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Description of the Tranquillo Phase 3 Clinical Trial Designs/Study Protocols to Assess Ritlecitinib in Adults and
Tatjana Lukic1, Pranab Ghosh2, Lynne Napatalung1,3
1Pfizer Inc, New York, NY, USA.
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.
Gov Registrations:
NCT05583526, NCT06163326, NCT06072183.
Insights
The Tranquillo phase 3 program is evaluating ritlecitinib for nonsegmental vitiligo (NSV). This JAK3/TEC inhibitor shows promise in treating NSV in adults and adolescents.
Area of Science:
- Dermatology
- Immunology
- Pharmacology
Background:
- Ritlecitinib is an oral, selective Janus kinase 3 (JAK3) and TEC family kinase inhibitor.
- Nonsegmental vitiligo (NSV) is an autoimmune condition affecting skin pigmentation.
- Previous studies indicate ritlecitinib's efficacy and tolerability in NSV patients.
Purpose of the Study:
- To evaluate the efficacy, safety, and tolerability of ritlecitinib in adult and adolescent patients with NSV.
- To assess the effects of once-daily 50-mg and 100-mg ritlecitinib doses.
- To determine the durability of response and long-term safety profiles.
Main Methods:
- The Tranquillo phase 3 program includes three studies: Tranquillo, Tranquillo LTE, and Tranquillo 2.
- These are randomized, double-blind, placebo-controlled trials with extension phases.
- Participants aged ≥12 years with NSV are enrolled, with specific criteria for disease severity and body surface area involvement.
Main Results:
- Primary efficacy endpoints include achieving ≥75% improvement in Facial Vitiligo Area Scoring Index (F-VASI75) at Week 52.
- Coprimary/key secondary endpoints involve Total Vitiligo Area Scoring Index (T-VASI50) at Week 52.
- Safety and tolerability are assessed throughout all study phases.
Conclusions:
- The Tranquillo program aims to provide robust data on ritlecitinib's efficacy and safety for NSV treatment.
- Results will inform the potential use of ritlecitinib as a novel therapeutic option for NSV.
- Further analysis of the completed studies will establish the long-term benefits and risks.
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