Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active ankylosing spondylitis.
Eligibility Criteria
Inclusion
- Provide signed informed consent.
- AS diagnosis consistent with the Modified New York Criteria for AS (1984);
- Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 and a Patient's Assessment of Total Back Pain score \>= 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
- Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
- If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
- BMI ≥18 kg/m2
Exclusion
- Pregnant women or refuse to receive contraception during the study.
- Lab abnormality within 4 weeks of randomization as follows: WBC count \<3.0×10\^9/L；neutrophil count\<1.5×10\^9/L;hemoglobin level\<90.0 g/L ; platelet count \<100×10\^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
- History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
- Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 6 months of randomization.
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2023
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT04481139
Start Date
October 14 2020
End Date
May 12 2023
Last Update
July 27 2023
Active Locations (1)
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1
Zhanguo Li
Beijing, Beijing Municipality, China, 100044