Evidence map›Paper›PMID 39924925›Full record

ArticlePediatric dermatology

A Phase 1, Open-Label Study of the Pharmacokinetics of Ritlecitinib in Children Aged 6-12 Years With Alopecia Areata.

Mercedes E Gonzalez, John Browning, Stacy Smith, Anna Plotka, Jing Daisy Zhu, Shyam Parvatini, Yeamin Huh, Robert Wolk

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Pediatric dermatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05650333 (AN INTERVENTIONAL PK, PD, PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE PK AND PD OF MULTIPLE-DOSE RITLECITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT05650333 phase1completednot on this map

An interventional pk, pd, phase 1, open-label study to investigate pk and pd of multiple-dose ritlecitinib in children 6 to less than 12 years of age with severe alopecia areata

TypeinterventionalSponsorPfizerRan2023 to 2023Enrolled15ConditionsAlopecia AreataArmsRitlecitinib 20 mg
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
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

8 authors.

Mercedes E GonzalezPediatric Skin Research, Coral Gables, Florida, USA.
John BrowningUniversity of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
Stacy SmithCalifornia Dermatology and Clinical Research Institute, Encinitas, California, USA.
Anna PlotkaPfizer Inc, Collegeville, Pennsylvania, USA.
Jing Daisy ZhuPfizer Inc, Collegeville, Pennsylvania, USA.
Shyam ParvatiniPfizer Healthcare India Pvt Ltd, Chennai, India.
Yeamin HuhPfizer Inc, Groton, Connecticut, USA.
Robert WolkPfizer Inc, Groton, Connecticut, USA.

Funding

Pfizer
6 · The paper itself

Abstract

backgroundAlopecia areata (AA) is an autoimmune disease characterized by hair loss that can negatively impact quality of life. AA has a significant pediatric prevalence; however, no systemic treatments are approved for AA in patients aged < 12 years. Ritlecitinib, a JAK3/TEC family kinase inhibitor, is approved to treat adults and adolescents with severe AA aged ≥ 12 years. This study evaluated ritlecitinib pharmacokinetic (PK) parameters and safety in pediatric patients with AA aged 6 to < 12 years.

methodsIn this single-group, uncontrolled, open-label study, participants received ritlecitinib 20 mg once daily for 7 days. PK parameters of ritlecitinib on Day 7 were measured and summarized descriptively. Safety outcomes, including incidence of adverse events (AEs), were evaluated.

resultsFifteen participants were enrolled and 14 (93.3%) completed the study. The median time to maximum concentration (T

conclusionsRitlecitinib PK parameters in pediatric patients were successfully characterized in the present study. Ritlecitinib 20 mg once daily was generally well tolerated in pediatric patients with AA.

trial registrationNCT05650333.

Indexed as

Alopecia AreataProtein Kinase InhibitorsChildFemaleHumansMaleProtein Kinase Inhibitorsalopecia areatachildrenclinical trialpediatricspharmacokinetics

Identifiers

PMID39924925
PMCPMC12285561

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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.