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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05583526
Registration number
NCT05583526
Ethics application status
Date submitted
6/10/2022
Date registered
17/10/2022
Date last updated
3/06/2024
Titles & IDs
Public title
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo
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Scientific title
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 NON SEGMENTAL VITILIGO
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Secondary ID [1]
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Tranquillo
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Secondary ID [2]
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B7981040
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Universal Trial Number (UTN)
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Trial acronym
Tranquillo
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stable Nonsegmental Vitiligo
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Active Nonsegmental Vitiligo
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Condition category
Condition code
Skin
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ritlecitinib
Treatment: Drugs - Placebo
Experimental: Ritlecitinib 50 mg - Ritlecitinib 50 mg QD (ritilecitinib 50 mg QD arm; approximately 400 participants)
Placebo Comparator: Placebo - Placebo (placebo arm; approximately 200 participants)
Treatment: Drugs: Ritlecitinib
50 mg capsule
Treatment: Drugs: Placebo
Matching capsule
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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US only Co-Primary Endpoints: Response based on Total body Vitiligo Area Scoring Index 75 (T-VASI75) at Week 52 and T-VASI50 at Week 52
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Assessment method [1]
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Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline) and T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)
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Timepoint [1]
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Week 52
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Primary outcome [2]
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Global (Other than US): Response based on Facial Vitiligo Area Scoring Index 75 (F-VASI75) at Week 52
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Assessment method [2]
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Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
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Timepoint [2]
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Week 52
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Primary outcome [3]
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Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs), leading to discontinuation, and clinically significant laboratory abnormalities
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Assessment method [3]
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safety and tolerability of ritlecitinib in participants with nonsegmental vitaligo
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Timepoint [3]
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Baseline through Week 52
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Secondary outcome [1]
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US-Only: Response based on F-VASI75 at 24, 26 and 52 weeks
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Assessment method [1]
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Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline.
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Timepoint [1]
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24, 36 and 52 Weeks
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Secondary outcome [2]
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US-Only: Response based on T-VASI50 at 24 and 36 weeks
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Assessment method [2]
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Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
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Timepoint [2]
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24 and 36 weeks
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Secondary outcome [3]
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Global (Other than US):Patient Global Impression of Severity-Face (PGIS-F)
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Assessment method [3]
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To assess the effect of ritlecitinib compared to placebo on the PGIS-F at Week 36 and 52
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Timepoint [3]
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Week 36 and week 52
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Secondary outcome [4]
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Global (Other than US): Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
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Assessment method [4]
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To assess the effect of ritlecitinib compared to placebo on the PGIS-V at Week 36 and 52
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Timepoint [4]
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Week 36 and week 52
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Secondary outcome [5]
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Global (Other Than US): Response based on T-VASI50 at Week 52
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Assessment method [5]
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Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline).
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Timepoint [5]
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Week 52
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Secondary outcome [6]
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Patient Global Impression of Change-Face (PGIC-F)
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Assessment method [6]
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To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Weeks 36 and 52.
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Timepoint [6]
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Week 36 and week 52
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Secondary outcome [7]
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Patient Global Impression of Change- Overall vitiligo(PGIC-V)
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Assessment method [7]
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To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Weeks 36 and 52.
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Timepoint [7]
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Week 36 and week 52
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Secondary outcome [8]
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Global (Other than US): Response based on F-VASI75 at 24 and 36 weeks
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Assessment method [8]
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Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline).
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Timepoint [8]
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Week 24 and week 36
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Secondary outcome [9]
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Global (Other than US): Response based on PGIS-V
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Assessment method [9]
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Proportion of participants achieving PGIC-V response
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Timepoint [9]
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36 and 52 weeks
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Secondary outcome [10]
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Global (Other than US): Response based on F-VASI75
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Assessment method [10]
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Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)
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Timepoint [10]
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24 and 36 weeks
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Secondary outcome [11]
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Change from baseline in Dermatology Life Quality Index (DLQI) or Children Dermatology Life Quality Index (CDLQI)
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Assessment method [11]
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To evaluate the change from baseline in DLQI or CDLQI at week 52
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Timepoint [11]
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Week 52
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Secondary outcome [12]
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Proportion of participants achieving disease stabilization
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Assessment method [12]
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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
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Timepoint [12]
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Baseline through week 52
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Secondary outcome [13]
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Response based on T-VASI50
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Assessment method [13]
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Proportion of participants achieving T-VASI50 (defined as at least 50% improvement in T-VASI from Baseline)
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Timepoint [13]
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Baseline through week 4, week 8, week 12, week 48.
