Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43243   clinical trials with a EudraCT protocol, of which   7156   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-004677-27
    Sponsor's Protocol Code Number:ABX464-301
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2018-004677-27
    A.3Full title of the trial
    Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFα) therapy, or intolerance to anti-TNFα therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.
    A.4.1Sponsor's protocol code numberABX464-301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbivax
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAbivax
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbivax
    B.5.2Functional name of contact pointVP Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address5 Rue de la Baume
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 0 15383 0961
    B.5.6E-mailpaul.gineste@abivax.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameABX464
    D.3.2Product code ABX464
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABX464
    D.3.9.2Current sponsor codeABX464
    D.3.9.3Other descriptive nameABX464
    D.3.9.4EV Substance CodeSUB184487
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis (RA) is a chronic progressive inflammatory disease in the joints that often results in painful deformity and immobility, especially in the fingers, wrists, feet, and ankles.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003268
    E.1.2Term Arthritis rheumatoid
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the safety of ABX464 given at two different doses (100mg and 50 mg) vs placebo in combination with MTX when administered once daily in patients with moderate to severe active Rheumatoid Arthritis.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of the different dose groups of ABX464 at Weeks 2, 4, 8 and 12 on the American College of Rheumatology (ACR) 20/50/70 response and each of its components versus placebo;
    To evaluate the effects of the different dose groups of ABX464 at Weeks 2, 4, 8 and 12 on disease activity scores (DAS28 scores, simplified disease activity score [SDAI] and clinical disease activity score [CDAI]) versus placebo;
    To evaluate the effects of the different dose groups of ABX464 at Weeks 2, 4, 8 and 12 on clinical response (DAS28 EULAR good and moderate responses), Low Disease Activity (LDA) or remission (DAS28-ESR remission, ACR/EULAR remission, SDAI and CDAI remission) versus placebo;
    To evaluate the effects of the different dose groups of ABX464 at Weeks 2, 4, 8 and 12 on the (PRO) & (HAQ-DI);
    To assess the PK of the ABX464 and its main active metabolite N-Glu-ABX464 after oral administration of different daily doses of ABX464 in patients with rheumatoid Arthritis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
    - Men or women age 18 - 75 years;
    - Patient with a confirmed and documented diagnosis of adult-onset rheumatoid arthritis, for at least 12 weeks, according to the revised 2010 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 of ≥ 4 (28-joint count) and tender joint count ≥4 (28-joint count) at screening;
    - Patient with a moderate to severe disease activity score DAS28 CRP of ≥ 3.2 and 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-TNFα therapy (both administered for at least 12 weeks before IR) or were intolerant to anti- TNFα therapy.
    In addition, MTX treatment should be given at a stable dose ≥ 10 mg/week (for at least 4 weeks prior to randomization). The maximal dose of methotrexate should not exceed a total of 20 mg/week. MTX treatment should be associated with folic acid at a dose ≥ 5 mg/week.
    For the anti-TNFα therapy, the following wash-out period will be required:
    o 30 days prior to randomization for adalimumab and etanercept
    o 2 months prior to randomization for infliximab, certolizumab pegol, golimumab
    - Patients with the following hematological and biochemical laboratory parameters obtained within 14 days prior to baseline:
    o Hemoglobin > 9.0 g dL-1;
    o Absolute neutrophil count ≥ 1000 mm-3;
    o Platelets ≥ 100,000 mm-3;
    o Total serum creatinine ≤ 1.3 x ULN (upper limit of normal);
    o Creatinine clearance > 50 mL min-1 by the Cockcroft-Gault equation within 60 days prior to baseline;
    o Total serum bilirubin < 1.5 x ULN;
    o Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 1.5 x ULN;
    o Negative screening for TB and HIV, HCV, HBV
    - Patients are able and willing to comply with study visits and procedures as per protocol;
    - Patients should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures are performed;
    - Patients should be affiliated to a social security regimen (for French sites only);
    - Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 3 months after end of study or early termination. Contraception should be in place at least 2 weeks prior to screening. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy and male patients should use condom and must not donate sperm must not donate sperm during the trial and for 3 months post completion of their participation in the trial.
    E.4Principal exclusion criteria
    The following criteria should be checked at the time of screening. If ANY exclusion criterion applies, the patient will not be included in the study:
    - Patient with a known positive anti-double stranded deoxyribonucleic acid (DNA [anti-dsDNA]) and confirmed diagnosis of systemic lupus erythematosus (SLE);
    - Patients with active infection or the following history of infection(s) (the list is not exhaustive):
    o Active infection (except benign infections, according to investigator's
    opinion) within 14 days prior to inclusion.
    o Serious infection, defined as an infection requiring hospitalization or IV infusion of anti infective agents in the 2 months prior to inclusion.
    o A history of opportunistic, recurrent or chronic infections that, in the investigator's opinion, could render this study detrimental to the patient.
    - Patients who have received or are expected to receive a live (including attenuated) vaccine within 3 months prior to baseline;
    - Acute, chronic or history of clinically relevant (as per investigator’s judgement) pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable 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 (approved or investigational) non-anti-TNF biological disease-modifying antirheumatic drugs (bDMARDs), and targeted DMARDs (tDMARDS) prior to baseline. These treatments include: IL-6 antagonists, Janus Kinase (JAK) inhibitors, cytotoxic T lymphocyte-associated molecule CTLA-4Fc Chimera, rituximab;
    - Patient treated with systemic corticosteroids >10 mg/day during the 2 weeks prior to and at randomization; IV or IM injections of glucocorticoids 4 weeks prior to randomization and IA glucocorticoids 2 weeks prior to randomization;
    - Patients treated with other immunosuppressive drugs;
    - History of malignancy (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence) unless it has been treated and a cure is achieved for at least 5 years;
    - Serious illness requiring systemic treatment and/or hospitalization within 3 weeks prior to baseline;
    - Pregnant or breast-feeding woman;
    - Illicit drug or alcohol abuse or dependency;
    - Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer
    - Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the incidence of treatment-emergent adverse events in the ABX464 treated Patients versus placebo, categorized by severity.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation of this end point from day 0 to EoS.
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    Main Efficacy Endpoint:
    Proportion of patients achieving a categorical ACR20 response at Week 12.
    The components of ACR20 assessment include:
    o C-Reactive Protein (CRP) (mg/L),
    o Tender/painful joint count (TJC) (28 joints),
    o Swollen joint count (SJC) (28 joints),
    o Patient assessment of joint pain (Pain-VAS),
    o Patient global assessment of disease (PtGA),
    o Physician's Global Assessment of Disease (PrGA),
    o Disability index of the healthy assessment questionnaire (HAQ-DI)

