Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-03-04 @ 6:59 PM
Study NCT ID:
NCT03622658
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2018-07-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Namilumab for Moderate-to-severe Axial Spondyloarthritis
Sponsor:
Izana Bioscience Ltd.
Organization:
Study Overview
Official Title:
A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAMASTE
Brief 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: