Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis

NCT04049448 | Completed Phase 2

• 1 other identifier: ABX464-302
• Study Type: interventional
• Target: 40
• Locations: 4 countries
• Sites: 14

Brief Summary

A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Keywords

moderate to severe Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity

  Incidence of adverse events emerging during the treatment

  through study completion (average of 104 weeks)

Secondary Outcomes (8)

• Proportion of patients achieving Low Disease Activity (LDA)

  Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

• Proportion of patients achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission

  Week 4, Week 12, Week24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

• Proportion of patients achieving Simplified Disease Activity Score (SDAI) remission

  Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

• Proportion of patients achieving Clinical Disease Activity (CDAI) remission

  Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

• Proportion of patients achieving ACR20/50/70 response

  Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104

Study Arms (1)

ABX464 50 mg

EXPERIMENTAL

All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks)

Drug: ABX464

Interventions

ABX464 DRUG

All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks).

ABX464 50 mg

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients previously enrolled in the ABX464-301 clinical study who have completed the initial 12 weeks of treatment period;
• Criteria that should be met by patients at week 52 to be eligible for 52 additional weeks of study treatment:
• ▪ Patients should be in clinical response. Clinical response is defined as: DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα.

You may not qualify if:

• Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (14)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

CHU de Brest - Hôpital Cavale Blanche

Brest, France

Location

CHU DE MONTPELLIER - Hôpital Lapeyronie

Montpellier, France

Location

CHR d'Orléans

Orléans, France

Location

Complex Medical Centre - Déli Klinika

Budapest, Hungary

Location

CRU Hungary Ltd.

Miskolc, Hungary

Location

CMed Rehabilitációs és Diagnosztikai Központ

Székesfehérvár, Hungary

Location

ClinicMed Daniluk, Nowak Sp. J.

Bialystok, Poland

Location

Pratia MCM

Krakow, Poland

Location

Zespół Poradni Specjalistycznych REUMED

Lublin, Poland

Location

NZOZ Lecznica MAK-MED S.C.

Nadarzyn, Poland

Location

Medyczne Centrum Hetmańska

Poznan, Poland

Location

National Institute of Geriatrics

Warsaw, Poland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ABX464

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laurence Desroys du Roure, PharmD

  Abivax S.A.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, follow-up study

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: October 25, 2019
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); HU (3); BE (2); PL (6)