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NCT06163326 · ClinicalTrials.gov registry record · Phase 3

A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

A Phase 3 study of Vitiligo, sponsored by Pfizer.

Recruiting
Registry status
Phase 3
Development phase
400
Enrollment target
20
Study locations

NCT06163326 is a Phase 3 study of Vitiligo that is actively recruiting participants, run by Pfizer. The registered enrollment target is 400 participants, below the 1,098-participant average among 15 other Vitiligo trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT06163326, a Phase 3 study of Vitiligo, is actively recruiting participants, sponsored by Pfizer.

RECRUITING
Registry status
Phase 3
Development phase
400 participants
Enrollment target
20
Study locations

Study 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. On study visit days, 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 a

Conditions Studied

Vitiligo

Interventions

  • DRUG Placebo
  • DRUG Ritlecitinib 100 mg
  • DRUG Ritlecitinib

Study Locations (20)

North Carolina

  • University of North Carolina Medical Center - Chapel Hill
  • Clinical & Translational Research Center (CTRC) - Chapel Hill
  • Accellacare - Wilmington - Wilmington
  • Wilmington Health, PLLC - Wilmington

California

  • California Dermatology & Clinical Research Institute - Encinitas
  • Marvel Clinical Research - Huntington Beach
  • Wallace Medical Group, Inc - Los Angeles

Florida

  • Encore Medical Research of Boynton Beach - Boynton Beach
  • Skin Care Research - Hollywood
  • ForCare Clinical Research - Tampa

Ohio

  • University Hospitals Cleveland Medical Center - Cleveland
  • Remington-Davis, Inc - Columbus

Indiana

  • Dawes Fretzin Clinical Research Group, LLC - Indianapolis

Louisiana

  • DelRicht Research - Baton Rouge

Maryland

  • Lawrence J. Green, MD LLC - Rockville

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2024-01-19
Est. Completion 2027-04-23
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06163326

The ClinicalTrials.gov registry entry for NCT06163326 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,098-participant average among 15 other Vitiligo trials with a reported enrollment target (64% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Vitiligo appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT06163326 reports 20 study locations spanning 12 distinct geographic areas - top geographies include North Carolina, California, Florida.

Frequently Asked Questions

What is clinical trial NCT06163326 about?

NCT06163326 is a clinical study titled "A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo". 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-...

What is the current status of trial NCT06163326?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2024-01-19. Estimated completion is 2027-04-23.

What conditions does trial NCT06163326 study?

This clinical trial studies the following conditions: Vitiligo.

What interventions are being tested in trial NCT06163326?

The interventions under investigation include: Placebo (DRUG), Ritlecitinib 100 mg (DRUG), Ritlecitinib (DRUG).

Who is sponsoring clinical trial NCT06163326?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06163326 being conducted?

This trial has 20 study locations across California, Florida, Indiana, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.