A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderate to Severe Hidradenitis Suppurativa
Status: Active_not_recruiting
Location: See all (68) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Has signs and symptoms of hidradenitis suppurativa (HS) for ≥6 months prior to Screening and a clinical diagnosis of HS at Screening
• Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III
• Has a history of inadequate response to a course of systemic antibiotics for treatment of HS or intolerance to or has a contraindication to systemic antibiotics for treatment of HS
• Has ≤20 draining tunnel count at Screening and Randomization
Locations
United States
Alabama
Cahaba Dermatology & Skin Health Center ( Site 0012)
Birmingham
Arkansas
Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)
Rogers
Arizona
Medical Dermatology Specialists ( Site 0027)
Phoenix
California
Northridge Clinical Trials ( Site 0004)
Northridge
Integrative Skin Science and Research ( Site 0015)
Sacramento
Florida
Olympian Clinical Research ( Site 0010)
Tampa
Georgia
Skin Care Physicians of Georgia ( Site 0033)
Macon
Indiana
Dawes Fretzin Clinical Research Group, LLC ( Site 0025)
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center ( Site 0044)
Boston
Michigan
Revival Research Institute, LLC ( Site 0005)
Troy
North Carolina
DJL Clinical Research, PLLC ( Site 0021)
Charlotte
New York
Mount Sinai Doctors - East 85th Street ( Site 0050)
New York
Ohio
University Hospitals Cleveland Medical Center ( Site 0046)
Cleveland
Wright State Physicians Health Center ( Site 0041)
Fairborn
South Carolina
Palmetto Clinical Trial Services, LLC ( Site 0023)
Anderson
Texas
Arlington Center for Dermatology ( Site 0045)
Arlington
Texas Dermatology Research Center ( Site 0019)
Dallas
Reveal Research Institute ( Site 0018)
Frisco
Progressive Clinical Research ( Site 0020)
San Antonio
Other Locations
Argentina
CIPREC ( Site 0202)
Caba
Derma Internacional SA ( Site 0206)
Caba
Hospital Italiano de Buenos Aires ( Site 0205)
Caba
Psoriahue ( Site 0203)
Caba
Australia
Fremantle Dermatology ( Site 1402)
Fremantle
Liverpool Hospital ( Site 1403)
Liverpool
The Alfred Hospital ( Site 1401)
Melbourne
Canada
Brunswick Dermatology Center ( Site 0101)
Frederiction
Lynderm Research Inc. ( Site 0104)
Markham
SKiN Centre for Dermatology ( Site 0103)
Peterborough
York Dermatology Clinic & Research Centre ( Site 0106)
Richmond Hill
Wiseman Dermatology Research Inc. ( Site 0107)
Winnipeg
Chile
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)
Santiago
Centro Skin Med Limitada ( Site 0305)
Santiago
Clinica Dermacross ( Site 0301)
Santiago
China
The First Hospital of Jilin University ( Site 1502)
Changchun
The Second Xiangya Hospital of Central South University ( Site 1505)
Changsha
Dermatology Hospital of Southern Medical University ( Site 1504)
Guangzhou
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1501)
Hangzhou
Huashan Hospital of Fudan University ( Site 1506)
Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 1515)
Shanghai
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 1509)
Ürümqi
Colombia
Fundación Valle del Lili ( Site 0403)
Cali
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura San Diego ( Site 0404)
Medellín
France
CHU de Bordeaux Hop St ANDRE ( Site 0603)
Bordeaux
Hôpital Edouard Herriot ( Site 0601)
Lyon
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0602)
Paris
HIA Sainte Anne ( Site 0606)
Toulon
Germany
Charite - Universtitatsmedizin Berlin CCM ( Site 0708)
Berlin
Frankfurt Universitaetsklinikum EC ( Site 0706)
Frankfurt Am Main
Italy
AOU Ospedali Riuniti di Ancona ( Site 1805)
Ancona
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico ( Site 1806)
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
Roma
Japan
Fukuoka University Hospital ( Site 1604)
Fukuoka
University of the Ryukyus Hospital ( Site 1601)
Ginowan
University Hospital,Kyoto Prefectural University of Medicine ( Site 1605)
Kyoto
Nagoya City University Hospital ( Site 1603)
Nagoya
Medical Corporation Kojinkai Sapporo Skin Clinic ( Site 1606)
Sapporo
Nihon University Itabashi Hospital ( Site 1602)
Tabashi City
Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 0902)
Breda
Erasmus Medisch Centrum ( Site 0901)
Rotterdam
Singapore
National Skin Centre ( Site 0801)
Singapore
National Universtity Hospital IMU ( Site 0802)
Singapore
Spain
Hospital Universitari de Bellvitge ( Site 1101)
Barcelona
Hospital Universitari Vall d'Hebron ( Site 1102)
Barcelona
Hospital Universitario Virgen Nieves ( Site 1104)
Granada
Hospital de Manises ( Site 1103)
Manises
United Kingdom
Russells Hall Hospital ( Site 1303)
Dudley
Royal London Hospital ( Site 1301)
London
Time Frame
Start Date: 2025-06-09
Completion Date: 2029-01-22
Participants
Target number of participants: 147
Treatments
Experimental: Arm 1: High Dose
Participants receive a high dose tulisokibart regimen.
Experimental: Arm 2: Medium Dose
Participants receive a medium dose tulisokibart regimen.
Experimental: Arm 3: Low Dose
Participants receive a low dose tulisokibart regimen.
Placebo_comparator: Arm 4: Placebo
Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC