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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04346316




Registration number
NCT04346316
Ethics application status
Date submitted
7/01/2020
Date registered
15/04/2020
Date last updated
2/12/2020

Titles & IDs
Public title
A Phase II Study in Patients With Alopecia Areata
Scientific 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
Secondary ID [1] 0 0
RSJ10521
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR0302

Active Comparator: SHR0302 Dose#1 -

Active Comparator: SHR0302 Dose#2 -

Active Comparator: SHR0302 Dose#3 -

Placebo Comparator: Placebo -


Treatment: Drugs: SHR0302
Oral tablets taken once daily (QD)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
week 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [2] 0 0
Novatrials - Kogarah
Recruitment hospital [3] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [4] 0 0
Skin Health Institute - Carlton
Recruitment hospital [5] 0 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [6] 0 0
Sinclair Dermatology - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2289 - Kogarah
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
China
State/province [8] 0 0
Beijing
Country [9] 0 0
China
State/province [9] 0 0
Chongqing
Country [10] 0 0
China
State/province [10] 0 0
Fujian
Country [11] 0 0
China
State/province [11] 0 0
Guangdong
Country [12] 0 0
China
State/province [12] 0 0
Guangzhou
Country [13] 0 0
China
State/province [13] 0 0
Henan
Country [14] 0 0
China
State/province [14] 0 0
Jiangsu
Country [15] 0 0
China
State/province [15] 0 0
Liaoning
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
China
State/province [17] 0 0
Tianjin
Country [18] 0 0
China
State/province [18] 0 0
Zhejiang

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Reistone Biopharma Company Limited
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT04346316
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wenfeng Wu
Address 0 0
Country 0 0
Phone 0 0
08613810231439
Fax 0 0
Email 0 0
wenfeng.wu@reistonebio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04346316