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

Recruiting

• Conditions: Janus Kinase Inhibitors; Alopecia Areata
• Interventions: Drug: Baricitinib; Drug: Tofacitinib; Drug: Ruxolitinib; Drug: Upadacitinib; Drug: Ritlecitinib; Drug: Abrocitinib

• Registration Number: NCT06573593
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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 ifid...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-29
• Study First Submitted: 2024-08-25
• Study First Submitted QC: 2024-08-25
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Baritinib treated group	Baricitinib	In the real-world settings, patients with AA treated with baritinib.
Tofacitinib treated group	Tofacitinib	In the real-world settings, patients with AA treated with tofacitinib.
Ruxolitinib treated group	Ruxolitinib	In the real-world settings, patients with AA treated with ruxolitinib
Upadacitinib treated group	Upadacitinib	In the real-world settings, patients with AA treated with upadacitinib.
Ritlecitinib treated group	Ritlecitinib	In the real-world settings, patients with AA treated with ritlecitinib.
Abrocitinib treated group	Abrocitinib	In the real-world settings, patients with AA treated with abhicitinib.

Primary Outcome Measures

Name	Time	Method
Mean SALT	at week 24	Reduction of Severity of Alopecia Tool (SALT) score compared with baseline
SALT50	at week 24	Percentage of patient with more than 50% improvement in SALT score
SALT75	at week 24	Percentage of patient with more than 70% improvement in SALT score

Secondary Outcome Measures

Name	Time	Method
SALT75	at week 12, 36, 48, 56	Percentage of patient with more than 50% improvement in SALT score
Mean SALT	at week 12, 36, 48, 56	Reduction of Severity of Alopecia Tool (SALT) score compared with baseline
Safety profile	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.
SALT50	at week 12, 36, 48, 56	Percentage of patient with more than 75% improvement in SALT score

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China