Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Ubicaciones

Psoriahue ( Site 0205)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Stat Research S.A. ( Site 0204)

Buenos Aires, Buenos Aires F.D., Argentina

Centro de Investigaciones Metabólicas (CINME)-Dermatology ( Site 0203)

Buenos Aires, Buenos Aires F.D., Argentina

Instituto Medico Strusberg ( Site 0208)

Córdoba, Córdoba Province, Argentina

Hospital Aleman-Dermatologia ( Site 0209)

Buenos Aires, Argentina

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