A Phase II Study in Patients With Alopecia Areata
- Registration Number
- NCT04346316
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo SHR0302 - SHR0302 Dose#1 SHR0302 - SHR0302 Dose#2 SHR0302 - SHR0302 Dose#3 SHR0302 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Quest Dermatology Research
🇺🇸Northridge, California, United States
Moore Clinical Research
🇺🇸Brandon, Florida, United States
Dawes Fretzin Clinical Research
🇺🇸Indianapolis, Indiana, United States
Skin Search of Rochester, Inc
🇺🇸Rochester, New York, United States
Dermatologists of Southwest Ohio
🇺🇸Mason, Ohio, United States
The Skin Wellness Center
🇺🇸Knoxville, Tennessee, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
St George Dermatology and Skin Cancer Centre
🇦🇺Kogarah, New South Wales, Australia
Novatrials
🇦🇺Kogarah, New South Wales, Australia
Veracity Clinical Research
🇦🇺Woolloongabba, Queensland, Australia
Scroll for more (19 remaining)Quest Dermatology Research🇺🇸Northridge, California, United States