Back to resultsEvaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Core Treatment Active Experimental: SHR0302 Dose#1
Core Treatment Active Experimental: SHR0302 Dose#2
Core Treatment Placebo Comparator: Placebo
Extension Treatment Active Experimental: SHR0302 Dose#1
Extension Treatment Active Experimental: SHR0302 Dose#2
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg
- Subject has a diagnosis of atopic dermatitis for at least 1 year.
- Meets all of the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4
- Subject has a recent history (within 6 months before the screening visit) of inadequate response or inability to tolerate topical AD treatments (TCS or TCI) or who have required systemic treatments for control of their disease.
- Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
Exclusion Criteria:
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- Have received certain treatments that are contraindicated.
- Subject currently has been diagnosed and has active forms of other inflammatory skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with the evaluation of atopic dermatitis or response to treatment.
- Other active non-AD inflammatory skin diseases or conditions affecting skin
- Subject with active/severe concomitant disease (s)/symptom(s) that requires administering of systemic corticosteroids or otherwise interferes with study participation or requires active frequent monitoring (e.g., unstable chronic asthma).
- Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation.
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.
- Subject has a previously received systemic JAK inhibitors
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Sites / Locations
- Dermatology Research Institute Inc.
- Dr Chih-ho Hong Medical Inc.
- Enverus Medical Research
- Wiseman Dermatology Research
- CCA Medical Research
- SKiN Health
- DermEffects
- North York Research Inc.
- The Centre for Dermatology
- York Dermatology
- Toronto Research Centre
- Research Toronto
- AvantDerm
- XLR8 Clinical Research
- Clinique D
- First Affiliated Hospital of Anhui Medical University
- The second Affiliated Hospital of Anhui Medical University
- Peking University People's Hospital
- First Affiliated Hospital of Fujian Medical University
- Zhongshan Hospital, Fudan University(Xiamen Branch)
- Dermatology Hospital of Southern Medical University
- Guangdong Province Traditional Chinese Medical Hospital
- The First affiliated Hospital, Sun Yat-sen University
- Wuhan No.1 Hospital
- Xiangya Hospital of Central South University
- The Second Xiangya Hospital of Central South University
- Hospital for Skin Diseases, Chinese Academy of medical sciences
- Jiangsu province people's hospital
- Wuxi No.2 People's Hospital
- Affiliated Hospital of Jiangsu University
- Jiangxi Provincial Hospital of Dermatology
- The First Affiliated Hospital of Nanchang University
- The second Affiliated Hospital of Nanchang University
- The first hospital of jilin university
- West China Hospital of Sichuan University
- Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
- The First Affiliated Hospital of Zhejiang University School of Medicine
- The Children's Hospital Affiliated to Zhejiang University School of Medicine
- The first people's hospital of hangzhou
- The fourth hospital affiliated to zhejiang university school of medicine
- Beijing Children's Hospital, Capital Medical University
- Peking University third hospital
- Peking union medical college hospital
- Children's Hospital Capital Institute of Pediatrics
- The Third Xiangya Hospital of Central South University
- Chongqing Traditional Chinese medicine Hospital
- First affiliated hospital of chongqing medical university
- The Southwest Hospital of AMU
- Zhejiang province People's Hospital
- Dermatology hospital of Shanghai
- Huashan Hospital Affiliated to Fudan University
- The first hospital of China medical university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
Core Treatment Active Experimental: SHR0302 Dose#1
Core Treatment Active Experimental: SHR0302 Dose#2
Core Treatment Placebo Comparator: Placebo
Extension Treatment Active Experimental: SHR0302 Dose#1
Extension Treatment Active Experimental: SHR0302 Dose#2
Arm Description
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Outcomes
Primary Outcome Measures
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points at Week 16.
Eczema Area and Severity Index (EASI 75) at Week 16
Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at Week 16.
Secondary Outcome Measures
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) ≥4 from baseline at Week 16
Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12
Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits during placebo-controlled treatment phase other than Week 16.
Time to WI-NRS response
Time from baseline to achieve at least 4 points improvement of WI-NRS during placebo-controlled treatment phase.
EASI 75 at Week 1, 4, 8 and 12
Proportion of subjects achieving EASI 75 at all scheduled visits during placebo-controlled treatment phase except Week 16.
IGA 0/1 at Week 1, 4, 8 and 12
Proportion of subjects achieving IGA0/1 and a reduction from baseline of ≥2 points at all scheduled visits during placebo-controlled treatment phase except Week 16.
