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

NCT06573593 | Recruiting

• 1 other identifier: 20240699
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alopecia Areata; Janus Kinase Inhibitors

Outcome Measures

Primary Outcomes (3)

• Mean SALT

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

  at week 24

• SALT50

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

  at week 24

• SALT75

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

  at week 24

Secondary Outcomes (4)

• Mean SALT

  at week 12, 36, 48, 56

• SALT50

  at week 12, 36, 48, 56

• SALT75

  at week 12, 36, 48, 56

• Safety profile

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

Study Arms (6)

Tofacitinib treated group

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

Drug: Tofacitinib

Baritinib treated group

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

Drug: Baricitinib

Ruxolitinib treated group

In the real-world settings, patients with AA treated with ruxolitinib

Drug: Ruxolitinib

Upadacitinib treated group

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

Drug: Upadacitinib

Abrocitinib treated group

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

Drug: Abrocitinib

Ritlecitinib treated group

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

Drug: Ritlecitinib

Interventions

Tofacitinib DRUG

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

Tofacitinib treated group

Baricitinib DRUG

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

Baritinib treated group

Ruxolitinib DRUG

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

Ruxolitinib treated group

Upadacitinib DRUG

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

Upadacitinib treated group

Abrocitinib DRUG

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

Abrocitinib treated group

Ritlecitinib DRUG

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

Ritlecitinib treated group

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with alopecia areata treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months in Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Interventions

tofacitinib; baricitinib; ruxolitinib; upadacitinib; abrocitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xianjie Wu, Ph.D

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru Dai, MD

CONTACT

15982215914; dairu@zju.edu.cn

Wu

CONTACT

wuxianjie@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 27, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)