A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)
- Conditions
- Non-segmental Vitiligo
- Interventions
- Drug: Placebo
- Registration Number
- NCT06113328
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 169
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extension: Dose 2 Placebo Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm. Extension: Dose 1 MK-6194 Participants receive SC MK-6194 dose regimen 1. Participants from the arms "Base Study: Dose 1" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm. Base Study: Dose 2 Placebo Participants receive SC MK-6194 dose regimen 2. Base Study: Placebo Placebo Participants receive an SC placebo regimen. Base Study: Dose 1 MK-6194 Participants receive subcutaneous (SC) MK-6194 dose regimen 1. Base Study: Dose 2 MK-6194 Participants receive SC MK-6194 dose regimen 2. Extension: Dose 2 MK-6194 Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.
- Primary Outcome Measures
Name Time Method Number of Participants Who Discontinue Study Treatment Due to an AE 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.
Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 Baseline and Week 24 VASI is a validated scoring method that assesses the extent and severity of areas of vitiligo depigmentation. F-VASI will be calculated to indicate facial lesions, using the following scale: At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; and at 10%, only specks of depigmentation are present.
Number of Participants Who Experience an Adverse Event (AE) 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 Baseline and Week 24 VASI is a validated scoring method that assesses the extent and severity of areas of vitiligo depigmentation. T-VASI will be calculated to indicate all lesions on the body, using the following scale: At 100% depigmentation, no pigment is present; at 90%, specks of pigment are present; at 75%, the depigmented area exceeds the pigmented area; at 50%, the depigmented and pigmented areas are equal; at 25%, the pigmented area exceeds the depigmented area; and at 10%, only specks of depigmentation are present.
Trial Locations
- Locations (68)
The Vitiligo & Pigmentation Institute of Southern California ( Site 0115)
🇺🇸Los Angeles, California, United States
Ankara Bilkent Şehir Hastanesi-Dermatology ( Site 1502)
🇹🇷Ankara, Turkey
Cahaba Dermatology & Skin Health Center ( Site 0127)
🇺🇸Birmingham, Alabama, United States
Indiana University Health University Hospital-Indiana University School of Medicine, Department of (
🇺🇸Indianapolis, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC ( Site 0106)
🇺🇸Indianapolis, Indiana, United States
Burke Pharmaceutical Research ( Site 0124)
🇺🇸Hot Springs, Arkansas, United States
Metro Boston Clinical Partners ( Site 0110)
🇺🇸Brighton, Massachusetts, United States
Hamzavi Dermatology - Canton ( Site 0101)
🇺🇸Canton, Michigan, United States
Remington Davis Clinical Research-Outpatient ( Site 0104)
🇺🇸Columbus, Ohio, United States
Medical University of South Carolina-Dermatology Research ( Site 0114)
🇺🇸Charleston, South Carolina, United States
International Clinical Research - Tennessee LLC ( Site 0120)
🇺🇸Murfreesboro, Tennessee, United States
Progressive Clinical Research ( Site 0108)
🇺🇸San Antonio, Texas, United States
Virginia Clinical Research, Inc. ( Site 0109)
🇺🇸Norfolk, Virginia, United States
Dermatology Specialists of Spokane ( Site 0126)
🇺🇸Spokane, Washington, United States
Psoriahue ( Site 0205)
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Stat Research S.A. ( Site 0204)
🇦🇷Buenos Aires, Caba, Argentina
Centro de Investigaciones Metabólicas (CINME)-Dermatology ( Site 0203)
🇦🇷Ciudad Autónoma de Buenos Aires, Caba, Argentina
Instituto Medico Strusberg ( Site 0208)
🇦🇷Córdoba, Cordoba, Argentina
Hospital Aleman-Dermatologia ( Site 0209)
