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    Summary
    EudraCT Number:2019-000852-32
    Sponsor's Protocol Code Number:80-84800-98-82002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-10-08
    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 number2019-000852-32
    A.3Full title of the trial
    A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.
    Een preliminaire studie naar lage dosering Naltrexon voor de inductie van remissie bij patienten met milde tot matige ziekte van Crohn waarbij reguliere behandeling heeft gefaald.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.
    A.3.2Name or abbreviated title of the trial where available
    The LDN Crohn study
    A.4.1Sponsor's protocol code number80-84800-98-82002
    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 SponsorErasmusMC
    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.4.1Name of organisation providing supportErasmusMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmusMC
    B.5.2Functional name of contact pointCoordinating/Subinvestigator
    B.5.3 Address:
    B.5.3.1Street AddressDoctor Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.6E-maile.paulides@erasmusmc.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 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 nameNaltrexone hydrochloride
    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 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 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
    Inflammatory Bowel Disease, Crohn's disease
    De ziekte van Crohn
    E.1.1.1Medical condition in easily understood language
    Inflammatory Bowel Disease, Crohn's disease
    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 aim of this preliminary study is to prospectively assess the efficacy of LDN as induction therapy in CD.
    E.2.2Secondary objectives of the trial
    •Proportion of patient in steroid free clinical remission defined as by an HBI score of ≤4 and complete tapering of systemic corticosteroids and endoscopic remission at week 12
    •Response defined by a decrease in HBI of ≥3 points compared to baseline and endoscopic response defined as a reduction of SES-CD score by ≥50% vs baseline at week 12
    •Changes in laboratory measures of inflammation (CRP, fecal calprotectin)
    •Adverse events at every visit
    •Quality of life, via the disease specific and validated sIBDQ
    • Fatigue, via the FACIT-F and MFI
    • Anxiety, Depression, Sleepdisturbance, via the PROMIS NIH
    •Healthcare costs and utilization, via WPAI-UC and EQ-5D questionnaire
    •PROM, via the IBD validated PRO2-tool
    •Proportion of patients in corticosteroid free clinical remission
    •Response at week 24 and 52
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18 or older; must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures.
    • Diagnosis of Crohn’s disease ≥3 months before screening.
    • Objective evidence of inflammation at baseline as defined by endoscopy with mucosal ulcers in the ileum or colon or both, and a SES-CD score of 3-15.
    • Concurrent therapies with stable doses of azathioprine, mercaptopurine, MTX or steroids (prednisolone ≤30 mg/dl or budesonide ≤9 mg per day) are permitted. Tapering of corticosteroids is mandatory.
    E.4Principal exclusion criteria
    • Current use of i.v. corticosteroids.
    • Imminent need for in-hospital treatment.
    • Pregnancy or lactation.
    • Previous or current treatment with investigational drug; current or past treatment within 6 months prior to randomization with a biological agent.
    • Stool sample positive for Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp.
    • Other significant illnesses that may interfere with the study, stricture causing obstructive symptoms, or fistulising disease complicated by infection,
    • Opiates use or drugs and/or alcohol abuse.
    E.5 End points
    E.5.1Primary end point(s)
    •Endoscopic remission at week 12 defined as SES-CD ≤4 and ulcerated surface subscore ≤1 in all five segments
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    •Proportion of patient in steroid free clinical remission defined as by an HBI score of ≤4 and complete tapering of systemic corticosteroids and endoscopic remission at week 12
    •Response defined by a decrease in HBI of ≥3 points compared to baseline and endoscopic response defined as a reduction of SES-CD score by ≥50% vs baseline at week 12
    •Changes in laboratory measures of inflammation (CRP, fecal calprotectin)
    •Adverse events at every visit
    •Quality of life, via the disease specific and validated sIBDQ
    • Fatigue, via the FACIT-F and MFI
    • Anxiety, Depression, Sleepdisturbance, via the PROMIS NIH
    •Healthcare costs and utilization, via WPAI-UC and EQ-5D questionnaire
    •PROM, via the IBD validated PRO2-tool
    •Proportion of patients in corticosteroid free clinical remission
    •Response at week 24 and 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 2, 4, 6, 8, 12, 24, 36, 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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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
    Week 12 after induction phase and colonoscopy. Patients are allowed to participate in an open-label phase for maintenance until week 52
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 105
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 17
    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 state122
    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)
    Normal treatment or continue treatment with same medicine as study drug
    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 Decision2019-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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