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

NCT ID: NCT05051761

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-04
• Study Completion Date: 2023-12-27

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.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Jaktinib 50mg BID

Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks.

Group Type: EXPERIMENTAL

Jaktinib

Intervention Type: DRUG

Administered orally.

Jaktinib 75mg BID

Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks.

Group Type: EXPERIMENTAL

Jaktinib

Intervention Type: DRUG

Administered orally.

placebo

Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Administered orally.

Interventions

Jaktinib

Administered orally.

Intervention Type: DRUG

placebo

Administered orally.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Hospital for Skin Diseases, Chinese Academy of medical Sciences

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

ZGJAK018

Identifier Type: -

Identifier Source: org_study_id