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    The EU Clinical Trials Register currently displays   40626   clinical trials with a EudraCT protocol, of which   6627   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2014-005443-40
    Sponsor's Protocol Code Number:2014-100756
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-08-30
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-005443-40
    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 ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study)

    Beavatkozással járó, nyílt, IV. fázisú vizsgálat a colitis ulcerosa korai, illetve késői kezelésében alkalmazott vedolizumab hatásosságának, biztonságosságának és mucosalis gyógyulásra kifejtett hatásának értékelésére (LOw countries VEdolizumab in UC 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 efficacy, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset of ulcerative colitis versus subject with longer exisiting ulcerative colitis

    Nyílt vizsgálat a vedolizumab hatásosságának, biztonságosságának és a bélnyálkahártya gyógyulására kifejtett hatásának értékelésére a fekélyes vastagbélgyulladás (kolitisz ulceróza) rövidebb kórtörténetű („korai") és hosszabb kórtörténetű ("késői") formájában szenvedő betegeknél
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number2014-100756
    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.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.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.5.4Telephone number31205661125
    B.5.5Fax number31205669285
    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. name Entyvio
    D. 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.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Ulcerative colitis
    Colitis ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis
    Fekélyes vastagbélgyulladás (kolitisz ulceróza)
    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 ulcerative colitis 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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In the opinion of the investigator, the subject is capable of understanding and complying with
    protocol requirements.
    2. The subject signs and dates a written, informed consent form and any required privacy
    authorization prior to the initiation of any study procedures.
    3. Age 18 to 80.
    4. Male or non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
    5. Established diagnosis of ulcerative colitis with histopathological confirmation available in the record of the patient.
    6. Moderate to severe active UC (total Mayo score > 6) with objective evidence of inflammation that can be visualized on endoscopy. All endscopies will be video-taped for later review, rereading and quality assurance. Patients must have an endoscopic Mayo score of 2 or 3.
    7. Anti-TNF discontinued for at least 4 weeks before baseline.
    8. Written informed consent must be obtained and documented.

    1. Diagnosis of UC < 4 years prior to enrollment confirmed by clinical, endoscopic and histopathological evidence.
    2. Demonstrated failure to respond to aminosalicylates or intolerance to aminosalicylates
    and: 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
    and additionally, but not mandatory, lack of efficacy of thiopurines or intolerance to thiopurines (any duration). Patients who are using thiopurines (azathioprine, 6-mercaptopurine or 6-thioguanine) at screening must have used them for > 3 months (last 4 weeks at stable dose).

    1. Diagnosis of UC > 4 years confirmed by clinical, endoscopic and histopathological evidence.
    2. Demonstrated failure to respond to aminosalicylates or intolerance to aminosalicylates
    and: failure to respond to at least 3 months of thiopurines or intolerance to TP
    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. Loss of response to anti-TNF is defined as recurrence of symptoms during maintenance dosing following prior clinical benefit.
    May continue stable dose of conventional therapies for IBD incl. aminosalicylates and thiopurines and corticosteroids. Steroids will be tapered by protocol by week 26. Anti-TNF must be discontinued for > 4 weeks before baseline.
    E.4Principal exclusion criteria
    1. Previous exposure to any anti-integrin antibodies including vedolizumab, α4β7 antibodies, β7 antibodies, anti-MADCAM-1.
    2. Contraindication for endoscopy.
    3. History of colonic dysplasia or colonic cancer.
    4. Subjects with a pouch.
    5. Extensive colonic resection, i.e. subtotal or total colectomy with <15 cm colon remaining.
    6. Received other biologics within the last 4 weeks of the baseline visit.
    7. Use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment.
    8. Chronic hepatitis B or C infection.
    9. Subjects with ALT or AST 3x the upper limit of normal measured at screening.
    10. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment.
    11. Active or latent tuberculosis.
    12. Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
    13. Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
    14. Positive PML subjective symptom checklist before enrollment.
    15. Cancer (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence). Subject with a history of cancer and a documented 2-year disease free period before screening, may enter the study.
    16. Early UC group: previous exposure to any anti-TNF.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with clinical and endoscopic remission at Week 26 and 52-54, defined as a Mayo Clinic score ≤2 and no subscore >1
    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 endoscopic response (decrease of 1 point or more in the Mayo endoscopic score) at Weeks 26 and 52
    - Proportion of patients with clinical response (defined as reduction in Mayo clinic score of at least 3 points and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1) at all time points
    - Proportion of patients with clinical remission (Mayo Clinic score ≤2 and no subscore >1) at all other time points
    - Proportion of patients with corticosteroid-free clinical remission (Mayo Clinic score ≤2 and no subscore >1) at all other time points
    - Proportion of patients with normalized serum CRP at all time points
    - 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 week 10)
    - Proportion of patients with sustained clinical remission (remission at all time points after week 10)
    - 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 26 and 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. 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 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 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
    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 months19
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 100
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    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 Decision2017-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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