Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis

Suzhou Suncadia Biopharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: SHR-1314; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04840485

SHR-1314-302

Details and patient eligibility

About

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis

Enrollment: 548 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs

Exclusion criteria

• pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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548 participants in 3 patient groups, including a placebo group

Treatment group A

Experimental group

Treatment:

Drug: SHR-1314

Drug: SHR-1314

Treatment group B

Experimental group

Treatment:

Drug: SHR-1314

Drug: SHR-1314

Treatment group C

Placebo Comparator group

Treatment:

Drug: Placebo