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. On study visit days, 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
Ritlecitinib 50 mg capsule once daily
Ritlecitinib 100 mg capsule once daily
Matching capsule once daily
California Dermatology & Clinical Research Institute
Encinitas, California, United States
RECRUITINGMarvel Clinical Research
Huntington Beach, California, United States
RECRUITINGWallace Medical Group, Inc
Los Angeles, California, United States
RECRUITINGEncore Medical Research of Boynton Beach
Boynton Beach, Florida, United States
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
Time frame: Screening up to at least 30 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
Time frame: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to week 52
Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52
To assess the effect of ritlecitinib compared to placebo on the PGIC-F at weeks 24, 36, and 52
Time frame: Baseline to week 52
Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52
To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Week 24, 36, and 52
Time frame: Baseline to week 52
Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52
To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Week 24, 36, and 52
Time frame: Baseline to week 52
Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52
To assess the effect of ritlecitinib compared to placebo on the PGIC-V at weeks 24, 36, and 52
Time frame: Baseline to week 52
Proportion of participants achieving disease stabilization
The difference in the proportion of participants with stable disease at all scheduled timepoints
Time frame: Baseline to week 52
Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52
To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo
Time frame: Baseline to week 52
Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52
To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo
Time frame: Baseline to week 52
Time to loss of response (<F-VASI75 and <T-VASI50 at the same visit).
To compare the efficacy of ritlecitinib 100 mg QD, 50 mg QD, and placebo
Time frame: Baseline to week 52
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Skin Care Research
Hollywood, Florida, United States
RECRUITINGForCare Clinical Research
Tampa, Florida, United States
RECRUITINGDawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
RECRUITINGDelRicht Research
Baton Rouge, Louisiana, United States
ACTIVE_NOT_RECRUITINGLawrence J. Green, MD LLC
Rockville, Maryland, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
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