2023-503502-37-00招募中2 期
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants with Non-Segmental Vitiligo.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 13
- 主要终点
- Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
研究概览
简要总结
- To evaluate the efficacy of MK-6194 on the percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
- To evaluate the safety and tolerability of MK-6194
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Has a clinical diagnosis of non-segmental vitiligo
- •Has non-segmental vitiligo with disease duration of at least 6 months
- •Has depigmentation contributing to F-VASI ≥ 0.3 at screening and baseline
- •Has depigmented facial body surface area (BSA) ≥0.3% at screening and baseline
- •Has T-VASI ≥4 at screening and baseline
- •Has total body vitiligo area ≥4% at screening and baseline excluding hands and feet involvement
- •Is 18 to 75 years of age inclusive at the time of providing informed consent
排除标准
- •Has segmental vitiligo
- •Has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix
- •Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB
- •Has confirmed or suspected COVID-19 infection
- •Has history of drug or alcohol abuse within 6 months prior to Screening
- •Has had major surgery within 3 months prior to Screening OR has a major surgery planned during the study
- •Has had an inadequate response (as evaluated by a dermatologist or local physician specialist equivalent) to previous treatment with a Janus kinase inhibitor (JAKi) after an appropriate treatment duration (eg, ≥12 weeks)
- •Has received prohibited medications within protocol-specified timeframes prior to Randomization
- •Has participated in another investigational clinical study within 4 weeks prior to Randomization
- •Has donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit
- •Has received cosmetic or other procedures that could interfere with evaluation of vitiligo during the study
- •Has ≥50% leukotrichia on face or body
- •Has any other dermatological diseases that would interfere with vitiligo assessments
- •Has history of or current inflammatory condition other than vitiligo that, in the opinion of the investigator, could interfere with the evaluation of vitiligo
- •Has a known systemic hypersensitivity to interleukin 2 (IL-2), or modified IL-2 including MK-6194, or its inactive ingredients
- •Has an active or clinically significant infection, requiring hospitalization or treatment with intravenous (IV) anti-infectives within 4 weeks prior to Randomization, or oral/intramuscular anti-infective therapy within 2 weeks prior to Randomization
- •Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening
- •Has a severe chronic pulmonary disease requiring oxygen therapy
- •Has a transplanted organ, which requires continued immunosuppression
结局指标
主要结局
Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
Number of Participants Who Experience an Adverse Event (AE)
Number of Participants Who Experience an Adverse Event (AE)
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Discontinue Study Treatment Due to an AE
次要结局
- Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
研究者
Claudia Kaiser-Albers
Scientific
Merck Sharp & Dohme LLC
研究点 (13)
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