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

NCT06956235

Active Not RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Hidradenitis Suppurativa

Interventions: Tulisokibart, Placebo

Countries: United States, Argentina, Australia, Canada, Chile, China, Colombia, France

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (68)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Rogers, Arkansas, United States
  • Northridge, California, United States
  • Sacramento, California, United States
  • Tampa, Florida, United States
  • Macon, Georgia, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Troy, Michigan, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Cleveland, Ohio, United States
  • Fairborn, Ohio, United States
  • Anderson, South Carolina, United States
  • Arlington, Texas, United States
  • Dallas, Texas, United States
  • Frisco, Texas, United States
  • San Antonio, Texas, United States
  • CABA, Argentina
  • CABA, Argentina
  • CABA, Argentina
  • CABA, Argentina
  • Liverpool, New South Wales, Australia
  • Melbourne, Victoria, Australia
  • Fremantle, Western Australia, Australia
  • Winnipeg, Manitoba, Canada
  • Frederiction, New Brunswick, Canada
  • Markham, Ontario, Canada
  • Peterborough, Ontario, Canada
  • + 38 more on CT.gov