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

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Abivax S.A.
Updated on 28 September 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 on28 September 2021

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