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
Overview
- Phase
- Phase 2
- Intervention
- SHR0302
- Conditions
- Alopecia Areata
- Sponsor
- Reistone Biopharma Company Limited
- Enrollment
- 94
- Locations
- 29
- Primary Endpoint
- Percentage change from baseline in Severity of Alopecia Tool (SALT) score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Arms & Interventions
SHR0302 Dose#1
Intervention: SHR0302
SHR0302 Dose#2
Intervention: SHR0302
SHR0302 Dose#3
Intervention: SHR0302
Placebo
Intervention: SHR0302
Outcomes
Primary Outcomes
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