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Recruiting NCT06573593

Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

— Observational Alopecia Areata Janus Kinase Inhibitors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tofacitinib, Baricitinib, Ruxolitinib, Upadacitinib.
Who it may be relevant to
Registry conditions: Alopecia Areata, Janus Kinase Inhibitors. Basic parameters: 2 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study

Overview

The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.

Interventions

  • Drug Tofacitinib
    In the real-world settings, patients with AA treated with tofacitinib.
  • Drug Baricitinib
    In the real-world settings, patients with AA treated with Baricitinib.
  • Drug Ruxolitinib
    In the real-world settings, patients with AA treated with Ruxolitinib.
  • Drug Upadacitinib
    In the real-world settings, patients with AA treated with Upadacitinib.
  • Drug Abrocitinib
    In the real-world settings, patients with AA treated with Abrocitinib.
  • Drug Ritlecitinib
    In the real-world settings, patients with AA treated with Ritlecitinib.

Primary outcome measures

  • Mean SALT [Time frame: at week 24]
  • SALT50 [Time frame: at week 24]
  • SALT75 [Time frame: at week 24]
Secondary outcome measures (4)
  • Mean SALT [Time frame: at week 12, 36, 48, 56]
  • SALT50 [Time frame: at week 12, 36, 48, 56]
  • SALT75 [Time frame: at week 12, 36, 48, 56]
  • Safety profile [Time frame: at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56]

Eligibility criteria

Inclusion criteria

  • Patients with alopecia areata between 2 to 18 years old
  • Patients diagnosed with alopecia areata according to AA guideline
  • AA Patients treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months

Exclusion criteria

  • Patients had previously received hair implants
  • Other alopecia
  • Other diseases may induce alopecia including psoriasis, lichen planus, et al.
  • Unable to estimate SALT score at baseline or at follow-up
  • Patients are participating in other clinical trials

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Second Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou

Identifiers

NCT: NCT06573593 · 20240699

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