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

NCT06956235 | Active Not Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 7240-012U1111-1316-52632024-520039-33-00jRCT2011250007MK-7240-012
• Study Type: interventional
• Target: 147
• Locations: 15 countries
• Sites: 68

Brief 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).

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at 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 Outcomes (4)

• Percentage of Participants Achieving HiSCR75 at Week 16

  Week 16

• Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

  Week 16

• Percentage of Participants Who Experience One or More Adverse Events (AEs)

  Up to ~130 weeks

• Percentage of Participants Who Discontinue Study Intervention Due to an AE

  Up to ~116 weeks

Study Arms (4)

Arm 1: High Dose

EXPERIMENTAL

Participants receive a high dose tulisokibart regimen.

Drug: Tulisokibart

Arm 2: Medium Dose

EXPERIMENTAL

Participants receive a medium dose tulisokibart regimen.

Drug: Tulisokibart

Arm 3: Low Dose

EXPERIMENTAL

Participants receive a low dose tulisokibart regimen.

Drug: Tulisokibart

Arm 4: Placebo

PLACEBO COMPARATOR

Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.

Drug: Placebo

Interventions

Tulisokibart DRUG

Solution in autoinjector for subcutaneous (SC) injection

Also known as: PRA023, MK-7240

Arm 1: High Dose; Arm 2: Medium Dose; Arm 3: Low Dose

Placebo DRUG

Solution in autoinjector for SC injection

Arm 4: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (68)

Cahaba Dermatology & Skin Health Center ( Site 0012)

Birmingham, Alabama, 35244, United States

Location

Medical Dermatology Specialists ( Site 0027)

Phoenix, Arizona, 85006, United States

Location

Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049)

Rogers, Arkansas, 72758, United States

Location

Northridge Clinical Trials ( Site 0004)

Northridge, California, 91325, United States

Location

Integrative Skin Science and Research ( Site 0015)

Sacramento, California, 95815, United States

Location

Olympian Clinical Research ( Site 0010)

Tampa, Florida, 33615, United States

Location

Skin Care Physicians of Georgia ( Site 0033)

Macon, Georgia, 31217, United States

Location

Dawes Fretzin Clinical Research Group, LLC ( Site 0025)

Indianapolis, Indiana, 46250, United States

Location

Beth Israel Deaconess Medical Center ( Site 0044)

Boston, Massachusetts, 02215, United States

Location

Revival Research Institute, LLC ( Site 0005)

Troy, Michigan, 48084, United States

Location

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

New York, New York, 10028, United States

Location

DJL Clinical Research, PLLC ( Site 0021)

Charlotte, North Carolina, 28211, United States

Location

University Hospitals Cleveland Medical Center ( Site 0046)

Cleveland, Ohio, 44106, United States

Location

Wright State Physicians Health Center ( Site 0041)

Fairborn, Ohio, 45324, United States

Location

Palmetto Clinical Trial Services, LLC ( Site 0023)

Anderson, South Carolina, 29621, United States

Location

Arlington Center for Dermatology ( Site 0045)

Arlington, Texas, 76011, United States

Location

Texas Dermatology Research Center ( Site 0019)

Dallas, Texas, 75246, United States

Location

Reveal Research Institute ( Site 0018)

Frisco, Texas, 75033, United States

Location

Progressive Clinical Research ( Site 0020)

San Antonio, Texas, 78213, United States

Location

CIPREC ( Site 0202)

CABA, C1061AAT, Argentina

Location

Hospital Italiano de Buenos Aires ( Site 0205)

CABA, C1199ABB, Argentina

Location

Psoriahue ( Site 0203)

CABA, C1425DKG, Argentina

Location

Derma Internacional SA ( Site 0206)

CABA, C1426EGR, Argentina

Location

Liverpool Hospital ( Site 1403)

Liverpool, New South Wales, 1871, Australia

Location

The Alfred Hospital ( Site 1401)

Melbourne, Victoria, 3004, Australia

Location

Fremantle Dermatology ( Site 1402)

Fremantle, Western Australia, 6160, Australia

Location

Wiseman Dermatology Research Inc. ( Site 0107)

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Brunswick Dermatology Center ( Site 0101)

Frederiction, New Brunswick, E3B 1G9, Canada

Location

Lynderm Research Inc. ( Site 0104)

