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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   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:2017-000330-61
    Sponsor's Protocol Code Number:CHI-DIP-2016-01
    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:2017-04-07
    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 number2017-000330-61
    A.3Full title of the trial
    Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study
    Efecto del dipropionato de beclometasona (DPB) en los niveles de calprotectina fecal en pacientes con colitis ulcerosa clínicamente inactiva con riesgo de recaída. Estudio BeCalCU.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study
    Efecto del dipropionato de beclometasona (DPB) en los niveles de calprotectina fecal en pacientes con colitis ulcerosa clínicamente inactiva con riesgo de recaída. Estudio BeCalCU.
    A.3.2Name or abbreviated title of the trial where available
    BeCalCU
    BeCalCU
    A.4.1Sponsor's protocol code numberCHI-DIP-2016-01
    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 SponsorCHIESI ESPAÑA S.A.U.
    B.1.3.4CountrySpain
    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 supportCHIESI ESPAÑA S.A.U.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L
    B.5.2Functional name of contact pointDepartamento de Ensayos Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressC/ Azcona 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.6E-mailm.dominguez@dynasolutions.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 Yes
    D.2.1.1.1Trade name Clipper
    D.2.1.1.2Name of the Marketing Authorisation holderCHIESI ESPAÑA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameBeclometasone dipropionate
    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 INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    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
    Clinically inactive Ulcerative Colitis at risk of relapse
    Colitis ulcerosa clínicamente inactiva con riesgo de recaída
    E.1.1.1Medical condition in easily understood language
    Clinically inactive Ulcerative Colitis at risk of relapse
    Colitis ulcerosa clínicamente inactiva con riesgo de recaída
    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 19.1
    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 assess the superiority of oral beclometasone dipropionate (BDP) over placebo on lowering levels of faecal calprotectin (FC) below 100 µg/g after 4 weeks of treatment in patients with clinical remission and at risk of relapse who are receiving treatment with 5-aminosalicylate (5-ASA)
    Evaluar la superioridad del dipropionato de beclometasona (DPB) oral sobre el placebo para disminuir los niveles de calprotectina fecal (CF) por debajo de los 100 µg/g tras 4 semanas de tratamiento en pacientes en remisión clínica con riesgo de recaída que estén recibiendo tratamiento con 5-aminosalicilatos (5-ASA).
    E.2.2Secondary objectives of the trial
    • To assess the effect of oral BDP on lowering FC levels below 100 µg/g after 8 weeks of treatment.
    • To assess the effect of oral BDP on lowering FC levels below 150 µg/g after 4 and 8 weeks of treatment.
    • To assess the effect of oral BDP on lowering FC levels below 50 µg/g after 4 and 8 weeks of treatment.
    • To assess the effect of oral BDP on intra-patient change of FC levels after 4 and 8 weeks of treatment.
    • To assess the effect of oral BDP on disease activity after 4 and 8 weeks of treatment.
    • To evaluate the safety of oral BDP treatment.
    • Evaluar el efecto del DPB oral en la disminución de los niveles de CF por debajo de 100 µg/g tras 8 semanas de tratamiento.
    • Evaluar el efecto del DPB oral en la disminución de los niveles de CF por debajo de 150 µg/g tras 4 y 8 semanas de tratamiento.
    • Evaluar el efecto del DPB oral en la disminución de los niveles de CF por debajo de 50 µg/g tras 4 y 8 semanas de tratamiento.
    • Evaluar el efecto del DPB oral en los cambios de nivel de CF en el mismo paciente tras 4 y 8 semanas de tratamiento.
    • Evaluar el efecto del DPB oral en la actividad de la enfermedad tras 4 y 8 semanas de tratamiento.
    • Evaluar la seguridad del tratamiento con DPB oral.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients 18 years of age or older.
    2. Patients with a diagnosis of left-sided or extended ulcerative colitis at least one year before the screening visit.
    3. Patients in clinical remission (Partial Mayo Score Index ≤2 with no single item >1 and rectal bleeding score = 0) at the screening visit.
    4. Patients who had at least one relapse of the disease in the 2 years prior to the screening visit.
    5. Patients who, according to the medical history, have FC levels above 250 µg/g of faeces in the 30 days preceding the screening visit confirmed between screening and baseline visit by a central laboratory.
    6. Receiving treatment at stable doses of oral 5-aminosalicylate for at least 4 weeks prior to the screening visit.
    7. Patients who have signed the informed consent form for participating in the study.
    1. Pacientes, hombres o mujeres, de al menos 18 años de edad.
    2. Pacientes con un diagnóstico de colitis ulcerosa izquierda o extensa de al menos un año antes de la Visita de Selección.
    3. Pacientes en remisión clínica (puntuación del índice de Mayo parcial ≤ 2 sin ninguna puntuación > 1 y puntuación de sangrado rectal = 0) en la Visita de Selección.
    4. Pacientes que hayan tenido al menos una recaída de la enfermedad en los 2 años previos a la Visita de Selección.
    5. Pacientes que, según el historial médico, muestren niveles de CF por encima de 250 µg/g en heces en los 30 días previos a la Visita de Selección, confirmado entre las Visita de Selección y Visita basal por un laboratorio central.
    6. Pacientes que reciben tratamiento con dosis estables de 5-aminosalicilatos por vía oral durante al menos 4 semanas antes de la Visita de Selección.
