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    Summary
    EudraCT Number:2021-004398-30
    Sponsor's Protocol Code Number:ABX464-108
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-25
    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 ConcernedSpain - AEMPS
    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
    Estudio abierto de Fase II de seguimiento para evaluar el perfil de seguridad y la eficacia a largo plazo de ABX464 administrado a una dosis de 25 mg una vez al día a pacientes con colitis ulcerosa activa de moderada a grave.
    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.
    Efectos de ABX464 durante el tratamiento a largo plazo en pacientes con colitis ulcerosa de moderada a grave.
    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.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 pointVice President 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+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.3.2Product 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.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
    Colitis ulcerosa de moderada a grave
    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)
    En la colitis ulcerosa, el revestimiento del colon se inflama y desarrolla pequeñas llagas abiertas que producen pus y mucosidad. Esto provoca molestias abdominales y el vaciado frecuente del colon
    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 evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.
    El objetivo principal del estudio es evaluar la seguridad a largo plazo de ABX464 administrando 25 mg una vez al día en sujetos con colitis ulcerosa activa de moderada a grave.
    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.
    Los objetivos secundarios son:
    1. Evaluar el efecto a largo plazo de ABX464 en la remisión clínica;
    2. Evaluar el efecto a largo plazo de ABX464 en la remisión endoscópica;
    3. Evaluar el efecto a largo plazo de ABX464 en la respuesta clínica;
    4. Evaluar el efecto a largo plazo de ABX464 en la mejora endoscópica;
    5. Evaluar el efecto a largo plazo de ABX464 en los marcadores inflamatorios (proteína C reactiva (PCR), calprotectina);
    El cambio desde el valor de referencia en los niveles de PCR y calprotectina fecal.
    6. Evaluar el perfil de seguridad de ABX464;
    7. Evaluar el efecto de ABX464 en la expresión de miR-124 en sangre total en cada punto de tiempo definido en la tabla de procedimientos.

