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

NCT ID: NCT04481139

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2023-05-12

Brief Summary

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

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SHR0302 dose1

SHR0302 dose1 for 24 weeks

Group Type: EXPERIMENTAL

SHR0302

Intervention Type: DRUG

SHR0302, oral, once daily

SHR0302 dose2

SHR0302 dose2 for 24 weeks

Group Type: EXPERIMENTAL

SHR0302

Intervention Type: DRUG

SHR0302, oral, once daily

SHR0302 dose3

SHR0302 dose3 for 24 weeks

Group Type: EXPERIMENTAL

SHR0302

Intervention Type: DRUG

SHR0302, oral, once daily

Placebo

Placebo for 12 weeks

Group Type: PLACEBO_COMPARATOR

SHR0302 placebo

Intervention Type: DRUG

SHR0302 placebo, oral, once daily

Interventions

SHR0302

SHR0302, oral, once daily

Intervention Type: DRUG

SHR0302 placebo

SHR0302 placebo, oral, once daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhanguo Li

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

SHR0302-302

Identifier Type: -

Identifier Source: org_study_id