We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

A Phase II Study in Patients With Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04346316
Recruitment Status : Completed
First Posted : April 15, 2020
Last Update Posted : July 16, 2021
Information provided by (Responsible Party):
Reistone Biopharma Company Limited

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: SHR0302 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 13, 2020
Actual Primary Completion Date : June 10, 2021
Actual Study Completion Date : June 29, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: SHR0302 Dose#1 Drug: SHR0302
Oral tablets taken once daily (QD)

Active Comparator: SHR0302 Dose#2 Drug: SHR0302
Oral tablets taken once daily (QD)

Active Comparator: SHR0302 Dose#3 Drug: SHR0302
Oral tablets taken once daily (QD)

Placebo Comparator: Placebo Drug: SHR0302
Oral tablets taken once daily (QD)

Primary Outcome Measures :
  1. Percentage change from baseline in Severity of Alopecia Tool (SALT) score [ Time Frame: week 24 ]
    Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346316

Show Show 34 study locations
Sponsors and Collaborators
Reistone Biopharma Company Limited
Layout table for additonal information
Responsible Party: Reistone Biopharma Company Limited
ClinicalTrials.gov Identifier: NCT04346316    
Other Study ID Numbers: RSJ10521
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical