Axial Spondyloarthritis
Conditions
Keywords
IL-17A, Autoimmune disease
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.
Interventions
BIOLOGICALGR1501 low dose
3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly
BIOLOGICALGR1501 high dose
3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly
BIOLOGICALplacebo
* Core treatment period:placebo * Maintenance treatment period: GR1501 injection
Sponsors
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind
Intervention model description
A total of 465 patients were randomly assigned to 100mg GR1501 injection, 200mg GR1501 injection, and placebo group at 1:1:1. Randomized stratification factors included history of biologic therapy and weight. After the completion of 16-week ,subjects in the GR1501 injection group continued to be administered GR1501 injection, and those in the placebo group were randomly assigned 1:1 to the 100mg GR1501 injection and 200mg GR1501 injection.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change From Baseline in Mobility on the BASMI | week 16，32，48 | 5 clinical measurements Bath Ankylosing Spondylitis Metrology Index |
| 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 |
| 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 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 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 BASDAI Response | week 16，32，48 | 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis |
Countries
China
Outcome results
None listed