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NCT Number: NCT06163326

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-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 and other market applications are pending.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Skin Hospital, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Ritlecitinib

Drug

Ritlecitinib 50 mg capsule once daily

Ritlecitinib 100 mg

Drug

Ritlecitinib 100 mg capsule once daily

Placebo

Drug

Matching capsule once daily

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation

    Time frame: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)

    To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo

  2. Incidence of clinically significant laboratory abnormalities

    Time frame: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)

    To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo

Secondary outcomes

  1. Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52

    Time frame: Baseline to week 52

    Proportion of participants achieving at least a 75% improvement in T-VASI from Baseline

  2. Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52

    Time frame: Baseline to week 52

    Proportion of participants achieving at least a 75% improvement in F-VASI from Baseline

  3. Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52

    Time frame: Baseline to Week 52

    Proportion of participants achieving at least a 50% improvement in T-VASI from Baseline

  4. Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52

    Time frame: Baseline to week 52

    Proportion of participants achieving at least a 50% improvement in F-VASI from Baseline

  5. Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52

    Time frame: Baseline to week 52

    Proportion of participants achieving at least a 90% improvement in T-VASI from Baseline

  6. Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52

    Time frame: Baseline to week 52

    Proportion of participants achieving at least a 90% improvement in F-VASI from Baseline

  7. Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52

    Time frame: Baseline to week 52

    Proportion of participants achieving at least a 100% improvement in T-VASI from Baseline

  8. Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52

    Time frame: Baseline to week 52

    Proportion of participants achieving at least a 100% improvement in F-VASI from Baseline

  9. Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52

    Time frame: Baseline to week 52

    To assess the effect of ritlecitinib compared to placebo on the PGIC-F at weeks 24, 36, and 52

  10. Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52

    Time frame: Baseline to week 52

    To assess the effect of ritlecitinib compared to placebo on the PGIC-V at Week 24, 36, and 52

  11. Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52

    Time frame: Baseline to week 52

    To assess the effect of ritlecitinib compared to placebo on the PGIC-F at Week 24, 36, and 52

  12. Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52

    Time frame: Baseline to week 52

    To assess the effect of ritlecitinib compared to placebo on the PGIC-V at weeks 24, 36, and 52

  13. Proportion of participants achieving disease stabilization

    Time frame: Baseline to week 52

    The difference in the proportion of participants with stable disease at all scheduled timepoints

  14. Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52

    Time frame: Baseline to week 52

    To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo

  15. Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52

    Time frame: Baseline to week 52

    To compare the efficacy of ritlecitinib 100mg QD, 50mg QD, and placebo

  16. Time to loss of response (<F-VASI75 and <T-VASI50 at the same visit).

    Time frame: Baseline to week 52

    To compare the efficacy of ritlecitinib 100 mg QD, 50 mg QD, and placebo

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Acronym: Tranquillo LTE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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