Clinical trial NCT05881785: Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Axial Spondyloarthritis
Keywords: IL-17A
Autoimmune disease
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Proportion of Participants Who Achieve an ASAS 20 Response
timeFrame: week 16
Secondary outcomes:
measure: The Proportion of Participants Who Achieve an ASAS 20 Response
timeFrame: week 2 to 48
measure: The Proportion of Participants Who Achieve an ASAS 40 Response
timeFrame: week 2 to 48
measure: The Proportion of Participants Who Achieve an ASAS 5/6 Response
timeFrame: week 16，32，48
measure: Change From Baseline in Mobility on the BASMI
timeFrame: week 16，32，48
measure: Change From Baseline in BASDAI Response
timeFrame: week 16，32，48
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: week 16，32，48
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: week 16，32，48
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: week 16，32，48
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union Medical Hosipital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: xiaofeng zeng, PHD
role: PRINCIPAL_INVESTIGATOR
References: