NCT05051761

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	Jaktinib	Administered orally.
DRUG	placebo	Administered orally.

Timeline

• Start date: 2021-09-04
• Primary completion: 2023-12-27
• Completion: 2023-12-27
• First posted: 2021-09-21
• Last updated: 2025-03-14

Locations

2 sites across 1 country: China