CompletedPhase 3

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

China425 participantsStarted 2021-09-04

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24

Timeframe: Week 24

Trial details

NCT IDNCT05051761

SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-27

View on ClinicalTrials.gov More Alopecia Areata trials