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    EudraCT Number:2021-004398-30
    Sponsor's Protocol Code Number:ABX464-108
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2021-004398-30
    A.3Full title of the trial
    A follow-up Phase II open-label study to evaluate the long-term safety and efficacy profile of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis
    Následná otvorená štúdia fázy II na vyhodnotenie dlhodobého profilu bezpečnosti a účinnosti lieku ABX464 podávaného jedenkrát denne v dávke 25 mg účastníkom so stredne ťažkou až ťažkou aktívnou ulceróznou kolitídou.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of ABX464 during long-term treatment in patients with moderate to severe ulcerative colitis.
    Účinky ABX464 počas dlhodobej liečby u pacientov so stredne závažnou až závažnou ulceróznou kolitídou.
    A.4.1Sponsor's protocol code numberABX464-108
    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.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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABIVAX
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address7/11 Boulevard Haussmann
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75009
    B.5.4Telephone number+1858531 9185
    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.3.2Product 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 number25
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Stredne ťažká až ťažká ulcerózna kolitída
    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)
    Pri ulceróznej kolitíde sa sliznica hrubého čreva zapáli a vznikajú malé otvorené rany, ktoré produkujú hnis a hlien. To spôsobuje ťažkosti v bruchu a časté vyprázdňovanie hrubého čreva (hnačka).
    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 10017947 - Gastrointestinal disorders
    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 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.
    Primárny cieľ skúšania je zhodnotiť dlhodobú bezpečnosť lieku ABX464 podávaného v dávke 25 mg jedenkrát denne u účastníkov so stredne ťažkou až ťažkou aktívnou ulceróznou kolitídou.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    1. To evaluate the long-term effect of ABX464 on clinical remission;
    2. To evaluate the long-term effect of ABX464 on endoscopic remission;
    3. To evaluate the long-term effect of ABX464 on clinical response;
    4. To evaluate the long-term effect of ABX464 on endoscopic improvement;
    5. To evaluate the long-term effect of ABX464 on inflammatory markers (C-reactive protein (CRP), calprotectin);
    6. To evaluate the safety profile of ABX464;
    7. To evaluate the effect of ABX464 on miR-124 expression in total blood at every timepoint defined in the schedule of assessment.

    Echocardiography objective:
    8. To evaluate the effect of ABX464 on cardiac function as assessed through echocardiograms.

    Sekundárne ciele sú:
    1. Hodnotenie dlhodobého účinku lieku ABX464 na klinickú remisiu.
    2. Hodnotenie dlhodobého účinku lieku ABX464 na endoskopickú remisiu.
    3. Hodnotenie dlhodobého účinku lieku ABX464 na klinickú odpoveď.
    4. Hodnotenie dlhodobého účinku lieku ABX464 na endoskopické zlepšenie.
    5. Hodnotenie dlhodobého účinku lieku ABX464 na zápalové markery (C-reaktívny proteín (CRP), kalprotektín).
    6. Hodnotenie bezpečnostného profilu lieku ABX464.
    7. Hodnotenie účinku lieku ABX464 na expresiu miR-124 v plnej krvi v každom časovom bode definovanom v harmonograme hodnotení.

