Study of Efficacy and Safety of GR1501 in Patients With Radiographic Axial Spondyloarthritis
- Conditions
- Axial Spondyloarthritis
- Interventions
- Biological: GR1501 low doseBiological: placeboBiological: GR1501 high dose
- Registration Number
- NCT05881785
- Lead Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 465
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group 1 GR1501 low dose GR1501 low dose treatment group 3 placebo placebo Treatment group 2 GR1501 high dose GR1501 high dose
- Primary Outcome Measures
Name Time Method The Proportion of Participants Who Achieve an ASAS 20 Response 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 Outcome Measures
Name Time Method Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) week 16，32，48 The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) week 16，32，48 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
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) week 16，32，48 ASDAS is a composite index to assess disease activity in AS
Change From Baseline in Mobility on the BASMI week 16，32，48 5 clinical measurements Bath Ankylosing Spondylitis Metrology Index
Change From Baseline in BASDAI Response week 16，32，48 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis
The Proportion of Participants Who Achieve an ASAS 20 Response week 2 to 48 ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains
The Proportion of Participants Who Achieve an ASAS 40 Response week 2 to 48 ASAS40 response is defined as an improvement of ≥40% and ≥2 units in at least three of the four ASAS main domains
The Proportion of Participants Who Achieve an ASAS 5/6 Response week 16，32，48 The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains
Trial Locations
- Locations (1)
Peking union Medical Hosipital
🇨🇳Beijing, Beijing, China