Evidence map›Paper›PMID 39846397›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2025

Long-term safety and efficacy of ritlecitinib in adults and adolescents with alopecia areata and at least 25% scalp hair loss: Results from the ALLEGRO-LT phase 3, open-label study.

C Tziotzios, R Sinclair, A Lesiak, S Mehlis, M Kinoshita-Ise, A Tsianakas, X Luo, E H Law, R Ishowo-Adejumo, R Wolk and 2 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2025. 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 trial NCT04006457 (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), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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.

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
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

C TziotziosSt John's Institute of Dermatology, King's College London, London, UK.
R SinclairSinclair Dermatology, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0001-6751-1428
A LesiakDepartment of Dermatology, Pediatric Dermatology and Oncology, Medical University of Lodz, Lodz, Poland.
S MehlisDivision of Dermatology, Department of Medicine, NorthShore University HealthSystem, Evanston, Illinois, USA.
M Kinoshita-IseDepartment of Dermatology, Kyorin University Faculty of Medicine, Tokyo, Japan.
A TsianakasDepartment of Dermatology, Fachklinik Bad Bentheim, Bad Bentheim, Germany.
X LuoPfizer Inc, Groton, Connecticut, USA.
E H LawPfizer Inc, New York City, New York, USA.ORCID https://orcid.org/0000-0002-6111-8008
R Ishowo-AdejumoPfizer Inc, Collegeville, Pennsylvania, USA.
R WolkPfizer Inc, Groton, Connecticut, USA.
M SadrarhamiPfizer Inc, New York City, New York, USA.
A LejeunePfizer Inc, Paris, France.

Funding

Pfizer Inc
6 · The paper itself

Abstract

backgroundALLEGRO-LT is an ongoing, long-term, open-label, multicentre, phase 3 study of ritlecitinib in adults and adolescents with alopecia areata (AA).

objectivesTo evaluate ritlecitinib safety and efficacy through Month 24 in patients with AA and ≥25% scalp hair loss.

methodsALLEGRO-LT enrolled rollover patients who previously received study intervention in either ALLEGRO phase 2a or 2b/3 studies and de novo patients who had not received treatment in either study. The de novo cohort results are reported here. Patients aged ≥12 years with AA and ≥25% scalp hair loss received a daily, 4-week 200-mg ritlecitinib loading dose, followed by daily 50-mg ritlecitinib. Analyses are based on data up to the cut-off (December 2022). Efficacy outcomes included proportions of patients achieving Severity of Alopecia Tool (SALT) scores ≤20 and ≤10, Patient Global Impression of Change (PGI-C) score of 'moderately improved' or 'greatly improved' and eyebrow assessment (EBA) and eyelash assessment (ELA) response (≥2-grade improvement from baseline or normal score in patients with abnormal baseline EBA/ELA).

resultsMean (SD) ritlecitinib exposure among the 449 de novo patients enrolled was 728.7 (273.81) days. At Month 24 (as observed), 73.5% and 66.4% of patients achieved SALT score ≤20 and ≤10; 82.4% had PGI-C response; 60.8% and 65.7% had EBA and ELA response. 86.1% of patients reported treatment-emergent adverse events (AEs); most were mild or moderate in severity, with the most frequent being positive SARS-CoV-2 test (24.2%), headache (20.8%) and pyrexia (13.0%). Rates of serious AEs, severe AEs and treatment discontinuations were 4.9%, 6.0% and 6.5%, respectively. Herpes zoster infection occurred in six patients, serious infections in four, malignancies (excluding nonmelanoma skin cancer) in three and major adverse cardiovascular events in three.

conclusionsIn patients with AA and ≥25% scalp hair loss, ritlecitinib demonstrated clinical efficacy and had an acceptable safety profile with long-term treatment. CLINICAL

trial registrationClinicalTrials.gov NCT04006457.

Indexed as

Alopecia AreataAdolescentAdultFemaleHumansMaleMiddle AgedPyrimidinesPyrrolesTreatment OutcomeYoung AdultPF-06651600PyrimidinesPyrroles

Identifiers

PMID39846397
PMCPMC12105460

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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.