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Moderate to Severe Rheumatoid ArthritisPhase 2NCT06306339

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

A Phase 2 study testing Burfiralimab in people with Moderate to Severe Rheumatoid Arthritis, run by ImmuneMed, Inc. at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Moderate to Severe Rheumatoid Arthritis
What is being tested?
Burfiralimab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteNetherlands
Study dates
Mar 2024to Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

1 site in 1 country.

Sungman Park, Ph.D. contact

82-2-6956-0410

smpark@immunemed.co.kr

Eunju Lee contact

82-2-6956-0642

leeej@immunemed.co.kr

Netherlands1 site

  • University Medical Center Urtrecht

    Utrecht, GA

Other trials in Netherlands

About this study

Official title: 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).

Read the 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.

Being tested
Burfiralimab, SOC (Standard of care), Placebo
Keywords
Rheumatoid arthritis, RA
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BurfiralimabDrug

    Also called hzVSF-v13

    Humanized monoclonal antibody.

  • SOC (Standard of care)Drug

    Also called bDMARD or csDMARD

    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)

  • PlaceboDrug

    Also called The placebo for Burfiralimab (hzVSF-v13)

    The placebo for Burfiralimab (hzVSF-v13)

Study groups in NCT06306339
Study groupRoleWhat they receive
Placebo infusionPlacebo comparatorPlacebo + SOC
Receives: Drug: SOC (Standard of care); Drug: Placebo
Burfiralimab(hzVSF-v13) 200mg IV infusionExperimentalBurfiralimab (hzVSF-v13) 200mg/dose + SOC
Receives: Drug: Burfiralimab; Drug: SOC (Standard of care)
Burfiralimab(hzVSF-v13) 600mg IV infusionExperimentalBurfiralimab (hzVSF-v13) 600mg/dose + SOC
Receives: Drug: Burfiralimab; Drug: SOC (Standard of care)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and Week 12

Secondary outcomes (5)

  1. 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

    Measured: Baseline and Week 12

  2. Clinical response at Week 12, assessed as remission defined

    • DAS28-CRP ≤ 2.6
    • CDAI ≤ 2.8

    Measured: Baseline and Week 12

  3. 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

    Measured: Baseline and Week 12

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

    • NRS-11 (11-point numeric scale)

    Measured: Baseline and Week 12

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

    EuroQoL (EQ-5D-5L)

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study startMar 2024 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06306339
Sponsor's protocol ID
hzVSF_v13-0015
Status last verified
Feb 2024
First submitted
7 Feb 2024
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Burfiralimab in people with Moderate to Severe Rheumatoid Arthritis, run by ImmuneMed, Inc. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sungman Park, Ph.D. (82-2-6956-0410, smpark@immunemed.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants achieving clinical response according to the ACR 20 criteria at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06306339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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