Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
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
1 other identifier
interventional
336
2 countries
52
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2021
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2021
CompletedFirst Submitted
Initial submission to the registry
May 1, 2021
CompletedFirst Posted
Study publicly available on registry
May 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2023
CompletedJune 1, 2023
March 1, 2023
1.3 years
May 1, 2021
May 31, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
16 Weeks
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.
16 Weeks
Secondary Outcomes (5)
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
Week 16
Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12
Week 1, 4, 8 and 12
Time to WI-NRS response
Baseline to Week 16
EASI 75 at Week 1, 4, 8 and 12
Week 1, 4, 8 and 12
IGA 0/1 at Week 1, 4, 8 and 12
Week 1, 4, 8 and 12
Other Outcomes (12)
NRS-4 at Week 24, 32, 40, 52 and 56
All scheduled visits from Week 24 - 56
EASI 75 at Week 24, 32, 40, 52 and 56
All scheduled visits from Week 16 24 - 56
IGA 0/1 at Week 24, 32, 40, 52 and 56
All scheduled visits from Week 24 - 56
- +9 more other outcomes
Study Arms (5)
Core Treatment Active Experimental: SHR0302 Dose#1
EXPERIMENTALDrug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Core Treatment Active Experimental: SHR0302 Dose#2
EXPERIMENTALDrug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Core Treatment Placebo Comparator: Placebo
PLACEBO COMPARATORDrug: Placebo Oral tablets taken once daily (QD) for 16 weeks
Extension Treatment Active Experimental: SHR0302 Dose#1
EXPERIMENTALDrug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Extension Treatment Active Experimental: SHR0302 Dose#2
EXPERIMENTALDrug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Interventions
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Dermatology Research Institute Inc.
Calgary, Alberta, T2J 7E1, Canada
Dr Chih-ho Hong Medical Inc.
Surrey, British Columbia, V3R 6A7, Canada
Enverus Medical Research
Surrey, British Columbia, V3V 0C6, Canada
Wiseman Dermatology Research
Winnipeg, Manitoba, R3M 3Z4, Canada
CCA Medical Research
Ajax, Ontario, L1S 7K8, Canada
SKiN Health
Cobourg, Ontario, K9A 0Z4, Canada
DermEffects
London, Ontario, N6H 5L5, Canada
North York Research Inc.
North York, Ontario, M2M 4J5, Canada
The Centre for Dermatology
Richmond Hill, Ontario, L4B 1A5, Canada
York Dermatology
Richmond Hill, Ontario, L4C 9M7, Canada
Toronto Research Centre
Toronto, Ontario, M3H 5Y8, Canada
Research Toronto
Toronto, Ontario, M4W 2N4, Canada
AvantDerm
Toronto, Ontario, M5A 3R6, Canada
XLR8 Clinical Research
Windsor, Ontario, N8W 1E6, Canada
Clinique D
Laval, Quebec, H7N 6L2, Canada
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beiing, 100044, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Zhongshan Hospital, Fudan University(Xiamen Branch)
Xiamen, Fujian, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, Guangdong, China
The First affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Hospital for Skin Diseases, Chinese Academy of medical sciences
Nanjing, Jiangsu, China
Jiangsu province people's hospital
Nanjing, Jiangsu, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, 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
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, 300120, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, 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, 100045, China
Peking University third hospital
Beijing, 100191, China
Peking union medical college hospital
Beijing, 100730, China
Children's Hospital Capital Institute of Pediatrics
Beijing, China
The Third Xiangya Hospital of Central South University
Changsha, 410013, China
Chongqing Traditional Chinese medicine Hospital
Chongqing, China
First affiliated hospital of chongqing medical university
Chongqing, China
The Southwest Hospital of AMU
Chongqing, China
Zhejiang province People's Hospital
Hangzhou, 310014, China
Dermatology hospital of Shanghai
Shanghai, China
Huashan Hospital Affiliated to Fudan University
Shanghai, China
The first hospital of China medical university
Shenyang, 110001, China
Related Publications (1)
Zhao Y, Gooderham M, Yang B, Wu J, Wu L, Loo WJ, Toth D, Sauder M, Li J, Chen A, Tao X, Lu J, Song Z, Han J, Li H, Li Y, Xu L, Zhang J. Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):688-697. doi: 10.1001/jamadermatol.2025.0982.
PMID: 40305055DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2021
First Posted
May 6, 2021
Study Start
April 30, 2021
Primary Completion
August 12, 2022
Study Completion
May 23, 2023
Last Updated
June 1, 2023
Record last verified: 2023-03