CTIS2022-501668-16-00RecruitingPhase 1
B7981040 - A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO - B7981040
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Pfizer Inc.
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Participants =18 years of age at screening. Adolescents (12 to <18 years of age) are also eligible for this study, but only if approved by the local IRB/EC and regulatory health authority. Where these approvals have not been granted, only participants =18 years of age will be enrolled., Eligible participants must have at both Screening and Baseline: A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and BSA involvement 4%-60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet; and BSA =0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids); and F-VASI =0.5 & T-VASI =3; and Either active or stable disease nonsegmental vitiligo at both Screening and Baseline visits. All participants who do not have the features of active vitiligo (defined below) are required to have stable disease., Participants must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit.
Exclusion Criteria
- •Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin., History of severe allergic or anaphylactoid reaction to any kinase inhibitor., Adolescent participants 12 to <18 years of age without one of the following: Documented evidence from a health professional of having received varicella vaccination (2 doses); or Evidence of prior exposure to VZV based on serological testing (ie, a positive VZV IgG Ab result) at screening.
Investigators
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