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Active, not recruiting Phase 2

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

NCT06956235 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2025-06-09
Last updated
2026-10-02

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

Tulisokibart →Placebo

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)

  • Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16 — 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.

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 Spain