Hidradenitis Suppurativa Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 350 |
| Est. completion date | July 2026 |
| Est. primary completion date | August 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Sunshine Coast University Hospital | Birtinya | Queensland |
| Australia | East Sydney Doctors | Darlinghurst | New South Wales |
| Australia | Fremantle Dermatology | Fremantle | Western Australia |
| Australia | Holdsworth House Medical Practice | Sydney | |
| Australia | Westmead Hospital | Westmead | New South Wales |
| Canada | Simcoderm Medical & Surgical Dermatology Centre | Barrie | Ontario |
| Canada | Beacon Dermatology | Calgary | Alberta |
| Canada | Alberta Dermasurgery Centre | Edmonton | Alberta |
| Canada | Brunswick Dermatology Center | Fredericton | New Brunswick |
| Canada | DermEffects - Probity - PPDS | London | Ontario |
| Canada | Center de Recherche St Louis | Quebec City | Quebec |
| Canada | Wiseman Dermatology Research Inc. | Winnipeg | Manitoba |
| Germany | Hautzentrum Friedrichshain - Dermatologie | Berlin | |
| Germany | Hautarztpraxis Mahlow | Blankenfelde-Mahlow | Brandenburg |
| Germany | Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital | Bochum | Nordrhein-Westfalen |
| Germany | Universitätsklinikum Bonn | Bonn | Nordrhein-Westfalen |
| Germany | Hautklinik Erlangen | Erlangen | Bayern |
| Germany | Universitätsklinikum Frankfurt | Frankfurt am Main | Hessen |
| Germany | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Universitätsklinikum Münster - Albert Schweitzer Campus | Muenster | Westfalen |
| Greece | Hospital of Venereal and Skin Diseases A.Syggros | Athens | Attiki |
| Greece | Hospital of Venereal and Skin Diseases A.Syggros | Athens | Attiki |
| Greece | University General Hospital of Heraklion | Heraklion | |
| Greece | Papageorgiou General Hospital of Thessaloniki | Thessaloniki | Thessaloníki |
| Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | Pomorskie |
| Poland | Centrum Medyczne Pratia Katowice | Katowice | Slaskie |
| Poland | Klinika Badawcza Centrum Badan Klinicznych Wojciech Brzezicki | Malbork | Pomorskie |
| Poland | Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji | Warszawa | Mazowieckie |
| Poland | Wro Medica | Wroclaw | Dolnoslaskie |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | DermDox Centers for Dermatology Loc. 17 | Camp Hill | Pennsylvania |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Darst Dermatology | Charlotte | North Carolina |
| United States | Dermatology Specialists of Charlotte | Charlotte | North Carolina |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Columbia Dermatology & Aesthetics | Columbia | South Carolina |
| United States | Modern Research Associates | Dallas | Texas |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | University of Connecticut | Farmington | Connecticut |
| United States | First OC Dermatology Research Inc | Fountain Valley | California |
| United States | Center for Dermatology Clinical Research, Inc. | Fremont | California |
| United States | North Texas Clinical Research | Frisco | Texas |
| United States | Direct Helpers Research Center | Hialeah | Florida |
| United States | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana |
| United States | Dermatology Research Associates | Los Angeles | California |
| United States | Derm Research LLC | Louisville | Kentucky |
| United States | Skin Research of South Florida | Miami | Florida |
| United States | University of Miami | Miami | Florida |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | International Clinical Research - Tennessee LLC Research) | Murfreesboro | Tennessee |
| United States | Arkansas Research Trials, LLC | North Little Rock | Arkansas |
| United States | Skin Specialists, P.C | Omaha | Nebraska |
| United States | Medical Dermatology Specialists | Phoenix | Arizona |
| United States | Saguaro Dermatology Associates, LLC - Probity - PPDS | Phoenix | Arizona |
| United States | ActivMed Practices & Research, Inc. Loc. 5 | Portsmouth | New Hampshire |
| United States | Northwest Arkansas Clinical Trials Center | Rogers | Arkansas |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Advanced Medical Research, PC | Sandy Springs | Georgia |
| United States | Dermatology Institute and Skin Care Center | Santa Monica | California |
| United States | NorthShore Medical Group Dermatology - Skokie | Skokie | Illinois |
| United States | Jordan Valley Dermatology Center | South Jordan | Utah |
| United States | Dermatology Specialists of Spokane | Spokane | Washington |
| United States | DermDox Dermatology Centers | Sugarloaf | Pennsylvania |
| United States | Alliance Clinical Research of Tampa Loc. 1 | Tampa | Florida |
| United States | ForCare Clinical Research | Tampa | Florida |
| United States | Olympian Clinical Research | Tampa | Florida |
| United States | Revival Research Institute - Troy | Troy | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Australia, Canada, Germany, Greece, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) | Week 16 | ||
| Secondary | Mean Change from Baseline in Total Number of Abscesses and Inflammatory Nodules | Baseline, Week 16 | ||
| Secondary | Mean Change from Baseline in HS-related Average Skin Pain Numerical Rating Scale (NRS) | Baseline, Week 16 | ||
| Secondary | Pharmacokinetics (PK): Plasma Concentrations of Eltrekibart | Baseline through Week 16 |
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