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

Jiangsu HengRui Medicine Co., Ltd.504 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

504

Conditions

Ankylosing Spondylitis

Interventions

SHR0302DRUG

SHR0302, oral, once daily

SHR0302 placeboDRUG

SHR0302 placebo, oral, once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 \<3.0×10\^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.

Locations (1)

Zhanguo Li

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12.

ASAS20 is defined as a \>= 20% improvement and an absolute improvement of \>= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of \>= 20% and a net worsening of \>= 1 unit \[on a scale of 0 to 10\])

Time frame: Week 12

Secondary Outcomes

Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 24.

Time frame: Week 24

Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 12 and Week 24.

ASAS40 is defined as a \>= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.

Time frame: Week 12 and Week 24

Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 5/6 response at Week 12 and Week 24.

ASAS5/6 is defined as an improvement of at least 20 % in at least five of these six domains (patient global, pain, function, inflammation, CRP, and spinal mobility).

Time frame: Week 12 and Week 24

Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Data from ClinicalTrials.gov

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