A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients With Radiographic Axial Spondyloarthritis
Overview
- Phase
- Phase 3
- Intervention
- GR1501 low dose
- Conditions
- Axial Spondyloarthritis
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Enrollment
- 465
- Locations
- 1
- Primary Endpoint
- The Proportion of Participants Who Achieve an ASAS 20 Response
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Treatment group 1
GR1501 low dose
Intervention: GR1501 low dose
Treatment group 2
GR1501 high dose
Intervention: GR1501 high dose
treatment group 3
placebo
Intervention: placebo
Outcomes
Primary Outcomes
The Proportion of Participants Who Achieve an ASAS 20 Response
Time Frame: week 16
ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains
Secondary Outcomes
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(week 16，32，48)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)(week 16，32，48)
- Change From Baseline in Mobility on the BASMI(week 16，32，48)
- Change From Baseline in BASDAI Response(week 16，32，48)
- The Proportion of Participants Who Achieve an ASAS 20 Response(week 2 to 48)
- The Proportion of Participants Who Achieve an ASAS 40 Response(week 2 to 48)
- The Proportion of Participants Who Achieve an ASAS 5/6 Response(week 16，32，48)
- Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)(week 16，32，48)