NCT05881785CompletedPhase 3
Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
Source: ClinicalTrials.gov · Last updated 25 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 465 (actual)
- First submitted
- 21 May 2023
- Start date
- 13 Jun 2022
- Primary completion date
- 18 Dec 2023
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT05881785
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 465
- From 13 Jun 2022 to the primary completion date, 18 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Ongoing or serious infection
- Either a current diagnosis or a recent history of malignant disease
Other
- Total ankylosis of the spine
- Are pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking union Medical Hosipital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.