to Evaluate the Preliminary Efficacy and Safety of GR1501 Injection in Patients With Active Axial Spondyloarthritis

Genrix (Shanghai) Biopharmaceutical

Status and phase: Completed; Phase 2

Conditions: Axial Spondyloarthritis

Treatments: Biological: IL-17A antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT05162937

GR1501-002

Details and patient eligibility

About

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

Full description

This is a randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy, safety, pharmacokinetic, and immunogenicity of GR1501 injection (IL-17A antiboby) at different doses and dosing frequency in patients with active axial spinal arthritis.

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

Treatment group 1

Experimental group

Description:

Drug：GR1501 100mg

Treatment:

Biological: IL-17A antibody

Treatment group 2

Experimental group

Description:

Drug：GR1501 200mg

Treatment:

Biological: IL-17A antibody

Treatment group 3

Experimental group

Description:

Drug：GR1501 300mg

Treatment:

Biological: IL-17A antibody

Treatment group 4

Placebo Comparator group

Description:

Drug：placebo

Treatment:

Biological: IL-17A antibody