    Other secondary endpoints:
    Change from Baseline in the following disease parameters at Week 2, Week 4, Week 8 and Week 12:
    o Individual components of the ACR20 response (CRP, TJC(28), SJC(28), Pain-VAS, PtGA, PrGA, HAQ-DI);
    o Erythrocyte Sedimentation Rate (ESR);
    o DAS28-CRP and DAS28-ESR. The components of DAS28 assessment include TJC(28), SJC(28), CRP/ESR, and PtGA;
    o SDAI score which includes TJC(28), SJC(28), CRP, PtGA, and PrGA;
    o CDAI score which includes TJC(28), SJC(28), PtGA, and PrGA;
    o FACIT-Fatigue score.

    • Proportion of patients achieving at Week 2, Week 4, Week 8 and Week 12:
    o ACR20/50/70 response
    o Categorical DAS28-CRP response. Proportion of patients achieving categorical DAS28-CRP response will be measured as moderate/good European League Against Rheumatism (EULAR) response at each assessment time point;
    o Low Disease Activity (LDA) (DAS28 ≤ 3.2)
    o DAS28-ESR remission (DAS28 < 2.6)
    o ACR/EULAR remission (TJC(28), SJC(28), CRP, and PtGA: all≤1);
    o SDAI remission (SDAI ≤ 3.3);
    o CDAI remission (CDAI ≤ 2.8).

    Concentration of miR-124 expression in total blood (determined by qPCR) at baseline and Week 8
    Change from Baseline in miR-124 expression in total blood at Week 8

    PK parameters:
    o Pre-dose plasma concentration of ABX464/N-Glu at Week 2 and Week 8;
    o Post-dose plasma concentration of ABX464/N-Glu at 1-, 2- and 3-hours post-dose at Baseline, Week 2 and Week 8;
    o Trough plasma concentration of ABX464/N-Glu at End of Study Visit

    The number of incidences of treatment-emergent serious adverse events (through the whole study)
    The number of incidences of treatment-emergent adverse events of special interest (through the whole study)
    The number of incidences of adverse events leading to investigational product discontinuation (through the whole study)
    The number of incidences of clinically significant laboratory abnormalities through the whole study)
    The number of incidences of all AE (causally related and non-related) and SAE, further categorized by severity (through the whole study)
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2 for Timepoint(s) of evaluation of this end point
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After Day 84, patients willing to carry on the study treatment will be able to take part in the long-term maintenance study (ABX464-302).
    In any other case, patients will exit the study (EOS) and will be treated according to the standard of care. The ABX464-302 follow-up study is a separate clinical protocol subject to health authorities and ethics committee approvals.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-27
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA