Non-segmental Vitiligo Clinical Trial
Official title:
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
The purpose of this study is to evaluate the efficacy, safety, and tolerability of MK-6194 in participants with non-segmental vitiligo. The primary hypothesis is that at least 1 MK-6194 dose is superior to placebo with regards to percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24.
| Status | Recruiting |
| Enrollment | 165 |
| Est. completion date | December 29, 2025 |
| Est. primary completion date | June 2, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Hospital Aleman-Dermatologia ( Site 0209) | Buenos Aires | Caba |
| Argentina | Stat Research S.A. ( Site 0204) | Buenos Aires | Caba |
| Argentina | Psoriahue ( Site 0205) | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Centro de Investigaciones Metabólicas (CINME)-Dermatology ( Site 0203) | Ciudad Autónoma de Buenos Aires | Caba |
| Argentina | Instituto Medico Strusberg ( Site 0208) | Córdoba | Cordoba |
| Australia | Skin Health Institute Inc.-Trials ( Site 1702) | Carlton | Victoria |
| Australia | Sinclair Dermatology ( Site 1704) | Melbourne | Victoria |
| Australia | Paratus Clinical Research Woden ( Site 1703) | Phillip | Australian Capital Territory |
| Australia | Westmead Hospital-Dermatology ( Site 1701) | Westmead | New South Wales |
| Belgium | UZ Gent ( Site 0604) | Gent | Oost-Vlaanderen |
| Canada | Centre de Recherche Dermatologique du Quebec metropolitain ( Site 0002) | Quebec | |
| Canada | Diex Recherche Quebec Inc. ( Site 0008) | Quebec | |
| Canada | Diex Recherche sherbrooke Inc. ( Site 0007) | Sherbrooke | Quebec |
| Canada | Enverus Medical Research ( Site 0006) | Surrey | British Columbia |
| Chile | Dermisur ( Site 0305) | Osorno | Los Lagos |
| Chile | Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302) | Santiago | Region M. De Santiago |
| 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 | Clinical Research Chile SpA ( Site 0304) | Valdivia | Los Rios |
| France | CHU de Bordeaux Hop St ANDRE ( Site 0804) | Bordeaux | Aquitaine |
| France | HENRI MONDOR HOSPITAL ( Site 0801) | Créteil | Val-de-Marne |
| France | Hôpital Edouard Herriot ( Site 0802) | Lyon | Rhone-Alpes |
| France | Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0803) | Nice | Alpes-Maritimes |
| Germany | Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901) | Berlin | |
| Germany | Universitaetsklinikum Erlangen-Hautklinik Studienambulanz ( Site 0905) | Erlangen | Bayern |
| Germany | Universitätsklinikum Münster-Hautklinik ( Site 0904) | Münster | Nordrhein-Westfalen |
| Israel | Rambam Health Care Campus-Dermatology ( Site 1002) | Haifa | |
| Israel | Sheba Medical Center-Dermatology ( Site 1001) | Ramat Gan | |
| Japan | Nagoya City University Hospital-Dermatology ( Site 2002) | Nagoya | Aichi |
| Japan | Tokyo Medical University Hospital ( Site 2001) | Shinjuku-ku | Tokyo |
| Japan | Osaka University Hospital ( Site 2004) | Suita | Osaka |
| Korea, Republic of | 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 | |
| Netherlands | Amsterdam UMC, locatie AMC-Dermatology ( Site 1101) | Amsterdam | Noord-Holland |
| Spain | 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 |
| Switzerland | Cantonal Hospital St.Gallen ( Site 1402) | st.Gallen | Sankt Gallen |
| United Kingdom | New Cross Hospital ( Site 1601) | Wolverhampton | |
| United States | Cahaba Dermatology & Skin Health Center ( Site 0127) | Birmingham | Alabama |
| United States | Metro Boston Clinical Partners ( Site 0110) | Brighton | Massachusetts |
| United States | Hamzavi Dermatology - Canton ( Site 0101) | Canton | Michigan |
| United States | Medical University of South Carolina-Dermatology Research ( Site 0114) | Charleston | South Carolina |
| United States | Remington Davis Clinical Research-Outpatient ( Site 0104) | Columbus | Ohio |
| United States | Burke Pharmaceutical Research ( Site 0124) | Hot Springs | Arkansas |
| United States | Dawes Fretzin Clinical Research Group, LLC ( Site 0106) | Indianapolis | Indiana |
| United States | Indiana University Health University Hospital-Indiana University School of Medicine, Department of ( | Indianapolis | Indiana |
| United States | The Vitiligo & Pigmentation Institute of Southern California ( Site 0115) | Los Angeles | California |
| United States | International Clinical Research - Tennessee LLC ( Site 0120) | Murfreesboro | Tennessee |
| United States | Virginia Clinical Research, Inc. ( Site 0109) | Norfolk | Virginia |
| United States | Progressive Clinical Research ( Site 0108) | San Antonio | Texas |
| United States | Dermatology Specialists of Spokane ( Site 0126) | Spokane | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Belgium, Canada, Chile, France, Germany, Israel, Japan, Korea, Republic of, Netherlands, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at 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. | Baseline and Week 24 | |
| Primary | Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 24 weeks | |
| Primary | Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 24 weeks | |
| Secondary | Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at 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. | Baseline and Week 24 |
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