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

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05255237
Collaborator
(none)
210
1
18

Study Details

Study Description

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".

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Adult Patients With Moderate to Severe Alopecia Areata
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Jaktinib

Patients will administer the study product twice per day for 24 weeks, for the safty assessment.

Drug: Jaktinib
75mg BID

Outcome Measures

Primary Outcome Measures

  1. Number of subjects reporting treatment-emergent adverse events [Baseline through week 24]

    Patients with treatment-emergent adverse events/all patients *100%

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

  • Principal Investigator: Jianzhong Zhang,, PhD, Peking University People's Hospital
  • Principal Investigator: Qianjin Lu, PhD, Hospital for skin diseases, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT05255237
Other Study ID Numbers:
  • ZGJAK020
First Posted:
Feb 24, 2022
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2022