Full Information
NCT ID
NCT04875169
First Posted
May 1, 2021
Last Updated
May 31, 2023
Sponsor
Reistone Biopharma Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT04875169
Brief Title
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Official Title
A Randomized, Double Blind and Placebo Controlled Phase 3 Study to Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
May 23, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic dermatitis.
Detailed Description
This study consists of a screening period followed by a placebo-controlled treatment period and then an extension treatment period and completed after a follow-up period after the completion of active treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
336 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Core Treatment Active Experimental: SHR0302 Dose#1
Arm Type
Experimental
Arm Description
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Arm Title
Core Treatment Active Experimental: SHR0302 Dose#2
Arm Type
Experimental
Arm Description
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Arm Title
Core Treatment Placebo Comparator: Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks
Arm Title
Extension Treatment Active Experimental: SHR0302 Dose#1
Arm Type
Experimental
Arm Description
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Arm Title
Extension Treatment Active Experimental: SHR0302 Dose#2
Arm Type
Experimental
Arm Description
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Intervention Type
Drug
Intervention Name(s)
Core Treatment Active Experimental: SHR0302 Dose#1
Intervention Description
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Core Treatment Active Experimental: SHR0302 Dose#2
Intervention Description
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Core Treatment Placebo Comparator: Placebo
Intervention Description
Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Extension Treatment Active Experimental: SHR0302 Dose#1
Intervention Description
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Intervention Type
Drug
Intervention Name(s)
Extension Treatment Active Experimental: SHR0302 Dose#2
Intervention Description
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Primary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
Description
Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points at Week 16.
Time Frame
16 Weeks
Title
Eczema Area and Severity Index (EASI 75) at Week 16
Description
Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at Week 16.
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
Description
Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) ≥4 from baseline at Week 16
Time Frame
Week 16
Title
Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12
Description
Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits during placebo-controlled treatment phase other than Week 16.
Time Frame
Week 1, 4, 8 and 12
Title
Time to WI-NRS response
Description
Time from baseline to achieve at least 4 points improvement of WI-NRS during placebo-controlled treatment phase.
Time Frame
Baseline to Week 16
Title
EASI 75 at Week 1, 4, 8 and 12
Description
Proportion of subjects achieving EASI 75 at all scheduled visits during placebo-controlled treatment phase except Week 16.
Time Frame
Week 1, 4, 8 and 12
Title
IGA 0/1 at Week 1, 4, 8 and 12
Description
Proportion of subjects achieving IGA0/1 and a reduction from baseline of ≥2 points at all scheduled visits during placebo-controlled treatment phase except Week 16.
Time Frame
Week 1, 4, 8 and 12
Other Pre-specified Outcome Measures:
Title
NRS-4 at Week 24, 32, 40, 52 and 56
Description
Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits during extension treatment phase.
Time Frame
All scheduled visits from Week 24 - 56
Title
EASI 75 at Week 24, 32, 40, 52 and 56
Description
Proportion of subjects achieving EASI 75 at all scheduled visits during extension treatment phase.
Time Frame
All scheduled visits from Week 16 24 - 56
Title
IGA 0/1 at Week 24, 32, 40, 52 and 56
Description
Proportion of subjects achieving IGA0/1 and a reduction from baseline of ≥2 points at all scheduled visits during extension treatment phase.
Time Frame
All scheduled visits from Week 24 - 56
Title
EASI 50 and EASI 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Description
Proportion of subjects with ≥50% EASI improvement from baseline (EASI 50) at all scheduled visits.
Time Frame
Day 1 to Week 56
Title
Change of EASI from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Description
Change from baseline in the eczema area and severity index (EASI) total score at all scheduled visits. The EASI score ranges from 0.0 to 72.0, can be varied in increments of 0.1, Higher scores indicate greater severity.
Time Frame
Day 1 to Week 56
Title
SCORAD 50, SCORAD 75 and SCORAD 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Description
SCORing Atopic Dermatitis (SCORAD). Score of 0-103. Higher scores mean more severe. Proportion of subjects achieving a ≥50%, 75% and 90% improvement in SCORAD (SCORAD 50, SCORAD 75 and SCORAD 90) from baseline at all scheduled visits.
