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

Axial Spondyloarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05881785
• Other study ID #: GR1501-007
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 13, 2022
• Est. completion date: April 2, 2025

Study information

• Verified date: May 2023
• Source: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 465
• Est. completion date: April 2, 2025
• Est. primary completion date: November 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Biological:
• GR1501 low dose
3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly
• GR1501 high dose
3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly
• placebo
Core treatment period:placebo Maintenance treatment period: GR1501 injection

Locations

Country	Name	City	State
China	Peking union Medical Hosipital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change From Baseline in Mobility on the BASMI	5 clinical measurements Bath Ankylosing Spondylitis Metrology Index	week 16,32,48
Secondary	Change From Baseline in BASDAI Response	6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis	week 16,32,48
Secondary	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
Secondary	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
Secondary	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