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    The EU Clinical Trials Register currently displays   44157   clinical trials with a EudraCT protocol, of which   7327   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).

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    Summary
    EudraCT Number:2018-000930-37
    Sponsor's Protocol Code Number:M15-722
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-22
    Trial results View 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 number2018-000930-37
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
    Estudio multicéntrico, aleatorizado, doble ciego, control con placebo para investigar la eficacia y seguridad de ABBV-323 en pacientes con Colitis Ulcerosa moderada a severa con fallo a terapias previas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
    Estudio para investigar la seguridad y como funciona ABBV-323 en pacientes con Colitis Ulcerosa de Moderada a Severa que han fallado en terapias previas.
    A.4.1Sponsor's protocol code numberM15-722
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie INC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU clinical trials helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie house, Vanwell business park
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 nameABBV-323
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRAVAGALIMAB
    D.3.9.2Current sponsor codeABBV-323
    D.3.9.3Other descriptive nameABBV-323
    D.3.9.4EV Substance CodeSUB192927
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for concentrate for solution for injection/infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    Colitis Ulcerosa
    E.1.1.1Medical condition in easily understood language
    A long-term (chronic) condition where the colon and rectum (large intestine or large bowel) become inflamed.
    Condiciones a largo plazo (crónico) en las que el colon y el recto (intestino grueso) está inflamado.
    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 10045365
    E.1.2Term 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
    To characterize the efficacy, safety, and tolerability of ABBV-323 as induction treatment in subjects with moderately to severely active UC.
    Caracterizar la eficacia, seguridad y tolerabilidad de ABBV-323 como tratamiento de inducción en pacientes con Colitis Ulcerosa de moderada a severa.
    E.2.2Secondary objectives of the trial
    1. To assess pharmacokinetics (PK) and receptor occupancy (RO) of ABBV-323 in subjects with moderately to severely active UC.
    2. To characterize the efficacy, safety, and tolerability of ABBV-323 as maintenance therapy in subjects with clinical response to ABBV-323 following induction therapy.
    1. Evaluar la farmacocinética y la ocupación del receptor de ABBV-323 en pacientes con Colitis Ulcerosa de moderada a severa.
    2. Caracterizar la eficacia, seguridad y tolerabilidad de ABBV-323 como terapia de mantenimiento en pacientes con respuesta clínica a ABBV-323 después de la terapia de inducción.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ·Subjects must voluntarily sign and date an informed consent, approved
    by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
    ·Adult male or female, between 18 and 75 years of age, inclusive, at time of the Baseline visit.
    ·Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC or in the assessment of the Investigator, must be available.
    ·Subject meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
    ·History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug).
    ·Laboratory values that meet the following criteria:
    - Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 × upper limit of
    normal (ULN);Total white blood cell (WBC) count ≥ 3.0 × 10^9 /L;
    · Los pacientes deben firmar y fechar el consentimiento informado voluntariamente, aprobado por un comité ético (CEIm), antes de iniciar cualquier procedimiento de selección o específico del estudio.
    · Varones o Mujeres adultas entre 18 y 75 años, en el momento de la visita basal.
    · Diagnóstico de Colitis Ulcerosas desde al menos hace tres meses antes de la selección. Documentar apropiadamente los resultados de una biopsia con diagnóstico de colitis ulcerosa o evaluación del investigador, debe estar disponible.
    · Los pacientes deben reunir los siguientes criterios de actividad de la enfermedad: Colitis Ulcerosa Activa con Adapten Mayo de 5 a 9 puntos y una puntación sub-endoscópica de 2 a 3 confirmado por un revisor central.
    ·Historial de respuesta inadecuada, perdida de respuesta o intolerancia a una o más terapias biológicas: Infliximab, adalimumab, golimumab, vedolizumab, y/o tofacitinib (Nota: Si tofacitinib se recibió en ensayos clínicos, los pacientes deben haberlo reicibido en abierto)
    · Los valores de laboratorio deben reunir los siguientes criterios:
    - Aspartato transaminasa sérica (AST) y Alanina transaminada sérica (ALT) ≤ 2 × límite superior normal); El recuento total de células blancas sanguíneas ≥ 3.0 × 10^9 /L;
    E.4Principal exclusion criteria
    - Subject must not have an active, chronic, or recurrent infection that based on the
    Investigator's clinical assessment makes the subject an unsuitable candidate for the study

    - Subject must not have any malignancy except for successfully treated non metastatic cutaneous
    squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.

    - Subject must not have history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy
    performed during the Screening endoscopy
    - Los pacientes no tienen que tener infección activa, recurrente o crónica que en opinión de la evaluación clínica del investigador el paciente no sea un buen candidato para el estudio.
    - Los pacientes no tienen que tener ninguna malignidad excepto para los tratados con éxito en carcinoma metastásico de células cutáneas escamosas o carcinoma de células basales o carcinoma localizado in situ de cérvix.
    - Los pacientes no tienen que tener historial de displasia o evidendia de displasia gastrointestinal en alguna biopsia de la endoscopia en el screening.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects with endoscopic improvement (Mayo endoscopic subscore of 0 or 1) at Week 8.
    La proporción de pacientes con mejora en la endoscopia (Subpuntación endoscópica de mayo de 0 o 1) en la semana 8
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 8
    En semana 8
    E.5.2Secondary end point(s)
    Secondary Endpoints for Double-Blind Induction Period (Weeks 0 to 12):
    - Proportion of subjects with clinical remission per Adapted Mayo score at Week 8
    - Proportion of subjects with clinical response per Adapted Mayo score at Week 8
    - Proportion of subjects with clinical response per Partial Adapted Mayo score over time
    - Proportion of subjects with clinical remission per Full Mayo score at Week 8 in subjects with a Full Mayo score of 6 to 12 at Baseline.
    - Proportion of subjects with endoscopic remission at Week 8
    Variables secundarias para doble ciego en el periodo de inducción (semanas 0 a 12):
    - Proporción de pacientes con remisión clínica por la puntuación de Adapted Mayo en la semana 8
    - Proporción de pacientes con respuesta clínica por la puntuación de Adapted Mayo en la semana 8
    - Proporción de pacientes con respuesta clínica pro Adapted Mayo a lo largo del tiempo
    - Proporción de pacientes con remisión clínica por puntuación de Full Mayo en la semana 8 en los pacientes con Full Mayo de 6 a 12 en el momento basal.
    - Proporción de pacientes con remisión en la endoscopia en la semana 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time points provided in E.5.2
    Puntos de tiempo en E.5.2
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA14
    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
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    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
    84 days after the last subject last dose of study drug
    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 months2
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days24
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    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)
    Not applicable
    No aplica
    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 Decision2019-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-27
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