Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis

  • STATUS
    Recruiting
  • days left to enroll
    63
  • participants needed
    60
  • sponsor
    Abivax S.A.
Updated on 27 January 2021
methotrexate
tumor necrosis factor
tumor necrosis factor alpha
rheumatism
tumour necrosis
erosion
rheumatoid factor

Summary

This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha (TNF) therapies.

Description

This is a randomized, double-blind, placebo-controlled, multicenter study. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase.

Approximately 60 participants with active Rheumatoid Arthritis will be randomly assigned to receive placebo, 50mg ABX464 or 100mg ABX464 during the treatment phase.

The maximum period of active treatment will be 12 weeks. The maximum duration of study participation will be 17 weeks.

Participant safety will be monitored throughout the study. In addition, several experimental and clinical endpoints will be assessed to obtain information on preliminary efficacy.

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Treatment methotrexate, Matching Placebo, ABX464 50mg, ABX464 100mg
Clinical Study IdentifierNCT03813199
SponsorAbivax S.A.
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient with a confirmed and documented diagnosis of adult-onset rheumatoid arthritis, for at least 12 weeks, according to the revised 2010 American College of RheumatologyEuropean League Against Rheumatism (ACR-EULAR) classification criteria, including at least one positive criteria among the following: Rheumatoid Factor (RF), Anti-Citrullinated Peptide Antibody (ACPA) or bone erosion
Swollen joint count (SJC) of 4 (28-joint count) and tender joint count (TJC) 4 (28-joint count) at screening
Patient with a moderate to severe disease activity score Disease Activity Score (28 joints) C-Reactive Protein [DAS28 CRP] 3.2 and C-reactive Protein (CRP) 5 mg/L ( 4.76 nmol)/L) at screening
Patient who had an inadequate response (IR), or failed either methotrexate (MTX) or/and anti- Tumor Necrosis Factor alpha (TNF) therapy (both administered for at least 12 weeks before IR) or were intolerant to anti- TNF therapy

Exclusion Criteria

Patient with a known positive anti-double stranded deoxyribonucleic acid (DNA [anti-dsDNA]) and confirmed diagnosis of systemic lupus erythematosus (SLE)
Patient with known active infections at screening such as CytoMegaloVirus (CMV), herpes virus and/or recent infectious hospitalization
Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable Central Nervous System (CNS) pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history
Acute, chronic or history of immunodeficiency or other autoimmune disease
Patient previously treated with any non-anti-TNF biological Disease-Modifying AntiRheumatic Drugs (bDMARDs), and targeted DMARDs (tDMARDS) prior to baseline
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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