Markham, Ontario, L3P 1X3, Canada

Location

SKiN Centre for Dermatology ( Site 0103)

Peterborough, Ontario, K9J 5K2, Canada

Location

York Dermatology Clinic & Research Centre ( Site 0106)

Richmond Hill, Ontario, L4B 1L1, Canada

Location

Centro Skin Med Limitada ( Site 0305)

Santiago, Region M. de Santiago, 7580206, Chile

Location

Clinica Dermacross ( Site 0301)

Santiago, Region M. de Santiago, 7640881, Chile

Location

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

Santiago, Region M. de Santiago, 8420383, Chile

Location

Dermatology Hospital of Southern Medical University ( Site 1504)

Guangzhou, Guangdong, 516006, China

Location

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

Changsha, Hunan, 410011, China

Location

The First Hospital of Jilin University ( Site 1502)

Changchun, Jilin, 130021, China

Location

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

Shanghai, Shanghai Municipality, 200025, China

Location

Huashan Hospital of Fudan University ( Site 1506)

Shanghai, Shanghai Municipality, 200040, China

Location

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

Ürümqi, Xinjiang, 830001, China

Location

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

Hangzhou, Zhejiang, 310003, China

Location

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

Medellín, Antioquia, 050021, Colombia

Location

Fundación Valle del Lili ( Site 0403)

Cali, Valle del Cauca Department, 760032, Colombia

Location

Hôpital Edouard Herriot ( Site 0601)

Lyon, Auvergne-Rhône-Alpes, 69003, France

Location

CHU de Bordeaux Hop St ANDRE ( Site 0603)

Bordeaux, Gironde, 33000, France

Location

HIA Sainte Anne ( Site 0606)

Toulon, Var, 83800 Cede, France

Location

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0602)

Paris, 75679, France

Location

Frankfurt Universitaetsklinikum EC ( Site 0706)

Frankfurt am Main, Hesse, 60590, Germany

Location

Charite - Universtitatsmedizin Berlin CCM ( Site 0708)

Berlin, 10117, Germany

Location

AOU Ospedali Riuniti di Ancona ( Site 1805)

Ancona, The Marches, 60126, Italy

Location

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

Milan, 20122, Italy

Location

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

Roma, 00168, Italy

Location

Nagoya City University Hospital ( Site 1603)

Nagoya, Aichi-ken, 467-8602, Japan

Location

Medical Corporation Kojinkai Sapporo Skin Clinic ( Site 1606)

Sapporo, Hokkaido, 060-0063, Japan

Location

University of the Ryukyus Hospital ( Site 1601)

Ginowan, Okinawa, 901-2725, Japan

Location

Nihon University Itabashi Hospital ( Site 1602)

tabashi City, Tokyo, 173-8610, Japan

Location

Fukuoka University Hospital ( Site 1604)

Fukuoka, 814-0180, Japan

Location

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

Kyoto, 602-8566, Japan

Location

Amphia Ziekenhuis, locatie Breda Molengracht ( Site 0902)

Breda, North Brabant, 4818 CK, Netherlands

Location

Erasmus Medisch Centrum ( Site 0901)

Rotterdam, South Holland, 3015 GD, Netherlands

Location

National Universtity Hospital IMU ( Site 0802)

Singapore, Central Singapore, 117599, Singapore

Location

National Skin Centre ( Site 0801)

Singapore, Central Singapore, 308205, Singapore

Location

Hospital de Manises ( Site 1103)

Manises, Valencia, 46940, Spain

Location

Hospital Universitari Vall d'Hebron ( Site 1102)

Barcelona, 08035, Spain

Location

Hospital Universitari de Bellvitge ( Site 1101)

Barcelona, 08907, Spain

Location

Hospital Universitario Virgen Nieves ( Site 1104)

Granada, 18012, Spain

Location

Russells Hall Hospital ( Site 1303)

Dudley, England, DY1 2HQ, United Kingdom

Location

Royal London Hospital ( Site 1301)

London, England, E1 1BB, United Kingdom

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 4, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): November 16, 2026
• Study Completion (Estimated): January 22, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (7); JP (6); SG (2); AR (4); CO (2); IT (3); DE (2); FR (4); US (19); CA (5); GB (2); AU (3); ES (4); CL (3); NL (2)