    Echokardiografické ciele:
    8. Hodnotenie účinku lieku ABX464 na srdcovú funkciu podľa hodnotenia echokardiogramami.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who previously completed the ABX464-102 or ABX464-104 clinical studies;
    2. Subjects should be in endoscopic improvement with a rectal bleeding sub-score = 0 point at the end of treatment period in the previous study (ABX464-102 or ABX464-104). Endoscopic improvement is defined as: a Mayo endoscopic sub score of ≤1 ;
    3. Subjects able and willing to comply with study visits and procedures;
    4. Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures;
    5. Women of childbearing potential and men receiving the study treatment and their partners must agree to continue a highly effective contraceptive method during the study and for at least 21 days after end of study or early termination. 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. The WOCB must be willing to perform once a month a urine 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 subject. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male subjects must not be planning pregnancy during the trial and for at least 21 days post completion of their participation in the trial. In addition, male subjects should use condom during the trial and for at least 21 days post completion of their participation in the study. Male subjects must not donate sperm as long as contraception is required. For the purpose of this protocol, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. Finally, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy;
    6. Subjects should be affiliated to a social security regimen (for French sites only).
    1. Účastníci, ktorí dokončili klinické skúšanie ABX464-102 alebo ABX464-104.
    2. Účastníci, ktorí majú endoskopické zlepšenie s podskóre rektálneho krvácania = 0 bodov na konci obdobia liečby v predchádzajúcom skúšaní (ABX464-102 alebo ABX464-104). Endoskopické zlepšenie je definované ako endoskopické podskóre Mayo ≤ 1.
    3. Účastníci sú schopní a ochotní dodržiavať návštevy a postupy skúšania.
    4. Účastníci musia porozumieť, podpísať a datovať písomný formulár dobrovoľného informovaného súhlasu na návšteve pred akýmikoľvek postupmi špecifickými pre protokol.
    5. Ženy v plodnom veku, muži dostávajúci skúšanú liečbu a ich partnerky musia súhlasiť s používaním vysokoúčinnej metódy antikoncepcie počas skúšania a po dobu aspoň 21 dní od ukončenia skúšania alebo jeho predčasného ukončenia. Ženy musia byť chirurgicky sterilné alebo ak sú v plodnom veku, musia používať vysokoúčinnú metódu antikoncepcie. Ženy v plodnom veku vstúpia do skúšania po potvrdení menštruačného cyklu a negatívnom tehotenskom teste. Ženy v plodnom veku musia byť ochotné urobiť si jeden krát za mesiac tehotenský test z moču. Vysokoúčinné metódy antikoncepcie zahŕňajú úplnú abstinenciu, vnútromaternicové teliesko (IUD) alebo hormonálnu antikoncepciu s cieľom inhibovať ovuláciu, vnútromaternicový systém uvoľňujúci hormóny, bilaterálne podviazanie vajcovodov, partnera po vazektómii. Úplná abstinencia je definovaná tak, aby bola v súlade s preferovaným a bežným životným štýlom účastníka. Toto odporúčanie sa tiež vzťahuje na ženy v plodnom veku s nečastým alebo nepravidelným menštruačným cyklom. Ženské účastníčky a mužskí účastníci nesmú plánovať tehotenstvo počas skúšania a po dobu aspoň 21 dní po ukončení účasti na klinickom skúšaní. Okrem toho, mužskí účastníci by mali používať počas skúšania a po dobu aspoň 21 dní po ukončení účasti na skúšaní kondóm. Mužskí účastníci nesmú darovať spermie tak dlho, ako je vyžadovaná antikoncepcia. Na účely tohto protokolu skúšania sa žena považuje za plodnú, t. j. fertilnú, po menarché až do obdobia po menopauze, pokiaľ nie je trvalo sterilná. Medzi permanentné sterilizačné metódy patrí hysterektómia, bilaterálna salpingektómia a bilaterálna ooforektómia. Postmenopauzálny stav je definovaný ako stav bez menštruácie po dobu 12 mesiacov bez alternatívnej lekárskej príčiny. Vysoká hladina folikuly stimulujúceho hormónu (FSH) v rozsahu po menopauze sa môže použiť na potvrdenie postmenopauzálneho stavu u žien, ktoré nepoužívajú hormonálnu antikoncepciu ani hormonálnu náhradnú liečbu. Muž sa považuje za plodného po puberte, pokiaľ nie je trvalo sterilizovaný bilaterálnou orchidektómiou.
    6. Účastníci by mali byť zapojení do systému sociálneho zabezpečenia (len pre pracoviská skúšania vo Francúzsku).
    E.4Principal exclusion criteria
    1. Subjects 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;
    2. Subjects 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 subject inappropriate for entry into this study;
    3. Subjects who are participating or plan to participate in other investigational studies (other than induction study) during the study.
    1. Účastníci, u ktorých sa vyvinuli vážne choroby/stavy alebo existujú dôkazy o nestabilnom klinickom stave (okrem ulceróznej kolitídy), ktoré, podľa posúdenia skúšajúceho lekára, podstatne zvýšia riziko pre účastníka, ak sa zúčastní na tomto skúšaní.
    2. Účastníci s akýmkoľvek závažným akútnym alebo chronickým zdravotným alebo psychiatrickým stavom či laboratórnymi alebo EKG abnormalitami, ktoré môžu zvýšiť riziko spojené s účasťou na skúšaní alebo podávaním skúšaného lieku, či môžu interferovať s interpretáciou výsledkov skúšania a podľa posúdenia skúšajúceho lekára sa stanú nevhodnými pre zapojenie sa do tohto skúšania.
    3. Účastníci, ktorí sa zúčastňujú alebo plánujú zúčastňovať iných výskumných skúšaní (iných ako indukčné skúšanie) počas tohto skúšania.
    E.5 End points
    E.5.1Primary end point(s)
    Number of Adverse Events (AEs) in ABX464 treated subjects.
    Počet nežiadúcich príhod (AE) u účastníkov liečených prípravkom ABX464.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Posledná návšteva posledného účastníka (LSLV)
    E.5.2Secondary end point(s)
    1. Percentage of subjects reaching clinical remission at yearly visits.
    2. Percentage of subjects reaching endoscopic remission at yearly visits.
    3. Percentage of subjects reaching clinical response at yearly visits.
    4. Percentage of subjects reaching endoscopic improvement at yearly visits.
    5. The change from Baseline in CRP and fecal calprotectin levels.
    6a.Number and rate of all AEs and causally-related AEs, all Serious Adverse Events (SAEs) and causally-related SAEs, all AEs of Specific Interest (AESIs) and causally-related AESIs, classified by severity;
    6b. Incidence of AEs leading to investigational medicinal product discontinuation;
    6c. The number of clinically-significant laboratory abnormalities.
    7. Change relative to baseline in miRNA-124 expression in total blood at every defined timepoint.