Time Frame
Day 1 to Week 56
Title
Change of SCORAD from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Description
Change from baseline in SCORAD at all scheduled visits
Time Frame
Day 1 to Week 56
Title
Change of BSA from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Description
Change from baseline in body surface area (BSA) affected at all scheduled visits
Time Frame
Day 1 to Week 56
Title
Change of IgE from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Description
Change from baseline in the level of serum IgE in peripheral blood at all scheduled visits.
Time Frame
Day 1 to Week 56
Title
Change of eosinophils from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Description
Change from baseline in the level of serum eosinophils in peripheral blood at all scheduled visits.
Time Frame
Day 1 to Week 56
Title
Change of dermatology life quality index (DLQI) or Children's DLQI (CDLQI) PROs from baseline at Week 4, 8, 12, 16, 24, 32, 40, 52 and 56
Description
Change from baseline in dermatology life quality index (DLQI) or Children's DLQI (CDLQI) score at all scheduled visits. The DLQI CDLQI consists of questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. This is not a scale. There are no minimum or maximum values. The quality index just captures a subjects perception of the impact of skin disease on different aspects of their health-related quality of life over the last week.
Time Frame
Day 1 to Week 56
Title
Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 4, 8, 12, 16, 24, 32, 40, 52 and 56
Description
Change from baseline in Patient-Oriented Eczema Measure (POEM) at all scheduled visits. 7-item, patient-administered scale that assesses disease severity in children and adults. Subjects respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week. Response categories include "No days," "1-2 days," "3-4 days," "5-6 days," and "Every day" with corresponding scores of 0, 1, 2, 3, and 4, respectively. Scores range from 0-28 with higher total scores indicating greater disease severity.
Time Frame
Day 1 to Week 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg
Subject has a diagnosis of atopic dermatitis for at least 1 year.
Meets all of the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4
Subject has a recent history (within 6 months before the screening visit) of inadequate response or inability to tolerate topical AD treatments (TCS or TCI) or who have required systemic treatments for control of their disease.
Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
Exclusion Criteria:
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
Have received certain treatments that are contraindicated.
Subject currently has been diagnosed and has active forms of other inflammatory skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with the evaluation of atopic dermatitis or response to treatment.
Other active non-AD inflammatory skin diseases or conditions affecting skin
Subject with active/severe concomitant disease (s)/symptom(s) that requires administering of systemic corticosteroids or otherwise interferes with study participation or requires active frequent monitoring (e.g., unstable chronic asthma).
Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation.
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.
Subject has a previously received systemic JAK inhibitors
Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
Facility Information:
Facility Name
Dermatology Research Institute Inc.
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Facility Name
Dr Chih-ho Hong Medical Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Wiseman Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
CCA Medical Research
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Facility Name
SKiN Health
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 0Z4
Country
Canada
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
North York Research Inc.
City
North York
State/Province
Ontario
ZIP/Postal Code
M2M 4J5
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
York Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Toronto Research Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
Research Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Facility Name
AvantDerm
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5A 3R6
Country
Canada
Facility Name
XLR8 Clinical Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Clinique D
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7N 6L2
Country
Canada
Facility Name
First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beiing
ZIP/Postal Code
100044
Country
China
Facility Name
First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Zhongshan Hospital, Fudan University(Xiamen Branch)
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Guangdong Province Traditional Chinese Medical Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Wuhan No.1 Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Hospital for Skin Diseases, Chinese Academy of medical sciences
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jiangsu province people's hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Wuxi No.2 People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Provincial Hospital of Dermatology
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The first hospital of jilin university
City
Changchun
State/Province
Jilin
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
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 School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
The Children's Hospital Affiliated to Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The first people's hospital of hangzhou
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The fourth hospital affiliated to zhejiang university school of medicine
City
Yiwu
State/Province
Zhejiang
Country
China
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100045
Country
China
Facility Name
Peking University third hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Peking union medical college hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Children's Hospital Capital Institute of Pediatrics
City
Beijing
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Chongqing Traditional Chinese medicine Hospital
City
Chongqing
Country
China
Facility Name
First affiliated hospital of chongqing medical university
City
Chongqing
Country
China
Facility Name
The Southwest Hospital of AMU
City
Chongqing
Country
China
Facility Name
Zhejiang province People's Hospital
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Facility Name
Dermatology hospital of Shanghai
City
Shanghai
Country
China
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
Country
China
Facility Name
The first hospital of China medical university
City
Shenyang
ZIP/Postal Code
110001
Country
China
12. IPD Sharing Statement
Learn more about this trial
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
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