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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

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening up to at least 30 days after last dose of study drug (week 52 or early termination)

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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