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

Primary Purpose

Axial Spondyloarthritis

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

GR1501 low dose

GR1501 high dose

placebo

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring IL-17A, Autoimmune disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Peking union Medical Hosipital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group 1

Treatment group 2

treatment group 3

Arm Description

GR1501 low dose

GR1501 high dose

placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Change From Baseline in Mobility on the BASMI

5 clinical measurements Bath Ankylosing Spondylitis Metrology Index

Change From Baseline in BASDAI Response

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

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

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

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

ASDAS is a composite index to assess disease activity in AS

Full Information

NCT ID

NCT05881785

First Posted

May 21, 2023

Last Updated

May 21, 2023

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05881785

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 13, 2022 (Actual)

Primary Completion Date

November 10, 2024 (Anticipated)

Study Completion Date

April 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Axial Spondyloarthritis

Keywords

IL-17A, Autoimmune disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double blind

Allocation

Randomized

Enrollment

465 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group 1

Arm Type

Experimental

Arm Description

GR1501 low dose

Arm Title

Treatment group 2

Arm Type

Experimental

Arm Description

GR1501 high dose

Arm Title

treatment group 3

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Biological

Intervention Name(s)

GR1501 low dose

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

GR1501 high dose

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

Core treatment period:placebo Maintenance treatment period: GR1501 injection

Primary Outcome Measure Information:

Title

The Proportion of Participants Who Achieve an ASAS 20 Response

Description

ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains

Time Frame

week 16

Secondary Outcome Measure Information:

Title

The Proportion of Participants Who Achieve an ASAS 20 Response

Description

ASAS20 response is defined as an improvement of ≥20% and ≥1 units in at least three of the four ASAS main domains

Time Frame

week 2 to 48

Title

The Proportion of Participants Who Achieve an ASAS 40 Response

Description

ASAS40 response is defined as an improvement of ≥40% and ≥2 units in at least three of the four ASAS main domains

Time Frame

week 2 to 48

Title

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

Description

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

Time Frame

week 16，32，48

Title

Change From Baseline in Mobility on the BASMI

Description

5 clinical measurements Bath Ankylosing Spondylitis Metrology Index

Time Frame

week 16，32，48

Title

Change From Baseline in BASDAI Response

Description

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

Time Frame

week 16，32，48

Title

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

Description

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

Time Frame

week 16，32，48

Title

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

Description

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

Time Frame

week 16，32，48

Title

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

Description

ASDAS is a composite index to assess disease activity in AS

Time Frame

week 16，32，48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

xiaofeng zeng, PHD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking union Medical Hosipital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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