Evidence map›Paper›PMID 41917311›Full record

Trial reportAmerican journal of clinical dermatology2026

Long-Term Efficacy and Safety of Ritlecitinib in Adults and Adolescents with Alopecia Areata: 3-Year Results from the ALLEGRO Phase 2b/3 and ALLEGRO-LT Phase 3 Clinical Studies.

Maryanne Senna, Jennifer Soung, Ignasi Figueras, Brett King, Misaki Kinoshita-Ise, Sameh Hanna, Wenyu Wu, Dalia Wajsbrot, Deborah Woodworth, Robert Wolk and 3 more

Erratum issued 4 registry-linked trialsAbstract readClinical Trial, Phase IIIClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in American journal of clinical dermatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02974868 phase2completednot on this map

A phase 2a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety profile of pf-06651600 and pf-06700841 in subjects with moderate to severe alopecia areata with a single-blind extension period and a cross-over open label extension period

TypeinterventionalSponsorPfizerRan2016 to 2019Enrolled142ConditionsAlopecia AreataArmsPF-06651600, PF-06700841, Placebo
NCT03732807 phase2 / phase3completednot on this map

A phase 2b/3 randomized, double-blind, placebo-controlled, dose-ranging study to investigate the efficacy and safety of pf-06651600 in adult and adolescent alopecia areata (aa) subjects with 50% or greater scalp hair loss

TypeinterventionalSponsorPfizerRan2018 to 2021Enrolled718ConditionsAlopecia AreataArmsPF-06651600 Induction Dose, PF-06651600 Maintenance Dose #1, PF-06651600 Maintenance Dose #2, PF-06651600 Maintenance Dose #3, Placebo
NCT04006457 phase3completednot on this map

A phase 3 open-label, multi-center, long-term study investigating the safety and efficacy of pf-06651600 in adult and adolescent participants with alopecia areata

TypeinterventionalSponsorPfizerRan2019 to 2026Enrolled1,057ConditionsAlopecia AreataArmsPF-06651600, Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine, Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
NCT04517864 phase2terminatednot on this map

A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA

TypeinterventionalSponsorPfizerRan2020 to 2024Enrolled71ConditionsAlopecia AreataArmsPF-06651600, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Maryanne SennaLahey Hospital and Medical Center, Burlington, MA, USA.
Jennifer SoungSouthern California Dermatology, Inc, Santa Ana, CA, USA.
Ignasi FiguerasBellvitge Hospital, University of Barcelona, Barcelona, Spain.
Brett KingDermatology Physicians of Connecticut, Fairfield, CT, USA.
Misaki Kinoshita-IseDepartment of Dermatology, Kyorin University School of Medicine, Shinkawa, Mitaka, Tokyo, Japan.
Sameh HannaUniversity of Toronto, Toronto, ON, Canada.
Wenyu WuHuashan Hospital, Fudan University, Shanghai, China.
Dalia WajsbrotPfizer Inc, Groton, CT, USA.
Deborah WoodworthPfizer Inc, Collegeville, PA, USA.
Robert WolkPfizer Inc, Groton, CT, USA.
Alanna ChaudhryPfizer Inc, Collegeville, PA, USA.
Alexandre LejeunePfizer Inc, Paris, France.
Helen TranPfizer Inc, New York, NY, USA. Helen.Tran@pfizer.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectiveRitlecitinib, an oral JAK3/TEC family kinase inhibitor, demonstrated efficacy over 48 weeks in patients aged ≥ 12 years with alopecia areata (AA) in the ALLEGRO phase 2b/3 study and initial extension up to month 24 in the ALLEGRO-LT study. We aimed to evaluate the efficacy of ritlecitinib up to 3 years in patients with AA from the ALLEGRO phase 2b/3 and ongoing phase 3, open-label ALLEGRO-LT studies.

methodsPatients aged ≥ 12 years with AA and ≥ 50% scalp hair loss who received daily ritlecitinib 50 mg in ALLEGRO-2b/3 and rolled over to ALLEGRO-LT (continued 50 mg) were included. Observed and last observation carried forward (LOCF) data are reported based on the data cutoff (25 June 2024). Variables associated with treatment response were assessed using multivariable logistic regression.

resultsA total of 191 patients were included. At 3 years, 65.1% (observed) and 47.1% (LOCF) of patients had Severity of Alopecia Tool (SALT) score ≤ 20. Among patients with SALT score ≤ 20 at 1 year, most (88.3-89.6%) maintained this response at 3 years. SALT score ≤ 10 response rates at 3 years were 52.3% (observed) and 36.7% (LOCF). At 3 years, 31.2% (observed) and 22.5% (LOCF) of patients achieved SALT score 0 (complete scalp hair regrowth). Patients' Global Impression of Change response ("moderately" or "greatly" improved) rates at 3 years were 68.4% (observed) and 55.6% (LOCF). Female sex, White race, and less extensive and shorter duration of hair loss at baseline were associated with treatment response. The safety profile was consistent with the known safety profile of ritlecitinib.

conclusionsRitlecitinib 50 mg demonstrated clinically meaningful clinician- and patient-reported efficacy up to 3 years, with no new safety signals observed. These data support the long-term use of ritlecitinib in patients aged ≥ 12 years with severe AA. [Graphical abstract and video abstract available online.]. CLINICAL

trial registrationNCT03732807, NCT04006457, NCT04517864, NCT02974868.

Indexed as

Alopecia AreataProtein Kinase InhibitorsAdministration, OralAdolescentAdultChildFemaleFollow-Up StudiesHumansMaleMiddle AgedSeverity of Illness IndexTime FactorsTreatment OutcomeYoung AdultProtein Kinase Inhibitors

Identifiers

PMID41917311
PMCPMC13578053

What Socratic holds

Textmetadata
Read underepoch 390

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 Socratic graph.