Clinical trial

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

Name

ZGJAK020

Description

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".

Trial arms

Trial start

2022-03-25

Estimated PCD

2024-06-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Jaktinib

75mg BID

Arms:

Jaktinib

Size

210

Primary endpoint

Number of subjects reporting treatment-emergent adverse events

Baseline through week 24

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 210, 'type': 'ESTIMATED'}}

Updated at

2023-10-23

1 organization

1 product

1 indication

Organization

Suzhou Zelgen Biopharmaceuticals

Product

Jaktinib

Indication

Alopecia Areata