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Clinical Trials in the UK / NCT06956235
Active, not recruiting Phase 2

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

NCT06956235 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 2
Started
2025-06-09
Last updated
2026-09-15

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

TulisokibartPlacebo

Tulisokibart: Solution in autoinjector for subcutaneous (SC) injection

Placebo: Solution in autoinjector for SC injection

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (68)

FacilityCityRegionStatus
Cahaba Dermatology & Skin Health Center ( Site 0012) Birmingham Alabama
Medical Dermatology Specialists ( Site 0027) Phoenix Arizona
Northwest Arkansas Clinical Trials Center, PLLC ( Site 0049) Rogers Arkansas
Northridge Clinical Trials ( Site 0004) Northridge California
Integrative Skin Science and Research ( Site 0015) Sacramento California
Olympian Clinical Research ( Site 0010) Tampa Florida
Skin Care Physicians of Georgia ( Site 0033) Macon Georgia
Dawes Fretzin Clinical Research Group, LLC ( Site 0025) Indianapolis Indiana
Beth Israel Deaconess Medical Center ( Site 0044) Boston Massachusetts
Revival Research Institute, LLC ( Site 0005) Troy Michigan
Mount Sinai Doctors - East 85th Street ( Site 0050) New York New York
DJL Clinical Research, PLLC ( Site 0021) Charlotte North Carolina
University Hospitals Cleveland Medical Center ( Site 0046) Cleveland Ohio
Wright State Physicians Health Center ( Site 0041) Fairborn Ohio
Palmetto Clinical Trial Services, LLC ( Site 0023) Anderson South Carolina
Arlington Center for Dermatology ( Site 0045) Arlington Texas
Texas Dermatology Research Center ( Site 0019) Dallas Texas
Reveal Research Institute ( Site 0018) Frisco Texas
Progressive Clinical Research ( Site 0020) San Antonio Texas
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
The Alfred Hospital ( Site 1401) Melbourne Victoria
Fremantle Dermatology ( Site 1402) Fremantle Western Australia
Wiseman Dermatology Research Inc. ( Site 0107) Winnipeg Manitoba
Brunswick Dermatology Center ( Site 0101) Frederiction New Brunswick
Lynderm Research Inc. ( Site 0104) Markham Ontario
SKiN Centre for Dermatology ( Site 0103) Peterborough Ontario
York Dermatology Clinic & Research Centre ( Site 0106) Richmond Hill Ontario
Centro Skin Med Limitada ( Site 0305) Santiago Region M. de Santiago
Clinica Dermacross ( Site 0301) Santiago Region M. de Santiago
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302) Santiago Region M. de Santiago
Dermatology Hospital of Southern Medical University ( Site 1504) Guangzhou Guangdong
The Second Xiangya Hospital of Central South University ( Site 1505) Changsha Hunan
The First Hospital of Jilin University ( Site 1502) Changchun Jilin
Ruijin Hospital Shanghai Jiaotong University School of Medicine ( Site 1515) Shanghai Shanghai Municipality
Huashan Hospital of Fudan University ( Site 1506) Shanghai Shanghai Municipality
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 1509) Ürümqi Xinjiang

+ 28 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06956235 on ClinicalTrials.gov ↗ ← All trials in the UK