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

January 16, 2026 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study consists of a 16-week Double-blind Period and a 100-week Long-term Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension.

Study Type

Interventional

Enrollment (Estimated)

147

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, C1061AAT
        • CIPREC ( Site 0202)
      • CABA, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires ( Site 0205)
      • CABA, Argentina, C1425DKG
        • Psoriahue ( Site 0203)
      • CABA, Argentina, C1426EGR
        • Derma Internacional SA ( Site 0206)
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 1871
        • Liverpool Hospital ( Site 1403)
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital ( Site 1401)
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Dermatology ( Site 1402)
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research Inc. ( Site 0107)
    • New Brunswick
      • Frederiction, New Brunswick, Canada, E3B 1G9
        • Brunswick Dermatology Center ( Site 0101)
    • Ontario
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc. ( Site 0104)
      • Peterborough, Ontario, Canada, K9J 5K2
        • SKiN Centre for Dermatology ( Site 0103)
      • Richmond Hill, Ontario, Canada, L4B 1L1
        • York Dermatology Clinic & Research Centre ( Site 0106)
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7580206
        • Centro Skin Med Limitada ( Site 0305)
      • Santiago, Region M. de Santiago, Chile, 7640881
        • Clinica Dermacross ( Site 0301)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 516006
        • Dermatology Hospital of Southern Medical University ( Site 1504)
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University ( Site 1505)
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University ( Site 1502)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 1515)
      • Shanghai, Shanghai Municipality, China, 200040
        • Huashan Hospital of Fudan University ( Site 1506)
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 1509)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1501)
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Servicios de Salud IPS Suramericana S.A.S. - IPS Sura San Diego ( Site 0404)
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Fundacion Valle del Lili ( Site 0403)
  • France
      • Paris, France, 75679
        • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0602)
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69003
        • Hôpital Edouard Herriot ( Site 0601)
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • CHU de Bordeaux Hop St ANDRE ( Site 0603)
    • Var
      • Toulon, Var, France, 83800 Cede
        • HIA Sainte Anne ( Site 0606)
  • Germany
      • Berlin, Germany, 10117
        • Charite - Universtitatsmedizin Berlin CCM ( Site 0708)
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Frankfurt Universitaetsklinikum EC ( Site 0706)
  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico ( Site 1806)
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
    • The Marches
      • Ancona, The Marches, Italy, 60126
        • AOU Ospedali Riuniti di Ancona ( Site 1805)
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital ( Site 1604)
      • Kyoto, Japan, 602-8566
        • University Hospital,Kyoto Prefectural University of Medicine ( Site 1605)
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital ( Site 1603)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0063
        • Medical Corporation Kojinkai Sapporo Skin Clinic ( Site 1606)
    • Okinawa
      • Ginowan, Okinawa, Japan, 901-2725
        • University of the Ryukyus Hospital ( Site 1601)
    • Tokyo
      • tabashi City, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital ( Site 1602)
  • Netherlands
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818 CK
        • Amphia Ziekenhuis, locatie Breda Molengracht ( Site 0902)
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Erasmus Medisch Centrum ( Site 0901)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 117599
        • National Universtity Hospital IMU ( Site 0802)
      • Singapore, Central Singapore, Singapore, 308205
        • National Skin Centre ( Site 0801)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron ( Site 1102)
      • Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge ( Site 1101)
      • Granada, Spain, 18012
        • Hospital Universitario Virgen Nieves ( Site 1104)
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises ( Site 1103)
  • United Kingdom
    • England
      • Dudley, England, United Kingdom, DY1 2HQ
        • Russells Hall Hospital ( Site 1303)
      • London, England, United Kingdom, E1 1BB
        • Royal London Hospital ( Site 1301)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology & Skin Health Center ( Site 0012)
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Medical Dermatology Specialists ( Site 0027)
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)
    • California
      • Northridge, California, United States, 91325
        • Northridge Clinical Trials ( Site 0004)
      • Sacramento, California, United States, 95815
        • Integrative Skin Science and Research ( Site 0015)
    • Florida
      • Tampa, Florida, United States, 33615
        • Olympian Clinical Research ( Site 0010)
    • Georgia
      • Macon, Georgia, United States, 31217
        • Skin Care Physicians of Georgia ( Site 0033)
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group, LLC ( Site 0025)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center ( Site 0044)
    • Michigan
      • Troy, Michigan, United States, 48084
        • Revival Research Institute, LLC ( Site 0005)
    • New York
      • New York, New York, United States, 10028
        • Mount Sinai Doctors - East 85th Street ( Site 0050)
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • DJL Clinical Research, PLLC ( Site 0021)
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center ( Site 0046)
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians Health Center ( Site 0041)
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Palmetto Clinical Trial Services, LLC ( Site 0023)
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Center for Dermatology ( Site 0045)
      • Dallas, Texas, United States, 75246
        • Texas Dermatology Research Center ( Site 0019)
      • Frisco, Texas, United States, 75033
        • Reveal Research Institute ( Site 0018)
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research ( Site 0020)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: High Dose
Participants receive a high dose tulisokibart regimen.
Drug: Tulisokibart
Solution in autoinjector for subcutaneous (SC) injection
Other Names:
  • PRA023
  • MK-7240
Experimental: Arm 2: Medium Dose
Participants receive a medium dose tulisokibart regimen.
Drug: Tulisokibart
Solution in autoinjector for subcutaneous (SC) injection
Other Names:
  • PRA023
  • MK-7240
Experimental: Arm 3: Low Dose
Participants receive a low dose tulisokibart regimen.
Drug: Tulisokibart
Solution in autoinjector for subcutaneous (SC) injection
Other Names:
  • PRA023
  • MK-7240
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.
Drug: Placebo
Solution in autoinjector for SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16
Time Frame: Week 16
The percentage of participants with ≥50% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR50) will be reported.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Time Frame: Week 16
The DLQI is a validated dermatology-specific instrument that measures the HRQoL in adult patients with skin diseases. The DLQI consists of 10 questions and provides a total HRQoL score, as well as scores for 6 aspects of QoL: symptoms and feelings; daily activities; leisure; work/school; personal relationships; and treatment. The recall period is over the last week. Question responses are assessed using a 4-point Likert rating scale ranging from "not at all" (scored 0) to "very much" (scored 3). The final score ranges from 0 (no impact on QOL) to 30 (maximum impairment). The mean change from baseline in DLQI at Week 16 will be reported.
Week 16
Percentage of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: Up to ~130 weeks
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants with any AE will be reported.
Up to ~130 weeks
Percentage of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to ~116 weeks
An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants discontinuing from study intervention due to AE will be reported.
Up to ~116 weeks
Percentage of Participants Achieving HiSCR75 at Week 16
Time Frame: Week 16
The percentage of participants with ≥75% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR75) will be reported.
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Estimated)

November 16, 2026

Study Completion (Estimated)

January 22, 2029

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240-012
  • U1111-1316-5263 (Registry Identifier: UTN)
  • 2024-520039-33-00 (Registry Identifier: EU CT)
  • jRCT2011250007 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • MK-7240-012 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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