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ArticleDermatology and therapy2026

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

Tatjana Lukic, Pranab Ghosh, Lynne Napatalung, Cunshan Wang, Samantha K Kurosky, Iltefat Hamzavi, Rodney Sinclair, Leihong Xiang, Kenneth Steil, David Rosmarin and 3 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05583526 phase3completednot on this map

A phase 3 randomized, double-blind, 52-week placebo-controlled, multi-center study investigating the efficacy, safety, and tolerability of ritlecitinib in adult and adolescent participants with non segmental vitiligo

TypeinterventionalSponsorPfizerRan2022 to 2026Enrolled607ConditionsStable Nonsegmental Vitiligo, Active Nonsegmental VitiligoArmsRitlecitinib, Placebo
NCT06072183 phase3active not recruitingnot on this map

A phase 3 randomized, double-blind, 52-week placebo-controlled multi-center study with a double-blind 52-week extension period with randomized dose up/dose down titration investigating the efficacy, safety, and tolerability of ritlecitinib in adult participants with nonsegmental vitiligo

TypeinterventionalSponsorPfizerRan2023 to 2027Enrolled1,571ConditionsStable Nonsegmental Vitiligo, Active Nonsegmental VitiligoArmsRitlecitinib, Placebo
NCT06163326 phase3active not recruitingnot on this map

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

TypeinterventionalSponsorPfizerRan2024 to 2027Enrolled394ConditionsVitiligoArmsRitlecitinib, Ritlecitinib 100 mg, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Tatjana LukicPfizer Inc, New York, NY, USA.
Pranab GhoshPfizer Inc, Cambridge, MA, USA.
Lynne NapatalungPfizer Inc, New York, NY, USA.
Cunshan WangPfizer Inc, Groton, CT, USA.
Samantha K KuroskyPfizer Inc, New York, NY, USA.
Iltefat HamzaviHenry Ford Health, Detroit, MI, USA.
Rodney SinclairUniversity of Melbourne, Melbourne, VIC, Australia.
Leihong XiangHuashan Hospital, Fudan University, Shanghai, China.
Kenneth SteilCCT Research, Scottsdale, AZ, USA.
David RosmarinIndiana University School of Medicine, Indianapolis, IN, USA.
Davinder ParsadPostgraduate Institute of Medical Education and Research, Chandigarh, India.
Khaled EzzedineUniversité Paris-Est Créteil, Créteil, France.
Roni AdiriPfizer Pharmaceutical Israel Ltd, Arye Shenkar St 9, 4672509, Herzliya, Israel. Roni.Adiri@pfizer.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRitlecitinib 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.

methodsTranquillo (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.

Indexed as

Janus kinase 3Research designRitlecitinibTEC kinasesVitiligo

Identifiers

PMID42171987
PMCPMC13280265

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.