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Secondary outcome [14]
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Response based on F-VASI75
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Assessment method [14]
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Proportion of participants achieving F-VASI75 (defined as at least 75% improvement in F-VASI from Baseline)
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Timepoint [14]
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Baseline through week 4, week 8, week 12, week 48.
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Secondary outcome [15]
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US only: Response based on T-VASI75
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Assessment method [15]
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Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)
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Timepoint [15]
0
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Baseline through week 4, week 8, week 12, week 24, week 36, week 48.
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Secondary outcome [16]
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Global (Other than US): Response based on T-VASI75
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Assessment method [16]
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Proportion of participants achieving T-VASI75 (defined as at least 75% improvement in T-VASI from Baseline)
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Timepoint [16]
0
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Baseline through week 52
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Secondary outcome [17]
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All Countries: Time to rescue medication
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Assessment method [17]
0
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Timepoint [17]
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Baseline through week 52
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Secondary outcome [18]
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Percentage change from baseline in F-VASI
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Assessment method [18]
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Timepoint [18]
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Baseline through week 52
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Secondary outcome [19]
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Percentage change from baseline in T-VASI
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Assessment method [19]
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Timepoint [19]
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Baseline through week 52
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Secondary outcome [20]
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Response based on T-VASI90
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Assessment method [20]
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Proportion of participants achieving T-VASI90 (defined as at least 90% improvement in T-VASI from Baseline)
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Timepoint [20]
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Baseline through week 52
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Secondary outcome [21]
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Response based on T-VASI100
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Assessment method [21]
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Proportion of participants achieving T-VASI100 (defined as at least 100% improvement in T-VASI from Baseline)
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Timepoint [21]
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Baseline through week 52
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Secondary outcome [22]
0
0
Response based on F-VASI50
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Assessment method [22]
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Proportion of participants achieving F-VASI50 (defined as at least 50% improvement in F-VASI from Baseline).
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Timepoint [22]
0
0
Baseline through week 52
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Secondary outcome [23]
0
0
Response based on F-VASI90
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Assessment method [23]
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0
Proportion of participants achieving F-VASI90 (defined as at least 50% improvement in F-VASI from Baseline).
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Timepoint [23]
0
0
Baseline through week 52
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Secondary outcome [24]
0
0
Response based on F-VASI100
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Assessment method [24]
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Proportion of participants achieving F-VASI100 (defined as at least 100% improvement in F-VASI from Baseline).
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Timepoint [24]
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Baseline through week 52
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Secondary outcome [25]
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Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
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Assessment method [25]
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To assess the effect of ritlecitinib compared to placebo on depression and anxiety subscales of the HADS at week 52
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Timepoint [25]
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Week 52
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Secondary outcome [26]
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The proportion of patients achieving absence of depression on HADS depression subscale
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Assessment method [26]
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Response based on a 'normal' subscale score indicative of an absence of depression (in participants with baseline HADS subscale scores indicative of depression)
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Timepoint [26]
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Week 52
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Secondary outcome [27]
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The proportion of patients achieving absence of anxiety on HADS anxiety subscale
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Assessment method [27]
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Response based on a 'normal' subscale score indicative of an absence of anxiety (in participants with baseline HADS subscale scores indicative of anxiety)
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Timepoint [27]
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Week 52
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Secondary outcome [28]
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0
US-Only: Patient Global Impression of Severity-Face (PGIS-F)
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Assessment method [28]
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To assess the effect of ritlecitinib compared to placebo on the PGIS-F at 52
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Timepoint [28]
0
0
Week 52
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Secondary outcome [29]
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0
US-Only: Patient Global Impression of Severity-Overall Vitiligo (PGIS-V)
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Assessment method [29]
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To assess the effect of ritlecitinib compared to placebo on the PGIS-V at 52
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Timepoint [29]
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Week 52
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Eligibility
Key inclusion criteria
1. Participants =18 years of age at Screening. Adolescents (12 to <18 years of age) are
also eligible for this study, but only if approved by the local IRB/EC and regulatory
health authority. Where these approvals have not been granted, only participants =18
years of age will be enrolled.
Disease Characteristics:
2. Eligible participants must have at both Screening and Baseline:
- A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and
- BSA involvement 4%-60% inclusive, excluding involvements at palms of the hands,
soles of the feet, or dorsal aspect of the feet; and
- BSA =0.5% involvement on the face (face is defined as including the area on the
forehead to the original hairline, on the cheek vertically to the jawline, and
laterally from the corner of the mouth to the tragus. The face will not include
scalp, ears, neck, or surface area of the lips, but will include the nose and the
eyelids; and
- F-VASI =0.5 & T-VASI =3; and
- Either active or stable disease nonsegmental vitiligo at both Screening and
Baseline visits. All participants who do not have the features of active vitiligo
(defined below) are required to have stable disease.
