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
Overview
- Phase
- Phase 3
- Intervention
- Jaktinib
- Conditions
- Alopecia Areata
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Enrollment
- 425
- Locations
- 2
- Primary Endpoint
- Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Jaktinib 50mg BID
Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks.
Intervention: Jaktinib
Jaktinib 75mg BID
Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks.
Intervention: Jaktinib
placebo
Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
Intervention: placebo
Outcomes
Primary Outcomes
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24
Time Frame: Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
Secondary Outcomes
- Percentage of Participants Achieving 50% Improvement of SALT (SALT50)(Week 24)