Vitiligo
Conditions
Interventions
Ritlecitinib 50 mg capsule once daily
Ritlecitinib 100 mg capsule once daily
Matching capsule once daily
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo - Incidence of treatment-emergent adverse events, serious adverse events, and adverse events leading to discontinuation - Incidence of clinically significant laboratory abnormalities | — |
Secondary
| Measure | 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) 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) 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) 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) 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) 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) 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) 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) To assess the effect of ritlecitinib compared to placebo on the 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 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 Patient Global Impression of Change-Face (PGIC-F) at Weeks 24, 36, and 52 To assess the effect of ritlecitinib compared to placebo on the Patient Global Impression of Change- Overall vitiligo (PGIC-V) at Weeks 24, 36, and 52 The difference in the proportion of participants with stable disease at all scheduled timepoints Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52 %CFB in T-VASI at weeks 4, 8, 12, 2 | — |
Countries
Australia, Bulgaria, Canada, China, Germany, Japan, Korea, Republic of, Mexico, Poland, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed