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

Merck Sharp & Dohme (MSD)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo; Drug: Tulisokibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT06956235

7240-012

U1111-1316-5263 (Registry Identifier)

2024-520039-33-00 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 147 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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147 participants in 4 patient groups, including a placebo group

Arm 1: High Dose

Experimental group

Description:

Participants receive a high dose tulisokibart regimen.

Treatment:

Drug: Tulisokibart

Arm 2: Medium Dose

Experimental group

Description:

Participants receive a medium dose tulisokibart regimen.

Treatment:

Drug: Tulisokibart

Arm 3: Low Dose

Experimental group

Description:

Participants receive a low dose tulisokibart regimen.

Treatment:

Drug: Tulisokibart

Arm 4: Placebo

Placebo Comparator group

Description:

Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.

Treatment:

Drug: Placebo