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    Summary
    EudraCT Number:2019-001578-27
    Sponsor's Protocol Code Number:ABX464-302
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-09-02
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-001578-27
    A.3Full title of the trial
    A follow-up Phase 2a open-label study to evaluate the long-term safety and efficacy profile of ABX464 in patients with moderate to severe active Rheumatoid Arthritis.
    II.a fázisú, nyílt utánkövetési vizsgálat az ABX464 egyéves biztonságossági és hatékonysági profiljának felmérésére közepesen súlyos vagy súlyos aktív rheumatoid arthritisben szenvedő betegekben.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Follow-up Phase 2a study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.
    A.4.1Sponsor's protocol code numberABX464-302
    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 153830961
    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
    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 23.1
    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 long-term safety of ABX464 given at 50mg once daily in patients with moderate to severe active Rheumatoid Arthritis.
    E.2.2Secondary objectives of the trial
    - To evaluate the long-term effects of ABX464 on Low Disease Activity (LDA) or remission (DAS28-ESR remission, ACR/EULAR remission, SDAI and CDAI remission);

    - To evaluate the long-term effects of ABX464 on disease activity scores (DAS28 scores, simplified disease activity score [SDAI] and clinical disease activity score [CDAI]).

    - To evaluate the long-term effects of ABX464 on the Patient Reported Outcomes (PRO), Healthy Assessment Questionnaire Disability Index (HAQ-DI) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue;

    - To evaluate the long-term effects of ABX464 on the American College of Rheumatology (ACR) 20/50/70 response and each of its components and the European League Against Rheumatism (EULAR) response (based on DAS28-CRP response).

    - To evaluate the expression of miR-124 in total blood (determined by qPCR) at Week 52 and 104.

    Echocardiography:
    - To evaluate the effect of ABX464 in cardiac function as assessed through echocardiograms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible to participate in this study if ALL the following criteria are met:

    - Patients previously enrolled in the ABX464-301 clinical study who have completed the ABX464-301 study;

    - 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 enrolment visit prior to any protocol-specific procedures are performed;

    - Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months after end of study or early termination. Contraception should be in place at least 2 weeks prior to study participation. 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 during the trial and for 6 months post completion of their participation in the trial.

    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.
    - Patients able and willing to continue the study treatment and who are compliant with study visits and procedures and who signed the update of the written voluntary informed consent form
    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:

    - 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)
    Primary safety endpoint

    - Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 104 weeks
    E.5.2Secondary end point(s)
    Main efficacy Endpoint:

    - Proportion of patients achieving DAS28-ESR remission (DAS28 ESR < 2.6) at Week 52 and at Week 104

    Other secondary endpoints:

    - Proportion of patients achieving at Week 4, Week 12, Week 24, Week 36, Week 52, Week 65, Week 78, Week 91, and Week 104:

    o Low Disease Activity (LDA) (DAS28 ESR ? 3.2)

    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);

    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

    - Time to onset of the LDA and DAS28-ESR remission;

    - Time to onset of the ACR/EULAR remission;

    - Change from Baseline in the following disease parameters at Week 4, Week 12, Week 24, Week 36, Week 52, Week 65, Week 78, Week 91, and Week 104:

    o Individual components of the ACR20 response: CRP, TJC(28), SJC(28), Pain-VAS, PtGA, PrGA, HAQ-DI;

    o DAS-28-CRP and DAS28-ESR scores;

    o SDAI score;

    o CDAI score;

    o FACIT-Fatigue score;

    Both baseline values from the primary randomized study ABX464-301 (Day 0) and from this open-label study ABX464-302 (Day 84 of ABX464-301) will be compared.

    - Quantification of miR-124 expression in total blood (determined by qPCR) at Week 52 and Week 104.

    - The number of incidences of treatment-emergent serious adverse events;

    - The number of incidences of treatment-emergent adverse events of special interest;

    - The number of incidences of adverse events leading to investigational product discontinuation;

    - The number of incidences of clinically significant laboratory abnormalities;

    - The number of incidences of all AE (causally related and non-related) and SAE, further categorized by severity.

    The secondary endpoints for the echocardiography [10] are:
    - Absolute (%) change-from-previous echocardiogram of Left ventricle Ejection Fraction (EF) as measured by 2- or 3-dimensional
    echocardiography
    - Number of subjects with a clinically relevant reduction (change-from previous echocardiogram) of EF, defined as more than 10% absolute reduction to EF < 50%
    - Absolute (%) change in Global Longitudinal Strain
    - Number of subjects with a clinically relevant change of GLS, defined as a relative change-from-previous echocardiogram of > 15% (e.g., -22% to -18%)
    - Number of subjects with an absolute reduction of LVER > 10% to EF >50% with a relative fall in GLS of > 15%
    - Number of subjects with an absolute reduction of LVEF <10% to ED <50%
    - Changes of other echocardiographic parameters as described in a standard protocol, including 2- and 3-dimensional volumes, RV size and systolic function and valve function.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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) Yes
    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 state15
    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)
    patients will exit the study (EOS) and will be treated according to the standard of care.
    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 Decision2019-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-01-23
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