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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04346316




Registration number
NCT04346316
Ethics application status
Date submitted
7/01/2020
Date registered
15/04/2020
Date last updated
16/07/2021

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
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2021
Sample size
Target
Accrual to date
Final
94
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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04346316