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    Summary
    EudraCT Number:2019-002093-32
    Sponsor's Protocol Code Number:LUM-002
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-28
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-002093-32
    A.3Full title of the trial
    Randomised, open, non-inferiority within patient-controlled trial evaluating the diagnostic usefulness of Lumentin® 44 when used as contrast agent in CT-enterography as compared to MRI- enterography in patients with small bowel Crohn’s disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, open, within-patient controlled trial to evaluate the diagnostic usefulness of Computed Tomography with the new contrast agent Lumentin® 44 as compared to Magnetic Resonance Imaging in patients with small bowel Crohn’s disease.
    A.4.1Sponsor's protocol code numberLUM-002
    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 SponsorLument AB
    B.1.3.4CountrySweden
    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 supportLument AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLument AB
    B.5.2Functional name of contact pointOlof Böök
    B.5.3 Address:
    B.5.3.1Street AddressBox 719
    B.5.3.2Town/ cityLUND
    B.5.3.3Post codeSE-220 07
    B.5.3.4CountrySweden
    B.5.6E-mailolof.book@lumentab.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 nameLumentin 44
    D.3.2Product code L 44
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    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 INNEgg Albumen Powder
    D.3.9.3Other descriptive nameEGG WHITE PROTEIN
    D.3.9.4EV Substance CodeSUB188408
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number57
    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 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 typePowder for oral foam containing Egg White Protein
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Movprep
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine BV
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Oral solution
    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 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
    None.
    Lumentin 44 is a contrast agent. The diagnostic usefulness of CT with Lumentin 44 as contrast agent as compared to MRE will be investigated in this trial.
    Patients with confirmed small bowel Crohn's disease referred to MRE examination will be included in the trial. Neither their medical condition nor disease will be investigated.
    E.1.1.1Medical condition in easily understood language
    No disease will be studied.
    Lumentin 44 is a contrast agent. The techniques Computed Tomography, with Lumentin 44 as contrast agent, and Magnetic Resonance Imaging will be compared in this trial.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10011603
    E.1.2Term CT scan
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the Radiological Crohn’s disease Activity Score (RCDAS) of a CT-enterography performed with Lumentin® 44 as a bowel filling contrast agent with the RCDAS of a routinely performed MR-enterography
    E.2.2Secondary objectives of the trial
    • To evaluate if the radiologist’s evaluation of the CTE-L enterography is at least as useful for the gastroenterologist in setting the patient’s diagnosis, as the radiologist’s evaluation of the patient’s MRI-enterography.
    • To compare the Radiological Crohn’s disease Activity Score (RCDAS) for the SB of a CT-enterography performed with Lumentin® 44 as a bowel filling contrast agent with the RCDAS for the SB of a routinely performed MR-enterography
    • To compare the Radiological Crohn’s disease Activity Score (RCDAS) for the colon of a CT-enterography performed with Lumentin® 44 as a bowel filling contrast agent with the RCDAS for the colon of a routinely performed MR-enterography
    • To compare CTE-L, with MRE with respect to CD activity in the terminal ileum and colon
    • To compare CTE-L, with MRE with respect to complications of CD

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects of either gender at least 18 years of age at time of signing the informed consent.
    2. Subjects with a confirmed Crohn's disease (CD) diagnosis
    3. Clinical indication for an MRE examination of the small bowel, i.e. need for disease status evaluation due to, for example, a relapse/flare, disease status evaluation before starting a new treatment, evaluation of therapeutic effect of given treatment, change in symptomatology, follow-up of longstanding disease, and/or pre-operative mapping/investigation
    4. Females must either present a negative pregnancy test or be surgically sterile (hysterectomy or tubal ligation) or postmenopausal (i.e. experienced 12 consecutive months without menstruation)
    5. Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any trial related activity is carried out
    E.4Principal exclusion criteria
    1. Clinical suspicion of a severe general or an acute abdominal condition (i.e. bowel obstruction, bowel perforation, severe bleeding or severe inflammation), requiring acute or subacute management.
    2. Moderate to severe dysphagia
    3. Known allergy to egg albumin
    4. Known severe retention of urine
    5. Known cardiac arrythmia
    6. Having untreated glaucoma
    7. Having known manifest thyrotoxicosis
    8. Having known phenylketonuria
    9. Having known Glucose-6-phosphatase deficiency
    10. Contraindicated IV administration of contrast media used in MRE or CTE
    11. Known sensitivity to any of the components of the investigational product
    12. Having metallic implants incompatible with MRI examination
    13. Being, in the opinion of the investigator, unlikely to comply with the clinical trial protocol
    14. Previously randomised to participate in this trial
    15. Patients with CD participating in, or having participated in another, clinical trial where the final trial treatment was given within the last 6 weeks. (Patients on long term maintenance dose only, may be included.)


    E.5 End points
    E.5.1Primary end point(s)
    Two investigators will evaluate both CT-enterography (CTE) and MR-enterography (MRE) from each of the patients. The evaluation will be done using the Radiological Crohn’s Disease Activity Score (RCDAS) which includes 18 evaluations. For each investigator and patient, it will be counted how many of these 18 evaluations that are exactly the same (matches) when evaluating CTE as when evaluating MRE. The percentage of matches will then be calculated and this can then result in a figure between 0% (no matching at all) and 100% (perfect matching). The mean value between the investigators for the matching percentages will be calculated for each patient and this mean value is then the primary endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 of each investigation (CTE with Lumentin 44 and MRE respectively)
    E.5.2Secondary end point(s)
    • To evaluate if the radiologist’s evaluation of the CTE-L enterography is at least as useful for the gastroenterologist in setting the patient’s diagnosis, as the radiologist’s evaluation of the patient’s MRI-EnterographyRadiologist’s assessment of CD activity in the SB according to the RCDAS
    • Radiologist’s assessment of CD activity in the colon according to the RCDAS
    • Radiologist’s assessment of MRE and CTE images with respect to overall disease activity according to the CDMRIS scale
    • Radiologist’s assessment of MRE and CTE images with respect to terminal ileum disease activity according to the CDMRIS scale
    • Radiologist’s assessment of MRE and CTE images with respect to overall disease damage according to the Lémann Index
    • Gastroenterologist’s assessments of the capsule examination with respect to the following parameters: Severity of disease distribution, Stricture. Extent Rating, Disease severity according to modified Lewis score, and Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD)
    • Gastroenterologist’s assessments of the ultrasound examination with respect to the following parameters: Bowel wall thickening and flow, presence of; ulcers, stricture, fistula, abscess, free fluid, enlarged mesenteric lymph nodes, and mesenteric hypertrophy
    • Subjects assessment of taste, smell, consistency, ability to swallow and fullness according to a questionnaire filled out after intake of the contrast agent
    • The contrast agent volume and time to drink at CTE examinations
    • Radiologists assessment CTE images with respect to bowel filling properties in 5 subsegments of the small bowel

    Safety parameters:
    • Any AEs
    • Any adverse drug reactions (ADRs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary end points will be evaluated on Day 1 of each investigation.
    Safety parameters will be evaluated from start of intake of the first dose of contrast agent on Day 1 and until the follow-up visit on Day 14 after the second scan.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Within subject controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state60
    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 Decision2019-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
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