Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Registration Number
- NCT04875169
- Lead Sponsor
- Reistone Biopharma Company Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Investigator's Global Assessment (IGA) score of 0/1 at Week 16 16 Weeks 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 16 Weeks 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
Name Time Method Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16 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 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 Baseline to Week 16 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 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 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.
Trial Locations
- Locations (52)
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
Clinique D
🇨🇦Laval, Quebec, Canada
Zhejiang province People's Hospital
🇨🇳Hangzhou, China
Hospital for Skin Diseases, Chinese Academy of medical sciences
🇨🇳Nanjing, Jiangsu, China
Dr Chih-ho Hong Medical Inc.
🇨🇦Surrey, British Columbia, Canada
Toronto Research Centre
🇨🇦Toronto, Ontario, Canada
Wiseman Dermatology Research
🇨🇦Winnipeg, Manitoba, Canada
Enverus Medical Research
🇨🇦Surrey, British Columbia, Canada
Zhongshan Hospital, Fudan University(Xiamen Branch)
🇨🇳Xiamen, Fujian, China
Wuxi No.2 People's Hospital
🇨🇳Wuxi, Jiangsu, China
Jiangsu province people's hospital
🇨🇳Nanjing, Jiangsu, China
Dermatology Research Institute Inc.
🇨🇦Calgary, Alberta, Canada
DermEffects
🇨🇦London, Ontario, Canada
CCA Medical Research
🇨🇦Ajax, Ontario, Canada
York Dermatology
🇨🇦Richmond Hill, Ontario, Canada
SKiN Health
🇨🇦Cobourg, Ontario, Canada
The second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Research Toronto
🇨🇦Toronto, Ontario, Canada
North York Research Inc.
🇨🇦North York, Ontario, Canada
XLR8 Clinical Research
🇨🇦Windsor, Ontario, Canada
The First affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking University People's Hospital
🇨🇳Beijing, Beiing, China
First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospital
🇨🇳Guangzhou, Guangdong, China
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Wuhan No.1 Hospital
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Jiangxi Provincial Hospital of Dermatology
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The first hospital of jilin university
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjin, Tianjin, China
The Children's Hospital Affiliated to Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The first people's hospital of hangzhou
🇨🇳Hangzhou, Zhejiang, China
The fourth hospital affiliated to zhejiang university school of medicine
🇨🇳Yiwu, Zhejiang, China
Beijing Children's Hospital, Capital Medical University
🇨🇳Beijing, China
Peking union medical college hospital
🇨🇳Beijing, China
Chongqing Traditional Chinese medicine Hospital
🇨🇳Chongqing, China
First affiliated hospital of chongqing medical university
🇨🇳Chongqing, China
Children's Hospital Capital Institute of Pediatrics
🇨🇳Beijing, China
The Southwest Hospital of AMU
🇨🇳Chongqing, China
Dermatology hospital of Shanghai
🇨🇳Shanghai, China
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, China
The first hospital of China medical university
🇨🇳Shenyang, China
AvantDerm
🇨🇦Toronto, Ontario, Canada
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Peking University third hospital
🇨🇳Beijing, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, China