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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41031   clinical trials with a EudraCT protocol, of which   6716   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2010-020448-37
    Sponsor's Protocol Code Number:ENC-0303-CL-203
    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:2010-12-22
    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 number2010-020448-37
    A.3Full title of the trial
    Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.
    A.4.1Sponsor's protocol code numberENC-0303-CL-203
    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 SponsorEnceladus Pharmaceuticals
    B.1.3.4CountryNetherlands
    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 supportEnceladus
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Leuven
    B.5.2Functional name of contact pointProf. Dr. Severine Vermeire
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number321634 42 18
    B.5.5Fax number3216 34 44 19
    B.5.6E-mailseverine.vermeire@uz.kuleuven.ac.be
    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 namePEG-liposomal prednisolone sodium phosphate
    D.3.2Product code Nanocort
    D.3.4Pharmaceutical form Concentrate and diluent for solution 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 INNPrednisolone Sodium Phosphate
    D.3.9.1CAS number 125-02-0
    D.3.9.2Current sponsor codeNanocort
    D.3.9.3Other descriptive namePREDNISOLONE SODIUM PHOSPHATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.0 to 3.2
    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 typeliposomal encapsulated active substance (Prednisolone Sodium Phosphate)
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel disease
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety of PEG-liposomal prednisolone sodium phosphate (Nanocort)
    E.2.2Secondary objectives of the trial
    • To explore the efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort)
    • To evaluate the pharmacokinetics of free prednisolone and prednisolone phosphate in the plasma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥ 18 to 75 years of age.
    2. Documented history of UC (at least 6 months) as assessed by endoscopy and confirmed by histological measurements with a minimal disease extent of 15 cm from the anal verge and a minimal period of active disease of 14 days.
    3. Negative stool culture for enteric pathogens, including Clostridium difficile, ova and parasites.
    4. Mayo score ≥ 5 with endoscopic sub-score of ≥ 2 and rectal bleeding sub-score ≥1.
    5. Medication: 6-MP/azathioprine, MTX receiving for at least 12 weeks and stable dose for > 4 weeks or discontinued for > 4 weeks; rectal medications stopped for > 4 weeks, 5-ASA stable or stopped for > 2 weeks. If receiving cyclosporine or biologics (e.g. TNFalpha-blocker), these medications should be continued at the same dose for at least two cycles after Day 1. A cycle commonly takes 8 weeks, but may be shorter in the individual subjects, when loss of response has been encountered previously and the dosing interval has been adjusted.
    6. In good physical and mental health (other than the disease under study) as determined by medical history and physical examination.
    7. The results of the following laboratory tests at screening must be as specified below:
    a. Hemoglobin ≥ 8.5 g/dL (International System of Units [SI]: ≥ 85 g/L)
    b. White blood cells (WBC) ≥ 3.0 x 103 cells/mm3 (SI: ≥ 3.0 x109 cells/L)
    c. Neutrophils ≥ 1.5 x 103 cells/mm3 (SI: ≥ 1.5 x109 cells/L)
    d. Platelets ≥ 100 x 103 cells/mm3 (SI: ≥ 100 x109 cells/L)
    e. Serum ALT ≤ 1.5 x upper limit of normal (ULN)
    f. Total bilirubin level ≤ 1.25 x ULN
    g. Creatinine clearance ≥ 80 mL/min using the Cockroft formula
    8. Female subjects must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy or have been post-menopausal for at least 1 year (at least 12 consecutive months without menses).
    9. Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study drug. Medically acceptable forms of birth control include oral contraceptives, injectable or implantable methods, intrauterine devices, tubal ligation (if performed more than 1 year before screening), or double-barrier contraception. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue for at least 12 weeks after the last dose of study drug.
    10. Able and willing to give voluntary written informed consent and agree to schedule of assessments.
    E.4Principal exclusion criteria
    1. Treatment with local or oral corticosteroids within 4 weeks before screening or with intra articular or intramuscular corticosteroids within 8 weeks before screening. If non-systemic steroids are being used for other chronic inflammatory conditions, subjects may be included at the discretion of the Investigator after discussion with the medical monitor.
    2. Severe colitis, defined as a bloody stool frequency of more than six per day with any one of tachycardia (pulse > 90 beats/min), temperature (> 37.8 degrees C), anaemia (haemoglobin < 10.5 g/dL or 6,5 mmol/L) or raised erythrocyte sedimentation rate (> 30 mm/h),
    3. Intolerance of or unresponsiveness to corticosteroids, especially a history of steroid psychosis.
    4. A history of significant psychological, neurologic, renal, gastrointestinal (other than UC), or metabolic disease (diabetes mellitus).
    5. A history of clinically severe or unstable medical condition involving cardiac, pulmonary, liver or endocrine disorders.
    6. Any concurrent illness, disability or clinically significant abnormality (including laboratory tests) that may affect the interpretation of clinical safety or efficacy data or prevent the subject from safely completing the assessments required by the protocol as judged by the Investigator.
    7. Stoma, proctocolectomy or total colectomy or imminent need for surgery.
    8. Concurrent bowel and intestine malignancy or a history of cancer (other than basal cell carcinoma or cervical carcinoma successfully treated more than 5 years prior to screening).
    9. Subjects with, other bleeding, infectious, ischemic, or immunological diseases with or without gastrointestinal involvement.
    10. Be currently pregnant or breastfeeding or not willing to maintain birth control methods for at least 12 weeks after last study medication administration.
    11. Medical, psychiatric, cognitive, or other conditions that, according to investigator’s medical judgment, compromise the subject's ability to understand the subject information, to give informed consent, to comply with the requirements of the study protocol (that is likely to affect the subject’s return for visits on schedule), or ability to complete the study.
    12. Participation in another experimental therapy study within 90 days prior to screening for this study or current enrollment in any other study with investigational drugs or device.
    13. Positive serology for human immunodeficiency virus (HIV) 1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A.
    E.5 End points
    E.5.1Primary end point(s)
    • Frequency of Serious adverse events in Nanocort versus placebo group
    • Frequency of Adverse events in Nanocort versus placebo group
    • Changes in clinical status, vital signs and laboratory parameters over the duration of the study in Nanocort versus placebo group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 2 and 15 of treatment
    Day 29, 57 and 87 after treatment period
    E.5.2Secondary end point(s)
    • Percentage of subjects achieving clinical remission at Day 29 as measured by Mayo score in Nanocort versus placebo group.
    • Percentage of subjects achieving clinical remission at Day 15, 29, 57 and 85 as measured by partial Mayo score in Nanocort versus placebo group.
    • Percentage of subjects achieving clinical response at Day 15, 29, 57 and 85 as measured by partial Mayo score in Nanocort versus placebo group.
    • Percentage of subjects maintaining a clinical response in Nanocort versus placebo group, in subjects having previously achieved a clinical response after baseline evaluations.
    • Scoring the histopathological assessments on biopsies by microscopic evaluation (acute inflammation score and grading scale of inflammation) in Nanocort versus placebo group.
    • Free prednisolone and liposomal prednisolone phosphate levels in the plasma at Day 1, 15, 29 and 57 in Nanocort versus placebo group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At day 15, 29, 57 and 85
    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) 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    The end of the study will be when the last subject has performed his/her last visit according to the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days15
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    After the subject has ended his/her participation in the trial, the treatment or care will be the expected normal treatment for Ulcerative Colitis.
    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 Decision2010-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-02
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