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

NCT03813199 | Completed Phase 2 Results

• 1 other identifier: ABX464-301
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 24

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo

  TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment

  through study completion, an average of 15 weeks

Secondary Outcomes (20)

• Number of Patients Achieving ACR20 Response

  at Week 12

• Number of Patients Achieving ACR20/50/70 Response

  Week 12

• Change From Baseline in C-reactive Protein (CRP)

  Week 12

• Number of Patients Achieving DAS28-CRP Response

  Week 12

• Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]

  Week 12

Study Arms (3)

ABX464 50mg + methotrexate

EXPERIMENTAL

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

Drug: ABX464 50mg; Drug: Matching Placebo; Drug: Methotrexate

ABX464 100mg + methotrexate

EXPERIMENTAL

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

Drug: ABX464 100mg; Drug: Methotrexate

Placebo + methotrexate

PLACEBO COMPARATOR

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

Drug: Matching Placebo; Drug: Methotrexate

Interventions

ABX464 50mg DRUG

ABX464 is a new anti-inflammatory drug

Also known as: obefazimod 50mg

ABX464 50mg + methotrexate

Matching Placebo DRUG

placebo matching with ABX464

Also known as: Placebo

ABX464 50mg + methotrexate; Placebo + methotrexate

ABX464 100mg DRUG

ABX464 is a new anti-inflammatory drug

Also known as: obefazimod 100mg

ABX464 100mg + methotrexate

Methotrexate DRUG

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

Also known as: MTX

ABX464 100mg + methotrexate; ABX464 50mg + methotrexate; Placebo + methotrexate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abivax S.A.: lead

Study Sites (24)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

ZNA Jan Palfijn

Merksem, Belgium

Location

Fakultni Tomayerova nemocnice

Prague, Czechia

Location

Revmatologicky ustav

Prague, Czechia

Location

CHU de Brest - Hôpital Cavale Blanche

Brest, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

CHU de Montpellier - Lapeyronie

Montpellier, France

Location

GHR Mulhouse Sud-Alsace

Mulhouse, France

Location

CHU de Nice - Hôpital Pasteur

Nice, France

Location

CHR d'Orléans

Orléans, France

Location

APHP - Hôpital Salpétrière

Paris, France

Location

CHU de Tours - Hôpital Trousseau

Tours, 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

RHEUMA MEDICUS Zakład Opieki Zdrowotnej

Warsaw, Poland

Location

Related Publications (1)

• 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.

  PMID: 35641124 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ABX464; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Vice President Clinical Operations
• Organization: Abivax

paul.gineste@abivax.com

01 53 83 08 41

Study Officials

• Paul GINESTE, PharmD

  Abivax S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 23, 2019
• Study Start: July 4, 2019
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: February 15, 2023
• Results First Posted: April 7, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (7); BE (4); FR (8); CZ (2); HU (3)