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

NCT06306339 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-12

No results posted yet for this study

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).

Conditions

  • Moderate to Severe Rheumatoid Arthritis

Interventions

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)

Sponsors & Collaborators

  • ImmuneMed, Inc.

    lead INDUSTRY

Principal Investigators

  • Jacob M. van Laar, MD · Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-05-31
Completion
2025-07-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306339 on ClinicalTrials.gov