    7. Pacientes que hayan firmado el consentimiento informado para participar en el estudio.
    E.4Principal exclusion criteria
    1. Presence of stoma or prior colon resection.
    2. Patients with ulcerative colitis confined to the rectum (15 cm or less from the anal border)
    3. Receiving treatment with oral or rectal treatment with systemic corticosteroids, immunomodulating agents [thiopurines (azathioprine and 6-mercaptopurine), methotrexate, calcineurin inhibitors (cyclosporine and tacrolimus)] or biologic treatment in the 12 weeks prior to the screening visit
    4. Previous intolerance or toxicity associated with systemic corticosteroids.
    5. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) unless are using one or more of the highly effective contraceptive measures* at the screening visit.
    6. Presence of any disease for which corticosteroid treatment is contraindicated.
    7. Any serious disease or comorbidity.
    8. Treatment with nonsteroidal anti-inflammatory drugs during more than 7 consecutive days within the 3 months prior to the screening visit.
    9. Patients with 8 years or more after the onset of colitic symptoms without a colonoscopy in the 3 years prior to the screening visit.
    10. Patients who received any investigational new drug, or participated in a clinical study within the last 8 weeks.
    11. Any other condition that, in the judgment of the Investigator, may prevent a patient from completing all the procedures required or patients who refuse to, or lack the capacity to, provide consent.
    1. Presencia de estoma o resección previa de colon.
    2. Pacientes con colitis ulcerosa confinada al recto (15 cm o menos desde el borde anal).
    3. Pacientes que reciban tratamiento oral o rectal con corticosteroides sistémicos, , agentes inmunomoduladores [tiopurinas (azatioprina y 6-mercaptopurina), metotrexato, inhibidores de la calcineurina (ciclosporina y tacrolimus)] o tratamiento biológico en las 12 semanas anteriores a la Visita de Selección
    4. Intolerancia o toxicidad previas asociadas a los corticosteroides sistémicos.
    5. Mujeres embarazadas o en periodo de lactancia y todas las mujeres fisiológicamente capaces de quedarse embarazadas (es decir, mujeres con potencial de embarazo) a menos que estén utilizando uno o más de las medidas anticonceptivas de alta eficacia * en el momento de la Visita de Selección.
    6. Presencia de alguna enfermedad para la cual esté contraindicado el tratamiento con corticosteroides.
    7. Cualquier enfermedad o comorbilidad grave.
    8. Tratamiento con medicamentos antiinflamatorios no esteroideos durante más de 7 días consecutivos en un periodo de 3 meses antes de la Visita de Selección.
    9. Pacientes que hayan detectado los síntomas de la colitis desde hace 8 años o más y que no se hayan realizado una colonoscopia en los 3 años anteriores a la Visita de Selección.
    10. Pacientes que hayan recibido algún nuevo medicamento en investigación o que hayan participado en algún estudio clínico en las últimas 8 semanas.
    11. Cualquier otra condición que a juicio de los investigadores pueda evitar que un paciente complete todos los procedimientos requeridos o aquellos pacientes que rechacen proporcionar su consentimiento o que carezcan de la capacidad necesaria para hacerlo.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with FC levels below 100 µg/g after 4 weeks of treatment.
    Porcentaje de pacientes con niveles de CF por debajo de 100 µg/g después de 4 semanas de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation after 4 weeks of treatment
    Evaluación tras 4 semanas de tratamiento
    E.5.2Secondary end point(s)
    • Percentage of patients with FC levels below 100 µg/g after 8 weeks of treatment.
    • Percentage of patients with FC levels below 150 µg/g after 4 and 8 weeks of treatment.
    • Percentage of patients with FC levels below 50 µg/g after 4 and 8 weeks of treatment.
    • Mean intra-patient change in FC levels after 4 and 8 weeks of treatment.
    • Percentage of patients with disease worsening – after 4 and 8 weeks of treatment: increase of the Partial Mayo Score Index, hospitalization, treatment with classic corticosteroids or changes in maintenance treatment.
    • Porcentaje de pacientes con niveles de CF por debajo de 100 µg/g después de 8 semanas de tratamiento.
    • Porcentaje de pacientes con niveles de CF por debajo de 150 µg/g después de 4 y 8 semanas de tratamiento.
    • Porcentaje de pacientes con niveles de CF por debajo de 50 µg/g después de 4 y 8 semanas de tratamiento.
    • Cambio medio intrapaciente de los niveles de CF después de 4 y 8 semanas de tratamiento.
    • Porcentaje de pacientes con empeoramiento de la enfermedad tras 4 y 8 semanas de tratamiento: aumento de la puntuación del índice de Mayo parcial, hospitalización, tratamiento con corticosteroides clásicos o cambios en el tratamiento de mantenimiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation after 4 and 8 weeks of treatment
    Evaluación tras 4 y 8 semanas de tratamiento
    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 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Segunda parte es abierto, no randomizado y una unica rama de tratamiento con DPB
    Second part is Open-label, non-randomized and single arm design with BDP.
    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 trial1
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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 No
    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
    Last patient last visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state64
    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)
    Treatment after clinical trial according to normal practice
    Tratamiento después del ensayo clínico según práctica clínica habitual
    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 Decision2017-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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