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

NCT06306339 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: hzVSF_v13-0015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Moderate to Severe Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, RA

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving clinical response according to the ACR 20 criteria at Week 12

  Participants who met following 2 conditions for improvement from baseline were classified as meeting the ACR(American College of Rheumatology) 20 response criteria: * ≥ 20% improvement in 66-swollen joint count * ≥ 20% improvement in 68-tender joint count

  Baseline and Week 12

Secondary Outcomes (5)

• Clinical response at Week 12, assessed as the attainment of an LDA (Low Disease Activity) state defined

  Baseline and Week 12

• Clinical response at Week 12, assessed as remission defined

  Baseline and Week 12

• Improvement of physical function at Week 12

  Baseline and Week 12

• Pain relief at Week 12 assessed by the (mean) change from Baseline

  Baseline and Week 12

• Health-related quality of life at Week 12, assessed as the change from Baseline

  Baseline and Week 12

Study Arms (3)

Placebo infusion

PLACEBO COMPARATOR

Placebo + SOC

Drug: SOC (Standard of care); Drug: Placebo

Burfiralimab(hzVSF-v13) 200mg IV infusion

EXPERIMENTAL

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

Drug: Burfiralimab; Drug: SOC (Standard of care)

Burfiralimab(hzVSF-v13) 600mg IV infusion

EXPERIMENTAL

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

Drug: Burfiralimab; Drug: SOC (Standard of care)

Interventions

Burfiralimab DRUG

Humanized monoclonal antibody.

Also known as: hzVSF-v13

Burfiralimab(hzVSF-v13) 200mg IV infusion; Burfiralimab(hzVSF-v13) 600mg IV infusion

SOC (Standard of care) 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)

Also known as: bDMARD or csDMARD

Burfiralimab(hzVSF-v13) 200mg IV infusion; Burfiralimab(hzVSF-v13) 600mg IV infusion; Placebo infusion

Placebo DRUG

The placebo for Burfiralimab (hzVSF-v13)

Also known as: The placebo for Burfiralimab (hzVSF-v13)

Placebo infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participant has moderate to severe RA at Screening and Baseline.
• Participant has had an inadequate response to, loss of response, or intolerance to at least 2 bDMARDs or tsDMARDs.
• Participant is positive for anti-citrullinated protein antibodies (ACPA).
• Participant has a C-reactive protein (CRP) \> upper limit normal (ULN) (5.0 g/L).
• 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.

You may not qualify if:

• Participant has Class IV RA according to ACR revised response criteria.
• 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,
• Participant has known history of prosthetic or native joint infection or human immunodeficiency virus or neurologic symptoms suggestive of central nervous system demyelinating disease.
• 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.

Sponsors & Collaborators

• ImmuneMed, Inc.: lead

Study Sites (1)

University Medical Center Urtrecht

Utrecht, GA, Netherlands

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jacob M. van Laar, MD

  Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sungman Park, Ph.D.

CONTACT

82-2-6956-0410; smpark@immunemed.co.kr

Eunju Lee

CONTACT

82-2-6956-0642; leeej@immunemed.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)