Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
Purpose
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).
Condition
- Hidradenitis Suppurativa
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Has signs and symptoms of hidradenitis suppurativa (HS) for ≥6 months prior to Screening and a clinical diagnosis of HS at Screening - Has moderate or severe HS defined as a total combined number of ≥ 5 abscesses and/or inflammatory nodules, with HS lesions present in ≥ 2 distinct anatomical areas and ≥ 1 anatomic area of HS involvement characterized as Hurley Stage II or III - 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
Exclusion Criteria
- Has other active skin conditions that may, in the judgment of the investigator, 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 nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years - Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments - Has a known infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) - Has any active infection - Has active tuberculosis - Has had major surgery within the past 3 months or has a major surgery planned during the study - Has a history of clinically significant drug or alcohol abuse within the past 6 months - Has prior exposure to tulisokibart - Has undergone laser therapy or surgical procedures for their lesions within the past 6 weeks or is planning to have laser therapy or surgical procedures for lesions during participation in the study - Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1: High Dose |
Participants receive a high dose tulisokibart regimen. |
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Experimental Arm 2: Medium Dose |
Participants receive a medium dose tulisokibart regimen. |
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Experimental Arm 3: Low Dose |
Participants receive a low dose tulisokibart regimen. |
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Placebo Comparator Arm 4: Placebo |
Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16. |
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Recruiting Locations
More Details
- NCT ID
- NCT06956235
- Status
- Active, not recruiting
- Sponsor
- Merck Sharp & Dohme LLC
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.