Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06573593

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Janus Kinase Inhibitors Skin Diseases Skin and Connective Tissue Diseases

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Ru Dai, Ph.D

CONTACT

[email protected]

86 15982215914

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tofacitinib

Drug

In the real-world settings, patients with AA treated with tofacitinib.

Baricitinib

Drug

In the real-world settings, patients with AA treated with Baricitinib.

Ruxolitinib

Drug

In the real-world settings, patients with AA treated with Ruxolitinib.

Upadacitinib

Drug

In the real-world settings, patients with AA treated with Upadacitinib.

Abrocitinib

Drug

In the real-world settings, patients with AA treated with Abrocitinib.

Ritlecitinib

Drug

In the real-world settings, patients with AA treated with Ritlecitinib.

Primary outcomes

  1. Mean SALT

    Time frame: at week 24

    Reduction of Severity of Alopecia Tool (SALT) score compared with baseline

  2. SALT50

    Time frame: at week 24

    Percentage of patient with more than 50% improvement in SALT score

  3. SALT75

    Time frame: at week 24

    Percentage of patient with more than 70% improvement in SALT score

Secondary outcomes

  1. Mean SALT

    Time frame: at week 12, 36, 48, 56

    Reduction of Severity of Alopecia Tool (SALT) score compared with baseline

  2. SALT50

    Time frame: at week 12, 36, 48, 56

    Percentage of patient with more than 75% improvement in SALT score

  3. SALT75

    Time frame: at week 12, 36, 48, 56

    Percentage of patient with more than 50% improvement in SALT score

  4. Safety profile

    Time frame: at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56

    Any adverse events including infection, hypohepatia, thrombus, gastrointestinal reaction and any other system events.

Study contacts

Contact information is provided by the study sponsor or research team.

Ru Dai, MD

CONTACT

[email protected]

15982215914

Wu

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.