A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis

  • STATUS
    Recruiting
  • End date
    Feb 23, 2023
  • participants needed
    480
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 26 January 2021

Summary

This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active ankylosing spondylitis.

Details
Condition Ankylosing spondylitis, Ankylosing spondylitis
Treatment SHR0302, SHR0302 placebo
Clinical Study IdentifierNCT04481139
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

Pregnant women or refuse to receive contraception during the study
Lab abnormality within 4 weeks of randomization as follows: WBC count <3.010^9/Lneutrophil count<1.510^9/L;hemoglobin level<90.0 g/L ; platelet count <10010^9/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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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