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

NCT ID: NCT04049448

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-25
• Study Completion Date: 2023-01-23

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.

Detailed Description

This Phase 2a open-label study aims at investigating the long-term safety and efficacy of an oral dose of ABX464 in patients who have been previously enrolled in the ABX464-301 clinical study and who are willing to continue their treatment.

All patients will receive ABX464 given at 50mg o.d. irrespectively of their previous treatment received in the ABX464-301 study (i.e. ABX464 or Placebo).

The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.

Patients will be treated with ABX464 for a period of 52 weeks. If they achieve a clinical response on Week 52 (defined as DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα), they will be eligible to continue treatment for up to 104 weeks.Patients will be followed up at week , week 2 and then, on a monthly basis the first year (up to W52), and quaterly the second year (up to W104).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABX464 50 mg

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

Group Type: EXPERIMENTAL

ABX464

Intervention Type: DRUG

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

Interventions

ABX464

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abivax S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence Desroys du Roure, PharmD

Role: STUDY_CHAIR

Abivax S.A.

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

UZ Gent

Ghent, , Belgium

CHU de Brest - Hôpital Cavale Blanche

Brest, , France

CHU DE MONTPELLIER - Hôpital Lapeyronie

Montpellier, , France

CHR d'Orléans

Orléans, , France

Complex Medical Centre - Déli Klinika

Budapest, , Hungary

CRU Hungary Ltd.

Miskolc, , Hungary

CMed Rehabilitációs és Diagnosztikai Központ

Székesfehérvár, , Hungary

ClinicMed Daniluk, Nowak Sp. J.

Bialystok, , Poland

Pratia MCM

Krakow, , Poland

Zespół Poradni Specjalistycznych REUMED

Lublin, , Poland

NZOZ Lecznica MAK-MED S.C.

Nadarzyn, , Poland

Medyczne Centrum Hetmańska

Poznan, , Poland

National Institute of Geriatrics

Warsaw, , Poland

Countries

Belgium; France; Hungary; Poland

Other Identifiers

ABX464-302

Identifier Type: -

Identifier Source: org_study_id