MK-6194 in Adult Participants with Non-Segmental Vitiligo

Phase 2

• Conditions: on-segmental Vitiligo

• Registration Number: JPRN-jRCT2031230622
• Lead Sponsor: Tanaka Yoshiyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 10

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified