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

  • STATUS
    Recruiting
  • End date
    Dec 28, 2023
  • participants needed
    420
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Updated on 28 May 2022
areata alopecia

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.

Details
Condition Alopecia Areata
Treatment Placebo, Jaktinib
Clinical Study IdentifierNCT05051761
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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