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

NCT05881785 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2024-09-25

No results posted yet for this study

Summary

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.

Conditions

  • Axial Spondyloarthritis

Interventions

BIOLOGICAL

GR1501 low dose

3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly

BIOLOGICAL

GR1501 high dose

3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly

BIOLOGICAL

placebo

* Core treatment period:placebo * Maintenance treatment period: GR1501 injection

Sponsors & Collaborators

  • Genrix (Shanghai) Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • xiaofeng zeng, PHD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2023-12-18
Completion
2024-05-21

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05881785 on ClinicalTrials.gov