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

Alopecia Areata Clinical Trial

— AA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05051761
• Other study ID #: ZGJAK018
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 4, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Jaktinib
Administered orally.
• placebo
Administered orally.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	Hospital for Skin Diseases, Chinese Academy of medical Sciences	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Week 24
Secondary	Percentage of Participants Achieving 50% Improvement of SALT (SALT50)	Percentage of participants achieving SALT50	Week 24