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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
425
Administered orally.
Administered orally.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Hospital for Skin Diseases, Chinese Academy of medical Sciences
Nanjing, Jiangsu, China
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at 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).
Time frame: Week 24
Percentage of Participants Achieving 50% Improvement of SALT (SALT50)
Percentage of participants achieving SALT50
Time frame: Week 24
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