A Phase II Study in Patients With Alopecia Areata

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Brief Title

A Phase II Study in Patients With Alopecia Areata

Official Title

A Randomized, Double Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 Tablets in Adult Patients With Alopecia Areata

Brief Summary

      This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational
      study drug (called SHR0302) in adults with moderate to severe alopecia areata.
    

Detailed Description

      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).
      This is a dose-ranging study, investigating 3 different dosing regimens. It will be
      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 2

Study Type

Interventional


Primary Outcome

Percentage change from baseline in Severity of Alopecia Tool (SALT) score


Condition

Alopecia Areata

Intervention

SHR0302

Study Arms / Comparison Groups

 SHR0302 Dose#1
Description:  

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

80

Start Date

May 13, 2020

Completion Date

November 30, 2021

Primary Completion Date

July 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female subjects between 18-65 years of age (both inclusive), at the time of
             informed consent;

          -  Must have moderate to severe alopecia areata.

        Exclusion Criteria:

          -  Other types of alopecia or other diseases that can cause hair loss

          -  Other scalp diseases that could interfere with assessment of hair loss/regrowth

          -  Any previous use of any Janus kinase (JAK) inhibitor
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, 086 21 68813356, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT04346316

Organization ID

RSJ10521


Responsible Party

Sponsor

Study Sponsor

Reistone Biopharma Company Limited


Study Sponsor

, , 


Verification Date

November 2019