Completed

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis

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What is being tested

GR1501 low dose

+ GR1501 high dose

+ placebo

Biological
Who is being recruted

Axial Spondyloarthritis+9

+ Ankylosis

+ Arthritis

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2022
See protocol details

Summary

Principal SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 13, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleA Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
NCT05881785
Principal SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

465 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Axial SpondyloarthritisAnkylosisArthritisAutoimmune DiseasesBone DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesSpinal DiseasesSpondylitisSpondylarthritisSpondylarthropathies

Criteria

2 inclusion criteria required to participate
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
4 exclusion criteria prevent from participating
Total ankylosis of the spine
Ongoing or serious infection
Either a current diagnosis or a recent history of malignant disease
Are pregnant or breastfeeding

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
GR1501 low dose

Group II

Experimental
GR1501 high dose

Group III

Placebo
placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Peking union Medical Hosipital

Beijing, ChinaOpen Peking union Medical Hosipital in Google Maps
CompletedOne Study Center