Authorised Therapeutic confirmatory (Phase III) nonsegmental vitiligo

A Phase 3 Placebo-Controlled Study With Randomized Dose Up/Dose Down Extension Period Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib 100 mg and 50 mg QD in Adult Participants with Nonsegmental Vitiligo

EU CTIS ID: 2022-502518-98-00

What this study is testing

Part Ia: 1. To compare the efficacy of ritlecitinib 100 mg QD versus placebo in participants with nonsegmental vitiligo 2. To evaluate the safety and tolerability of ritlecitinib over time in participants with nonsegmental vitiligo Part Ib: To evaluate the long-term safety and tolerability of ritlecitinib 100 mg QD, ritlecitinib 50 mg QD, and placebo in adult participants with nonsegmental vitiligo Part II: To evaluate the safety and tolerability of ritlecitinib 100 mg QD in adult participants with nonsegmental vitiligo

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Participants must be ≥18 years of age at Screening.
  • Eligible participants must have at both Screening and BL: • A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and • Body surface area (BSA) involvement between 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 and T-VASI ≥3; and • Either active or stable nonsegmental vitiligo at both Screening and BL visits. All participants who do not have the features of active vitiligo (defined below) will be classified as having stable disease.

You likely can't join if

  • Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Australia
  • South Africa
  • Taiwan
  • Canada
  • China
  • United Kingdom
  • Turkey
  • Mexico
  • Japan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Australia; South Africa; Taiwan; Canada; China; United Kingdom and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.