Clinical trial NCT04875169: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Reistone Biopharma Company Limited
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 336
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg
2. Subject has a diagnosis of atopic dermatitis for at least 1 year.
3. Meets all of the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥16. IGA ≥3. WI-NRS ≥4
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.
5. Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).

Exclusion Criteria:

1. 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.
2. Have received certain treatments that are contraindicated.
3. 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.
4. Other active non-AD inflammatory skin diseases or conditions affecting skin
5. 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).
6. Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation.
7. 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.
8. Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
9. 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.
10. Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.
11. Subject has a previously received systemic JAK inhibitors
12. Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study

Primary outcomes:
measure: Investigator's Global Assessment (IGA) score of 0/1 at Week 16
timeFrame: 16 Weeks
measure: Eczema Area and Severity Index (EASI 75) at Week 16
timeFrame: 16 Weeks
Secondary outcomes:
measure: Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
timeFrame: Week 16
measure: Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12
timeFrame: Week 1, 4, 8 and 12
measure: Time to WI-NRS response
timeFrame: Baseline to Week 16
measure: EASI 75 at Week 1, 4, 8 and 12
timeFrame: Week 1, 4, 8 and 12
measure: IGA 0/1 at Week 1, 4, 8 and 12
timeFrame: Week 1, 4, 8 and 12
Other outcomes:
measure: NRS-4 at Week 24, 32, 40, 52 and 56
timeFrame: All scheduled visits from Week 24 - 56
measure: EASI 75 at Week 24, 32, 40, 52 and 56
timeFrame: All scheduled visits from Week 16 24 - 56
measure: IGA 0/1 at Week 24, 32, 40, 52 and 56
timeFrame: All scheduled visits from Week 24 - 56
measure: EASI 50 and EASI 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
timeFrame: Day 1 to Week 56
measure: Change of EASI from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
timeFrame: Day 1 to Week 56
measure: SCORAD 50, SCORAD 75 and SCORAD 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
timeFrame: Day 1 to Week 56
measure: Change of SCORAD from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
timeFrame: Day 1 to Week 56
measure: Change of BSA from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
timeFrame: Day 1 to Week 56
measure: Change of IgE from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
timeFrame: Day 1 to Week 56
measure: Change of eosinophils from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
timeFrame: Day 1 to Week 56
measure: 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
timeFrame: Day 1 to Week 56
measure: Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 4, 8, 12, 16, 24, 32, 40, 52 and 56
timeFrame: Day 1 to Week 56
Locations:
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc.
state: Alberta
city: Surrey
country: Canada
facility: Dr Chih-ho Hong Medical Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research
state: Manitoba
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Cobourg
country: Canada
facility: SKiN Health
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: North York
country: Canada
facility: North York Research Inc.
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Toronto
country: Canada
facility: AvantDerm
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Clinical Research
state: Ontario
city: Laval
country: Canada
facility: Clinique D
state: Quebec
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beiing
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital, Fudan University(Xiamen Branch)
state: Fujian
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Province Traditional Chinese Medical Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Wuhan
country: China
facility: Wuhan No.1 Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Hospital for Skin Diseases, Chinese Academy of medical sciences
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu province people's hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi No.2 People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial Hospital of Dermatology
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The first hospital of jilin university
state: Jilin
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Children's Hospital Affiliated to Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The first people's hospital of hangzhou
state: Zhejiang
city: Yiwu
country: China
facility: The fourth hospital affiliated to zhejiang university school of medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University third hospital
city: Beijing
country: China
facility: Peking union medical college hospital
city: Beijing
country: China
facility: Children's Hospital Capital Institute of Pediatrics
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
city: Chongqing
country: China
facility: Chongqing Traditional Chinese medicine Hospital
city: Chongqing
country: China
facility: First affiliated hospital of chongqing medical university
city: Chongqing
country: China
facility: The Southwest Hospital of AMU
city: Hangzhou
country: China
facility: Zhejiang province People's Hospital
city: Shanghai
country: China
facility: Dermatology hospital of Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
city: Shenyang
country: China
facility: The first hospital of China medical university
Study officials:
References: