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NCT Number: NCT05881785

Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis

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.

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Autoimmune Diseases Bone Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking union Medical Hosipital

Beijing, Beijing Municipality, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GR1501 low dose

Biological

3×low dose GR1501 every 2 weeks,then low dose GR1501 monthly

GR1501 high dose

Biological

3×high dose GR1501 every 2 weeks,then high dose GR1501 monthly

Placebo

Biological
  • Core treatment period:placebo
  • Maintenance treatment period: GR1501 injection

Primary outcomes

  1. 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

  1. The Proportion of Participants Who Achieve an ASAS 20 Response

    Time frame: 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

  2. The Proportion of Participants Who Achieve an ASAS 40 Response

    Time frame: 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

  3. The Proportion of Participants Who Achieve an ASAS 5/6 Response

    Time frame: week 16，32，48

    The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains

  4. Change From Baseline in Mobility on the BASMI

    Time frame: week 16，32，48

    5 clinical measurements Bath Ankylosing Spondylitis Metrology Index

  5. Change From Baseline in BASDAI Response

    Time frame: week 16，32，48

    6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis

  6. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: 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

  7. Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

    Time frame: week 16，32，48

    The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity

  8. Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: week 16，32，48

    ASDAS is a composite index to assess disease activity in AS

Sponsors and collaborators

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 31, 2023
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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