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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2014-005376-29
    Sponsor's Protocol Code Number:2014-100757
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-005376-29
    A.3Full title of the trial
    An open-label interventional phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study)
    Een fase 4, interventionele open-label studie ter evaluatie van de effectiviteit , veiligheid en genezing van het darmslijmvlies bij vedolizumab gebruik in een vroeg stadium versus een later stadium van de ziekte van Crohn: de LOVE-CD studie ( LOw countries VEdolizumab in CD study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease.
    Een open-label studie om het effect, de veiligheid en de genezing van het darmslijmvlies bij het gebruik van vedolizumab te vergelijken in een vroeg versus een later stadium van de ziekte van Crohn
    A.3.2Name or abbreviated title of the trial where available
    LOVE-CD
    LOVE-CD
    A.4.1Sponsor's protocol code number2014-100757
    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 Center, Gastroenterology
    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 supportTakeda
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointIBD trial office
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31205661125
    B.5.5Fax number31205669285
    B.5.6E-maile.clasquin@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 Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 nameVedolizumab IV
    D.3.2Product code MLN0002
    D.3.4Pharmaceutical form Powder for concentrate for dispersion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVedolizumab
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Crohn's disease
    Actieve ziekte van Crohn
    E.1.1.1Medical condition in easily understood language
    Active Crohn's disease
    Actieve ziekte van Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this prospective open label study is to assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active Crohn's disease in an 'early' and a 'late' disease population after 54 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Measures of clinical disease activity (including clinical response and remission) over the 1 year study period will be described. The mucosal healing capacity of vedolizumab treatment will be observed by assessing the endoscopic and histopathologic response to treatment over the 1 year study period.
    The additional endoscopic healing effect of dose intensification at month 6 will also be studied after approval of amendment 4
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Established diagnosis of ileal, ileocolonic or colonic Crohn’s disease with histopathological confirmation available in the record of the patient.
    - Moderately to severely active CD (CDAI 220-450) with objective evidence of ulcerations visualized on endoscopy.
    - Anti-TNF discontinued for at least 4 weeks from baseline
    - May continue stable dose of conventional therapies for IBD including thiopurines, methotrexate and corticosteroids
    -Age 18 to 80

    - GROUP 1 (EARLY CD):
    Diagnosis of CD < 24 months prior to enrollment
    Demonstrated failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids
    or: need for 1 course of steroids since diagnosis
    or: steroid dependency at any dose since diagnosis
    or: need for early biological treatment per Investigator’s discretion even without prior steroid or thiopurine treatment.
    and additionally, but not mandatory, lack of efficacy ofthiopurines or intolerance to thiopurines (any duration). Patients who are using thiopurines at screening must have used them for > 3 months (last 4 weeks at stable dose).

    GROUP 2 (LATE CD)
    Subjects has been treated with corticosteroids and demonstrated failure to respond to at least 3 months of thiopurines or intolerance to thiopurines and: failure to respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response to at least 1 anti-TNF.
    E.4Principal exclusion criteria
    - previous exposure to any anti-integrin autibodies including vedolizumab, alpha 4 beta7 anti-bodies, beta7 antibodies, anti-MADCAM-1
    - Contraindication for endoscopy.
    - History of colonic dysplasia or colonic cancer
    - Presence of stoma
    - Subjects with a pouch
    - Received other biologics within the last 4 weeks of baseline
    - Early CD group: previous exposure to any anti-TNF
    - use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment
    - chronic hepatitis B or C infection
    - Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment
    - Active or latent tuberculosis
    - Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
    - Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
    - Positive PML subjective symptom checklist before enrollment.
    - Subjects with known allergy or hyposensitivity to vedolizumab or its components
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of patients with clinical and endoscopic remission at Week 26 and 52-54, defined as CDAI of 150 or lower and SES-CD <4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26 and week 52
    E.5.2Secondary end point(s)
    - Proportion of patients with absence of ulcers at Weeks 26 and 52-54
    - Proportion of patients with endoscopic response (SES-CD reduction by ≥ 50 %) at Weeks 26 and 52
    - Proportion of patients with 25% and 75% reduction of SES-CD at Weeks 26 and 52
    - Proportion of patients with clinical response (CDAI decrease of ≥ 70 points from baseline) at all time points
    - Proportion of patients with clinical remission (CDAI <=150) at all time other points
    - Proportion of patients with corticosteroid- free clinical remission (CDAI <=150) at all other time points
    - Proportion of patients with normalized serum CRP at all time points
    - Proportion of patients with no granulocytes in the biopsies at Weeks 26 and 52.
    - Proportion of patients with 25%, 50% and 75% reduction in the Geboes histology score at Weeks 26 and 52.
    - Proportion of patients with sustained clinical response (response at all time points after and on week 10)
    - Proportion of patients with sustained clinical remission (remission at all time points after week 10)
    - Proportion of patients with draining fistulas
    - Proportion of patients that need to be hospitalized
    - Quality of life measured by IBDQ and Euroquol
    - Work productivity Index
    - Serum concentrations of vedolizumab and antibodies to vedolizumab before every infusion
    - Incremental mucosal healing effects of dose intensification to every 4 weeks vedolizumab in endoscopic non responers (SES-CD ≥ 50 %) at month 6
    E.5.2.1Timepoint(s) of evaluation of this end point
    all time points, week 2, week 6, week 10 , week 14, week 22, week 26, week 30, week 38, week 46, week 52
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 260
    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)
    None
    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 Decision2015-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-26
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