Extension Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata

Phase 3

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: Jaktinib

• Registration Number: NCT05255237
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

This study (Unique Protocol ID: ZGJAK020) as an extension of the ongoing "Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (Unique Protocol ID:ZGJAK020)" study. After completion of ZGJAK018 study, the study will be directly extend with an "open-label design".

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-02-24
• Study Start: 2022-03-25
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

• Subjects voluntarily sign the informed consent form.
• Patients who participated in ZGJAK018.

Exclusion Criteria

• Subjects who are unsuitable to the trial, as identified by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Jaktinib	Jaktinib	Patients will administer the study product twice per day for 24 weeks, for the safety assessment.

Primary Outcome Measures

Name	Time	Method
Number of subjects reporting treatment-emergent adverse events	Baseline through week 24	Patients with treatment-emergent adverse events/all patients \*100%

Trial Locations

Locations (1)

11 Xizhimen South Street; 🇨🇳 Beijing, Beijing, China