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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05881785
Other study ID # GR1501-007
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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