Clinical trial NCT04481139: A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Adaptive Seamless Phase 2/3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Ankylosing Spondylitis Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-22
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12.
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 24.
timeFrame: Week 24
measure: Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 12 and Week 24.
timeFrame: Week 12 and Week 24
measure: Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 5/6 response at Week 12 and Week 24.
timeFrame: Week 12 and Week 24
measure: Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Week 12 and Week 24
measure: Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24.
timeFrame: Week 12 and Week 24
measure: Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24.
timeFrame: Week 12 and Week 24
measure: Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24.
timeFrame: Week 12 and Week 24
measure: Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24.
timeFrame: Week 12 and Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhanguo Li
state: Beijing
Study officials:
References: