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: Recruiting
Location: See all (60) 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 and a clinical diagnosis of HS at screening
• Has moderate or severe HS
• 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)
RECRUITING
Birmingham
Arkansas
Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)
RECRUITING
Rogers
Arizona
Medical Dermatology Specialists ( Site 0027)
RECRUITING
Phoenix
California
Northridge Clinical Trials ( Site 0004)
RECRUITING
Northridge
Integrative Skin Science and Research ( Site 0015)
RECRUITING
Sacramento
Florida
Olympian Clinical Research ( Site 0010)
RECRUITING
Tampa
Georgia
Skin Care Physicians of Georgia ( Site 0033)
RECRUITING
Macon
Indiana
Dawes Fretzin Clinical Research Group, LLC ( Site 0025)
RECRUITING
Indianapolis
Michigan
Revival Research Institute, LLC ( Site 0005)
RECRUITING
Troy
North Carolina
DJL Clinical Research, PLLC ( Site 0021)
RECRUITING
Charlotte
New York
Mount Sinai Doctors - East 85th Street ( Site 0050)
RECRUITING
New York
Ohio
University Hospitals Cleveland Medical Center ( Site 0046)
RECRUITING
Cleveland
Wright State Physicians Health Center ( Site 0041)
RECRUITING
Fairborn
South Carolina
Palmetto Clinical Trial Services, LLC ( Site 0023)
RECRUITING
Anderson
Texas
Arlington Center for Dermatology ( Site 0045)
RECRUITING
Arlington
Texas Dermatology Research Center ( Site 0019)
RECRUITING
Dallas
Reveal Research Institute ( Site 0018)
RECRUITING
Frisco
Progressive Clinical Research ( Site 0020)
RECRUITING
San Antonio
Other Locations
Argentina
CIPREC ( Site 0202)
RECRUITING
Caba
Derma Internacional SA ( Site 0206)
RECRUITING
Caba
Hospital Italiano de Buenos Aires ( Site 0205)
RECRUITING
Caba
Psoriahue ( Site 0203)
RECRUITING
Caba
Australia
Fremantle Dermatology ( Site 1402)
RECRUITING
Fremantle
Liverpool Hospital ( Site 1403)
RECRUITING
Liverpool
The Alfred Hospital ( Site 1401)
RECRUITING
Melbourne
Canada
SKiN Centre for Dermatology ( Site 0103)
RECRUITING
Peterborough
York Dermatology Clinic & Research Centre ( Site 0106)
RECRUITING
Richmond Hill
Chile
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)
RECRUITING
Santiago
Centro Skin Med Limitada ( Site 0305)
RECRUITING
Santiago
Clinica Dermacross ( Site 0301)
RECRUITING
Santiago
China
The First Hospital of Jilin University ( Site 1502)
RECRUITING
Changchun
The Second Xiangya Hospital of Central South University ( Site 1505)
RECRUITING
Changsha
Dermatology Hospital of Southern Medical University ( Site 1504)
RECRUITING
Guangzhou
Huashan Hospital of Fudan University ( Site 1506)
RECRUITING
Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 1515)
RECRUITING
Shanghai
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 1509)
RECRUITING
Ürümqi
Colombia
Servicios de Salud IPS Suramericana S.A.S. - IPS Sura San Diego ( Site 0404)
RECRUITING
Medellín
Fundación Valle del Lili ( Site 0403)
RECRUITING
Santiago De Cali
France
Hôpital Edouard Herriot ( Site 0601)
RECRUITING
Lyon
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0602)
RECRUITING
Paris
HIA Sainte Anne ( Site 0606)
RECRUITING
Toulon
Germany
Charite - Universtitatsmedizin Berlin CCM ( Site 0708)
RECRUITING
Berlin
Frankfurt Universitaetsklinikum EC ( Site 0706)
RECRUITING
Frankfurt Am Main
Italy
AOU Ospedali Riuniti di Ancona ( Site 1805)
RECRUITING
Ancona
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico ( Site 1806)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
RECRUITING
Roma
Japan
Fukuoka University Hospital ( Site 1604)
RECRUITING
Fukuoka
University of the Ryukyus Hospital ( Site 1601)
RECRUITING
Ginowan
University Hospital,Kyoto Prefectural University of Medicine ( Site 1605)
RECRUITING
Kyoto
Nagoya City University Hospital ( Site 1603)
RECRUITING
Nagoya
Medical Corporation Kojinkai Sapporo Skin Clinic ( Site 1606)
RECRUITING
Sapporo
Nihon University Itabashi Hospital ( Site 1602)
RECRUITING
Tabashi City
Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 0902)
RECRUITING
Breda
Erasmus Medisch Centrum ( Site 0901)
RECRUITING
Rotterdam
Spain
Hospital Universitari de Bellvitge ( Site 1101)
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron ( Site 1102)
RECRUITING
Barcelona
Hospital Universitario Virgen Nieves ( Site 1104)
RECRUITING
Granada
Hospital de Manises ( Site 1103)
RECRUITING
Manises
United Kingdom
Russells Hall Hospital ( Site 1303)
RECRUITING
Dudley
Royal London Hospital ( Site 1301)
RECRUITING
London
Contact Information
Primary
Toll Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-06-09
Estimated 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