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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Moderate to Severe Rheumatoid Arthritis
• Intervention / Treatment: Drug: SOC (Standard of care); Drug: Placebo; Drug: Burfiralimab

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sungman Park, Ph.D.; Phone Number: 82-2-6956-0410; Email: smpark@immunemed.co.kr
• Study Contact Backup: Name: Eunju Lee; Phone Number: 82-2-6956-0642; Email: leeej@immunemed.co.kr

Study Locations

• Netherlands
  • GA
    • Utrecht, GA, Netherlands
      • University Medical Center Urtrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo infusion; Placebo + SOC	Drug: SOC (Standard of care); The following medications listed are allowed to be administered during the course of the clinical study.; biologic disease-modifying antirheumatic drug (bDMARD); conventional synthetic disease-modifying antirheumatic drug (csDMARD); Other Names: bDMARD or csDMARD; Drug: Placebo; The placebo for Burfiralimab (hzVSF-v13); Other Names: The placebo for Burfiralimab (hzVSF-v13)
Experimental: Burfiralimab(hzVSF-v13) 200mg IV infusion; Burfiralimab (hzVSF-v13) 200mg/dose + SOC	Drug: SOC (Standard of care); The following medications listed are allowed to be administered during the course of the clinical study.; biologic disease-modifying antirheumatic drug (bDMARD); conventional synthetic disease-modifying antirheumatic drug (csDMARD); Other Names: bDMARD or csDMARD; Drug: Burfiralimab; Humanized monoclonal antibody.; Other Names: hzVSF-v13
Experimental: Burfiralimab(hzVSF-v13) 600mg IV infusion; Burfiralimab (hzVSF-v13) 600mg/dose + SOC	Drug: SOC (Standard of care); The following medications listed are allowed to be administered during the course of the clinical study.; biologic disease-modifying antirheumatic drug (bDMARD); conventional synthetic disease-modifying antirheumatic drug (csDMARD); Other Names: bDMARD or csDMARD; Drug: Burfiralimab; Humanized monoclonal antibody.; Other Names: hzVSF-v13

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response at Week 12, assessed as the attainment of an LDA (Low Disease Activity) state defined	ACR 50 and ACR 70; DAS28-CRP < 3.2; CDAI (Clinical Disease Activity Index) ≤ 10	Baseline and Week 12
Clinical response at Week 12, assessed as remission defined	DAS28-CRP ≤ 2.6; CDAI ≤ 2.8	Baseline and Week 12
Improvement of physical function at Week 12	≥ 0.22 decrease in patient-reported ACR Core Set Values in participant's assessment of physical function using the HAQ-DI (Health Assessment Questionnaire - Disability Index); <0.5 in participant's assessment of physical function using the HAQ-DI	Baseline and Week 12
Pain relief at Week 12 assessed by the (mean) change from Baseline	- NRS-11 (11-point numeric scale)	Baseline and Week 12
Health-related quality of life at Week 12, assessed as the change from Baseline	EuroQoL (EQ-5D-5L)	Baseline and Week 12

Collaborators and Investigators

• Sponsor: ImmuneMed, Inc.
• Investigators: Principal Investigator: Jacob M. van Laar, MD, Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis, RA
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: hzVSF_v13-0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No