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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2017-003284-35
    Sponsor's Protocol Code Number:ABX464-102
    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:2018-04-09
    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 number2017-003284-35
    A.3Full title of the trial
    A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis
    Ensayo clínico de seguimiento en fase IIa para evaluar el perfil de seguridad y eficacia a largo plazo de ABX464 administrado una vez al día en una dosis de 50 mg en 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
    Investigate the efficacy and safety of study drug ABX464 50 mg once daily in patients with moderate to severe Active Ulcerative Colitis.
    Evaluar la seguridad y la eficacia de ABX464 50 mg una vez al día en sujetos con Colitis Ulcerosa Activa Moderada a Grave
    A.3.2Name or abbreviated title of the trial where available
    A follow-up study in patients with moderate to severe active ulcerative colitis.
    Ensayo clínico de seguimiento en pacientes con colitis ulcerosa activa de moderada a grave.
    A.4.1Sponsor's protocol code numberABX464-102
    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 dela 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 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
    Moderate to severe Ulcerative Colitis.
    Colitis Ulcerosa Moderada a Severa
    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 los revestimientos del colon se inflaman y se crean pequeñas heridas abiertas que producen pus y mucosa. Esto causa malestar abdominal y diarrea
    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 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.
    El objetivo principal del estudio es evaluar la seguridad de ABX464 con dosis de 50 mg una vez al día en pacientes con colitis ulcerosa activa de moderada a grave.
    E.2.2Secondary objectives of the trial
    • To evaluate the long term effect of ABX464 on clinical and endoscopic remission in subjects with Moderate to Severe Active Ulcerative Colitis assessed by the MCS.
    • To evaluate the long-term effect of ABX464 on inflammatory markers (CRP, Calprotectin and ESR)
    • To evaluate the long-term of ABX464 on Quality of Life (QoL) measured by the SF-36 questionnaire in subjects with Moderate to Severe Active Ulcerative Colitis.
    ▪ Evaluar el efecto a largo plazo de ABX464 en la remisión endoscópica en pacientes con Colitis Ulcerosa de moderada a grave
    ▪ Evaluar el efecto a largo plazo de ABX464 en marcadores inflamatorios (CRP, calprotectina y ESR)
    ▪ Evaluar el efecto a largo plazo de ABX464 en la Calidad de vida (CdV) determinada con el cuestionario SF-36 en pacientes con Colitis Ulcerosa de moderada a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if ALL of the following criteria apply:
    • Subjects previously enrolled in the ABX464-101 clinical study who have completed the initial 2-month treatment phase;
    • Subjects able and willing to comply with study visits and procedures;
    • Subjects with hematological and biochemical laboratory parameters as follows at the D56 visit of the ABX464-101 study:
    o Hemoglobin > 9.0 g dL-1;
    o Absolute neutrophil count ≥ 750 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 of entry;
    o Total serum bilirubin < 1.5 x ULN;
    o Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 1.5 x
    ULN;

    -Subjects should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed;

    -Subjects 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 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 associated with inhibition of ovulation, intrauterine hormone releasing system (IUS), hormonal contraception (estrogen and progestogen or progestogen only) associated with inhibition of ovulation, bilateral tubal occlusion, 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.
    Criterios de inclusión:
    El paciente podrá participar en este estudio solo si cumple TODOS los criterios siguientes:
    ▪Pacientes que hayan participado anteriormente en el ABX464-101 studio clínico y que hayan completado los 2 meses de tratamiento;
    ▪Los pacientes deberán tener la capacidad y la voluntad de cumplir con las visitas y procedimientos del estudio según el protocolo.
    ▪Los pacientes con los siguientes parámetros de laboratorio hematológicos y bioquímicos 14 días antes de la visita inicial:
    o Hemoglobina > 9,0 g/dl-1
    o Recuento absoluto de neutrófilos ≥ 750 mm-3
    o Plaquetas ≥ 100 000 mm-3
    o Creatinina sérica total ≤ 1,3 x límite superior de normalidad (LSN)
    o Aclaramiento de creatinina > 50 ml/min-1 mediante la ecuación de Cockcroft-Gault en el plazo de 60 días después de la entrada
    o Bilirrubina total en suero < 1,5 x LSN
    o Fosfatasa alcalina, AST (SGOT) y ALT (SGPT) < 1,5 x LSN
    ▪Los pacientes deberán entender, firmar y fechar el formulario de consentimiento informado voluntario por escrito en la visita de selección antes de realizar ningún procedimiento específico del protocolo.
