jRCT2031260030RecruitingNot Applicable
A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb study to assess the efficacy and safety of GIA632 in adult participants with nonsegmental vitiligo, followed by an extension period (CGIA632B12201)
Not provided0 sites20 target enrollmentStarted: TBD
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18age old over to 99age old under (—)
- Sex
- All
Inclusion Criteria
- •Signed informed consent must be obtained prior to participation in the study
- •Male or female as assigned at birth >= 18 years of age at the time of screening
- •Individuals with a diagnosis of non-segmental vitiligo and confirmation of diagnosis through physical examination by the investigator
- •Non-segmental vitiligo, as assessed at screening, as
- •>= 0.5% Body Surface Area (BSA) on the face and F-VASI score >= 0.5
- •>= 3% BSA on non-facial areas (minimum of 3% should be calculated in addition to hands and feet) and T-VASI score = 3 to 60
Exclusion Criteria
- •Individuals unable or unwilling to follow the study procedures and/or to complete the study-related questionnaires
- •Presence of segmental or mixed vitiligo, or other skin comorbidities that may interfere with study assessments (e.g., hypopigmented mycosis fungoides, genetic diseases with pigmentary aberrations [such as piebaldism, Waardenburg, etc.], chemical- or druginduced leukoderma, etc.)
- •Previous exposure to biologic drugs directly targeting IL-15 or IL-15 receptors
- •Individual who previously attempted or completed depigmentation therapy for NSV
- •Use of prohibited medication & treatments. Other protocol-defined inclusion/exclusion criteria may apply
Investigators
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