Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06113328
Registration number
NCT06113328
Ethics application status
Date submitted
27/10/2023
Date registered
2/11/2023
Date last updated
4/06/2024
Titles & IDs
Public title
A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)
Query!
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
Query!
Secondary ID [1]
0
0
2023-503502-37-00
Query!
Secondary ID [2]
0
0
6194-007
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-segmental Vitiligo
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - 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.
Other interventions: MK-6194
MK-6194 administered subcutaneously (SC)
Treatment: Drugs: Placebo
Placebo comparator to MK-6194 administered SC
Query!
Intervention code [1]
0
0
Other interventions
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and Week 24
Query!
Primary outcome [2]
0
0
Number of Participants Who Experience an Adverse Event (AE)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to approximately 24 weeks
Query!
Primary outcome [3]
0
0
Number of Participants Who Discontinue Study Treatment Due to an AE
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Up to approximately 24 weeks
Query!
Secondary outcome [1]
0
0
Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline and Week 24
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/11/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
29/12/2025
Query!
Actual
Query!
Sample size
Target
165
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Query!
Recruitment hospital [1]
0
0
Paratus Clinical Research Woden ( Site 1703) - Phillip
Query!
Recruitment hospital [2]
0
0
Westmead Hospital-Dermatology ( Site 1701) - Westmead
Query!
Recruitment hospital [3]
0
0
Skin Health Institute Inc.-Trials ( Site 1702) - Carlton
Query!
Recruitment hospital [4]
0
0
Sinclair Dermatology ( Site 1704) - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2606 - Phillip
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [4]
0
0
3002 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Ohio
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
South Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Tennessee
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Virginia
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
Buenos Aires
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Caba
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Cordoba
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Oost-Vlaanderen
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
British Columbia
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Quebec
Query!
Country [18]
0
0
Chile
Query!
State/province [18]
0
0
Los Lagos
Query!
Country [19]
0
0
Chile
Query!
State/province [19]
0
0
Los Rios
Query!
Country [20]
0
0
Chile
Query!
State/province [20]
0
0
Region M. De Santiago
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Alpes-Maritimes
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Aquitaine
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Rhone-Alpes
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Val-de-Marne
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Bayern
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Nordrhein-Westfalen
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Berlin
Query!
Country [28]
0
0
Israel
Query!
State/province [28]
0
0
Haifa
Query!
Country [29]
0
0
Israel
Query!
State/province [29]
0
0
Ramat Gan
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Aichi
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Osaka
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Tokyo
Query!
Country [33]
0
0
Korea, Republic of
Query!
State/province [33]
0
0
Incheon
Query!
Country [34]
0
0
Korea, Republic of
Query!
State/province [34]
0
0
Seoul
Query!
Country [35]
0
0
Netherlands
Query!
State/province [35]
0
0
Noord-Holland
Query!
Country [36]
0
0
Spain
Query!
State/province [36]
0
0
Andalucia
Query!
Country [37]
0
0
Spain
Query!
State/province [37]
0
0
Barcelona
Query!
Country [38]
0
0
Spain
Query!
State/province [38]
0
0
Madrid, Comunidad De
Query!
Country [39]
0
0
Switzerland
Query!
State/province [39]
0
0
Sankt Gallen
Query!
Country [40]
0
0
United Kingdom
Query!
State/province [40]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Merck Sharp & Dohme LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06113328
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Toll Free Number
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-888-577-8839
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06113328
Download to PDF