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

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Brief Title

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

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20

Secondary Outcome

 Percentage of Participants Achieving 50% Improvement of SALT (SALT50)

Condition

Alopecia Areata

Intervention

Jaktinib

Study Arms / Comparison Groups

 Jaktinib 50mg BID
Description:  Jaktinib administered orally. Placebo administered orally to maintain the blind.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

390

Start Date

October 2021

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects 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:

          -  Subject has taken a JAK inhibitor prior to randomization;

          -  Subjects who are unsuitable to the trial, as identified by the investigator.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Jianzhong Zhang, PhD, +86-0731-85295999, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05051761

Organization ID

ZGJAK018


Responsible Party

Sponsor

Study Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd


Study Sponsor

Jianzhong Zhang, PhD, Principal Investigator, Peking University People's Hospital


Verification Date

September 2021