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

Hengrui Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: SHR0302 placebo; Drug: SHR0302

Study type: Interventional

Funder types: Industry

Identifiers

NCT04481139

SHR0302-302

Details and patient eligibility

About

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

Enrollment: 504 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

504 participants in 4 patient groups, including a placebo group

SHR0302 dose1

Experimental group

Description:

SHR0302 dose1 for 24 weeks

Treatment:

Drug: SHR0302

SHR0302 dose2

Experimental group

Description:

SHR0302 dose2 for 24 weeks

Treatment:

Drug: SHR0302

SHR0302 dose3

Experimental group

Description:

SHR0302 dose3 for 24 weeks

Treatment:

Drug: SHR0302

Placebo

Placebo Comparator group

Description:

Placebo for 12 weeks

Treatment:

Drug: SHR0302 placebo