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

NCT ID: NCT05255237

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-25

Study Completion Date

2024-06-28

Brief Summary

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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".

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Detailed Description

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Conditions

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Alopecia Areata

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Jaktinib

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

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

75mg BID

Interventions

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Jaktinib

75mg BID

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianzhong Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Qianjin Lu, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for skin diseases, Chinese Academy of Medical Sciences

Locations

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11 Xizhimen South Street

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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ZGJAK020

Identifier Type: -

Identifier Source: org_study_id

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