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

Last updated: March 13, 2025
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Overall Status: Completed

Phase

3

Condition

Hair Loss

Alopecia

Treatment

Jaktinib

placebo

Clinical Study ID

NCT05051761
ZGJAK018
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 lastingnot exceeding ≤8 years.

  • At least 50% scalp hair loss.

  • Willing to comply with the study visits and requirements of the study protocol.

Exclusion

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

Total Participants: 425
Treatment Group(s): 2
Primary Treatment: Jaktinib
Phase: 3
Study Start date:
September 04, 2021
Estimated Completion Date:
December 27, 2023

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • Hospital for Skin Diseases, Chinese Academy of medical Sciences

    Nanjing, Jiangsu 210042
    China

    Site Not Available

  • No. 12, Jiangwangmiao Street, Xuanwu District

    Nanjing, Jiangsu 210042
    China

    Active - Recruiting

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