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

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 NON SEGMENTAL VITILIGO

NCT05583526•Pfizer

View on ClinicalTrials.gov

Summary

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

Detailed 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).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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:
•2. 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.
•Active vitiligo is defined as:
•* 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:
+8 more criteria

Exclusion Criteria

•1. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
•* Suicidal ideation associated with actual intent and a method or plan in the past year: "Yes" answers on items 4 or 5 of the C-SSRS administered at the screening visit.
•* Previous history of suicidal behaviors in the past 5 years: "Yes" answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS.
•* For adults, any lifetime history of serious suicidal behavior or recurrent suicidal behavior. For adolescents, any previous lifetime history of suicidal behavior.
•2. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:
•* Participants that have other types of vitiligo that do not meet criteria for active or stable vitiligo as noted in inclusion criterion #2 (including, but not limited to, segmental vitiligo and mixed vitiligo).
•* Currently have active forms of other disorders of pigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation \[melanoma and mycosis fungoides\], post-inflammatory hypopigmentation, pityriasis alba \[minor manifestation of atopic dermatitis\], senile leukoderma \[age-related depigmentation\], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma (all types, including mixed), and congenital hypopigmentation disorder including piebaldism, Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica hereditarian, xeroderma pigmentosum, and nevus depigmentosus). NOTE: Coexistence of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted.
•* Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (for example, morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or Baseline Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment.
•* Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions OR leukotrichia in more than 33% of the total body surface area affected with vitiligo lesions.
•* Have a superficial skin infections within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves.
+31 more criteria

Locations (115)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Alabama at Birmingham Faculty Office Towers (Regulatory

Birmingham, Alabama, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Marvel Clinical Research

Huntington Beach, California, United States

Wallace Medical Group, Inc

Los Angeles, California, United States

Audiology

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Center for Dermatology and Dermatologic Surgery

Washington D.C., District of Columbia, United States

Encore Medical Research of Boynton Beach

Boynton Beach, Florida, United States

Skin Care Research

Hollywood, Florida, United States

Key Dates

Start Date

December 1, 2022

Primary Completion Date

February 5, 2026

Completion Date

February 5, 2026

Last Updated

February 27, 2026

Enrollment

607

ACTUAL participants

Conditions

Stable Nonsegmental VitiligoActive Nonsegmental Vitiligo

Interventions

Ritlecitinib

DRUG

Placebo

DRUG