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    Summary
    EudraCT Number:2019-000733-39
    Sponsor's Protocol Code Number:ABX464-104
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-09-06
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2019-000733-39
    A.3Full title of the trial
    A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
    Odslepené skúšanie fázy 2b skúmajúce účinnosť a bezpečnosť ABX464 v udržiavacej liečbe stredne závažnej až závažnej ulceróznej kolitídy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label maintenance therapy in moderate to severe Ulcerative Colitis patients
    Odslepená udržiavacia liečba pacientov so stredne závažnou až závažnou ulceróznou kolitídou
    A.4.1Sponsor's protocol code numberABX464-104
    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 pointClinical 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+33153830961
    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 nameObefazimod
    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 INNObefazimod
    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
    Moderate to Severe Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    In Ulcerative Colitis the lining of the colon becomes inflamed and develops tiny open sores that produce pus and mucous.This causes abdominal discomfort and frequent emptying of the colon (diarrhoea).
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 assess in all patients the long-term efficacy of ABX464 given at 50 mg QD on clinical remission at week 48 compared to the induction study baseline (ISB).
    E.2.2Secondary objectives of the trial
    To evaluate:
    -the clinical remission at week 48 compared to the baseline of the open label study (BOLS)
    -the proportion of patients with glucocorticoid-free clinical remission at W48
    -the effect of ABX464 50 mg QD:
    ~on Modified Mayo Score at week 48 and W96; and on partial MMS, among patients, at every study visit compared to ISB (Induction study baseline)
    ~on endoscopic improvement and remission and sustained endoscopic improvement and remission, by segment at W48 compared to ISB and BOLS
    ~on stool and rectal bleeding frequency at every study visit compared to BOLS
    ~on fecal calprotectin and CRP levels at W24,48,60,72,84,96 compared to BOLS
    ~on clinical response at W48 compared to ISB and BOLS
    ~on RNA later at W48 and 96 and in total blood at W24,48 and 96
    ~on patients' QoL at W24 and W48 compared to BOLS
    ~on the rectal/sigmoidal infiltrates at W48 compared to ISB and BOLS
    ~on cardiac function through echocardiograms
    -the long-term safety profile of ABX464 50 mg QD
    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 must have completed the 16-week (± 4 days) induction treatment period (ABX464-103);
     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 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 (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to screening. Women must be surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) or in the postmenopausal state (no menses for 12 months without an alternative medical cause) 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 during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required.
    Criteria that should be met by patients at week 48 to be eligible for 48 additional weeks of study treatment.
     Patients should be in clinical response. Clinical response is defined as: a reduction in Modified Mayo Score ≥ 2 points and ≥ 30 % from baseline (induction) with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
     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.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will be excluded from the study:
     Patients who permanently discontinued study the treatment in induction study (ABX464-103) because of an adverse event (AE) regardless of relatedness to investigational product;
     Patients who have developed any major illness/condition or evidence of an unstable clinical condition (except UC) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study;
     Patients with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for
    entry into this study;
     Patients who are participating or plan to participate in other investigational studies (other than induction study) during the study.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with clinical remission at week 48 compared to induction study baseline.
    Clinical remission based on the Mayo Scoring system, is defined as: stool frequency sub-score = 0 or 1 and rectal Bleeding sub-score = 0 and endoscopy sub-score = 0 or 1 (modified to exclude friability).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 48 and 96
    E.5.2Secondary end point(s)
    The week 24 and 48 secondary endpoints are:
    Reduction relative to baseline in Modified Mayo Score at week 48 and in partial Modified Mayo Score at every study visit among all patients.
    Proportion of patients with either endoscopic improvement or/and endoscopic remission by segment at week 48 among all patients. Endoscopic improvement is defined as a Mayo endoscopic sub score of ≤1 (excluding friability). Endoscopic remission is defined as a Mayo endoscopic sub score of 0.
    Proportion of patients with sustained endoscopic improvement or/and sustained endoscopic remission at week 48.
