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

NCT ID: NCT03813199

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2021-04-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ABX464 50mg + methotrexate

Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks

+ methotrexate

Group Type: EXPERIMENTAL

ABX464 50mg

Intervention Type: DRUG

ABX464 is a new anti-inflammatory drug

Matching Placebo

Intervention Type: DRUG

placebo matching with ABX464

Methotrexate

Intervention Type: DRUG

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

ABX464 100mg + methotrexate

Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks

+ methotrexate

Group Type: EXPERIMENTAL

ABX464 100mg

Intervention Type: DRUG

ABX464 is a new anti-inflammatory drug

Methotrexate

Intervention Type: DRUG

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

Placebo + methotrexate

Participants will receive two capsules of matching placebo once daily for 12 weeks

+ methotrexate

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

placebo matching with ABX464

Methotrexate

Intervention Type: DRUG

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

Interventions

ABX464 50mg

ABX464 is a new anti-inflammatory drug

Intervention Type: DRUG

Matching Placebo

placebo matching with ABX464

Intervention Type: DRUG

ABX464 100mg

ABX464 is a new anti-inflammatory drug

Intervention Type: DRUG

Methotrexate

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

Intervention Type: DRUG

Other Intervention Names

obefazimod 50mg; Placebo; obefazimod 100mg; MTX

Eligibility Criteria

Inclusion Criteria

• Patient with a confirmed and documented diagnosis of adult-onset rheumatoid arthritis, for at least 12 weeks, according to the revised 2010 American College of Rheumatology- European League Against Rheumatism (ACR-EULAR) classification criteria, including at least one positive criteria among the following: Rheumatoid Factor (RF), Anti-Citrullinated Peptide Antibody (ACPA) or bone erosion;
• Swollen joint count (SJC) of ≥ 4 (28-joint count) and tender joint count (TJC) ≥4 (28-joint count) at screening;
• Patient with a moderate to severe disease activity score Disease Activity Score (28 joints) C-Reactive Protein [DAS28 CRP] ≥ 3.2 and C-reactive Protein (CRP) ≥ 5 mg/L (≥ 4.76 nmol)/L) at screening;
• Patient who had an inadequate response (IR), or failed either methotrexate (MTX) or/and anti- Tumor Necrosis Factor alpha (TNFα) therapy (both administered for at least 12 weeks before IR) or were intolerant to anti- TNFα therapy.

Exclusion Criteria

• Patient with a known positive anti-double stranded deoxyribonucleic acid (DNA [anti-dsDNA]) and confirmed diagnosis of systemic lupus erythematosus (SLE);
• Patient with known active infections at screening such as CytoMegaloVirus (CMV), herpes virus and/or recent infectious hospitalization;
• Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable Central Nervous System (CNS) pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
• Acute, chronic or history of immunodeficiency or other autoimmune disease;
• Patient previously treated with any non-anti-TNF biological Disease-Modifying AntiRheumatic Drugs (bDMARDs), and targeted DMARDs (tDMARDS) prior to baseline.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abivax S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul GINESTE, PharmD

Role: STUDY_DIRECTOR

Abivax S.A.

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

UZ Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

ZNA Jan Palfijn

Merksem, , Belgium

Fakultni Tomayerova nemocnice

Prague, , Czechia

Revmatologicky ustav

Prague, , Czechia

CHU de Brest - Hôpital Cavale Blanche

Brest, , France

CHD Vendée

La Roche-sur-Yon, , France

CHU de Montpellier - Lapeyronie

Montpellier, , France

GHR Mulhouse Sud-Alsace

Mulhouse, , France

CHU de Nice - Hôpital Pasteur

Nice, , France

CHR d'Orléans

Orléans, , France

APHP - Hôpital Salpétrière

Paris, , France

CHU de Tours - Hôpital Trousseau

Tours, , 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

RHEUMA MEDICUS Zakład Opieki Zdrowotnej

Warsaw, , Poland

Countries

Belgium; Czechia; France; Hungary; Poland

References

Daien C, Krogulec M, Gineste P, Steens JM, Desroys du Roure L, Biguenet S, Scherrer D, Santo J, Ehrlich H, Durez P. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFalpha therapy: a placebo-controlled phase II study. Ann Rheum Dis. 2022 Jul 12;81(8):1076-1084. doi: 10.1136/annrheumdis-2022-222228.

Reference Type: DERIVED

PMID: 35641124 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABX464-301

Identifier Type: -

Identifier Source: org_study_id