Trials / Completed
CompletedNCT03622658
Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Izana Bioscience Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study will assess the effect of namilumab, a GM-CSF inhibitor, on the clinical response in subjects with axial spondyloarthritis. Subjects will receive treatment with either namilumab or placebo.
Detailed description
A phase 2a proof-of-concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti- TNF therapy (NAMASTE study).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Placebo | Placebo solution for subcutaneous injection. |
| BIOLOGICAL | Namilumab | Namilumab solution for subcutaneous injection |
Timeline
- Start date
- 2018-09-06
- Primary completion
- 2020-02-04
- Completion
- 2020-02-04
- First posted
- 2018-08-09
- Last updated
- 2022-03-08
- Results posted
- 2022-03-08
Locations
9 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03622658. Inclusion in this directory is not an endorsement.