NCT06956235进行中（未招募）2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 149
- 试验地点
- 137
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1: High Dose
Experimental
Participants receive a high dose tulisokibart regimen.
干预措施: Tulisokibart (Drug)
Arm 2: Medium Dose
Experimental
Participants receive a medium dose tulisokibart regimen.
干预措施: Tulisokibart (Drug)
Arm 3: Low Dose
Experimental
Participants receive a low dose tulisokibart regimen.
干预措施: Tulisokibart (Drug)
Arm 4: Placebo
Placebo Comparator
Participants receive a placebo regimen, and are then allocated to a medium or high tulisokibart dose regimen after Week 16.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 50 at Week 16
时间窗: 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.
次要结局
- Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16(Week 16)
- Percentage of Participants Who Experience One or More Adverse Events (AEs)(Up to ~130 weeks)
- Percentage of Participants Who Discontinue Study Intervention Due to an AE(Up to ~116 weeks)
- Percentage of Participants Achieving HiSCR75 at Week 16(Week 16)
- Mean Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16(Week 16)
- Percentage of Participants Who Experience One or More Adverse Events (AEs)(Up to ~130 weeks)
- Percentage of Participants Who Discontinue Study Intervention Due to an AE(Up to ~116 weeks)
研究者
研究点 (137)
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相关资讯
Merck's Tulisokibart Becomes First Anti-TL1A Biologic to Achieve Phase 3 Clinical Remission in Ulcerative Colitis- Merck announced positive topline results from the Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart in patients with moderately to severely active ulcerative colitis.
- Tulisokibart is the first anti-TL1A monoclonal antibody to demonstrate clinical remission at 12 weeks in a Phase 3 trial, meeting both primary and key secondary endpoints.
- The investigational drug targets TL1A, a novel target associated with immuno-fibrosis, addressing both intestinal inflammation and fibrosis in inflammatory bowel disease.
- Tulisokibart has the broadest development program in the anti-TL1A class, with ongoing studies across seven disease indications including Crohn's disease and multiple autoimmune conditions.2 months agoMerck Expands Tulisokibart Clinical Program with Three New Phase 2b Trials Across Immune-Mediated Inflammatory Diseases- Merck has initiated three Phase 2b trials evaluating tulisokibart, an anti-TL1A monoclonal antibody, in hidradenitis suppurativa, radiographic axial spondyloarthritis, and rheumatoid arthritis.
- The expansion brings tulisokibart's clinical development program to six diseases, with ongoing Phase 3 studies in ulcerative colitis and Crohn's disease already underway.
- Global recruitment has begun targeting enrollment of more than 640 patients across the three new studies, reflecting Merck's commitment to addressing immune-mediated inflammatory diseases.
- Tulisokibart targets the novel TL1A cytokine pathway and may help reduce intestinal fibrosis, potentially altering disease progression in inflammatory conditions.11 months ago