Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
NCT ID: NCT06956235
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
147 participants
INTERVENTIONAL
2025-06-09
2029-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1: High Dose
Participants receive a high dose tulisokibart regimen.
Tulisokibart
Solution in autoinjector for subcutaneous (SC) injection
Arm 2: Medium Dose
Participants receive a medium dose tulisokibart regimen.
Tulisokibart
Solution in autoinjector for subcutaneous (SC) injection
Arm 3: Low Dose
Participants receive a low dose tulisokibart regimen.
Tulisokibart
Solution in autoinjector for subcutaneous (SC) injection
Arm 4: Placebo
Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.
Placebo
Solution in autoinjector for SC injection
Interventions
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Tulisokibart
Solution in autoinjector for subcutaneous (SC) injection
Placebo
Solution in autoinjector for SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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U1111-1316-5263
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-520039-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2011250007
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-7240-012
Identifier Type: OTHER
Identifier Source: secondary_id
7240-012
Identifier Type: -
Identifier Source: org_study_id