A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Jaktinib in Adult Patients With Severe Alopecia Areata

ZGJAK018

This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called Jaktinib) in adults (≥18 years and \<65 years) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

2021-09-04

2024-12-01

2024-12-01

Active (not recruiting)

Early phase I

420

Inclusion Criteria: * participants voluntarily sign the informed consent form (ICF); * Age ≥ 18 years and \<65 years, either male or female; * Clinical presentation compatible with alopecia areata with a current episode lasting not exceeding ≤8 years. * At least 50% scalp hair loss. * Willing to comply with the study visits and requirements of the study protocol. Exclusion Criteria: * participants has taken a JAK inhibitor prior to randomization; * participants who are unsuitable to the trial, as identified by the investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 420, 'type': 'ESTIMATED'}}

2024-03-06