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A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo.
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-12-01
Primary completion: 2025-12-20
Study completion finish: 2025-12-20
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05583526
Intervention or treatment
DRUG: Ritlecitinib
DRUG: Placebo
Conditions
- • Stable Nonsegmental Vitiligo
- • Active Nonsegmental Vitiligo
Find a site
Closest Location:
The Alfred Hospital
Research sites nearby
Select from list below to view details:
The Alfred Hospital
Melbourne, Victoria, Australia
The Skin Hospital
Darlinghurst, New South Wales, Australia
North Eastern Health Specialists
Campbelltown, South Australia, Australia
Skin Health Institute Inc.
Carlton, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Ritlecitinib 50 mg
| DRUG: Ritlecitinib
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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) | 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) | 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 | Baseline through Week 52 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 | 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) | 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) | Week 52 |
US-Only: 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 | 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 | 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 | Week 52 |
US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) | Proportion of responders based on PGIS-V at 52 weeks | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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). | 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). | 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). | Baseline through week 52 |
Patient Global Impression of Severity-Face (PGIS-F) | Proportion of responders based on PGIS-F at 24 and 26 weeks | 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 | 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 | 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 | 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 | 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 | 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) | 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) | Week 52 |
Frequently Asked Questions
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