Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 147
- 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
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 Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16 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) will be reported.
- Secondary Outcome Measures
Name Time Method Percentage of participants achieving HiSCR75 at Week 16 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) will be reported.
Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16 Week 16 The DLQI is a validated dermatology-specific instrument that measures the HRQoL in adult patients with skin diseases. The DLQI consists of 10 questions and provides a total HRQoL score, as well as scores for 6 aspects of QoL: symptoms and feelings; daily activities; leisure; work/school; personal relationships; and treatment. The recall period is over the last week. Question responses are assessed using a 4-point Likert rating scale ranging from "not at all" (scored 0) to "very much" (scored 3). The final score ranges from 0 (no impact on QOL) to 30 (maximum impairment). The mean change from baseline in DLQI at Week 16 will be reported.
Percentage of Participants Who Experience One or More Adverse Events (AEs) Up to ~130 weeks An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants with any AE will be reported.
Percentage of Participants Who Discontinue Study Intervention Due to an AE Up to ~116 weeks An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants discontinuing from study intervention due to AE will be reported.
Trial Locations
- Locations (17)
Dawes Fretzin Clinical Research Group, LLC ( Site 0025)
🇺🇸Indianapolis, Indiana, United States
Palmetto Clinical Trial Services, LLC ( Site 0023)
🇺🇸Anderson, South Carolina, United States
The Second Xiangya Hospital of Central South University ( Site 1505)
🇨🇳Changsha, Hunan, China
Huashan Hospital of Fudan University ( Site 1506)
🇨🇳Shanghai, Shanghai, China
University Hospital,Kyoto Prefectural University of Medicine ( Site 1605)
🇯🇵Kyoto, Japan
Cahaba Dermatology & Skin Health Center ( Site 0012)
🇺🇸Birmingham, Alabama, United States
Northridge Clinical Trials ( Site 0004)
🇺🇸Northridge, California, United States
Integrative Skin Science and Research ( Site 0015)
🇺🇸Sacramento, California, United States
Skin Care Physicians of Georgia ( Site 0033)
🇺🇸Macon, Georgia, United States
Revival Research Institute, LLC ( Site 0005)
🇺🇸Troy, Michigan, United States
Scroll for more (7 remaining)Dawes Fretzin Clinical Research Group, LLC ( Site 0025)🇺🇸Indianapolis, Indiana, United StatesStudy CoordinatorContact317-516-5030