This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Axial Spondyloarthritis

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

Sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.

About this trial

Last updated 2 years ago

Study ID

GR1501-007

Status

Active, not recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status