NCT03813199

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

Phase IIa Randomized, Double Blind, Placebo Controlled, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to Anti-Tnfα, or Intolerance to Anti-Tnfα

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Abivax S.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 (TNFα) therapies.

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	ABX464 50mg	ABX464 is a new anti-inflammatory drug
DRUG	Matching Placebo	placebo matching with ABX464
DRUG	ABX464 100mg	ABX464 is a new anti-inflammatory drug
DRUG	Methotrexate	MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study

Timeline

• Start date: 2019-07-04
• Primary completion: 2021-04-27
• Completion: 2021-04-27
• First posted: 2019-01-23
• Last updated: 2023-02-15
• Results posted: 2022-04-07

Locations

24 sites across 5 countries: Belgium, Czechia, France, Hungary, Poland