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A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)

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ClinicalTrials.gov Identifier: NCT06113328
Recruitment Status : Recruiting
First Posted : November 2, 2023
Last Update Posted : April 29, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-segmental Vitiligo Biological: MK-6194 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 27, 2023
Estimated Primary Completion Date : September 11, 2025
Estimated Study Completion Date : April 9, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arms and Interventions
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Arm Intervention/treatment
Experimental: Base Study: Dose 1
Participants receive subcutaneous (SC) MK-6194 dose regimen 1.
 Biological: MK-6194
MK-6194 administered subcutaneously (SC)
Experimental: Base Study: Dose 2
Participants receive SC MK-6194 dose regimen 2.
 Biological: MK-6194
MK-6194 administered subcutaneously (SC)

Drug: Placebo
Placebo comparator to MK-6194 administered SC
Placebo Comparator: Base Study: Placebo
Participants receive an SC placebo regimen.
 Drug: Placebo
Placebo comparator to MK-6194 administered SC
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.
 Biological: MK-6194
MK-6194 administered subcutaneously (SC)
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.
 Biological: MK-6194
MK-6194 administered subcutaneously (SC)

Drug: Placebo
Placebo comparator to MK-6194 administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24 [ Time Frame: 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.

  2. Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: 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.

  3. Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: 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 :
  1. Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06113328


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT06113328    
Other Study ID Numbers: 6194-007
2023-503502-37-00 ( Registry Identifier: EU CT )
U1111-1287-4329 ( Other Identifier: Universal Trial Number )
MK-6194-007 ( Other Identifier: Merck )
jRCT2031230622 ( Registry Identifier: jRCT )
First Posted: November 2, 2023    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases