RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-06-16
Study Completion:2029-01-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06956235

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has signs and symptoms of hidradenitis suppurativa (HS) for ≥ 6 months and a clinical diagnosis of HS at screening
  2. * Has moderate or severe HS
  3. * 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
  4. * Has ≤20 draining tunnel count at Screening and Randomization
  1. * Has other active skin conditions that may interfere with the assessment of HS
  2. * Has any immune-mediated inflammatory condition that is not well controlled and which may potentially require biologic therapy
  3. * Has a transplanted organ and requires continued systemic immunosuppression
  4. * Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
  5. * Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Northridge Clinical Trials
Northridge, California, 91325
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

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 Registration Dates

Study Start Date2025-06-16
Study Completion Date2029-01-22

Study Record Updates

Study Start Date2025-06-16
Study Completion Date2029-01-22

Terms related to this study

Additional Relevant MeSH Terms

  • Hidradenitis Suppurativa