NCT06306339

A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug)

A Phase 2a Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Burfiralimab(hzVSF-v13) Added to Disease-modifying Antirheumatic Drugs in Participants With Moderate to Severe RA

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: ImmuneMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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, 18\~80years, are enrolled it they have moderate to severe RA and had an inadequate response to disease-modifying antirheumatic drug(DMARD) 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 1:1:1 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.

Conditions

• Moderate to Severe Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Burfiralimab	Humanized monoclonal antibody.
DRUG	SOC (Standard of care)	The following medications listed are allowed to be administered during the course of the clinical study. 1. biologic disease-modifying antirheumatic drug (bDMARD) 2. conventional synthetic disease-modifying antirheumatic drug (csDMARD)
DRUG	Placebo	The placebo for Burfiralimab (hzVSF-v13)

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-05-01
• Completion: 2025-07-01
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

1 site across 1 country: Netherlands