A Phase II Study in Patients With Alopecia Areata
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
1 other identifier
interventional
94
3 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2020
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Start
First participant enrolled
May 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2021
CompletedJuly 16, 2021
November 1, 2020
1.1 years
January 7, 2020
July 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage change from baseline in Severity of Alopecia Tool (SALT) score
Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss
week 24
Study Arms (4)
SHR0302 Dose#1
ACTIVE COMPARATORSHR0302 Dose#2
ACTIVE COMPARATORSHR0302 Dose#3
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Quest Dermatology Research
Northridge, California, 91324, United States
Moore Clinical Research
Brandon, Florida, 33511, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46250, United States
Skin Search of Rochester, Inc
Rochester, New York, 14623, United States
Dermatologists of Southwest Ohio
Mason, Ohio, 45040, United States
The Skin Wellness Center
Knoxville, Tennessee, 37922, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, 2217, Australia
Novatrials
Kogarah, New South Wales, 2289, Australia
Veracity Clinical Research
Woolloongabba, Queensland, 4102, Australia
Skin Health Institute
Carlton, Victoria, 3053, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Sinclair Dermatology
Melbourne, Victoria, 3002, Australia
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Chongqing Traditional Chinese medicine Hospital
Chongqing, Chongqing Municipality, 400011, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510030, China
The Dermatology Hospital of Nanfang Medical University
Guangzhou, Guangdong, China
The Dermatology Hospital of Nanfang Medical University
Guangzhou, Guangzhou, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Jiangsu Province People's Hospital
Nanjin, Jiangsu, 210029, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200071, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
April 15, 2020
Study Start
May 13, 2020
Primary Completion
June 10, 2021
Study Completion
June 29, 2021
Last Updated
July 16, 2021
Record last verified: 2020-11