Clinical trial NCT04346316: A Phase II Study in Patients With Alopecia Areata
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: Reistone Biopharma Company Limited
Sponsor class: INDUSTRY
First posted: 2020-04-15
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change from baseline in Severity of Alopecia Tool (SALT) score
timeFrame: week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Quest Dermatology Research
state: California
city: Brandon
country: United States
facility: Moore Clinical Research
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc
state: New York
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio
state: Ohio
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: Kogarah
country: Australia
facility: Novatrials
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Carlton
country: Australia
facility: Skin Health Institute
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Traditional Chinese medicine Hospital
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Dermatology Hospital of Nanfang Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Dermatology Hospital of Nanfang Medical University
state: Guangzhou
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanjin
country: China
facility: Jiangsu Province People's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: