Status:
COMPLETED
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Reistone Biopharma Company Limited
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2023
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT04875169
Start Date
April 30 2021
End Date
May 23 2023
Last Update
June 1 2023
Active Locations (52)
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1
Dermatology Research Institute Inc.
Calgary, Alberta, Canada, T2J 7E1
2
Dr Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada, V3R 6A7
3
Enverus Medical Research
Surrey, British Columbia, Canada, V3V 0C6
4
Wiseman Dermatology Research
Winnipeg, Manitoba, Canada, R3M 3Z4