A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
- Registration Number
- NCT06046729
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be given. Eltrekibart Dose 1 Eltrekibart Eltrekibart will be given subcutaneously (SC). Eltrekibart Dose 2 Eltrekibart Eltrekibart will be given SC. Eltrekibart Dose 3 Eltrekibart Eltrekibart will be given SC.
- Primary Outcome Measures
Name Time Method Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) Week 16
- Secondary Outcome Measures
Name Time Method Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules Baseline, Week 16 Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart Baseline through Week 16 Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS) Baseline, Week 16
Trial Locations
- Locations (74)
Darst Dermatology
๐บ๐ธCharlotte, North Carolina, United States
Medical Dermatology Specialists
๐บ๐ธPhoenix, Arizona, United States
Saguaro Dermatology Associates, LLC - Probity - PPDS
๐บ๐ธPhoenix, Arizona, United States
Arkansas Research Trials, LLC
๐บ๐ธNorth Little Rock, Arkansas, United States
Northwest Arkansas Clinical Trials Center
๐บ๐ธRogers, Arkansas, United States
First OC Dermatology Research Inc
๐บ๐ธFountain Valley, California, United States
Dermoklinika-Centrum Medyczne s.c
๐ต๐ฑLodz, Lodzkie, Poland
Center For Dermatology Clinical Research, Inc.
๐บ๐ธFremont, California, United States
Dermatology Research Associates
๐บ๐ธLos Angeles, California, United States
Dermatology Institute and Skin Care Center
๐บ๐ธSanta Monica, California, United States
University of Connecticut
๐บ๐ธFarmington, Connecticut, United States
Direct Helpers Research Center
๐บ๐ธHialeah, Florida, United States
University of Miami
๐บ๐ธMiami, Florida, United States
Skin Research of South Florida
๐บ๐ธMiami, Florida, United States
ForCare Clinical Research
๐บ๐ธTampa, Florida, United States
Alliance Clinical Research of Tampa
๐บ๐ธTampa, Florida, United States
Olympian Clinical Research
๐บ๐ธTampa, Florida, United States
Advanced Medical Research, PC
๐บ๐ธSandy Springs, Georgia, United States
NorthShore Medical Group Dermatology - Skokie
๐บ๐ธSkokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
๐บ๐ธIndianapolis, Indiana, United States
Equity Medical - Bowling Green
๐บ๐ธBowling Green, Kentucky, United States
Derm Research LLC
๐บ๐ธLouisville, Kentucky, United States
Care Access-Marriottsville
๐บ๐ธMarriottsville, Maryland, United States
Beth Israel Deaconess Medical Center
๐บ๐ธBoston, Massachusetts, United States
Revival Research Institute - Troy
๐บ๐ธTroy, Michigan, United States
Washington University School of Medicine
๐บ๐ธSaint Louis, Missouri, United States
Skin Specialists, P.C
๐บ๐ธOmaha, Nebraska, United States
ActivMed Practices & Research, Inc.
๐บ๐ธPortsmouth, New Hampshire, United States
Dermatology Specialists of Charlotte
๐บ๐ธCharlotte, North Carolina, United States
Duke University Medical Center
๐บ๐ธDurham, North Carolina, United States
University Hospitals Cleveland Medical Center
๐บ๐ธCleveland, Ohio, United States
Apex Clinical Research Center
๐บ๐ธMayfield Heights, Ohio, United States
DermDox Centers for Dermatology
๐บ๐ธCamp Hill, Pennsylvania, United States
DermDox Dermatology Centers
๐บ๐ธSugarloaf, Pennsylvania, United States
Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States
Columbia Dermatology & Aesthetics
๐บ๐ธColumbia, South Carolina, United States
International Clinical Research - Tennessee (IC Research)
๐บ๐ธMurfreesboro, Tennessee, United States
Advanced Research Experts
๐บ๐ธNashville, Tennessee, United States
Modern Research Associates
๐บ๐ธDallas, Texas, United States
North Texas Clinical Research
๐บ๐ธFrisco, Texas, United States
Jordan Valley Dermatology Center
๐บ๐ธSouth Jordan, Utah, United States
Dermatology Specialists of Spokane
๐บ๐ธSpokane, Washington, United States
Medical College of Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States
East Sydney Doctors
๐ฆ๐บDarlinghurst, New South Wales, Australia
Westmead Hospital
๐ฆ๐บWestmead, New South Wales, Australia
Sunshine Coast University Hospital
๐ฆ๐บBirtinya, Queensland, Australia
Sinclair Dermatology - East Melbourne
๐ฆ๐บEast Melbourne, Victoria, Australia
Alfred Hospital
๐ฆ๐บMelbourne, Victoria, Australia
Fremantle Dermatology
๐ฆ๐บFremantle, Western Australia, Australia
Holdsworth House Medical Practice
๐ฆ๐บSydney, Australia
Beacon Dermatology
๐จ๐ฆCalgary, Alberta, Canada
Alberta Dermasurgery Centre
๐จ๐ฆEdmonton, Alberta, Canada
Wiseman Dermatology Research Inc.
๐จ๐ฆWinnipeg, Manitoba, Canada
Brunswick Dermatology Center
๐จ๐ฆFredericton, New Brunswick, Canada
Simcoderm Medical & Surgical Dermatology Centre
๐จ๐ฆBarrie, Ontario, Canada
DermEffects - Probity - PPDS
๐จ๐ฆLondon, Ontario, Canada
Center de Recherche St Louis
๐จ๐ฆQuebec City, Quebec, Canada
Hautklinik Erlangen
๐ฉ๐ชErlangen, Bayern, Germany
Hautarztpraxis Mahlow
๐ฉ๐ชBlankenfelde-Mahlow, Brandenburg, Germany
Universitรคtsklinikum Frankfurt
๐ฉ๐ชFrankfurt am Main, Hessen, Germany
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital
๐ฉ๐ชBochum, Nordrhein-Westfalen, Germany
Universitรคtsklinikum Bonn
๐ฉ๐ชBonn, Nordrhein-Westfalen, Germany
Universitรคtsklinikum Mรผnster - Albert Schweitzer Campus
๐ฉ๐ชMuenster, Westfalen, Germany
Hautzentrum Friedrichshain - Dermatologie
๐ฉ๐ชBerlin, Germany
Universitaetsklinikum Hamburg-Eppendorf
๐ฉ๐ชHamburg, Germany
Hospital of Venereal and Skin Diseases A.Syggros
๐ฌ๐ทAthens, Attiki, Greece
University General Hospital of Heraklion Loc. 1
๐ฌ๐ทHeraklion, Irakleรญo, Greece
Papageorgiou General Hospital of Thessaloniki
๐ฌ๐ทThessaloniki, Thessalonรญki, Greece
Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spรณลka Partnerska
๐ต๐ฑWroclaw, Dolnoslaskie, Poland
Wro Medica
๐ต๐ฑWroclaw, Dolnoslaskie, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
๐ต๐ฑWarszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne
๐ต๐ฑGdansk, Pomorskie, Poland
Klinika Badawcza Centrum Badan Klinicznych Wojciech Brzezicki
๐ต๐ฑMalbork, Pomorskie, Poland
Centrum Medyczne Pratia Katowice
๐ต๐ฑKatowice, ลlฤ skie, Poland