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

Phase 3

Completed

• Conditions: Alopecia Areata
• Interventions: Drug: placebo; Drug: Jaktinib

• Registration Number: NCT05051761
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-04
• Study First Submitted: 2021-09-11
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-21
• Primary Completion: 2023-12-27
• Study Completion: 2023-12-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
Jaktinib 50mg BID	Jaktinib	Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks.
Jaktinib 75mg BID	Jaktinib	Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24	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 Outcome Measures

Name	Time	Method
Percentage of Participants Achieving 50% Improvement of SALT (SALT50)	Week 24	Percentage of participants achieving SALT50

Trial Locations

Locations (2)

Hospital for Skin Diseases, Chinese Academy of medical Sciences; 🇨🇳 Nanjing, Jiangsu, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China