Bellaire Dermatology Associates | Bellaire, TX
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About
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo
Full description
Study B7981040 is a Phase 3 randomized, double-blind, 52-week placebo-controlled, multi center study investigating the efficacy, safety, and tolerability of ritlecitinib in adult and adolescent participants with nonsegmental vitiligo (both active and stable vitiligo).
Enrollment
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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.
Disease Characteristics:
Eligible participants must have at both Screening and Baseline:
Active vitiligo is defined as:
Stable vitiligo is defined as an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) are required to have stable disease.
Eligibility is determined at Screening and Baseline based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA.
Other Inclusion Criteria:
If receiving concomitant medications for any reason other than vitiligo, participant must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant must be willing to stay on a stable regimen during the duration of the study.
Must agree to stop all other treatments for vitiligo from Screening through the final follow-up visit.
Exclusion criteria
Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:
General Infection History:
Specific Viral Infection History:
Medical Conditions, Other:
Prior/Concomitant Therapy:
Have received any of the prohibited treatment regimens specified.
Prior/Concurrent Clinical Study Experience:
Previous administration with an investigational drug or vaccine that do not affect vitiligo within 4 weeks of Day 1 [Baseline] or within 5 half-lives, whichever is longer.
Diagnostic Assessments:
Any of the following abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:
Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities
Other Exclusion Criteria:
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Adolescent participants 12 to <18 years of age without one of the following:
Primary purpose
Allocation
Interventional model
Masking
600 participants in 2 patient groups, including a placebo group
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Central trial contact
Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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