    Objetivo ecocardiográfico:
    8. Evaluar el efecto de ABX464 en la función cardíaca evaluada mediante ecocardiogramas.
    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 less or equal to 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 6 months (180 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. 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. 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 subjects must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male subjects should use condom during the trial and for 6 months (180 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. Sujetos que hayan completado previamente los estudios clínicos ABX464-102 o ABX464-104;
    2. Sujetos que estén en mejora endoscópica con una subpuntuación de hemorragia rectal = 0 puntos al final del período de tratamiento en el estudio anterior (ABX464-102 o ABX464-104). La mejora endoscópica se define como una subpuntuación endoscópica de Mayo menor o igual a 1;
    3. Sujetos capaces y dispuestos a cumplir con las visitas y los procedimientos del estudio;
    4. Los sujetos deben comprender, firmar y fechar el formulario de consentimiento informado voluntario por escrito en la visita, previamente a realizar cualquier procedimiento específico del protocolo;
    5. Las mujeres en edad fértil y los hombres que reciban el tratamiento del estudio, así como sus parejas, deben comprometerse a utilizar un método anticonceptivo altamente eficaz durante el estudio y durante los 6 meses (180 días) posteriores a la finalización del estudio o la terminación anticipada. Las mujeres deben tener esterilidad quirúrgica o, si están en edad fértil, deben usar un método anticonceptivo altamente eficaz. Las mujeres en edad fértil (WOCBP, por sus siglas en inglés) entrarán en el estudio después de un período menstrual confirmado y una prueba de embarazo negativa. Los métodos anticonceptivos más eficaces son la abstinencia completa, el dispositivo intrauterino (DIU) o la anticoncepción hormonal destinada a inhibir la ovulación, el sistema de liberación de hormonas intrauterino, la ligadura de trompas bilateral y la vasectomía de la pareja. La abstinencia completa se define cuando ésta se ajusta al estilo de vida preferido y habitual del sujeto. En cada caso de retraso del período menstrual (más de un mes entre menstruaciones) se requiere la confirmación de la ausencia de embarazo. Esta recomendación también se aplica a las mujeres WOCBP con ciclo menstrual poco frecuente o irregular. Los sujetos femeninos y masculinos no deben planificar un embarazo durante el ensayo ni durante los 6 meses posteriores a la finalización de su participación en el mismo. Además, los sujetos masculinos deben usar preservativos durante el ensayo y durante los 6 meses (180 días) posteriores a la finalización de su participación en el estudio. Los sujetos masculinos no deben donar esperma mientras se requiera anticoncepción. A efectos de este protocolo, se considera que una mujer está en edad fértil (WOCBP) después de la menarquia y hasta la posmenopausia, a menos que sea permanentemente estéril. Los métodos de esterilización permanente incluyen la histerectomía, la salpingectomía bilateral y la ooforectomía bilateral. Un estado posmenopáusico se define como la ausencia de menstruación durante 12 meses sin una causa médica alternativa. Se puede usar un nivel alto de hormona estimulante del folículo (FSH) en el rango posmenopáusico para confirmar un estado posmenopáusico en mujeres que no usan anticoncepción hormonal o terapia de reemplazo hormonal. Por último, se considera que un hombre es fértil después de la pubertad, a menos que sea permanentemente estéril por orquidectomía bilateral;
    6. Los sujetos deben estar afiliados a un régimen de seguridad social (solo para los centros franceses).
    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. Sujetos que hayan desarrollado cualquier enfermedad/afección importante o para los que haya evidencia de una afección clínica inestable (excepto CU) que, a criterio del investigador, aumentará sustancialmente el riesgo para el participante si participa en el estudio;
    2. Sujetos con cualquier otra afección médica o psiquiátrica aguda o crónica grave o anomalías del laboratorio o del electrocardiograma (ECG) que pueda aumentar el riesgo asociado con la participación en el estudio o a la administración del producto en investigación o que pueda interferir en la interpretación de los resultados del estudio y, a criterio del investigador, haga que el sujeto no sea apropiado para participar en este estudio;
    3. Sujetos que participen o planeen participar en otros estudios de investigación (distintos al estudio de inducción) durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of Adverse Events (AEs) in ABX464 treated subjects.
    Número de acontecimientos adversos (AA) en sujetos tratados con ABX464.
    E.5.1.1Timepoint(s) of evaluation of this end point
    LSLV
    Último sujeto, última visita.
    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 greater or equal than 50% with an accompanying fall in LVGLS > 15%;
    8f. Number of subjects with reduction in LVEF by > 10% (absolute percentage points) to a value greater or equal than 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. Porcentaje de sujetos que alcanzan la remisión clínica en las visitas anuales.
    2. Porcentaje de sujetos que alcanzan la remisión endoscópica en las visitas anuales.
    3. Porcentaje de sujetos que alcanzan la respuesta clínica en las visitas anuales.
    4. Porcentaje de sujetos que alcanzan una mejora endoscópica en las visitas anuales.
    5. El cambio desde el valor de referencia en los niveles de PCR y calprotectina fecal.
    6a. El número y la tasa de todos los AA y los AA con relación causal, todos los acontecimientos adversos graves (AAG) y los AAG con relación causal, todos los AA de interés especial (AAIE) y los AAIE con relación causal, clasificados por gravedad;
    6b. Incidencia de los acontecimientos adversos que conducen a la interrupción del medicamento en investigación;
    6c. El número de anomalías de laboratorio clínicamente significativas.
    7. Cambio en relación al valor de referencia en la expresión de miARN-124 en sangre total en cada punto de tiempo definido.

    Objetivos ecocardiográficos:

    8a. Cambio absoluto (%) del valor de referencia del ecocardiograma de la fracción de eyección del ventrículo izquierdo (FEVI) medido por ecocardiografía bidimensional;
    8b. Número de sujetos con una reducción clínicamente relevante (cambio del valor de referencia del ecocardiograma) de la FEVI, definida como una reducción de > 10 % (puntos porcentuales absolutos) hasta un valor de < 50 %;
    8c. Cambio absoluto (%) en la tensión longitudinal global del ventrículo izquierdo (SLGVI) con respecto al valor de referencia del ecocardiograma;
    8d. Número de sujetos con una reducción porcentual relativa en SLGVI en > 15 % del valor anterior;
    8e. Número de sujetos con una reducción de la FEVI de > 10 % (puntos porcentuales absolutos) a un valor mayor o igual que 50 % acompañada de una caída en SLGVI > 15 %;
    8f. Número de sujetos con reducción de la FEVI en > 10 % (puntos porcentuales absolutos) hasta a un valor mayor o igual que 50 %;
    8g. Cambios del valor de referencia de la ecocardiografía con respecto a otros parámetros ecocardiográficos como se describe en el Plan de Análisis Estadístico (PAE), incluidos los volúmenes bidimensionales, el tamaño del ventrículo derecho y la función sistólica y valvular.
    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
    1.-4. Visitas anuales
    5. Fin de estudio
    6a.-6c. Último sujeto, última visita
    7. Visitas anuales
    8a. Fin de estudio
    8b. Último sujeto, última visita
    8c. Fin de estudio
    8d.-8f. Último sujeto, última visita
    8g. Fin de estudio
    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.8.3 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 concerned1
    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
    Canada
    Austria
    France
    Poland
    Spain
    Czechia
    Germany
    Italy
    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
    Última visita, último sujeto
    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 months4
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    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)
    None
    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 Decision2022-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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