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Ritlecitinib for Vitiligo (Tranquillo LTE Trial)

Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening up to at least 30 days after last dose of study drug (week 52 or early termination)
Awards & highlights

Summary

This trial is studying a medication called ritlecitinib to see how safe and effective it is in treating non-segmental vitiligo, a skin disorder characterized by white patches on the skin

Who is the study for?
This trial is for adults and adolescents who have non-segmental vitiligo and participated in the previous study B7981040 for 52 weeks. They must start this study within 30 days after their last visit in the prior study.
What is being tested?
The safety and effectiveness of Ritlecitinib, an oral medication, are being tested to see if it can maintain or improve skin repigmentation in patients with non-segmental vitiligo over a period of 52 weeks compared to a placebo.
What are the potential side effects?
While specific side effects for ritlecitinib in this trial aren't listed, common side effects may include reactions at the site of administration, headaches, nausea, and potential immune system impacts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening up to at least 30 days after last dose of study drug (week 52 or early termination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening up to at least 30 days after last dose of study drug (week 52 or early termination) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of clinically significant laboratory abnormalities
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
Secondary study objectives
Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52
Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52
Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment3 Interventions
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
Group II: Arm 1Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Ritlecitinib
2020
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,625 Previous Clinical Trials
14,283,794 Total Patients Enrolled
8 Trials studying Vitiligo
183,777 Patients Enrolled for Vitiligo
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,458,370 Total Patients Enrolled
3 Trials studying Vitiligo
2,416 Patients Enrolled for Vitiligo
~267 spots leftby Jan 2027
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