CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
ABX464 50mg +3 moredrug
Likely dose
ABX464 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03813199
NCT03813199Phase 2Completed
CompareCT.gov

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

Abivax S.A.·interventional·Posted Jan 23, 2019·Updated Feb 15, 2023

In Brief

A Phase 2 clinical trial evaluating ABX464 50mg, Matching Placebo, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 60 participants across 24 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Czechia, France, Hungary, Poland
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 23, 2019
Enrollment StartJul 4, 2019
Primary CompletionApr 27, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.4 years ago

Interventions

ABX464 50mgdrug

ABX464 is a new anti-inflammatory drug

Matching Placebodrug

placebo matching with ABX464

ABX464 100mgdrug

ABX464 is a new anti-inflammatory drug

Methotrexatedrug

MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study