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    Summary
    EudraCT Number:2017-001240-35
    Sponsor's Protocol Code Number:M14-433
    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:2018-05-10
    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 number2017-001240-35
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy
    Estudio de inducción multicéntrico, aleatorizado, doble ciego y comparado con placebo para evaluar la eficacia y la seguridad de upadacitinib (ABT-494) en sujetos con enfermedad de Crohn de moderada a grave que han tenido una respuesta insuficiente o intolerancia a un tratamiento convencional pero no han presentado fracaso terapéutico con fármacos biológicos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy
    Un estudio de la eficacia y seguridad de Upadacitinib (ABT-494) en sujetos con enfermedad de Crohn moderada o gravemente activa que han respondido de manera inadecuada o son intolerantes a terapias convencionales pero no han fallado la terapia biológica
    A.4.1Sponsor's protocol code numberM14-433
    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, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number34901 20 01 03
    B.5.6E-mailabbvie_reec@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 nameUpadacitinib
    D.3.2Product code ABT-494
    D.3.4Pharmaceutical form Tablet
    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 INNUpadacitinib
    D.3.9.1CAS number 1310726-60-3
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB125895
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 Yes
    D.3.11.13.1Other medicinal product typeJanus Kinase (Jak) 1 inhibitor
    D.IMP: 2
    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 nameUpadacitinib
    D.3.2Product code ABT-494
    D.3.4Pharmaceutical form Tablet
    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 INNUpadacitinib
    D.3.9.1CAS number 1310726-60-3
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB125895
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    D.3.11.13.1Other medicinal product typeJanus Kinase (Jak) 1 inhibitor
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease (CD)
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    CD is an inflamatory bowel disease affects the lining of the digestive tract, often spreads into the layers of affected bowel tissue, can lead to abdominal pain, severe diarrhea, fatigue, weight loss.
    La EC es una enf inflam del intestino que afecta el revesti del tracto diges, a menudo se extiende a las capas del tejido intestinal afec, puede provocar dolor abd, diarrea severa, fatiga, pér de peso
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    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 objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
    El objetivo de este estudio es evaluar la eficacia y seguridad de upadacitinib en comparación con placebo como terapia de inducción en participantes con enfermedad de Crohn moderada y severamente activa (EC).
    E.2.2Secondary objectives of the trial
    To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.
    Evaluar las mejoras en varios parámetros de eficacia, incluida la discontinuidad de esteroides, parámetros de laboratorio y cuestionarios de calidad de vida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmed diagnosis of CD for at least 3 months prior to Baseline.
    - Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
    - Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
    - Demonstrated an inadequate response or intolerance to conventional therapies (Oral aminosalicylates, Oral locally acting steroids, Intravenous or oral corticosteroids, Immunosuppressants), in the opinion of the investigator.
    Note: Participants who have received prior biologic may be enrolled; however, participants must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease),
    - If female, subject must meet the contraception recommendations.
    -Diagnóstico confirmado de EC al menos 3 meses antes de la visita inicial.
    -Diagnóstico confirmado de EC de moderada a grave, evaluada mediante la puntuación de la frecuencia de las deposiciones (FD), dolor abdominal (DA)

    -Evidencia de inflamación de la mucosa basada en la puntuación endoscópica simplificada para la enfermedad de Crohn (SES-CD) en una endoscopia confirmada por un lector central.

    -Demostró una respuesta inadecuada o intolerancia a las terapias convencionales (aminosalicilatos orales, esteroides orales de acción local, corticosteroides intravenosos u orales, inmunosupresores), en opinión del investigado.
    -Nota: los participantes que hayan recibido terapia biología previa pueden sser reclutados; sin embargo, los participantes deben haber suspendido el tratamiento biológico por razones distintas a respuesta inadecuada o a la intolerancia (por ejemplo, cambio de seguro, enfermedad bien controlada)
    -Si es mujer, el sujeto debe cumplir con las recomendaciones de anticoncepción
    E.4Principal exclusion criteria
    - Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
    - Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
    - Participant with the following known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
    - Participant with ostomy or ileoanal pouch
    - Participant diagnosed with short gut or short bowel syndrome
    - Screening laboratory and other analyses show abnormal results.
    -Participante con un diagnóstico actual de colitis ulcerosa o colitis indeterminada.

