A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

Vitiligo Clinical Trial

— Tranquillo LTE  

Official title:

A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTI-CENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163326
• Other study ID #: B7981041
• Secondary ID: 2023-505804-42-0
• Status: Recruiting
• Phase: Phase 3
• Start date: January 19, 2024
• Est. completion date: August 8, 2026

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin. Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show: - if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo) - Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study - Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study. This study is seeking for participants who: - have non-segmental vitiligo (either active or stable) and - received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it. All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. At week 4 (or if it cannot be done then, at week 8) study visit, you must take the medication at the study site, and not at home. Participants may receive the study medicine or placebo for up to 52 weeks. The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo. Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study. Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 8, 2026
• Est. primary completion date: August 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Participants =18 years of age at Screening in Study B7981040. Adolescents (12 to <18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority.
• Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
• The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040

Exclusion Criteria:

• Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
• Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Ritlecitinib
Ritlecitinib 50 mg capsule once daily
• Ritlecitinib 100 mg
Ritlecitinib 100 mg capsule once daily
• Placebo
Matching capsule once daily

Locations

Country	Name	City	State
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Centre de Recherche Dermatologique du Quebec metropolitain	Quebec
Canada	Centre de Recherche Saint-Louis	Quebec
Japan	Nippon Medical School Hospital	Bunkyo-ku	Tokyo
Japan	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi
Japan	Nippon Medical School Hospital	Tokyo
United States	DelRicht Research	Baton Rouge	Louisiana
United States	Encore Medical Research of Boynton Beach	Boynton Beach	Florida
United States	Remington Davis Clinical Research	Columbus	Ohio
United States	Remington-Davis, Inc	Columbus	Ohio
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Austin Institute for Clinical Research	Houston	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Visage Dermatology and Aesthetic Center	Largo	Maryland
United States	Wallace Medical Group, Inc	Los Angeles	California
United States	Accellacare - Wilmington	Wilmington	North Carolina
United States	Wilmington Health, PLLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation	To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo	Screening up to at least 28 days after last dose of study drug (week 52 or Early Termination)
Primary	Incidence of clinically significant laboratory abnormalities	To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo	Screening up to at least 28 days after last dose of study drug (week 52 or Early Termination)
Secondary	Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 75% improvement in T-VASI from Baseline	Baseline to Week 52
Secondary	Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline	Baseline to week 52
Secondary	Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 50% improvement in T-VASI from Baseline	Baseline to Week 52
Secondary	Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 50% improvement in F-VASI from Baseline	Baseline to week 52
Secondary	Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 90% improvement in T-VASI from Baseline	Baseline to Week 52
Secondary	Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 90% improvement in F-VASI from Baseline	Baseline to week 52
Secondary	Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 100% improvement in T-VASI from Baseline	Baseline to Week 52
Secondary	Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52	Proportion of participants achieving at least a 100% improvement in F-VASI from Baseline	Baseline to week 52
Secondary	Patient Global Impression of Severity-Face (PGIS-F)	To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Week 52	Baseline to week 52
Secondary	Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)	To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Week 52	Baseline to week 52
Secondary	Patient Global Impression of Change-Face (PGIC-F)	To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Week 52	Baseline to Week 52
Secondary	Patient Global Impression of Change- Overall vitiligo (PGIC-V)	To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Week 52	Baseline to Week 52
Secondary	Proportion of participants achieving disease stabilization	The difference in the proportion of participants with stable disease at all scheduled timepoints	Baseline to week 52

External Links

•   To obtain contact information for a study center near you, click here.