The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands. Ritlecitinib has been tested in earlier clinical studies and has a favorable safety profile. At present there are no approved medications taken by mouth to treat nonsegmental vitiligo. This study is seeking participants who: * Are 18 years of age or older. * are confirmed to have nonsegmental vitiligo for at least 3 months. * Are willing to stop all other treatments that they may be taking for vitiligo. In this study participants will be chosen by chance, like drawing names out of a hat to receive 1 of 3 treatments: •Part I where two different amounts of ritlecitinib (50 mg and 100 mg) are taken once daily. It will be compared to placebo. Placebo is a dummy capsule. It doesn't have any medicine used in the study. Participants receiving placebo who have not responded to treatment after 52 weeks will be given 100 milligrams or 50 milligrams of ritlecitinib for the remaining 52 weeks of the study. • In Part II, participants will only receive 100 milligrams of ritlecitinib. About 1000 participants will take part in Part I and around 450 in Part II globally. The study will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help see if ritlecitinib is safe and effective. People in Part I will be in this study for about 26 months and people in Part II will be in this study for about 14 months. During the study, participants in part I will need to visit the study site at least 17 times. In part II, participants will visit at least 11 times. Participants will undergo various tests and procedures such as: * vitiligo rating, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG, * photographs of areas with vitiligo. Participants will be asked to complete questionnaires about their vitiligo.
Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,571
Center for Dermatology and Plastic Surgery/CCT Research
Scottsdale, Arizona, United States
Dermatology Trial Associates
Bryant, Arkansas, United States
First OC Dermatology Research Inc
Fountain Valley, California, United States
Seaside Audiology Vertigo & Ear Specialists
Huntington Beach, California, United States
Wallace Medical Group, Inc
Los Angeles, California, United States
US only Co-Primary Endpoints: Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52 and Total body Vitiligo Area Scoring Index 50 (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: 52 Weeks
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: 52 Weeks
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) leading to discontinuation.
To evaluate the safety and tolerability of ritlecitinib in adult participants with non segmental vitiligo
Time frame: Baseline through 108 weeks
Incidence of Clinically significant laboratory abnormalities.
Time frame: Baseline through 108 weeks
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: 24 and 36 Weeks
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: 24 and 36 weeks
Global (Other than US):Patient Global Impression of Severity-Face (PGIS-F)
To assess the effect of ritlecitinib compared to placebo on the PGIS-F at Week 24, 36 and 52
Time frame: Week 24, 36 and week 52
Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
To assess the effect of ritlecitinib compared to placebo on the PGIS-V at Week 24, 36 and 52
Time frame: Week 24, 36 and week 52
Global (Other Than US): Response based on T-VASI50 at Week 24, 36 and 52
Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
Time frame: Week 24, 36 and 52
Patient Global Impression of Change-Face (PGIC-F)
To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Weeks 36 and 52.
Time frame: Week 36 and week 52
Patient Global Impression of Change- Overall vitiligo(PGIC-V)
To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Weeks 36 and 52.
Time frame: Week 36 and week 52
Change from baseline in Dermatology Life Quality Index (DLQI)
To evaluate the change from baseline in DLQI at week 52
Time frame: Week 52
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 and 100mg compared to placebo
Time frame: Baseline through week 104
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, week 56, week 60, week 64, week 76, week 88 and week 104.
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, week 56, week 60, week 64, week 76, week 88 and week 104.
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, week 56, week 60, week 64, week 76, week 88 and week 104.
Global (Other than US): 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 52
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
Time to rescue medication use
Time frame: Baseline through week 104
US-Only: Percentage change from baseline (% CFB) in F-VASI at Weeks 24, 36 and 52
To compare the efficacy of ritlecitinib 100 mg QD versus placebo on % CFB in F-VASI at Weeks 24, 36 and 52
Time frame: Weeks 24, 36 and 52
US-Only: % CFB in T-VASI at weeks 24, 36 and 52
To compare the efficacy of ritlecitinib 100 mg QD versus placebo on % CFB in T-VASI at Weeks 24,36 and 52
Time frame: Weeks 24, 36 and 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-VASI90 (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 104
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
US-Only: Patient Global Impression of Severity-Face (PGIS-F)
To assess the effect of ritlecitinib compared to placebo on the PGIS-F at 52
Time frame: Week 52
US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
To assess the effect of ritlecitinib compared to placebo on the PGIS-V at 52
Time frame: Week 52
% CFB in F-VASI at Week 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104.
To compare the efficacy of ritlecitinib 100 mg QD versus placebo on % CFB in F-VASI at all time points
Time frame: Baseline through week 104
% CFB in T-VASI at Week 4, 8, 12, 48, 56, 60, 64, 76, 88 and 104.
To compare the efficacy of ritlecitinib 100 mg QD versus placebo on % CFB in T-VASI at all time points
Time frame: Baseline through week 104
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kaiser Permanente
Oakland, California, United States
Cura Clinical Research - Oxnard
Oxnard, California, United States
Mission Dermatology Center
Rancho Santa Margarita, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
...and 220 more locations