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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
Sponsor:
Information provided by (Responsible Party):
Reistone Biopharma Company Limited

Study Description
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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.
Study Design
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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


Arms and Interventions
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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)


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Reistone Biopharma Company Limited
More Information
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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

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