Alopecia Areata
Conditions
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.
Interventions
DRUGSHR0302
Oral tablets taken once daily (QD)
Sponsors
Reistone Biopharma Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in Severity of Alopecia Tool (SALT) score | week 24 | Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss |
Countries
Australia, China, United States
Outcome results
None listed