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

• ClinicalTrials.gov Identifier: NCT06113328
• Recruitment Status: Recruiting
• First Posted: November 2, 2023
• Last Update Posted: May 20, 2024
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: October 27, 2023
• First Posted Date: November 2, 2023
• Last Update Posted Date: May 20, 2024
• Actual Study Start Date: November 27, 2023
• Estimated Primary Completion Date: September 11, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2023)

• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 27, 2023)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Non-segmental Vitiligo

Intervention

• Biological: MK-6194
  MK-6194 administered subcutaneously (SC)
• Drug: Placebo
  Placebo comparator to MK-6194 administered SC

Study Arms

• Experimental: Base Study: Dose 1
  Participants receive subcutaneous (SC) MK-6194 dose regimen 1.
  Intervention: Biological: MK-6194
• Experimental: Base Study: Dose 2
  Participants receive SC MK-6194 dose regimen 2.
  Interventions:

  • Biological: MK-6194
  • Drug: Placebo
• Placebo Comparator: Base Study: Placebo
  Participants receive an SC placebo regimen.
  Intervention: Drug: Placebo
• 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.
  Intervention: Biological: MK-6194
• 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.
  Interventions:

  • Biological: MK-6194
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 27, 2023): 165
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 9, 2026
• Estimated Primary Completion Date: September 11, 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Argentina, Australia, Belgium, Canada, Chile, France, Germany, Israel, Japan, Korea, Republic of, Netherlands, Spain, Switzerland, United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: May 2024