Clinical trial NCT06113328: A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-segmental Vitiligo
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-11-02
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
timeFrame: Baseline and Week 24
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 24 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 24 weeks
Secondary outcomes:
measure: Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Health Center ( Site 0127)
state: Alabama
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research ( Site 0124)
state: Arkansas
city: Los Angeles
country: United States
facility: The Vitiligo & Pigmentation Institute of Southern California ( Site 0115)
state: California
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital-Indiana University School of Medicine, Department of (
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC ( Site 0106)
state: Indiana
city: Brighton
country: United States
facility: Metro Boston Clinical Partners ( Site 0110)
state: Massachusetts
city: Canton
country: United States
facility: Hamzavi Dermatology - Canton ( Site 0101)
state: Michigan
city: Columbus
country: United States
facility: Remington Davis Clinical Research-Outpatient ( Site 0104)
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina-Dermatology Research ( Site 0114)
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC ( Site 0120)
state: Tennessee
city: San Antonio
country: United States
facility: Progressive Clinical Research ( Site 0108)
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc. ( Site 0109)
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane ( Site 0126)
state: Washington
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Psoriahue ( Site 0205)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Stat Research S.A. ( Site 0204)
state: Caba
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)-Dermatology ( Site 0203)
state: Caba
city: Córdoba
country: Argentina
facility: Instituto Medico Strusberg ( Site 0208)
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Hospital Aleman-Dermatologia ( Site 0209)
city: Phillip
country: Australia
facility: Paratus Clinical Research Woden ( Site 1703)
state: Australian Capital Territory
city: Westmead
country: Australia
facility: Westmead Hospital-Dermatology ( Site 1701)
state: New South Wales
city: Carlton
country: Australia
facility: Skin Health Institute Inc.-Trials ( Site 1702)
state: Victoria
city: Melbourne
country: Australia
facility: Sinclair Dermatology ( Site 1704)
state: Victoria
city: Gent
country: Belgium
facility: UZ Gent ( Site 0604)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 0601)
state: Vlaams-Brabant
city: Surrey
country: Canada
facility: Enverus Medical Research ( Site 0006)
state: British Columbia
city: Sherbrooke
country: Canada
facility: Diex Recherche sherbrooke Inc. ( Site 0007)
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc. ( Site 0008)
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain ( Site 0002)
city: Osorno
country: Chile
facility: Dermisur ( Site 0305)
state: Los Lagos
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA ( Site 0304)
state: Los Rios
city: Santiago
country: Chile
facility: Clinica Dermacross ( Site 0301)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-CICUC ( Site 0308)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos (CIEC) ( Site 0302)
state: Region M. De Santiago
city: Envigado
country: Colombia
facility: CliniSalud ( Site 0401)
state: Antioquia
city: Medellín
country: Colombia
facility: IPS SURA San Diego ( Site 0408)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatología del Caribe ( Site 0405)
state: Atlantico
city: Zipaquira
country: Colombia
facility: Healthy Medical Center S.A.S ( Site 0403)
state: Cundinamarca
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0412)
state: Valle Del Cauca
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0803)
state: Alpes-Maritimes
city: Bordeaux
country: France
facility: CHU de Bordeaux Hop St ANDRE ( Site 0804)
state: Aquitaine
city: Lyon
country: France
facility: Hôpital Edouard Herriot ( Site 0802)
state: Rhone-Alpes
city: Creteil
country: France
facility: HENRI MONDOR HOSPITAL ( Site 0801)
state: Val-de-Marne
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen-Hautklinik Studienambulanz ( Site 0905)
state: Bayern
city: Münster
country: Germany
facility: Universitätsklinikum Münster-Hautklinik ( Site 0904)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0901)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Dermatology ( Site 1002)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-Dermatology ( Site 1001)
city: Nagoya
country: Japan
facility: Nagoya City University Hospital-Dermatology ( Site 2002)
state: Aichi
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 2004)
state: Osaka
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital ( Site 2001)
state: Tokyo
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital ( Site 1992)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital-Dermatology ( Site 1991)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Department of Dermatology ( Site 1993)
city: Cuauhtémoc, Ciudad De México
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V. ( Site 0515)
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Unidad biomedica avanzada monterrey-Clinical Trials ( Site 0504)
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: Centro de Atención e Investigación Clínica ( Site 0507)
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC-Dermatology ( Site 1101)
state: Noord-Holland
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar ( Site 1302)
state: Andalucia
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge-Dermatology ( Site 1307)
state: Barcelona
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra ( Site 1305)
state: Madrid, Comunidad De
city: St.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen ( Site 1402)
state: Sankt Gallen
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich ( Site 1401)
state: Zurich
city: Altindağ
country: Turkey
facility: Hacettepe Universite Hastaneleri-Dermatology ( Site 1501)
state: Ankara
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Dermatology ( Site 1502)
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri-Dermatology and Venereology ( Site 1506)
city: London
country: United Kingdom
facility: Royal London Hospital-Dermatology Research Unit ( Site 1605)
state: England
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham ( Site 1603)
state: Warwickshire
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital ( Site 1601)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: