CompletedPhase 3

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

China465 participantsStarted 2022-06-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The Proportion of Participants Who Achieve an ASAS 20 Response

Timeframe: week 16

Trial details

NCT IDNCT05881785

SponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-18

View on ClinicalTrials.gov More Axial Spondyloarthritis trials