RECRUITING

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

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).

Conditions

Hidradenitis Suppurativa
Talk to us

Related Conditions:

Hidradenitis Suppurativa

Study Overview

On this page

Study Details

Study overview

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).

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

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

Condition
Hidradenitis Suppurativa
Intervention / Treatment

-

Contacts and Locations

Northridge

Northridge Clinical Trials, Northridge, California, United States, 91325

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Has signs and symptoms of hidradenitis suppurativa (HS) for ≥ 6 months and a clinical diagnosis of HS at screening
  • * Has moderate or severe HS
  • * 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
  • * Has other active skin conditions that may 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 non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
  • * Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-01-22