices & Research, Inc. Loc. 5
        • Principal Investigator:
          • Abel Jarell
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Dermatology Specialists of Charlotte
        • Principal Investigator:
          • Deborah Nixon
      • Charlotte, North Carolina, United States, 28277-8014
        • Recruiting
        • Darst Dermatology
        • Principal Investigator:
          • Marc Darst
      • Durham, North Carolina, United States, 27710-3038
        • Not yet recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Tarannum Jaleel
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Neil Korman
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Recruiting
        • DermDox Centers for Dermatology Loc. 17
        • Principal Investigator:
          • Stephen Schleicher
      • Sugarloaf, Pennsylvania, United States, 18249
        • Not yet recruiting
        • DermDox Dermatology Centers
        • Contact:
          • Phone Number: 570-459-0029
        • Principal Investigator:
          • Stephen Schleicher
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Lara Wine Lee
      • Columbia, South Carolina, United States, 29212-8623
        • Recruiting
        • Columbia Dermatology & Aesthetics
        • Principal Investigator:
          • Jessica Burgy
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Recruiting
        • International Clinical Research - Tennessee LLC
        • Principal Investigator:
          • Christina Feser
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Modern Research Associates
        • Principal Investigator:
          • Jennifer Cather
      • Frisco, Texas, United States, 75034
        • Recruiting
        • North Texas Clinical Research
        • Principal Investigator:
          • Timothy Rodgers
    • Utah
      • South Jordan, Utah, United States, 84095
        • Recruiting
        • Jordan Valley Dermatology Center
        • Principal Investigator:
          • Douglass Forsha
    • Washington
      • Spokane, Washington, United States, 99202-1332
        • Recruiting
        • Dermatology Specialists of Spokane
        • Principal Investigator:
          • Katherine Reed
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin
        • Contact:
          • Phone Number: 414-955-3101
        • Principal Investigator:
          • Gretchen Roth

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 (Estimated)

August 1, 2025

Study Completion (Estimated)

July 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 (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

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.

Clinical Trials on Hidradenitis Suppurativa

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe