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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Biological: GR1501 low dose; Biological: GR1501 high dose; Biological: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 465
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking union Medical Hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group 1; GR1501 low dose	Biological: GR1501 low dose; 3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly
Experimental: Treatment group 2; GR1501 high dose	Biological: GR1501 high dose; 3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly
Placebo Comparator: treatment group 3; placebo	Biological: placebo; Core treatment period:placebo; Maintenance treatment period: GR1501 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Participants Who Achieve an ASAS 20 Response	ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains	week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Participants Who Achieve an ASAS 20 Response	ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains	week 2 to 48
The Proportion of Participants Who Achieve an ASAS 40 Response	ASAS40 response is defined as an improvement of ≥40% and ≥2 units in at least three of the four ASAS main domains	week 2 to 48
The Proportion of Participants Who Achieve an ASAS 5/6 Response	The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains	week 16，32，48
Change From Baseline in Mobility on the BASMI	5 clinical measurements Bath Ankylosing Spondylitis Metrology Index	week 16，32，48
Change From Baseline in BASDAI Response	6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis	week 16，32，48
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)	10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities	week 16，32，48
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)	The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity	week 16，32，48
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)	ASDAS is a composite index to assess disease activity in AS	week 16，32，48

Collaborators and Investigators

• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Investigators: Principal Investigator: xiaofeng zeng, PHD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Estimated): November 10, 2024
• Study Completion (Estimated): April 2, 2025

Study Registration Dates

• First Submitted: May 21, 2023
• First Submitted That Met QC Criteria: May 21, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Autoimmune disease; IL-17A
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Axial Spondyloarthritis
• Other Study ID Numbers: GR1501-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No