A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo
Study B7981040 is a Phase 3 randomized, double-blind, 52-week placebo-controlled, multi center study investigating the efficacy, safety, and tolerability of ritlecitinib in adult and adolescent participants with nonsegmental vitiligo (both active and stable vitiligo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
592
50 mg capsule
Matching capsule
US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and T-VASI50 at Week 52
Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline) and T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)
Time frame: Week 52
Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52
Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)
Time frame: Week 52
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities
Safety and tolerability of ritlecitinib in participants with nonsegmental vitiligo
Time frame: Baseline through Week 52
US-Only: Response based on F-VASI75 at 24 and 36 weeks
Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline
Time frame: Weeks 24 and 36
US-Only: Response based on T-VASI50 at 24 and 36 weeks
Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)
Time frame: Weeks 24 and 36
US-Only: Response based on T-VASI75 at 52 weeks
Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)
Time frame: Week 52
US-Only: Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham Faculty Office Towers (Regulatory
Birmingham, Alabama, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Wallace Medical Group, Inc
Los Angeles, California, United States
Audiology
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Center for Dermatology and Dermatologic Surgery
Washington D.C., District of Columbia, United States
Encore Medical Research of Boynton Beach
Boynton Beach, Florida, United States
Skin Care Research
Hollywood, Florida, United States
...and 105 more locations
Median % CFB in F-VASI in participants treated with ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 24, 36, and 52
US-Only: Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks
Median % CFB in T-VASI in participants treated with ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 24, 36, and 52
US-Only: Patient Global Impression of Severity-Face (PGIS-F)
Proportion of responders based on PGIS-F at 52 weeks
Time frame: Week 52
US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
Proportion of responders based on PGIS-V at 52 weeks
Time frame: Week 52
Global (Other than US): Response based on F-VASI75 at 24 and 36 weeks
Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)
Time frame: Weeks 24 and 36
Global (Other Than US): Response based on T-VASI50 at 24, 36, and 52 weeks
Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)
Time frame: Weeks 24, 36, and 52
Global (Other than US): Percentage change from baseline (% CFB) in F-VASI at 24, 36, and 52 weeks
Median % CFB in F-VASI in participants treated with ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 24, 36, and 52
Global (Other than US): Percentage change from baseline (% CFB) in T-VASI at 24, 36, and 52 weeks
Median % CFB in T-VASI in participants treated with ritlecitinib 50 mg QD versus placebo
Time frame: Weeks 24, 36, and 52
Global (Other than US): Patient Global Impression of Severity-Face (PGIS-F)
Proportion of responders based on PGIS-F at 24, 36, and 52 weeks
Time frame: Weeks 24, 36, and 52
Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
Proportion of responders based on PGIS-V at 24, 36, and 52 weeks
Time frame: Weeks 24, 36, and 52
All Countries: Proportion of participants achieving disease stabilization
The difference in the proportion of participants with stable disease at all timepoints in participants with non segmental vitiligo treated with ritlecitinib 50 mg QD compared to placebo
Time frame: Baseline through week 52
Response based on T-VASI50
Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)
Time frame: Baseline through week 4, week 8, week 12, week 48
Response based on F-VASI75
Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)
Time frame: Baseline through week 4, week 8, week 12, week 48
Response based on T-VASI75
Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)
Time frame: Baseline through week 4, week 8, week 12, week 24, week 36, week 48
Proportion of participants with sustained improvement in T-VASI
Defined as maintenance of ≥T-VASI50 from Week 36 to Week 52
Time frame: Week 36 through week 52
Proportion of participants with sustained improvement in F-VASI
Defined as maintenance of ≥F-VASI75 from Week 36 to 52
Time frame: Week 36 through week 52
All Countries: Time to rescue medication
Comparing time to rescue medication curves and difference in probabilities of using rescue medication
Time frame: Baseline through week 52
Percentage change from baseline in F-VASI
Median % CFB in F-VASI at appropriate timepoints in participants treated with ritlecitinib 50 mg QD versus placebo
Time frame: Baseline through week 52
Percentage change from baseline in T-VASI
Median % CFB in T-VASI at appropriate timepoints in participants treated with ritlecitinib 50 mg QD versus placebo
Time frame: Baseline through week 52
Response based on T-VASI90
Proportion of participants achieving T-VASI90 (defined as at least 90% improvement in T-VASI from Baseline)
Time frame: Baseline through week 52
Response based on T-VASI100
Proportion of participants achieving T-VASI100 (defined as at least 100% improvement in T-VASI from Baseline)
Time frame: Baseline through week 52
Response based on F-VASI50
Proportion of participants achieving F-VASI50 (defined as at least 50% improvement in F-VASI from Baseline).
Time frame: Baseline through week 52
Response based on F-VASI90
Proportion of participants achieving F-VASI90 (defined as at least 50% improvement in F-VASI from Baseline).
Time frame: Baseline through week 52
Response based on F-VASI100
Proportion of participants achieving F-VASI100 (defined as at least 100% improvement in F-VASI from Baseline).
Time frame: Baseline through week 52
Patient Global Impression of Severity-Face (PGIS-F)
Proportion of responders based on PGIS-F at 24 and 26 weeks
Time frame: Weeks 24 and 36
Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
Proportion of responders based on PGIS-V at 24 and 36 weeks
Time frame: Weeks 24 and 36
Patient Global Impression of Change-Face (PGIC-F)
To assess the effect of ritlecitinib compared to placebo on the PGIC-F at 24, 36, and 52 weeks
Time frame: Weeks 24, 36, and 52
Patient Global Impression of Change- Overall Vitiligo (PGIC-V)
To assess the effect of ritlecitinib compared to placebo on the PGIC-V at 24, 36, and 52 weeks
Time frame: Weeks 24, 36, and 52
Change from baseline in Dermatology Life Quality Index (DLQI) or Children Dermatology Life Quality Index (CDLQI)
To evaluate the change from baseline in DLQI or CDLQI at week 52
Time frame: Week 52
Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
To assess the effect of ritlecitinib compared to placebo on depression and anxiety subscales of the HADS at week 52
Time frame: Week 52
The proportion of patients achieving absence of depression on HADS depression subscale
Response based on a 'normal' subscale score indicative of an absence of depression (in participants with baseline HADS subscale scores indicative of depression)
Time frame: Week 52
The proportion of patients achieving absence of anxiety on HADS anxiety subscale
Response based on a 'normal' subscale score indicative of an absence of anxiety (in participants with baseline HADS subscale scores indicative of anxiety)
Time frame: Week 52