🇦🇷Buenos Aires, Argentina
Paratus Clinical Research Woden ( Site 1703)
🇦🇺Phillip, Australian Capital Territory, Australia
Westmead Hospital-Dermatology ( Site 1701)
🇦🇺Westmead, New South Wales, Australia
Skin Health Institute Inc.-Trials ( Site 1702)
🇦🇺Carlton, Victoria, Australia
Sinclair Dermatology ( Site 1704)
🇦🇺Melbourne, Victoria, Australia
UZ Gent ( Site 0604)
🇧🇪Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0601)
🇧🇪Leuven, Vlaams-Brabant, Belgium
Enverus Medical Research ( Site 0006)
🇨🇦Surrey, British Columbia, Canada
Diex Recherche sherbrooke Inc. ( Site 0007)
🇨🇦Sherbrooke, Quebec, Canada
Diex Recherche Quebec Inc. ( Site 0008)
🇨🇦Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain ( Site 0002)
🇨🇦Quebec, Canada
Dermisur ( Site 0305)
🇨🇱Osorno, Los Lagos, Chile
Clinical Research Chile SpA ( Site 0304)
🇨🇱Valdivia, Los Rios, Chile
Clinica Dermacross ( Site 0301)
🇨🇱Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 0308)
🇨🇱Santiago, Region M. De Santiago, Chile
Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)
🇨🇱Santiago, Region M. De Santiago, Chile
CliniSalud ( Site 0401)
🇨🇴Envigado, Antioquia, Colombia
IPS SURA San Diego ( Site 0408)
🇨🇴Medellín, Antioquia, Colombia
Centro Integral de Reumatología del Caribe ( Site 0405)
🇨🇴Barranquilla, Atlantico, Colombia
Healthy Medical Center S.A.S ( Site 0403)
🇨🇴Zipaquira, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 0412)
🇨🇴Cali, Valle Del Cauca, Colombia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0803)
🇫🇷Nice, Alpes-Maritimes, France
CHU de Bordeaux Hop St ANDRE ( Site 0804)
🇫🇷Bordeaux, Aquitaine, France
Hôpital Edouard Herriot ( Site 0802)
🇫🇷Lyon, Rhone-Alpes, France
HENRI MONDOR HOSPITAL ( Site 0801)
🇫🇷Creteil, Val-de-Marne, France
Universitaetsklinikum Erlangen-Hautklinik Studienambulanz ( Site 0905)
🇩🇪Erlangen, Bayern, Germany
Universitätsklinikum Münster-Hautklinik ( Site 0904)
🇩🇪Münster, Nordrhein-Westfalen, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901)
🇩🇪Berlin, Germany
Rambam Health Care Campus-Dermatology ( Site 1002)
🇮🇱Haifa, Israel
Sheba Medical Center-Dermatology ( Site 1001)
🇮🇱Ramat Gan, Israel
Nagoya City University Hospital-Dermatology ( Site 2002)
🇯🇵Nagoya, Aichi, Japan
Osaka University Hospital ( Site 2004)
🇯🇵Suita, Osaka, Japan
Tokyo Medical University Hospital ( Site 2001)
🇯🇵Shinjuku-ku, Tokyo, Japan
Inha University Hospital ( Site 1992)
🇰🇷Incheon, Korea, Republic of
Seoul National University Hospital-Dermatology ( Site 1991)
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System-Department of Dermatology ( Site 1993)
🇰🇷Seoul, Korea, Republic of
Cryptex Investigación Clínica S.A. de C.V. ( Site 0515)
🇲🇽Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico
Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0504)
🇲🇽Monterrey, Nuevo Leon, Mexico
Centro de Atención e Investigación Clínica ( Site 0507)
🇲🇽Aguascalientes, Mexico
Amsterdam UMC, locatie AMC-Dermatology ( Site 1101)
🇳🇱Amsterdam, Noord-Holland, Netherlands
Hospital Universitario Puerta del Mar ( Site 1302)
🇪🇸Cádiz, Andalucia, Spain
Hospital Universitari de Bellvitge-Dermatology ( Site 1307)
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra ( Site 1305)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Cantonal Hospital St.Gallen ( Site 1402)
🇨🇭St.Gallen, Sankt Gallen, Switzerland
UniversitätsSpital Zürich ( Site 1401)
🇨🇭Zürich, Zurich, Switzerland
Hacettepe Universite Hastaneleri-Dermatology ( Site 1501)
🇹🇷Altindağ, Ankara, Turkey
Erciyes Universitesi Tıp Fakultesi Hastaneleri-Dermatology and Venereology ( Site 1506)
🇹🇷Kayseri, Turkey
Royal London Hospital-Dermatology Research Unit ( Site 1605)
🇬🇧London, England, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 1603)
🇬🇧Birmingham, Warwickshire, United Kingdom
New Cross Hospital ( Site 1601)
🇬🇧Wolverhampton, United Kingdom