MedTrace Logo

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

NCT03813199 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-15

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Abivax S.A.

    lead INDUSTRY

Principal Investigators

  • Paul GINESTE, PharmD · Abivax S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-04
Primary Completion
2021-04-27
Completion
2021-04-27

Countries

  • Belgium
  • Czechia
  • France
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03813199 on ClinicalTrials.gov