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

JRCT ID: jRCT2031230659

Registered date:27/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Vitiligo
• Date of first enrollment: 01/03/2024
• Target sample size: 400
• Countries of recruitment: US,Japan
• Study type: Interventional

Intervention(s)

Ritlecitinib 50 mg capsule once daily
Ritlecitinib 100 mg capsule once daily
Matching capsule once daily

Outcome(s)

Primary Outcome

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 Outcome

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 Week 52
To assess the effect of ritlecitinib compared to placebo on the Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at Week 52
To assess the effect of ritlecitinib compared to placebo on the Patient Global Impression of Change-Face (PGIC-F) at Week 52
To assess the effect of ritlecitinib compared to placebo on the Patient Global Impression of Change- Overall vitiligo (PGIC-V) at Week 52
The difference in the proportion of participants with stable disease at all scheduled timepoints

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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 Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT06163326