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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05255237
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study Description
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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
Alopecia Areata Drug: Jaktinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : March 25, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of subjects reporting treatment-emergent adverse events [ Time Frame: Baseline through week 24 ]
    Patients with treatment-emergent adverse events/all patients *100%


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05255237


Contacts
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Contact: Xiaojun Wu +86-0512-57018308 wuxj@zelgen.com

Locations
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China, Beijing
11 Xizhimen South Street Recruiting
Beijing, Beijing, China
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
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Principal Investigator: Jianzhong Zhang, PhD Peking University People's Hospital
Principal Investigator: Qianjin Lu, PhD Hospital for skin diseases, Chinese Academy of Medical Sciences
More Information
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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT05255237    
Other Study ID Numbers: ZGJAK020
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical