A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Preliminary Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR1501 Injection by in Patients With Active Axial Spondyloarthritis

GR1501-002

Dosage: 100mg or 200mg or 300mg Administration frequency: Q2W administration in the first 4 weeks (W0, W2, W4), and subsequent Q4W administration (W8, W12) Administration: subcutaneous injection Specifications: 100mg/ 1mL/bottle or placebo 0mg/1ml/ bottle

2020-09-07

2021-07-30

2021-11-02

Completed

Early phase I

160

Inclusion Criteria: 1. According with the diagnosis of axial spondyloarthritis (axSpA) by the Assessment of Spondyloarthritis International Society (ASAS);, 2. During the screening period, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 points and the Spinal Pain (BASDAI Article 2) NRS score ≥ 4 points; Exclusion Criteria: 1. Previous or current Crohn's disease; 2. Suffering from ulcerative enteritis and requiring immunosuppressive therapy at present;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 160 patients were enrolled in the planned trial, and after passing the screening period of 2 weeks, they were randomly assigned to the 100mg group, 200mg group, 300mg group or placebo group according to 1:1:1:1. After the completion of the 16-week administration period, the follow-up period (\\~24 weeks) was initiated.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ACTUAL'}}

2023-04-05