MK-6194 in Adult Participants with Non-Segmental Vitiligo

JRCT ID: jRCT2031230622

Registered date:07/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-segmental Vitiligo
• Date of first enrollment: 15/03/2024
• Target sample size: 165
• Countries of recruitment: United States,Japan,Canada,Japan,Australia,Japan,South Korea,Japan,Argentina,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Belgium,Japan,France,Japan,Germany,Japan,Israel,Japan,Netherlands,Japan,Spain,Japan,Switzerland,Japan,Turkey,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Base Study: One of two MK-6194 dose regimens or placebo regimen
Extension: Either of two MK-6194 dose regimens

Outcome(s)

Primary Outcome

- 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 Discontinue Study Treatment Due to an AE

• Secondary Outcome: - Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- 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

Exclude criteria

- 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 clinically significant infection, or any infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks prior to Randomization, or any infection requiring oral/intramuscular anti-infective therapy within 2 weeks prior to Randomization
- Has symptomatic heart failure (New York Heart Association class lll 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

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT06113328