    - Participante que no esté en dosis estables de antibióticos relacionados con CD, aminosalicilatos orales, corticosteroides o metotrexato (MTX).

    - Participante con las siguientes complicaciones conocidas de la EC: abscesos (abdominales o peri-anales), estenosis intestinales sintomáticas, colitis fulminante, megacolon tóxico o cualquier otra manifestación que pueda requerir cirugía mientras esté inscrito en el estudio.
    -Participante con ostomía o bolsa ileoanal.

    -Participante diagnosticado con síndrome de intestino corto o intestino corto.
    -El análisis de laboratorio y otros análisis muestran resultados anormales.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary Endpoints:
    1. Proportion of subjects with clinical remission at Week 12, and
    2. Proportion of subjects with endoscopic response at Week 12.
    Co-primary Endpoints:
    1. Proporción de sujetos con remisión clínica en la semana 12, y

    2. Proporción de sujetos con respuesta endoscópica en la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    1. Proportion of subjects with clinical remission at Week 4
    2. Proportion of subjects with clinical remission per CDAI (CDAI < 150) in subjects with a Baseline CDAI of 220 to 450 at Week 12
    3. Proportion of subjects with enhanced clinical response at Week 2
    4. Proportion of subjects with endoscopic remission at Week 12
    5. Proportion of subjects who discontinue corticosteroid use and achieve clinical remission at Week 12, in subjects taking corticosteroids for CD at Baseline
    6. Proportion of subjects with ≥ 50% reduction in draining fistulas at Week 12, in subjects with draining fistulas at Baseline
    7. Change from Baseline in Crohn's Symptoms Severity Questionnaire at Week 12
    8. Proportion of subjects with hospitalizations due to CD during the 12 week double-blind induction period
    9. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12
    10. Change from Baseline in Short Form-36 (SF-36) at Week 12
    1. Proporción de sujetos con remisión clínica en la semana 4.

    2. Proporción de sujetos con remisión clínica por IAEC (CDAI <150) en sujetos con un CDAI inicial de 220 a 450 en la semana 12

    3. Proporción de sujetos con respuesta clínica mejorada en la semana 2.
    4. Proporción de sujetos con remisión endoscópica en la semana 12

    5. Proporción de sujetos que interrumpen el uso de corticosteroides y logran la remisión clínica en la semana 12, en sujetos que toman corticosteroides para EC al inicio del estudio.
    6. Proporción de sujetos con una reducción ≥ 50% en las fístulas de drenaje en la semana 12, en sujetos con fístulas de drenaje en la línea de base.
    7. Cambio en el Cuestionario de gravedad de síntomas de Crohn, desde la visita inicial en la semana 12.
    8. Proporción de sujetos con hospitalizaciones por EC durante el período de inducción doble ciego de 12 semanas.
    9. Cambio desde la visita inicial en la evaluación funcional para el tratamiento de enfermedades crónicas – fatiga (FACIT-F) en la semana 12.
    10. Cambio desde la visita inicial en el Formulario abreviado-36 (SF-36) en la semana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. week 4
    2. week 12
    3. week 2
    4. week 12
    5. week 12
    6. week 12
    7. week 12
    8. week 12
    9. week 12
    10. week 12
    1. semana 4
    2. semana 12
    3. semana 2
    4. semana 12
    5. semana 12
    6. semana 12
    7. semana 12
    8. semana 12
    9. semana 12
    10. semana 12
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA146
    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
    Argentina
    Australia
    Belarus
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Colombia
    Egypt
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Russian Federation
    Serbia
    Singapore
    South Africa
    Switzerland
    Taiwan
    Turkey
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days14
    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: 285
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 146
    F.4.2.2In the whole clinical trial 300
    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)
    Subjects who achieve clinical response at week 12 or 24 may be enroll in the maintenance/long-term extension study M14-430 with upadacitinib. Subjects who do not achieve clinical response to upadacitinib at week 24 will receive standard of care treatment, per the investigator’s decision.
    Los sujetos que logran respuesta clínica en la semana 12 o 24 pueden inscribirse en el estudio de mantenimiento / extensión a largo plazo M14-430 con upadacitinib. Los sujetos que no logren una respuesta clínica a upadacitinib en la semana 24 recibirán tratamiento de atención estándar, de acuerdo con la decisión del investigador
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-13
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