Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306339
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-07
Brief Title:
A Study to Assess the Efficacy and Safety of Burfiralimab hzVSF-v13 and DMRD Disease-modifying Antirheumatic Drug
Sponsor:
ImmuneMed Inc
Organization:
ImmuneMed Inc
Study Overview
Official Title:
A Phase 2a Multi-center Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of BurfiralimabhzVSF-v13 Added to Disease-modifying Antirheumatic Drugs in Participants With Moderate to Severe RA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy and safety of intravenous infusions of burfiralimab hzVSF-v13 when added to Disease-Modifying Antirheumatic Drug DMARD treatment as Standard of Care SOC in participants with moderate to severe Rheumatoid Arthritis RA
Detailed Description:
This study is a Phase 2a multi-center randomized double-blind placebo-controlled Efficacy and safety of biweekly intravenous infusions of burfiralimab hzVSF-v13 added to DMARD treatment as standard of care is evaluated in comparison with placebo Participants of either sex aged 1880years are enrolled it they have moderate to severe RA and had an inadequate response to disease-modifying antirheumatic drugDMARD treatments The study consists of a screening period for up to 4 weeks a treatment period of 10 weeks Eligible participants are randomized in a 111 ratio to 1 of the 3 treatment groups 200mg burfiralimab hzVSF-v13 SOC study group 1 600mg burfiralimab hzVSF-v13 SOC study group 2 or placebo SOC control group The primary focus of the study is to evaluate preliminary of the 2 doses of burfiralimab hzVSF-v13 200mg to 600mg administered by IV infusion biweekly for 10 weeks when compared to placebo in lowering disease activity in participants Efficacy analyses evaluate disease and health-related quality of life improvements at week 12 and week 18 Safety is assessed at up to 18 weeks
Study Oversight
Has Oversight DMC:
None
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?:
None