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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06113328




Registration number
NCT06113328
Ethics application status
Date submitted
27/10/2023
Date registered
2/11/2023

Titles & IDs
Public title
A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)
Scientific 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
Secondary ID [1] 0 0
2023-503502-37-00
Secondary ID [2] 0 0
6194-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-segmental Vitiligo 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MK-6194
Treatment: Drugs - Placebo

Experimental: Base Study: Dose 1 - Participants receive subcutaneous (SC) MK-6194 dose regimen 1.

Experimental: Base Study: Dose 2 - Participants receive SC MK-6194 dose regimen 2.

Placebo comparator: Base Study: Placebo - Participants receive an SC placebo regimen.

Experimental: Extension: Dose 1 - 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.

Experimental: Extension: Dose 2 - 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.


Treatment: Other: MK-6194
MK-6194 administered subcutaneously (SC)

Treatment: Drugs: Placebo
Placebo comparator to MK-6194 administered SC
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Primary outcome [2] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [2] 0 0
Up to approximately 24 weeks
Primary outcome [3] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [3] 0 0
Up to approximately 24 weeks
Secondary outcome [1] 0 0
Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
Timepoint [1] 0 0
Baseline and Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/10/2025
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Woden ( Site 1703) - Phillip
Recruitment hospital [2] 0 0
Westmead Hospital-Dermatology ( Site 1701) - Westmead
Recruitment hospital [3] 0 0
Skin Health Institute Inc.-Trials ( Site 1702) - Carlton
Recruitment hospital [4] 0 0
Sinclair Dermatology ( Site 1704) - Melbourne
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
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South Carolina
Country [9] 0 0
United States of America
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Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
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United States of America
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Washington
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Argentina
State/province [13] 0 0
Buenos Aires
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Argentina
State/province [14] 0 0
Caba
Country [15] 0 0
Argentina
State/province [15] 0 0
Cordoba
Country [16] 0 0
Belgium
State/province [16] 0 0
Oost-Vlaanderen
Country [17] 0 0
Belgium
State/province [17] 0 0
Vlaams-Brabant
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Chile
State/province [20] 0 0
Los Lagos
Country [21] 0 0
Chile
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Los Rios
Country [22] 0 0
Chile
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Region M. De Santiago
Country [23] 0 0
Colombia
State/province [23] 0 0
Antioquia
Country [24] 0 0
Colombia
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Atlantico
Country [25] 0 0
Colombia
State/province [25] 0 0
Cundinamarca
Country [26] 0 0
Colombia
State/province [26] 0 0
Valle Del Cauca
Country [27] 0 0
France
State/province [27] 0 0
Alpes-Maritimes
Country [28] 0 0
France
State/province [28] 0 0
Aquitaine
Country [29] 0 0
France
State/province [29] 0 0
Rhone-Alpes
Country [30] 0 0
France
State/province [30] 0 0
Val-de-Marne
Country [31] 0 0
Germany
State/province [31] 0 0
Bayern
Country [32] 0 0
Germany
State/province [32] 0 0
Nordrhein-Westfalen
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Ramat Gan
Country [36] 0 0
Japan
State/province [36] 0 0
Aichi
Country [37] 0 0
Japan
State/province [37] 0 0
Osaka
Country [38] 0 0
Japan
State/province [38] 0 0
Tokyo
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Korea, Republic of
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Incheon
Country [40] 0 0
Korea, Republic of
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Seoul
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Mexico
State/province [41] 0 0
Distrito Federal
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Mexico
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Nuevo Leon
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Mexico
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Aguascalientes
Country [44] 0 0
Netherlands
State/province [44] 0 0
Noord-Holland
Country [45] 0 0
Spain
State/province [45] 0 0
Andalucia
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid, Comunidad De
Country [48] 0 0
Switzerland
State/province [48] 0 0
Sankt Gallen
Country [49] 0 0
Switzerland
State/province [49] 0 0
Zurich
Country [50] 0 0
Turkey
State/province [50] 0 0
Ankara
Country [51] 0 0
Turkey
State/province [51] 0 0
Kayseri
Country [52] 0 0
United Kingdom
State/province [52] 0 0
England
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Warwickshire
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@merck.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06113328