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)
The First Affiliated Hospital of Chongqing Medical University
π¨π³Chongqing, Chongqing, China
The First Affiliated Hospital of Fujian Medical University
π¨π³Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
π¨π³Guangzhou, Guangdong, China
The Dermatology Hospital of Nanfang Medical University
π¨π³Guangzhou, Guangzhou, China
Henan Provincial People's Hospital
π¨π³Zhengzhou, Henan, China
The First Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
π¨π³Tianjin, Tianjin, China
Quest Dermatology Research
πΊπΈNorthridge, California, United States
Dawes Fretzin Clinical Research
πΊπΈIndianapolis, Indiana, United States
Skin Search of Rochester, Inc
πΊπΈRochester, New York, United States
Progressive Clinical Research
πΊπΈSan Antonio, Texas, United States
Novatrials
π¦πΊKogarah, New South Wales, Australia
SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
π¨π³Hangzhou, Zhejiang, China
Beijing Friendship Hospital, Capital Medical University
π¨π³Beijing, Beijing, China
China-Japan Friendship Hospital
π¨π³Beijing, Beijing, China
Peking University People's Hospital
π¨π³Beijing, Beijing, China
Chongqing Traditional Chinese medicine Hospital
π¨π³Chongqing, Chongqing, China
Moore Clinical Research
πΊπΈBrandon, Florida, United States
The Skin Wellness Center
πΊπΈKnoxville, Tennessee, United States
Dermatologists of Southwest Ohio
πΊπΈMason, Ohio, United States
Sinclair Dermatology
π¦πΊMelbourne, Victoria, Australia
Beijing Tongren Hospital, Capital Medical University
π¨π³Beijing, Beijing, China
Jiangsu Province People's Hospital
π¨π³Nanjin, Jiangsu, China
Shanghai Skin Disease Hospital
π¨π³Shanghai, Shanghai, China
The First Affiliated Hospital of Zhejiang University
π¨π³Hangzhou, Zhejiang, China
Skin Health Institute
π¦πΊCarlton, Victoria, Australia
St George Dermatology and Skin Cancer Centre
π¦πΊKogarah, New South Wales, Australia
Veracity Clinical Research
π¦πΊWoolloongabba, Queensland, Australia
Peking University First Hospital
π¨π³Beijing, Beijing, China