2022-501668-16-00RecruitingPhase 3
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
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Pfizer Inc.
- Enrollment
- 81
- Locations
- 19
- Primary Endpoint
- Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from BL) at Week 52; • Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation. • Incidence of clinically significant laboratory abnormalities
Study Overview
Brief Summary
To compare the efficacy of ritlecitinib 50 mg QD versus placebo in participants with nonsegmental vitiligo; To evaluate the safety and tolerability of ritlecitinib over time in participants with nonsegmental vitiligo.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Overall design
- Masking
- Double (Investigator, Monitor, Subject, Carer)
Eligibility Criteria
- Ages
- 0 years to 65+ years (65+ Years, 0-17 Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from BL) at Week 52; • Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation. • Incidence of clinically significant laboratory abnormalities
Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from BL) at Week 52; • Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation. • Incidence of clinically significant laboratory abnormalities
Secondary Outcomes
- % CFB in T-VASI at Weeks 24, 36, and 52.
- Response based on F-VASI75 at Weeks 24 and 36
- Response based on T-VASI50 at Weeks 24, 36, and 52
- % CFB in F-VASI at Weeks 24, 36, and 52.
- Response based on improvement in PGIS-Fb at Weeks 24, 36, and 52
- Response based on improvement in PGIS-Vc at Weeks 24, 36, and 52
Investigators
Clinical Medical Lead
Scientific
Pfizer Inc.
Study Sites (19)
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