Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis

Genrix (Shanghai) Biopharmaceutical

Status and phase: Completed; Phase 3

Conditions: Axial Spondyloarthritis

Treatments: Biological: GR1501 high dose; Biological: placebo; Biological: GR1501 low dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT05881785

GR1501-007

Details and patient eligibility

About

The purpose of this trial is to demonstrate the clinical efficacy of GR1501 at week 16; and to demonstrate safety and tolerability of GR1501 compared to placebo in patients with Radiographic Axial Spondyloarthritis at week 16 and long term safety up to Week 48。 The main question it aims to answer is whether GR1501 injection was superior to placebo in the proportion of subjects with ASAS20 response at week 16 in patients with Radiographic Axial Spondyloarthritis.

Full description

This is a randomized, double-blind, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of GR1501 injection in Radiographic Axial Spondyloarthritis, as well as a confirmatory clinical trial of immunogenicity.

This clinical trial was divided into four stages, namely screening period (W-4~W0), core treatment period (W0~W16), maintenance treatment period (W16~W32), and follow-up period (W32~W48).

target population： radiographic axial spondyloarthritis who had a inadequate response to NSAIDs or have a history of intolerance to NSAIDs.

primary outcome measure:percentage of participants achieving an ASAS20 response in week 16.

Enrollment: 465 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
• inadequate response, contraindications or intolerance to NSAIDs

Exclusion criteria

• Total ankylosis of the spine
• Ongoing or serious infection
• Either a current diagnosis or a recent history of malignant disease
• Are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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465 participants in 3 patient groups, including a placebo group

Treatment group 1

Experimental group

Description:

GR1501 low dose

Treatment:

Biological: GR1501 low dose

Treatment group 2

Experimental group

Description:

GR1501 high dose

Treatment:

Biological: GR1501 high dose

treatment group 3

Placebo Comparator group

Description:

placebo

Treatment:

Biological: placebo