Active vitiligo is defined as:
- Participants will be classified as having active vitiligo based on the presence
of at least one active lesion at baseline defined as one of the following:
- New/extending lesion(s) in the 3 months prior to Screening visit (confirmed by
photographs or medical record):
- Confetti-like lesion(s); Confetti-like depigmentation is characterized by the
presence of numerous 1-mm to 5-mm depigmented macules in clusters;
- Trichrome lesion(s);Trichrome lesions have a hypopigmented zone of varying width
between normal and completely depigmented skin, resulting in 3 different hues of
skin;
- Koebner phenomenon/phenomena (excluding Type 1 [history based on isomorphic
reaction]). The Koebner phenomenon manifests as depigmentation at sites of
trauma, usually in a linear arrangement.
Stable vitiligo is defined as an absence of signs of active disease. All participants
who do not have the features of active vitiligo (defined above) are required to have
stable disease.
Eligibility is determined at Screening and Baseline based on the resulting scores from
the local in-person reads of F-VASI, T-VASI, and BSA.
Other
3. If receiving concomitant medications for any reason other than vitiligo, participant
must be on a stable regimen, which is defined as not starting a new drug or changing
dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1. Participant
must be willing to stay on a stable regimen during the duration of the study.
4. Must agree to stop all other treatments for vitiligo from Screening through the final
follow-up visit.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Any psychiatric condition including recent or active suicidal ideation or behavior
that meets any of the following criteria:
- Suicidal ideation associated with actual intent and a method or plan in the past
year: "Yes" answers on items 4 or 5 of the C-SSRS administered at the screening
visit.
- Previous history of suicidal behaviors in the past 5 years: "Yes" answer (for
events that occurred in the past 5 years) to any of the suicidal behavior items
of the C-SSRS.
- For adults, any lifetime history of serious suicidal ideation or behavior or
recurrent suicidal behavior. For adolescents, any previous lifetime history of
suicidal behavior.
2. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the
skin:
- Participants that have other types of vitiligo that do not meet criteria for
active or stable vitiligo as noted in inclusion criterion #2 (including, but not
limited to, segmental vitiligo and mixed vitiligo).
- Currently have active forms of other disorders of pigmentation (including but not
limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation
[melanoma and mycosis fungoides], post-inflammatory hypopigmentation, pityriasis
alba [minor manifestation of atopic dermatitis], senile leukoderma [age-related
depigmentation], chemical/drug-induced leukoderma, ataxia telangiectasia,
tuberous sclerosis, melasma (all types, including mixed), and congenital
hypopigmentation disorder including piebaldism, Waardenburg syndrome,
hypomelanosis of Ito, incontinentia pigmenti, dyschromatosis symmetrica
hereditarian, xeroderma pigmentosum, and nevus depigmentosus). NOTE: Coexistence
of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted.
- Currently have active forms of inflammatory skin disease(s) or evidence of skin
conditions (for example, morphea, discoid lupus, leprosy, syphilis, psoriasis,
seborrheic dermatitis) at the time of the Screening or Baseline Visit that in the
opinion of the investigator would interfere with evaluation of vitiligo or
response to treatment.
- Leukotrichia in more than 33% of the face surface area affected with vitiligo
lesions OR leukotrichia in more than 33% of the total body surface area affected
with vitiligo lesions.
- Have a superficial skin infections within 2 weeks prior to first dose on Day 1.
NOTE: participants may be rescreened after the infection resolves.
3. General Infection History:
- Having a history of systemic infection requiring hospitalization, parenteral
antimicrobial, antiviral (including biologic treatment), antiparasitic,
antiprotozoal, or antifungal therapy, or as otherwise judged clinically
significant by the investigator within 6 months prior to Day 1.
- Have active acute or chronic infection requiring treatment with oral antibiotics,
antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior
to Day 1. NOTE: participants may be rescreened after the infection resolves.
- Evidence or history of untreated, currently treated or inadequately treated
active or latent infection with Mycobacterium TB
4. Specific Viral Infection History:
- History (single episode) of disseminated herpes zoster or disseminated herpes
simplex, or a recurrent (more than one episode of) localized, dermatomal herpes
zoster.
- Infected with hepatitis B or hepatitis C viruses: all participants will undergo
screening for hepatitis B and C for eligibility.
- Participants who are positive for HCVAb and HCV RNA will not be eligible for this
study.
- Have a known immunodeficiency disorder (including positive serology for HIV at
screening) or a first-degree relative with a hereditary immunodeficiency.
