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NCT06956235

PHASE2

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

147

Start Date

2025-06-09

Completion Date

2029-01-22

Last Updated

2026-01-20

Healthy Volunteers

Conditions

Hidradenitis Suppurativa

Interventions

DRUG

Tulisokibart

Solution in autoinjector for subcutaneous (SC) injection

DRUG

Placebo

Solution in autoinjector for SC injection

Inclusion Criteria: * 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 Exclusion Criteria: * Has other active skin conditions that may, in the judgment of the investigator, interfere with the assessment of HS * Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy * Has a transplanted organ and requires continued systemic immunosuppression * Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years * Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments * Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) * Has any active infection * Has active tuberculosis * Has had major surgery within the past 3 months or has a major surgery planned during the study * Has a history of clinically significant drug or alcohol abuse within the past 6 months * Has prior exposure to tulisokibart * Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study * Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Locations (68)

Cahaba Dermatology & Skin Health Center ( Site 0012)

Birmingham, Alabama, United States

Medical Dermatology Specialists ( Site 0027)

Phoenix, Arizona, United States

Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)

Rogers, Arkansas, United States

Northridge Clinical Trials ( Site 0004)

Northridge, California, United States

Integrative Skin Science and Research ( Site 0015)

Sacramento, California, United States

Olympian Clinical Research ( Site 0010)

Tampa, Florida, United States

Skin Care Physicians of Georgia ( Site 0033)

Macon, Georgia, United States

Dawes Fretzin Clinical Research Group, LLC ( Site 0025)

Indianapolis, Indiana, United States

Beth Israel Deaconess Medical Center ( Site 0044)

Boston, Massachusetts, United States

Revival Research Institute, LLC ( Site 0005)

Troy, Michigan, United States

Mount Sinai Doctors - East 85th Street ( Site 0050)

New York, New York, United States

DJL Clinical Research, PLLC ( Site 0021)

Charlotte, North Carolina, United States

University Hospitals Cleveland Medical Center ( Site 0046)

Cleveland, Ohio, United States

Wright State Physicians Health Center ( Site 0041)

Fairborn, Ohio, United States

Palmetto Clinical Trial Services, LLC ( Site 0023)

Anderson, South Carolina, United States

Arlington Center for Dermatology ( Site 0045)

Arlington, Texas, United States

Texas Dermatology Research Center ( Site 0019)

Dallas, Texas, United States

Reveal Research Institute ( Site 0018)

Frisco, Texas, United States

Progressive Clinical Research ( Site 0020)

San Antonio, Texas, United States

CIPREC ( Site 0202)

CABA, Argentina

Hospital Italiano de Buenos Aires ( Site 0205)

CABA, Argentina

Psoriahue ( Site 0203)

CABA, Argentina

Derma Internacional SA ( Site 0206)

CABA, Argentina

Liverpool Hospital ( Site 1403)

Liverpool, New South Wales, Australia

The Alfred Hospital ( Site 1401)

Melbourne, Victoria, Australia

Fremantle Dermatology ( Site 1402)

Fremantle, Western Australia, Australia

Wiseman Dermatology Research Inc. ( Site 0107)

Winnipeg, Manitoba, Canada

Brunswick Dermatology Center ( Site 0101)

Frederiction, New Brunswick, Canada

Lynderm Research Inc. ( Site 0104)

Markham, Ontario, Canada

SKiN Centre for Dermatology ( Site 0103)

Peterborough, Ontario, Canada

York Dermatology Clinic & Research Centre ( Site 0106)

Richmond Hill, Ontario, Canada

Centro Skin Med Limitada ( Site 0305)

Santiago, Region M. de Santiago, Chile

Clinica Dermacross ( Site 0301)

Santiago, Region M. de Santiago, Chile

Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)

Santiago, Region M. de Santiago, Chile

Dermatology Hospital of Southern Medical University ( Site 1504)

Guangzhou, Guangdong, China

The Second Xiangya Hospital of Central South University ( Site 1505)

Changsha, Hunan, China

The First Hospital of Jilin University ( Site 1502)

Changchun, Jilin, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 1515)

Shanghai, Shanghai Municipality, China

Huashan Hospital of Fudan University ( Site 1506)

Shanghai, Shanghai Municipality, China

PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 1509)

Ürümqi, Xinjiang, China

The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1501)

Hangzhou, Zhejiang, China

Servicios de Salud IPS Suramericana S.A.S. - IPS Sura San Diego ( Site 0404)

Medellín, Antioquia, Colombia

Fundación Valle del Lili ( Site 0403)

Cali, Valle del Cauca Department, Colombia

Hôpital Edouard Herriot ( Site 0601)

Lyon, Auvergne-Rhône-Alpes, France

CHU de Bordeaux Hop St ANDRE ( Site 0603)

Bordeaux, Gironde, France

HIA Sainte Anne ( Site 0606)

Toulon, Var, France

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0602)

Paris, France

Frankfurt Universitaetsklinikum EC ( Site 0706)

Frankfurt am Main, Hesse, Germany

Charite - Universtitatsmedizin Berlin CCM ( Site 0708)

Berlin, Germany

AOU Ospedali Riuniti di Ancona ( Site 1805)

Ancona, The Marches, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico ( Site 1806)

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)

Roma, Italy

Nagoya City University Hospital ( Site 1603)

Nagoya, Aichi-ken, Japan

Medical Corporation Kojinkai Sapporo Skin Clinic ( Site 1606)

Sapporo, Hokkaido, Japan

University of the Ryukyus Hospital ( Site 1601)

Ginowan, Okinawa, Japan

Nihon University Itabashi Hospital ( Site 1602)

tabashi City, Tokyo, Japan

Fukuoka University Hospital ( Site 1604)

Fukuoka, Japan

University Hospital,Kyoto Prefectural University of Medicine ( Site 1605)

Kyoto, Japan

Amphia Ziekenhuis, locatie Breda Molengracht ( Site 0902)

Breda, North Brabant, Netherlands

Erasmus Medisch Centrum ( Site 0901)

Rotterdam, South Holland, Netherlands

National Universtity Hospital IMU ( Site 0802)

Singapore, Central Singapore, Singapore

National Skin Centre ( Site 0801)

Singapore, Central Singapore, Singapore

Hospital de Manises ( Site 1103)

Manises, Valencia, Spain

Hospital Universitari Vall d'Hebron ( Site 1102)

Barcelona, Spain

Hospital Universitari de Bellvitge ( Site 1101)

Barcelona, Spain

Hospital Universitario Virgen Nieves ( Site 1104)

Granada, Spain

Russells Hall Hospital ( Site 1303)

Dudley, England, United Kingdom

Royal London Hospital ( Site 1301)

London, England, United Kingdom

Clinical Research Directory

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)