A Phase II Study in Patients With Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346316
• Other study ID #: RSJ10521
• Status: Completed
• Phase: Phase 2
• Start date: May 13, 2020
• Est. completion date: June 29, 2021

Study information

• Verified date: November 2020
• Source: Reistone Biopharma Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 29, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• SHR0302
Oral tablets taken once daily (QD)

Locations

Country	Name	City	State
Australia	Skin Health Institute	Carlton	Victoria
Australia	Sinclair Dermatology	East Melbourne	Victoria
Australia	Novatrials	Kogarah	New South Wales
Australia	St George Dermatology and Skin Cancer Centre	Kogarah	New South Wales
Australia	Sinclair Dermatology	Melbourne	Victoria
Australia	Veracity Clinical Research	Woolloongabba	Queensland
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Chongqing Traditional Chinese medicine Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The Dermatology Hospital of Nanfang Medical University	Guangzhou	Guangdong
China	The Dermatology Hospital of Nanfang Medical University	Guangzhou	Guangzhou
China	SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Province People's Hospital	Nanjin	Jiangsu
China	Shanghai Skin Disease Hospital	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin	Tianjin
China	Henan Provincial People's Hospital	Zhengzhou	Henan
United States	Moore Clinical Research	Brandon	Florida
United States	Dawes Fretzin Clinical Research	Indianapolis	Indiana
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Dermatologists of Southwest Ohio	Mason	Ohio
United States	Quest Dermatology Research	Northridge	California
United States	Skin Search of Rochester, Inc	Rochester	New York
United States	Progressive Clinical Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Reistone Biopharma Company Limited

Countries where clinical trial is conducted

United States,  Australia,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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