    Echocardiography endpoints:
    8a. Absolute (%) change from baseline echocardiogram of left ventricular ejection fraction (LVEF) as measured by 2-dimensional echocardiography;
    8b. Number of subjects with a clinically relevant reduction (change from baseline echocardiogram) of LVEF, defined as > 10% reduction (absolute percentage points) to a value < 50%;
    8c. Absolute (%) change in left ventricular global longitudinal strain (LVGLS) from baseline echocardiogram;
    8d. Number of subjects with a relative percentage reduction in LVGLS by > 15% from the previous value;
    8e. Number of subjects with a reduction of LVEF > 10% (absolute percentage points) to a value ≥ 50% with an accompanying fall in LVGLS > 15%;
    8f. Number of subjects with reduction in LVEF by > 10% (absolute percentage points) to a value ≥ 50%;
    8g. Changes from baseline echocardiography of other echocardiographic parameters as described in the Statistical Analysis Plan (SAP), including 2-dimensional volumes, right ventricle size and systolic function and valve function.
    1. Percentuálny podiel účastníkov dosahujúci klinickú remisiu pri ročných návštevách.
    2. Percentuálny podiel účastníkov dosahujúci endoskopickú remisiu pri ročných návštevách.
    3. Percentuálny podiel účastníkov dosahujúci klinickú odpoveď pri ročných návštevách.
    4. Percentuálny podiel účastníkov dosahujúci endoskopické zlepšenie pri ročných návštevách.
    5. Zmena hladín CRP a fekálneho kalprotektínu od počiatočnej hodnoty.
    6a. Počet a frekvencia všetkých AE a kauzálne súvisiacich AE, všetky závažné nežiaduce účinky (SAE) a kauzálne súvisiace SAE, všetky nežiaduce účinky špeciálneho záujmu (AESI) a kauzálne súvisiace AESI klasifikované podľa závažnosti.
    6b. Incidencia AE vedúcich k vysadeniu skúšaného lieku.
    6c. Počet klinicky významných laboratórnych abnormalít.

    7. Zmena v expresii miRNA-124 v plnej krvi v každom definovanom časovom bode oproti počiatočnej hodnote.

    Echokardiografické ciele :
    8a. Absolútna (%) zmena ejekčnej frakcie ľavej komory (LVEF) na echokardiograme od počiatočnej hodnoty nameranej pomocou 2-rozmernej echokardiografie.
    8b. Počet účastníkov s klinicky relevantným znížením (zmena echokardiogramu od počiatočnej hodnoty) > 10 % (absolútne percentuálne body) na hodnotu < 50 %.
    8c. Absolútna (%) zmena v globálnom longitudinálnom straine ľavej komory (LVGLS) od počiatočného echokardiogramu.
    8d. Počet účastníkov s relatívnym percentuálnym znížením LVGLS o > 15 % od predchádzajúcej hodnoty.
    8e. Počet účastníkov so znížením LVEF > 10 % (absolútne percentuálne body) na hodnotu ≥ 50 % so sprievodným poklesom LVGLS > 15 %.
    8f. Počet účastníkov so znížením LVEF o > 10 % (absolútne percentuálne body) na hodnotu ≥ 50 %.
    8g. Zmeny echokardiografie od počiatočnej hodnoty iných echokardiografických parametrov opísaných v časti Plán štatistických analýz (SAP) vrátane 2-rozmerných objemov, veľkosti pravej komory, systolickej funkcie a funkcie chlopní.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-4. Yearly visits
    5. EOS
    6a.-6c. LSLV
    7. Yearly visits
    8a. EOS
    8b. LSLV
    8c. EOS
    8d.-8f. LSLV
    8g. EOS
    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. 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.8.3 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 EEA54
    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
    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
    Posledná návšteva posledného účastníka
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 161
    F.4.2.2In the whole clinical trial 203
    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)
    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 Decision2021-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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