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

NCT ID: NCT06306339

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2025-07-31

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, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo infusion

Placebo + SOC

Group Type: PLACEBO_COMPARATOR

SOC (Standard of care)

Intervention Type: DRUG

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)

Placebo

Intervention Type: DRUG

The placebo for Burfiralimab (hzVSF-v13)

Burfiralimab(hzVSF-v13) 200mg IV infusion

Burfiralimab (hzVSF-v13) 200mg/dose + SOC

Group Type: EXPERIMENTAL

Burfiralimab

Intervention Type: DRUG

Humanized monoclonal antibody.

SOC (Standard of care)

Intervention Type: DRUG

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)

Burfiralimab(hzVSF-v13) 600mg IV infusion

Burfiralimab (hzVSF-v13) 600mg/dose + SOC

Group Type: EXPERIMENTAL

Burfiralimab

Intervention Type: DRUG

Humanized monoclonal antibody.

SOC (Standard of care)

Intervention Type: DRUG

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)

Interventions

Burfiralimab

Humanized monoclonal antibody.

Intervention Type: 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)

Intervention Type: DRUG

Placebo

The placebo for Burfiralimab (hzVSF-v13)

Intervention Type: DRUG

Other Intervention Names

hzVSF-v13; bDMARD or csDMARD; The placebo for Burfiralimab (hzVSF-v13)

Eligibility Criteria

Inclusion Criteria

1. Participant has a diagnosis of adult-onset RA for at least 3 months prior to Screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.

2. Participant has moderate to severe RA at Screening and Baseline.

3. Participant has had an inadequate response to, loss of response, or intolerance to at least 2 bDMARDs or tsDMARDs.

4. Participant is positive for anti-citrullinated protein antibodies (ACPA).

5. Participant has a C-reactive protein (CRP) > upper limit normal (ULN) (5.0 g/L).

6. Participant has a negative tuberculosis test at Screening, defined as either negative QuantiFERON® test or purified protein derivative <5 mm of induration at 48 to 72 hours after the test was placed.

Exclusion Criteria

1. Participant has Class IV RA according to ACR revised response criteria.

2. Participant has 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to the following:

• Poorly controlled diabetes or hypertension,
• Chronic kidney disease stage IIIb, IV, or V,
• Symptomatic heart failure according to New York Heart Association Classes II, III, or IV,
• Myocardial infarction, unstable angina pectoris, stroke, or transient ischemic attack, within the past 12 months before randomization,
• Severe chronic pulmonary disease, for example, requiring oxygen therapy,
• Clinically significant hepatic diseases (i.e., hemochromatosis, Wilson's disease, alcoholic hepatitis, autoimmune liver disease, nonalcoholic steatohepatitis, or α-1-antitrypsin deficiency,

3. Participant has known history of prosthetic or native joint infection or human immunodeficiency virus or neurologic symptoms suggestive of central nervous system demyelinating disease.

4. Participant has a chronic inflammatory disease or connective tissue disease other than RA, including but not limited to; systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non radiographic axial spondylarthritis, reactive arthritis, gout, scleroderma, polymyositis, dermatomyositis and/or active fibromyalgia and/or multiple sclerosis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneMed, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob M. van Laar, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht

Locations

University Medical Center Urtrecht

Utrecht, GA, Netherlands

Countries

Netherlands

Central Contacts

Sungman Park, Ph.D.

Role: CONTACT

smpark@immunemed.co.kr

82-2-6956-0410

Eunju Lee

Role: CONTACT

leeej@immunemed.co.kr

82-2-6956-0642

Other Identifiers

hzVSF_v13-0015

Identifier Type: -

Identifier Source: org_study_id