Vitiligo
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Vitiligo
6194-007 Enrolling

Non-Segmental Vitiligo Research Trial (58 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults of any sex/gender (from 18 to 75 years of age) with non-segmental vitiligo, may be eligible to participate.

Inclusion Criteria:

      • Clinical diagnosis of non-segmental vitiligo
      • Non-segmental vitiligo with disease duration of at least 6 months (defined as the length of time since onset of symptoms)
      • Depigmentation (loss of skin colour) on areas of the face and body (excluding hands and feet)

Why Participate?

      • No cost to participate or receive treatment
      • Regular visits with study doctors who specialize in treating non-segmental vitiligo (16 clinic visits, plus 4 phone visits)
      • Will receive either an investigational injected treatment (active study drug) or placebo
      • Reimbursement for study-related expenses will be provided

How Long Will The Study Last?

      • 58 weeks

Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Lorne Albrecht

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: May 19, 2024

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

ClinicalTrials.gov ID

NCT06113328

Sponsor

Merck Sharp & Dohme LLC

Study Description

  • 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:

    Non-segmental Vitiligo

  • Intervention/Treatment:

    Biological: MK-6194
    Biological: MK-6194
    Drug: Placebo
    Biological: MK-6194
    Biological: MK-6194
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 75 Years (Adult)

  • Sexes Eligible for Study:

    All

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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