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

October 20, 2023 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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

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".

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • 11 Xizhimen South Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects reporting treatment-emergent adverse events
Time Frame: Baseline through week 24
Patients with treatment-emergent adverse events/all patients *100%
Baseline through week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZGJAK020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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