5. Medical Conditions, Other:
- Current or recent history of clinically significant severe, progressive, or
uncontrolled renal (including but not limited to active renal disease or recent
kidney stones), hepatic, hematological, gastrointestinal, metabolic, endocrine
(eg, untreated hypovitaminosis D or hypothyroidism), pulmonary, cardiovascular,
psychiatric, immunologic/rheumatologic or neurologic disease; or have any other
severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration, or interfere with the interpretation of
study results; or in the opinion of the investigator or Pfizer (or designee), the
participant is inappropriate for entry into this study, or unwilling/unable to
comply with study procedures and lifestyle requirements.
- History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a
known allergy/hypersensitivity to any component (including excipients) of the
study intervention.
- Have hearing loss with progression over the previous 5 years, sudden hearing
loss, or middle or inner ear disease such as otitis media, cholesteatoma,
Meniere's disease, labyrinthitis, or other auditory condition that is considered
acute, fluctuating or progressive.
- Have a history of any lymphoproliferative disorder such as EBV-related
lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs
and symptoms suggestive of current lymphatic or lymphoid disease.
- Abnormal findings on the Screening chest imaging (eg, chest x-ray) including, but
not limited to, presence of active TB, general infections, cardiomyopathy, or
malignancy. Chest imaging may be performed up to 12 weeks prior to screening.
Documentation of the official reading must be located and available in the source
documentation.
- Long QT Syndrome, a family history of Long QT Syndrome, or a history of TdP.
- Have any malignancies or have a history of malignancies with the exception of
adequately treated or excised nonmetastatic basal cell or squamous cell cancer of
the skin or cervical carcinoma in situ.
- Significant trauma or major surgery within 1 month of the first dose of study
drug or considered in imminent need for surgery or with elective surgery
scheduled to occur during the study.
Prior/Concomitant Therapy:
6. Have received any of the prohibited treatment regimens specified.
Prior/Concurrent Clinical Study Experience:
7. Previous administration with an investigational drug or vaccine that do not affect
vitiligo within 4 weeks of Day 1 [Baseline] or within 5 half-lives, whichever is
longer.
Diagnostic Assessments:
8. Any of the following abnormalities in laboratory values at Screening, as assessed by
the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:
- Renal impairment
- Hepatic dysfunction
9. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities
Other
10. Investigator site staff directly involved in the conduct of the study and their family
members, site staff otherwise supervised by the investigator, and sponsor and sponsor
delegate employees directly involved in the conduct of the study and their family
members.
11. Adolescent participants 12 to <18 years of age without one of the following:
- Documented evidence from a health professional of having received varicella
vaccination (2 doses); or
- Evidence of prior exposure to VZV based on serological testing (ie, a positive
VZV IgG Ab result) at Screening.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/07/2025
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
0
0
The Skin Hospital - Darlinghurst
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Recruitment hospital [2]
0
0
North Eastern Health Specialists - Campbelltown
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Recruitment hospital [3]
0
0
Skin Health Institute Inc. - Carlton
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Recruitment hospital [4]
0
0
Dr Rodney Sinclair Pty Ltd - East Melbourne
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Recruitment hospital [5]
0
0
Sinclair Dermatology - East Melbourne
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Recruitment hospital [6]
0
0
The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
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Recruitment postcode(s) [2]
0
0
5074 - Campbelltown
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Recruitment postcode(s) [3]
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0
3053 - Carlton
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Recruitment postcode(s) [4]
0
0
3002 - East Melbourne
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Recruitment postcode(s) [5]
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0
3004 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
District of Columbia
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Indiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Louisiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Maryland
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Massachusetts
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Michigan
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Nebraska
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Country [12]
0
0
United States of America
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State/province [12]
0
0
New Mexico
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New York
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Country [14]
0
0
United States of America
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State/province [14]
0
0
North Carolina
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Ohio
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Country [16]
0
0
United States of America
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State/province [16]
0
0
South Carolina
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Texas
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Country [18]
0
0
Bulgaria
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State/province [18]
0
0
Dupnitsa
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Country [19]
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China
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China
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China
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China
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China
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Zhejiang
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Germany
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Italy
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Italy
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Milano
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Italy
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Italy
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Mexico
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Distrito Federal
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South Africa
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Madrid
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United Kingdom
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Funding & Sponsors
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Commercial sector/Industry
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Name
Pfizer
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Summary
Brief summary
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental
Vitiligo (Active and Stable) Tranquillo
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05583526
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Pfizer CT.gov Call Center
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1-800-718-1021
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05583526
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