    ▪Los pacientes deberán estar afiliados al régimen de la seguridad social (solo para centros en Francia).
    ▪Las mujeres y los hombres que reciban el tratamiento del estudio y sus respectivas parejas deben aceptar el uso de un método anticonceptivo efectivo durante el estudio y 3 meses después del final del estudio o de la finalización anticipada. El uso del método anticonceptivo deberá iniciarse al menos 2 semanas antes de participar en el estudio. Las mujeres deberán estar esterilizadas quirúrgicamente o si son mujeres en edad fértil deberán aceptar el uso de métodos anticonceptivos eficaces. Las mujeres en edad fértil entrarán en el estudio después del periodo menstrual confirmado y un resultado negativo en la prueba de embarazo. Los métodos anticonceptivos eficaces son los siguientes: abstinencia sexual real, dispositivo intrauterino (DIU) o anticonceptivos hormonales (estrógeno y progesterona ó progesterona sóla) asociados a la inhibición de la ovulación, dispositivo de liberación hormonal intrauterino, oclusión tubárica bilateral o pareja vasectomizada. La abstinencia real se define cuando dicha abstinencia es acorde con el tipo de vida preferido y habitual del paciente. En caso de retraso en el periodo menstrual (más de un mes entre menstruaciones) es necesario confirmar la ausencia de embarazo. Esta recomendación también corresponde a las mujeres en edad fértil con ciclos menstruales poco frecuentes o irregulares.
    E.4Principal exclusion criteria
    Any condition, which in the opinion of the investigator, could compromise the subject's safety or the adherence to the study protocol.
    Cualquier condición, que en opinion del investigador, pueda comprometer la salud del paciente o la adherencia al protocol del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of incidences of treatment-emergent adverse events in ABX464 treated subjects.
    ▪Número de incidencias de acontecimientos adversos que se presentan o empeoran a partir de la primera dosis del fármaco del estudio en pacientes tratados con ABX464.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation of this end point from day 0 to EoS.
    Tiempo de evaluacion de este punto final desde el dia 0 al EoS.
    E.5.2Secondary end point(s)
    The change from Day 0 in Total Mayo Score.
    . The change from Day 0 in Partial Mayo Score.
    .The time to UC worsening.
    .The change from Day 0 in fecal calprotectin, CRP levels and ESR.
    .The scores and changes from Day 0 in SF-36 Questionnaire scores
    .The number of incidences of treatment-emergent adverse serious adverse events.
    .The number of incidences of treatment-emergent adverse events leading to investigational product discontinuation.
    .The number of incidences of specific laboratory abnormalities.
    ▪El cambio respecto al día 0 en la puntuación total de la escala de la Clínica Mayo.
    ▪El cambio respecto al día 0 en la puntuación parcial de la escala de la Clínica Mayo.
    ▪El tiempo hasta el empeoramiento de la colitis ulcerosa.
    ▪El cambio respecto al día 0 en los niveles de calprotectina fecal, CRP y ESR.
    ▪Las puntuaciones y los cambios respecto al día 0 en la puntuación del cuestionario SF-36.
    ▪El número de incidencias de acontecimientos adversos graves que se presentan o empeoran a partir de la primera dosis del fármaco del estudio.
    ▪El número de incidencias de acontecimientos adversos de especial interés que se presentan o empeoran a partir de la primera dosis del fármaco del estudio.
    ▪El número de incidencias de acontecimientos adversos que provocan la interrupción del producto en fase de investigación clínica.
    ▪El número de incidencias de anomalías específicas de laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time point of evaluation for secondary endpoints are throughout the study.
    Los tiempos de evaluación para los puntos finales secundarios están presentes durante el studio.
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Normal 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 Decision2018-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Sun May 05 08:11:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA