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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2016-000420-26
    Sponsor's Protocol Code Number:UC0011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-05
    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 number2016-000420-26
    A.3Full title of the trial
    A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS
    ESTUDIO MULTICÉNTRICO, CON DISEÑO CIEGO PARA EL SUJETO Y PARA EL INVESTIGADOR, ALEATORIZADO Y CONTROLADO CON PLACEBO, PARA EVALUAR LA EFICACIA, LA SEGURIDAD, LA TOLERABILIDAD Y LA FARMACOCINÉTICA DE BIMEKIZUMAB (UCB4940), CON UNA DOSIS DE ATAQUE IV SEGUIDA POR ADMINISTRACIÓN SC, EN SUJETOS CON COLITIS ULCEROSA ACTIVA DE GRADO MODERADO A SEVERO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.
    El estudio prueba la efectividad de bimekizumab como tratamiento para la colitis ulcerosa para buscar efectos adversos no deseados y para medir como el fármaco se distribuye, modifica y elimina del cuerpo.
    A.4.1Sponsor's protocol code numberUC0011
    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 SponsorUCB Biopharma SPRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma Sprl
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB Biosciences GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number492173481515
    B.5.6E-mailclinicaltrials@ucb.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 nameBimekizumab
    D.3.2Product code UCB4940
    D.3.4Pharmaceutical form 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 INNBimekizumab
    D.3.9.1CAS number 1418205-77-2
    D.3.9.2Current sponsor codeCDP4940
    D.3.9.3Other descriptive nameUCB4940
    D.3.9.4EV Substance CodeSUB130157
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SEVERE ACTIVE ULCERATIVE COLITIS
    COLITIS ULCEROSA ACTIVA DE GRADO MODERADO A SEVERO
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis
    COLITIS ULCEROSA
    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 19.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    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
    To assess the efficacy of bimekizumab in adults with active ulcerative colitis who have not responded to standard therapy.
    Evaluar la eficacia de bimekizumab en adultos con colitis ulcerosa activa de grado moderado a severo que no hayan respondido a terapia convencional.
    E.2.2Secondary objectives of the trial
    To assess the safety and PK of bimekizumab in adults with active ulcerative colitis who have not responded to standard therapy.
    Evaluar la seguridad y farmacocinética de bimekizumab en adultos con colitis ulcerosa activa de grado moderado a severo que no hayan respondido a terapia convencional.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Subject has a diagnosis of Ulcerative Colitis (UC) confirmed (at least 90 days prior to Visit 1a) by clinical, endoscopic, and histologic evidence
    - Subject has a Mayo endoscopy subscore >=2
    - Subject has a Mayo rectal bleeding subscore >=1
    - Subject has moderate to severe active UC - Total Mayo score 6 to 12 within 11 (±3) days prior to Visit 2 (Week 0)
    - Subject has responded inadequately to convention therapy for UC
    - Subjets may have received treamtment with 1 biological therapy or a calcineurin inhibitor
    - Woman with childbearing potential must be either postmenopausal, permanently sterilized or willing
    to use at least 1 highly effective method of contraception in addition to a barrier method
    - El sujeto tiene un diagnóstico de CU confirmado (90 días antes de la Visita 1a como mínimo) clínica, endoscópica e histológicamente.
    - El sujeto tiene una subpuntuación de Mayo endoscópica ≥2
    - El sujeto tiene una sub-puntuación de Mayo de rectorragia ≥1
    - El sujeto presenta una CU activa de grado moderado a severo: puntuación total de Mayo entre 6 y 12 dentro de los 11 (±3) días previos a la Visita 2 (Semana 0).
    - El sujeto no ha respondido de forma adecuada (y/o es intolerante) a la terapia convencional para la CU.
    - Los sujetos podrán haber recibido tratamiento previo con una terapia biológica (distinta a un fármaco anti-IL17) o con un inhibidor de la calcineurina.
    - Las pacientes mujeres deberán: Ser posmenopáusicas, haberse sometido a esterilización permanente deberán estar de acuerdo en utilizar como mínimo un método anticonceptivo de elevada eficacia, además de un método de barrera.
    E.4Principal exclusion criteria
    - Subject who has had a resective colonic surgery, or has an ostomy or ileoanal pouch or is planning any resection while enrolled in the study
    - Subject with current diagnosis of Crohn´s Disease (CD) or indeterminant colitis or acute diverticulitis based on medical history
    - Subject has an extension of disease limited to ulcerative proctitis (disease extension) <15cm from the anal verge
    - Subject requiring immediate surgical, endoscopic or radiological intervention due to toxic megacolo intraabdominal or perianal abscess
    - Sujetos que se hayan sometido a cirugía con resección colónica o sean portadores de una ostomía o un reservorio ileoanal, o bien para los que esté prevista una resección durante su participación en el estudio
    - Sujetos con diagnóstico actual de enfermedad de Crohn, colitis indeterminada o diverticulitis aguda, basándose en sus antecedentes médicos.
    - Sujetos con una extensión de la enfermedad limitada a proctitis ulcerosa (extensión de la enfermedad) <15 cm desde el margen anal.
    - Sujetos que requieran un procedimiento quirúrgico, endoscópico o radiológico inmediato debido a megacolon tóxico o a un absceso intraabdominal o perianal
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of Participants with Clinical Response (Per Mayo Score) at week 8
    Tasa de respuesta clínica en la Semana 8, evaluada mediante la puntuación total de Mayo
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 8
    Semana 8
    E.5.2Secondary end point(s)
    -Proportion of Participants in Clinical Remission at Week 8
    -Proportion of Participants with Mucosal Healing at Week 8
    -Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
    -Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
    -Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
    -Change from Baseline in CRP plasma levels at Week 8
    -Incidence of Adverse Events throughout the study conduct up to Week 20
    - Tasa de remisión clínica en la Semana 8, evaluada mediante la puntuación total de Mayo
    - Tasa de curación de la mucosa en la Semana 8, indicada por la subpuntuación de Mayo endoscópica
    - Proporción de sujetos con subpuntuaciones de Mayo no endoscópicas individuales (frecuencia de las deposiciones, evaluación global del médico, rectorragias) indicativas de enfermedad de grado leve (puntuación de 0 o 1) en la Semana 8
    - Proporción de sujetos con evaluación global de la actividad de la enfermedad por parte del médico indicativas de enfermedad de grado leve (puntuación de 0 o 1) en la Semana 8
    - Proporción de sujetos con sangrado rectal indicativas de enfermedad de grado leve (puntuación de 0 o 1) en la Semana 8
    - Cambios de los valores de proteína C-reactiva (PCR) en la Semana 8 respecto a los valores basales
    - Incidencia de efectos adversos a lo largo del estudio hasta la semana 20.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8 up to Week 20
    Semana 8 a semana 20.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    Tolerabilidad
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Czech Republic
    France
    Georgia
    Italy
    Moldova, Republic of
    Poland
    Romania
    South Africa
    Spain
    United Kingdom
    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
    Last Subject Last Visit (LSLV)
    Ultima visita del ultimo paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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)
    Safety Follow-Up (SFU) Period (12 weeks). Safety follow-up information will be collected
    12 weeks after Week 8 (Visit 5) which is 14 weeks after the last administration of IMP (Week 6 [Visit 4]).
    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 Decision2016-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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