    Sustained endoscopic improvement is defined as the number of patients with endoscopic improvement at week 48 among patients who had endoscopic improvement during the Induction study (at week 8 or week 16).
    Sustained endoscopic remission is defined as the number of patients with endoscopic remission at week 48 among patients who had endoscopic remission during the Induction study (at week 8 or week 16).
    Proportion of patients with glucocorticoid-free clinical remission at week 48. Glucocorticoid-free clinical remission is defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 8 weeks prior to week 48.
    Reduction relative to baseline in stool and rectal bleeding frequency at every study visit.
    Reduction relative to baseline in fecal calprotectin and CRP levels at week 24 and 48.
    Proportion of patients with clinical response at week 48.
    Clinical response is defined as: a reduction in Mayo Score ≥ 2 points and ≥ 30 % from baseline with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
    Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at week 48 and in total blood at week 24 and week 48.
    Scores and changes from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) domains at week 24 and 48.
     Reduction relative to ISB of infiltrate/histopathology (rectal/ sigmoidal biopsies) using the Robarts Histopathology Index (RHI), the Geboes and Nancy Histology Scoring Scales at week 48.
    The week 96 secondary endpoints are:
     Reduction relative to baseline in Modified Mayo Score at week 96 and in partial Modified Mayo Score at every study visit (week 48 to 96)among all patients.
     Proportion of patients with either endoscopic improvement or/and endoscopic remission by segment at week 96
     Proportion of patients with sustained endoscopic improvement or/and sustained endoscopic remission at week 96.
     Reduction relative to baseline in stool and rectal bleeding frequency at every study visit (week 48 to 96).
     Reduction relative to baseline in fecal calprotectin and CRP levels at week 60, 72, 84 and 96.
     Proportion of patients with clinical response at week 96.
    -Change relative to baseline in miRNA-124 expression in
    rectal/sigmoidal biopsies and in total blood at week 96.
    The echocardiography secondary endpoints are:
    -Absolute (%) change-from-previous echocardiogram of Left ventricle Ejection Fraction (LVEF) as measured by 2- or 3-dimensional echocardiography.
    -Number of subjects with a clinically relevant reduction (change-from-previous echocardiogram) of LVEF, defined as by > 10% reduction
    (absolute percentage points) to a value < 50%.
    -Absolute (%) change from-previous echocardiogram in Global Longitudinal Strain (GLS).
    -Number of subjects with a relative percentage reduction in GLS by > 15% from the previous echocardiogram.
    -Number of subjects with a reduction of LVEF > 10% (absolute percentage points) to a value ≥ 50% with an accompanying fall in GLS >15%.
    -Number of subjects with reduction in LVEF by > 10% (absolute percentage points) to a value ≥ 50%.
    -Changes from previous echocardiography of other echocardiographic parameters as described in a standard protocol, including 2- and 3-dimensional volumes, RV size and systolic function and valve function.

    Safety endpoints are:
    Number and rate of all adverse events, causally-related adverse events, all SAE and causallyrelated SAEs classified by severity.
    Incidence of treatment-emergent serious adverse event, hospitalizations, total inpatient days.
    Incidence of adverse events leading to investigational product discontinuation.
    Number of clinically significant laboratory abnormalities.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) MMS at week 48 and pMMS at every visit
    2) at week 48
    3) at week 48
    4) at week 48
    5) at every study visit
    6) at week 24 and 48
    7) at week 48
    8) at week 24 and 48
    9) at week 24 and 48
    10) at week 48
    11) at week 96
    12) at week 96
    13) at week 96
    14) at every study visit
    15) at week 60, 72, 84 and 96
    16) at week 96
    17) through the study
    18) through the study
    19) through the study
    20) through the study
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Austria
    France
    Poland
    Spain
    Czechia
    Germany
    Belgium
    Hungary
    Slovakia
    Slovenia
    Ukraine
    Serbia
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 204
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 177
    F.4.2.2In the whole clinical trial 217
    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)
    No plans for treatment post-trial participation
    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 Decision2019-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-23
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