Back to resultsA Phase II Study in Patients With Alopecia Areata
Primary Purpose
Alopecia Areata
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SHR0302
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata
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
Sites / Locations
- Quest Dermatology Research
- Moore Clinical Research
- Dawes Fretzin Clinical Research
- Skin Search of Rochester, Inc
- Dermatologists of Southwest Ohio
- The Skin Wellness Center
- Progressive Clinical Research
- St George Dermatology and Skin Cancer Centre
- Novatrials
- Veracity Clinical Research
- Skin Health Institute
- Sinclair Dermatology
- Sinclair Dermatology
- China-Japan Friendship Hospital
- Peking University First Hospital
- Peking University People's Hospital
- Beijing Friendship Hospital, Capital Medical University
- Beijing Tongren Hospital, Capital Medical University
- Beijing Friendship Hospital, Capital Medical University
- Beijing Tongren Hospital, Capital Medical University
- Peking University People's Hospital
- Chongqing Traditional Chinese medicine Hospital
- The First Affiliated Hospital of Chongqing Medical University
- The First Affiliated Hospital of Fujian Medical University
- Guangdong Provincial People's Hospital
- The Dermatology Hospital of Nanfang Medical University
- The Dermatology Hospital of Nanfang Medical University
- Henan Provincial People's Hospital
- Jiangsu Province People's Hospital
- The First Hospital of China Medical University
- Shanghai Skin Disease Hospital
- Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
- The First Affiliated Hospital of Zhejiang University
- SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
SHR0302 Dose#1
SHR0302 Dose#2
SHR0302 Dose#3
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04346316
First Posted
January 7, 2020
Last Updated
July 15, 2021
Sponsor
Reistone Biopharma Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT04346316
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reistone Biopharma Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR0302 Dose#1
Arm Type
Active Comparator
Arm Title
SHR0302 Dose#2
Arm Type
Active Comparator
Arm Title
SHR0302 Dose#3
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
Oral tablets taken once daily (QD)
Primary Outcome Measure Information:
Title
Percentage change from baseline in Severity of Alopecia Tool (SALT) score
Description
Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Quest Dermatology Research
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Moore Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Dawes Fretzin Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Skin Search of Rochester, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Dermatologists of Southwest Ohio
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
St George Dermatology and Skin Cancer Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Novatrials
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2289
Country
Australia
Facility Name
Veracity Clinical Research
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Skin Health Institute
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Sinclair Dermatology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing Traditional Chinese medicine Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400011
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510030
Country
China
Facility Name
The Dermatology Hospital of Nanfang Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Dermatology Hospital of Nanfang Medical University
City
Guangzhou
State/Province
Guangzhou
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Jiangsu Province People's Hospital
City
Nanjin
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Shanghai Skin Disease Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200071
Country
China
Facility Name
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300120
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
SIR RUN RUN Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310020
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study in Patients With Alopecia Areata
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