NCT06956235

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study consists of a 16-week Double-blind Period and a 100-week Long-term Extension (LTE) composed of a 40-week Main Extension and a 60-week Optional Extension.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Tulisokibart	Solution in autoinjector for subcutaneous (SC) injection
DRUG	Placebo	Solution in autoinjector for SC injection

Timeline

• Start date: 2025-06-09
• Primary completion: 2026-11-16
• Completion: 2029-01-22
• First posted: 2025-05-04
• Last updated: 2026-01-20

Locations

68 sites across 15 countries: United States, Argentina, Australia, Canada, Chile, China, Colombia, France, Germany, Italy, Japan, Netherlands, Singapore, Spain, United Kingdom

Regulatory

• FDA-regulated drug study