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    Summary
    EudraCT Number:2017-001737-85
    Sponsor's Protocol Code Number:80-84800-98-81014
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-04-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-001737-85
    A.3Full title of the trial
    Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy
    Effectiviteit van albendazol voor het induceren van mucosale heling bij patiënten met de ziekte van Crohn en onder behandeling met anti-TNF monotherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy
    Effectiviteit van albendazol voor het induceren van mucosale heling bij patiënten met de ziekte van Crohn en onder behandeling met anti-TNF monotherapi
    A.3.2Name or abbreviated title of the trial where available
    ADD UP
    A.4.1Sponsor's protocol code number80-84800-98-81014
    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 Sponsoracademic medical centre
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Centre
    B.5.2Functional name of contact pointGeert D'Haens
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.4CountryNetherlands
    B.5.6E-mailg.dhaens@amc.uva.nl
    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 albendazole (Eskazole)
    D.2.1.1.2Name of the Marketing Authorisation holderglaxosmithkline
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namealbendazole
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 typeantihelmintic agent
    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
    Ziekte van Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    ziekte van Crohn
    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 LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    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
    In the current project the main objective is to evaluate the efficacy and safety of the addition of albendazole to anti-TNF monotherapy (≥4 months) in adult patients with Crohn’s disease with incomplete mucosal healing.
    E.2.2Secondary objectives of the trial
    Secondary objective is to conduct a cost-effectiveness and cost-utility analysis and a budget impact analysis of anti-TNF and albendazol combination therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients ≥18 years and ≤65 years
    2. Diagnosis of CD, based on endoscopy and histopathologic examination of mucosal biopsies
    3. Written informed consent
    4. Active mucosal disease as defined by a repeated faecal calprotectine ≥ 250 µg/g at 2 consecutive occasions (≥2 weeks and ≤3 months interval) AND presence of mucosal lesions as defined by a SES-CD > 6 (≥ 4 for L1 (ileal) disease) on screening ileocolonoscopy
    5. On anti-TNF therapy (ADM at a dose of 40mg Subcutaneous (SC) every week (QW) or every other week (Q2W) and IFX at a dose of 5-10 mg/kg every 4-8 weeks) for a period of at least 4 months at stable dose.
    6. Therapeutic trough serum concentrations of anti-TNF at screening (for IFX ≥ 3 µg/ml and for adalimumab (ADM) ≥ 5 µg/ml and undetectable levels of anti-drug antibodies (ADA’s) at baseline.
    E.4Principal exclusion criteria
    1. Ulcerative colitis or indeterminate colitis
    2. Current malignancy
    3. Women: current pregnancy wish, pregnancy or lactation. Men: active child wish
    4. Ongoing use of an immunomodulator (including azathioprine, methotrexate, 6-thioguanine, 6 mercaptopurine or mycophenolic acid).
    5. Prior failure on anti-TNF and immunomodulator combination therapy due to refractory disease per treating physicians opinion.
    6. Elevated liver enzymes (ALAT, ASAT, LDH, γ-GT, AF) >1.5 times the upper limit of normal (ULN)
    7. Current use of any CYP3A4 inducing or inhibiting agents
    8. Patients on prednisone >10mg/day or budesonide >6mg/day
    9. Patients who require rescue therapy with corticosteroids during the screening phase
    10. Leukopenia (neutrophil count < 1.8x10^9/L) and/or thrombopenia <50 x 10^9/L
    11. Other conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedure
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of patients with absence of ulcers on centrally read endoscopies after 12 weeks of albendazole and anti-TNF combination treatment compared to placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 12
    E.5.2Secondary end point(s)
    1. Proportion of patients with endoscopic response on centrally read endoscopies defined as a reduction in the Simple Endoscopic Severity index (SES-CD) score by ≥ 50% compared to baseline
    2. Proportion of patients with endoscopic remission on centrally read endoscopies defined as a SES-CD score < 3 in general or < 2 in case of L1 (ileal) disease
    3. Costs per Quality Adjusted Life year (QALY)
    4. Clinical endpoints:
    4.1. Change in CDAI from baseline to W12
    4.1.1. Clinical remission: CDAI < 150
    4.1.2. Clinical (partial) response: decrease in CDAI ≥ 70 points [CR-70])
    4.2. General and change in quality of life, as measured by the IBDQ, SF-36 and EQ-5D-5L at baseline, week 12 and 36
    4.3. Patient Reported Outcome Measure (PROM): assessment of the general and change in functional status and well-being measured from the patients’ perspective by the IBD-CONTROL questionnaire [25], at baseline, week 12 and 36
    4.4. Occurrence of (serious) adverse events (SAE)
    5. Change in Anti-TNF serum concentration and anti-drug-antibodies from baseline to W12
    6. Proportion of patients with hs-CRP < 5mg/L at W12
    7. Proportion of patients with fecal calprotectin < 250 µg/g at W12
    8. Proportion of patients with fecal calprotectin <100 µg/g at W12
    9. Histological changes from baseline to W12 based on centrally read scanned biopsies using the colonic and ileal global histologic disease activity scoring system (CGHAS/IGHAS, appendix 14.2) and the Robarts histology index (RHI, appendix 14.3).
    10. Presence of type 2 regulatory wound-healing macrophages (CD14+CD68+CD206+) by immunohistochemical staining and fluorescence-activated cell sorting on intestinal biopsies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Different timepoints during the 9 months duration of the trial (Week 0, 2, 4, 8, 12 and 36)
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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 years3
    E.8.9.1In the Member State concerned months
    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: 110
    F.1.3Elderly (>=65 years) No
    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 state110
    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)
    According to current treatment guidelines
    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 Decision2018-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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