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Clinical trial

Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (AA)

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Last updated:28th Nov 2022
Status: Recruiting
Identifier: NCT05051761
Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (AA)

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 (Clinical Trial)
Estimated Enrollment: 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: September 4, 2021
Estimated Primary Completion Date: December 2023
Estimated Study Completion Date: December 2023

- Experimental: Jaktinib 50mg BID
- Experimental: Jaktinib 75mg BID
- Placebo Comparator: placebo

Category Value
Study type(s) Interventional
Estimated enrolment 420
Actual Study start date 04 September 2021
Estimated Study Completion Date 01 December 2023

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