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 patient with moderate to severe Rheumatoid Arthritis

Trial details

Who runs it

Immunemed Inc.

Trial code

EU 2023-507944-35-00

Record updated

2024. április 22.

Original description

To evaluate the efficacy of low (200 mg) and high (600 mg) doses of burfiralimab compared to placebo on disease activity in participants with moderate to severe RA who have had an inadequate response to at least 2 DMARD therapiesRead full original descriptionShow less

To evaluate the efficacy of low (200 mg) and high (600 mg) doses of burfiralimab compared to placebo on disease activity in participants with moderate to severe RA who have had an inadequate response to at least 2 DMARD therapies

Inclusion: Participant has provided written informed consent for the study; 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; Participant is not pregnant and not lactating; If of childbearing potential, participant is practicing 1 of the following highly effective methods of birth control while on study and for 120 days after the last dose of the IP; If participant is sexually active and has a partner who may become pregnant (i.e., neither surgically sterile nor postmenopausal), agrees to use adequate contraception (e.g., sterilization, birth control pills, Depo Provera injections, or contraceptive implants) while on study and for 120 days after the last dose of the IP; Participant agrees to refrain from donating sperm during study and for 120 days following the last treatment with the IP; Participant is able to understand all study information provided and is willing to return to the study facility for all visits, including follow-up evaluations; Participant is of either sex, aged ≥18 years to ≤80 years; 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, defined by the presence of the following symptoms:  ≥2 swollen joints based on 66 joint count,  ≥6 tender joints based on 68 joint count; Participant has had a continued disease activity despite at least 3 months of adequate therapy or discontinued for an AE or intolerance as stated in the participant chart; Participant has had an inadequate response to, loss of response, or intolerance to at least 2 bDMARDs or tsDMARDs; Participant has taken an antirheumatic medication for a minimum of 3 months prior to Screening at a stable dose for at least 1 month; Participant is positive for anti-citrullinated protein antibodies (ACPA); Participant has a C-reactive protein (CRP) > upper limit normal (ULN) (5.0 g/L).

Exclusion: Participant has 1 or more significant concurrent medical conditions per investigator judgment; Participant has received any IP or was treated with an investigational device within 30 days before enrollment in this study; Participant has known allergy or significant adverse reaction to the IP or related compounds; Participant has any disorder that might interfere with the conduct of the study in the opinion of the investigator; 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; Participant has an unstable condition (e.g., psychiatric disorder, a recent history of substance abuse) or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol; Participant has reported any of the below criteria or has any other significant laboratory abnormality at Screening, which, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this study or interfere with the interpretation of the study results; Participant has Class IV RA according to ACR revised response criteria; Participant is pregnant or breast feeding or planning to become pregnant while enrolled in the study and for 120 days after the last dose of the IP.

EU CTIS 2023-507944-35-00