A Phase III Extended Clinical Trial of Long-term Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis

ZGJAK026

To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis

2023-01-11

2024-12-01

2024-12-01

Recruiting

Early phase I

400

Inclusion Criteria: * The investigator thinks that the subject can continue to benefit from participating in the extension trial; * Fully understand the extension trial and sign the informed consent form; * Complete the ZGJAK025 trial for 16 weeks and have good compliance; * It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks; Exclusion Criteria: * Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal; * The investigator thinks that the subject is not suitable for the trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}

2024-03-06