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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06163326
Registration number
NCT06163326
Ethics application status
Date submitted
30/11/2023
Date registered
8/12/2023
Date last updated
4/12/2024
Titles & IDs
Public title
A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
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Scientific title
A PHASE 3 OPEN-LABEL, MULTI-CENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
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Secondary ID [1]
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2023-505804-42-00
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Secondary ID [2]
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B7981041
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Universal Trial Number (UTN)
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Trial acronym
Tranquillo LTE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
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 - Ritlecitinib 100 mg
Treatment: Drugs - Placebo
Experimental: Arm 1 - Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040.
Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.
Experimental: Arm 2 - Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned
Treatment: Drugs: Ritlecitinib
Ritlecitinib 50 mg capsule once daily
Treatment: Drugs: Ritlecitinib 100 mg
Ritlecitinib 100 mg capsule once daily
Treatment: Drugs: Placebo
Matching capsule once daily
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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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Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
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Assessment method [1]
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To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo
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Timepoint [1]
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Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
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Primary outcome [2]
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Incidence of clinically significant laboratory abnormalities
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Assessment method [2]
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To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo
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Timepoint [2]
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Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
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Secondary outcome [1]
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Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52
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Assessment method [1]
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Proportion of participants achieving at least a 75% improvement in T-VASI from Baseline
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Timepoint [1]
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Baseline to week 52
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Secondary outcome [2]
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Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52
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Assessment method [2]
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Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline
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Timepoint [2]
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Baseline to week 52
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Secondary outcome [3]
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Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52
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Assessment method [3]
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Proportion of participants achieving at least a 50% improvement in T-VASI from Baseline
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Timepoint [3]
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Baseline to Week 52
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Secondary outcome [4]
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Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52
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Assessment method [4]
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Proportion of participants achieving at least a 50% improvement in F-VASI from Baseline
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Timepoint [4]
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Baseline to week 52
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Secondary outcome [5]
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Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52
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Assessment method [5]
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Proportion of participants achieving at least a 90% improvement in T-VASI from Baseline
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Timepoint [5]
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Baseline to week 52
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Secondary outcome [6]
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Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52
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Assessment method [6]
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Proportion of participants achieving at least a 90% improvement in F-VASI from Baseline
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Timepoint [6]
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Baseline to week 52
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Secondary outcome [7]
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Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52
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Assessment method [7]
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Proportion of participants achieving at least a 100% improvement in T-VASI from Baseline
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Timepoint [7]
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Baseline to week 52
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Secondary outcome [8]
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Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52
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Assessment method [8]
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Proportion of participants achieving at least a 100% improvement in F-VASI from Baseline
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Timepoint [8]
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Baseline to week 52
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Secondary outcome [9]
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Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52
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Assessment method [9]
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To assess the effect of ritlecitinib compared to placebo on the PGIC-F at weeks 24, 36, and 52
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Timepoint [9]
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Baseline to week 52
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Secondary outcome [10]
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Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52
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Assessment method [10]
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To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Week 24, 36, and 52
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Timepoint [10]
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Baseline to week 52
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Secondary outcome [11]
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Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52
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Assessment method [11]
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To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Week 24, 36, and 52
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Timepoint [11]
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Baseline to week 52
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Secondary outcome [12]
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Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52
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Assessment method [12]
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To assess the effect of ritlecitinib compared to placebo on the PGIC-V at weeks 24, 36, and 52
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Timepoint [12]
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Baseline to week 52
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Secondary outcome [13]
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Proportion of participants achieving disease stabilization
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Assessment method [13]
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The difference in the proportion of participants with stable disease at all scheduled timepoints
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Timepoint [13]
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Baseline to week 52
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Secondary outcome [14]
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Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52
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Assessment method [14]
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To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo
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Timepoint [14]
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Baseline to week 52
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Secondary outcome [15]
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Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52
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Assessment method [15]
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To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo
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Timepoint [15]
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Baseline to week 52
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Eligibility
Key inclusion 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
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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
* 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
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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
19/01/2024
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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
30/01/2027
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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North Eastern Health Specialists - Campbelltown
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Recruitment hospital [2]
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Skin Health Institute Inc. - Carlton
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Recruitment hospital [3]
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Dr Rodney Sinclair Pty Ltd - East Melbourne
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Recruitment hospital [4]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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5074 - Campbelltown
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Recruitment postcode(s) [2]
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3053 - Carlton
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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California
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Florida
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United States of America
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Indiana
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Louisiana
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Maryland
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Michigan
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Ohio
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Bulgaria
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Kyustendil
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Bulgaria
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Sofia (stolitsa)
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Bulgaria
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Ontario
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China
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Liaoning
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Tokyo
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Japan
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Yamanashi
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Nuevo LEÓN
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Catalunya [cataluña]
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LAS Palmas
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Spain
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Madrid, Comunidad DE
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Spain
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Córdoba
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Turkey
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Istanbul
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Turkey
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Kayseri
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Turkey
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Manisa
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV). Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin. Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show: * if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo) * Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study * Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study. This study is seeking for participants who: * have non-segmental vitiligo (either active or stable) and * received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it. All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. At week 4 (or if it cannot be done then, at week 8) study visit, you must take the medication at the study site, and not at home. Participants may receive the study medicine or placebo for up to 52 weeks. The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo. Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study. Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.
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Trial website
https://clinicaltrials.gov/study/NCT06163326
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for public queries
Name
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Pfizer CT.gov Call Center
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Address
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Phone
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1-800-718-1021
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06163326
Download to PDF