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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: Ritlecitinib
* Drug: Ritlecitinib 100 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040. Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned. | Drug: Ritlecitinib<br>* Ritlecitinib 50 mg capsule once daily<br>Drug: Ritlecitinib 100 mg<br>* Ritlecitinib 100 mg capsule once daily<br>Drug: Placebo<br>* Matching capsule once daily<br>|
| Experimental: Arm 2<br>Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned | Drug: Ritlecitinib<br>* Ritlecitinib 50 mg capsule once daily<br>Drug: Ritlecitinib 100 mg<br>* Ritlecitinib 100 mg capsule once daily<br>Drug: Placebo<br>* Matching capsule once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Proportion of participants achieving disease stabilization | The difference in the proportion of participants with stable disease at all scheduled timepoints | Baseline to week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stable vitiligo, Active vitiligo, Adults, Adolescents