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Introduction <p>Ritlecitinib is an oral, selective inhibitor of JAK3 and TEC family kinases under investigation for the treatment of nonsegmental vitiligo (NSV). In a phase 2b study, ritlecitinib was efficacious and well tolerated over 48&#xa0;weeks. The Tranquillo phase 3 program comprises three studies aiming to evaluate the efficacy, safety, and tolerability of once-daily 50-mg and 100-mg ritlecitinib in adult and adolescent patients with NSV.</p> Methods <p>Tranquillo (NCT05583526), a randomized, double-blind, placebo-controlled 52-week trial, compares the efficacy and safety of once-daily 50-mg ritlecitinib vs placebo (<i>N</i> ≈ 600). Tranquillo LTE (NCT06163326), a randomized, double-blind, withdrawal and dose-up titration 52-week extension study, investigates the safety, tolerability, and efficacy of once-daily 50-mg and 100-mg ritlecitinib and durability of response with once-daily 50-mg ritlecitinib following participation in Tranquillo (<i>N</i> ≈ 400). Tranquillo 2 (NCT06072183) comprises two parts: Part I, a 52-week randomized, double-blind, placebo-controlled study with 52-week extension with randomized dose-up/dose-down titration comparing once-daily 50-mg and 100-mg ritlecitinib with placebo (<i>N</i> ≈ 1000), and Part II, a de novo 52-week nonrandomized, open-label once-daily 100-mg ritlecitinib arm (<i>N</i> ≈ 450).</p> <p>Participants are aged ≥ 12&#xa0;years (Tranquillo 2: ≥ 18&#xa0;years) with clinical diagnosis of active or stable NSV for ≥ 3&#xa0;months, body surface area involvement 4%–60%, facial body surface area ≥ 0.5%, Facial Vitiligo Area Scoring Index (F-VASI) ≥ 0.5, and Total (T)-VASI ≥ 3.</p> Planned Outcomes <p>Tranquillo’s primary efficacy endpoint is the proportion of participants achieving ≥ 75% improvement in F-VASI from baseline (F-VASI75) at Week 52; T-VASI50 at Week 52 is a coprimary efficacy endpoint in the US and a key secondary endpoint globally (other than US). Tranquillo LTE’s primary endpoint is safety. Tranquillo 2’s primary efficacy endpoint is F-VASI75 at Week 52; T-VASI50 at Week 52 is a coprimary efficacy endpoint in the US and a key secondary endpoint globally (other than US). In all three studies, the safety and tolerability of ritlecitinib are assessed throughout.</p> <p>Graphical abstract available for this article.</p> Clinicaltrials.gov Registrations <p>NCT05583526, NCT06163326, NCT06072183.</p> Graphical abstract <p></p>

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Description of the Tranquillo Phase 3 Clinical Trial Designs/Study Protocols to Assess Ritlecitinib in Adults and Adolescents with Nonsegmental Vitiligo

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月22日

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  • Tatjana Lukic,
  • Pranab Ghosh,
  • Lynne Napatalung,
  • Cunshan Wang,
  • Samantha K. Kurosky,
  • Iltefat Hamzavi,
  • Rodney Sinclair,
  • Leihong Xiang,
  • Kenneth Steil,
  • David Rosmarin,
  • Davinder Parsad,
  • Khaled Ezzedine,
  • Roni Adiri

摘要

Introduction

Ritlecitinib is an oral, selective inhibitor of JAK3 and TEC family kinases under investigation for the treatment of nonsegmental vitiligo (NSV). In a phase 2b study, ritlecitinib was efficacious and well tolerated over 48 weeks. The Tranquillo phase 3 program comprises three studies aiming to evaluate the efficacy, safety, and tolerability of once-daily 50-mg and 100-mg ritlecitinib in adult and adolescent patients with NSV.

Methods

Tranquillo (NCT05583526), a randomized, double-blind, placebo-controlled 52-week trial, compares the efficacy and safety of once-daily 50-mg ritlecitinib vs placebo (N ≈ 600). Tranquillo LTE (NCT06163326), a randomized, double-blind, withdrawal and dose-up titration 52-week extension study, investigates the safety, tolerability, and efficacy of once-daily 50-mg and 100-mg ritlecitinib and durability of response with once-daily 50-mg ritlecitinib following participation in Tranquillo (N ≈ 400). Tranquillo 2 (NCT06072183) comprises two parts: Part I, a 52-week randomized, double-blind, placebo-controlled study with 52-week extension with randomized dose-up/dose-down titration comparing once-daily 50-mg and 100-mg ritlecitinib with placebo (N ≈ 1000), and Part II, a de novo 52-week nonrandomized, open-label once-daily 100-mg ritlecitinib arm (N ≈ 450).

Participants are aged ≥ 12 years (Tranquillo 2: ≥ 18 years) with clinical diagnosis of active or stable NSV for ≥ 3 months, body surface area involvement 4%–60%, facial body surface area ≥ 0.5%, Facial Vitiligo Area Scoring Index (F-VASI) ≥ 0.5, and Total (T)-VASI ≥ 3.

Planned Outcomes

Tranquillo’s primary efficacy endpoint is the proportion of participants achieving ≥ 75% improvement in F-VASI from baseline (F-VASI75) at Week 52; T-VASI50 at Week 52 is a coprimary efficacy endpoint in the US and a key secondary endpoint globally (other than US). Tranquillo LTE’s primary endpoint is safety. Tranquillo 2’s primary efficacy endpoint is F-VASI75 at Week 52; T-VASI50 at Week 52 is a coprimary efficacy endpoint in the US and a key secondary endpoint globally (other than US). In all three studies, the safety and tolerability of ritlecitinib are assessed throughout.

Graphical abstract available for this article.

Clinicaltrials.gov Registrations

NCT05583526, NCT06163326, NCT06072183.

Graphical abstract