Last updated 36 days ago

A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo

600 patients around the world

Available in United States, Mexico

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).

Pfizer

2Research sites

600Patients around the world

Requirements for the patient

From 12 Years

All Gender

Medical requirements

: Participants ≥18 years of age, inclusive. 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. Adolescent participants will not be enrolled in the United States.
Eligible participants must have at both Screening and Baseline:
A clinical diagnosis of non segmental vitiligo for at least 3 months; and
BSA involvement 4%-60% inclusive, excluding involvements at palms of the hands, dorsal aspect of fingers and thumbs including metacarpophalangeal joints, 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 check to the jawline 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 non segmental 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 will be classified as having active vitiligo based on the presence of at least one active lesion at baseline defined as one of the following:
New/extending lesion(s) in the 3 months prior to Screening visit (confirmed by photographs or medical record):
Confetti-like lesion(s);
Trichrome lesion(s);
Koebner phenomenon/phenomena (excluding Type 1 [history based on isomorphic reaction]). The Koebner phenomenon manifests as depigmentation at sites of trauma, usually in a linear arrangement.
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 based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA.
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.

: 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:
Prior/Concurrent Clinical Study Experience:
Diagnostic Assessments:
Other Exclusion Criteria:

Sites

Arke Estudios Clínicos S.A. de C.V. - Veracruz

Recruiting

Alacio Pérez 928, Consultorios 101 al 104, Ignacio Zaragoza, 91910 Veracruz

Hospital Universitario Ramón y Cajal

Recruiting

Madrid, 28034

StudyTranquillo

SponsorPfizer

Requirements

From 12 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05583526