A clinical study of MK-6194 for the treatment of vitiligo (MK-6194-007)
- Conditions
- on segmental vitiligoMedDRA version: 21.1Level: PTClassification code: 10047642Term: Vitiligo Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-503502-37-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 167
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1.To evaluate the efficacy of MK-6194 on the percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24<br>2.To evaluate the safety and tolerability of MK-6194;Secondary Objective: 1.To evaluate the efficacy of MK-6194 on the percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24;Primary end point(s): 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 Measures
Name Time Method Secondary end point(s):Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24