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

Phase 2

Not yet recruiting

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: Tulisokibart; Drug: Placebo

• Registration Number: NCT06956235
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04
• Study Start: 2025-06-09
• Primary Completion: 2026-11-16
• Study Completion: 2029-01-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Has signs and symptoms of HS for ≥ 6 months prior to Screening and a clinical diagnosis of HS at Screening
• Has moderate or severe HS
• Has a history of one of the following: 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: High Dose	Tulisokibart	Participants receive a high dose tulisokibart regimen.
Arm 3: Low Dose	Tulisokibart	Participants receive a low dose tulisokibart regimen.
Arm 2: Medium Dose	Tulisokibart	Participants receive a medium dose tulisokibart regimen.
Arm 4: Placebo	Placebo	Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.

Primary Outcome Measures

Name	Time	Method
Percentage of participants achieving HiSCR50	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of participants achieving HiSCR75	Week 16	The percentage of participants with ≥75% reduction in total abscesses and inflammatory nodules (AN) count with no increase in abscess count, and no increase in draining tunnels (ie, HiSCR75).
Change from baseline in Dermatology Life Quality Index (DLQI)	Week 16	The mean change from baseline in DLQI at Week 16.
Percentage of participants with an adverse event (AE)	Up to ~130 weeks	The percentage of participants with any AE.
Percentage of participants discontinuing from study intervention due to an AE	Up to ~116 weeks	The percentage of participants discontinuing from study intervention due to AE.