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
- 终止
- 入组人数
- 169
- 试验地点
- 68
- 主要终点
- Percent Change From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
研究概览
简要总结
Researchers are looking for a new way to treat people with non-segmental vitiligo (NSV). The goal of this study is to learn about the safety of MK-6194 and how well people tolerate it. Researchers also want to learn if people who take MK-6194 have more of a decrease in the amount of vitiligo on their face compared to people who take placebo.
详细描述
This study will consist of two periods. During the Double-Blind Treatment Period, participants will be randomized to one of three treatment arms to receive MK-6194 at one of two doses or placebo and will be evaluated for safety and efficacy. Participants who complete this period may enter the Blinded Extension Period, during which MK-6194 treatment will continue or placebo recipients will be re-randomized to MK-6194 at one of two doses.
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
- Quadruple (Participant, Care Provider, 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 a clinical diagnosis of non-segmental vitiligo
- •Has non-segmental vitiligo with disease duration of at least 6 months
- •Has depigmentation contributing to Facial Vitiligo Area Scoring Index (F-VASI) ≥ 0.3 at screening and baseline
- •Has depigmented facial body surface area (BSA) ≥0.3% at screening and baseline
- •Has Total Vitiligo Area Scoring Index (T-VASI) ≥4 at screening and baseline
- •Has total body vitiligo area ≥4% at screening and baseline excluding hands and feet involvement
排除标准
- •Has segmental vitiligo
- •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 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
- •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
研究组 & 干预措施
MK-6194 3 mg Q2W
Participants will receive subcutaneous (SC) MK-6194 3 mg every two weeks (Q2W).
干预措施: MK-6194 (Biological)
Placebo (double-blind)/ MK-6194 3 mg Q4W (extension)
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants will be re-randomized to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
干预措施: MK-6194 (Biological)
MK-6194 3 mg Q4W
Participants will receive SC MK-6194 3 mg every four weeks (Q4W).
干预措施: MK-6194 (Biological)
MK-6194 3 mg Q2W (double-blind) / MK-6194 3 mg Q2W (extension)
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q2W in the Double-Blind Treatment Period, participants will continue to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
干预措施: MK-6194 (Biological)
MK-6194 3 mg Q4W (double-blind) / MK-6194 3 mg Q4W (extension)
After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q4W in the Double-Blind Treatment Period, participants will continue to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.
干预措施: MK-6194 (Biological)
Placebo (double-blind)/ MK-6194 3 mg Q2W (extension)
After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants will be re-randomized to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.
干预措施: MK-6194 (Biological)
Placebo
Participants will receive SC Placebo Q2W.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
时间窗: Baseline and Week 24
VASI is a validated scoring method that measures the extent and severity of vitiligo depigmentation. The F-VASI measures vitiligo involvement of the facial area. For facial lesions, size is estimated using fingertip units (FTU), fingers, or thumbs: 1 FTU is approximately 0.03% body surface area (BSA), while a finger or thumb is approximately 0.1% BSA. Depigmentation at each site is graded to the nearest percentage: 0%, 10%, 25%, 50%, 75%, 90%, or 100%. F-VASI is calculated by multiplying the area (in FTUs) by the depigmentation percentage for each facial site and summing the values. Scores range from 0 to approximately 3.5, with higher scores indicating greater vitiligo involvement of the facial area (more severe depigmentation). Percent change from baseline calculated as post-baseline value minus baseline value, divided by baseline value and multiplied by 100%. Longitudinal data analysis (LDA) model-based least squares mean (LSM) percent change from baseline to Week 24 was reported.
Number of Participants Who Experienced an Adverse Event (AE)
时间窗: Up to approximately 28 weeks
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. The number of participants who experienced an AE is reported.
Number of Participants Who Discontinued Study Treatment Due to an AE
时间窗: Up to approximately 24 weeks
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported here.
次要结局
- Percent Change From Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24(Baseline and Week 24)