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    Summary
    EudraCT Number:2014-002981-64
    Sponsor's Protocol Code Number:CC-10004-UC-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-19
    Trial results View 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 number2014-002981-64
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin
    A.4.1Sponsor's protocol code numberCC-10004-UC-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02289417
    A.5.4Other Identifiers
    Name:IND NUMBERNumber:119696
    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 SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1-888-260-1599
    B.5.5Fax number+1 913-266-0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Tablet
    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 INNAPREMILAST
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Tablet
    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 INNAPREMILAST
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 3
    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 nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Tablet
    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 INNAPREMILAST
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Subjects with active ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis is a chronic inflammatory condition of the colon of unknown origin, that is characterized by bloody diarrhea and pain in the lower abdomen.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 the study is to evaluate the clinical efficacy of apremilast (30 mg BID and 40 mg BID), compared with placebo, in subjects with active ulcerative colitis (UC).
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the safety and tolerability of apremilast (30 mg BID and 40 mg BID), compared with placebo, in subjects with active UC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged 18 and over at the time of signing the informed consent.
    2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
    3. Must be able to adhere to the study visit schedule and other protocol requirements.
    4. Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit
    5. TMS ≥ 6 to ≤ 11 (range: 0-12) prior to randomization in the study.
    6. Endoscopic subscore ≥ 2 (range: 0-3) on the Mayo score prior to randomization in the study.
    7. Subjects are required to have a colonoscopy if not performed within 12 months of the Screening Visit
    8. Subjects must have had a therapeutic failure, been intolerant to, or have a contraindication to, at least one of the following: oral aminosalicylates (ie, 5-aminosalicylic acid [5-ASA] compounds or sulfasalazine [SSZ]), budesonide, systemic corticosteroids, or immunosuppressants (eg, 6-mercaptopurine [6-MP], azathioprine [AZA], or methotrexate [MTX]).
    9. Subjects receiving oral corticosteroids may continue their use during the study, provided that the dose (prednisone ≤ 20 mg/day or equivalent, budesonide ≤ 9 mg/day) has been stable for 3 weeks prior to the Screening Visit. If oral corticosteroids were recently discontinued, discontinuation must have been completed at least 3 weeks prior to the Screening Visit. Corticosteroid doses should remain stable until the subject is eligible to start corticosteroids tapering, beginning at the Week 12 Visit.
    10. Oral aminosalicylates are permitted during the study, provided that treatment started at least 6 weeks prior to randomization with a stable dose of at least 14 days prior to the Screening Visit. The dose of oral aminosalicylates must remain stable through Week 52 or early termination from the study.
    11. Must meet the following laboratory criteria:
    - White blood cell count ≥ 3000/mm3 (≥ 3.0 X 10E9/L) and < 14,000/mm3 (< 14 X 10E9/L)
    - Platelet count ≥ 100,000/mm3 (≥ 100 X 10E9/L)
    - Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
    - AST (SGOT) and ALT (SGPT) ≤2 X upper limit of normal (ULN). If initial test shows ALT or AST > 2 times the ULN, one repeat test is allowed during the screening period
    - Total bilirubin ≤ 2 mg/dL (≤ 34 μmol/L) or albumin > lower limit of normal (LLN). If initial test result is > 2 g/dL, one repeat test is allowed during the screening period
    - Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L)
    12. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and the Baseline Visit. While on IP and for at least 28 days after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options2 described below:
    Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner’s vasectomy
    OR
    Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide
    13. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.
    E.4Principal exclusion criteria
    1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis.
    2. Ulcerative colitis restricted to the distal 15 cm or less (eg, ulcerative proctitis).
    3. Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
    4. Clinical signs suggestive of fulminant colitis or toxic megacolon.
    5. Evidence of pathogenic enteric infection.
    6. History of colorectal cancer or colorectal dysplasia.
    7. Prior use of any TNF inhibitor (or any biologic agent).
    8. Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine or thalidomide.
    9. Use of IV corticosteroids within 2 weeks of the Screening Visit
    10. Use of immunosuppressants (AZA, 6-MP or MTX) within 8 weeks of the Screening Visit.
    11. Use of topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2
    weeks of the Screening Visit
    12. History of any clinically significant neurological, renal, hepatic, gastrointestinal,
    pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or
    disease, or any other medical condition that, in the investigator's opinion, would preclude
    participation in the study.
    13. Prior history of suicide attempt at any time in the subject’s lifetime prior to
    randomization in the study or major psychiatric illness requiring hospitalization within 3
    years of study randomization.
    14. Any condition, including the presence of laboratory abnormalities, which places the
    subject at unacceptable risk if he/she was to participate in the study or confounds the
    ability to interpret data from the study.
    15. Pregnant or breast feeding.
    16. History of any of the following cardiac conditions within 6 months of screening:
    myocardial infarction, acute coronary syndrome, unstable angina, new onset atrial
    fibrillation, new onset atrial flutter, second- or third-degree atrioventricular block,
    ventricular fibrillation, ventricular tachycardia, heart failure, cardiac surgery,
    interventional cardiac catheterization (with or without a stent placement), interventional
    electrophysiology procedure, or presence of implanted defibrillator.
    17. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or
    other infections (including but not limited to tuberculosis and atypical mycobacterial
    disease and herpes zoster), human immunodeficiency virus (HIV), or any major episode
    of infection requiring hospitalization or treatment with intravenous (IV) or oral
    antibiotics within 4 weeks of screening.
    18. Subjects with active hepatitis B infection as described in Appendix E are ineligible for
    the study. Subjects without current hepatitis B infection, as described in Appendix F, may
    participate in the study.
    19. Subjects who are positive for the hepatitis C antibody are not eligible for the study.
    20. History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
    21. History of malignancy, except for:
    a. Treated (ie, cured) basal cell or squamous cell in situ skin carcinomas
    b. Treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
    22. Any condition that could affect oral drug absorption, including gastric resections,
    gastroparesis or bariatric surgery, such as gastric bypass.
    23. Subjects who have received any investigational drug or device within 3 months of study
    randomization.
    24. History of alcohol, drug, or chemical abuse within the 6 months prior to screening.
    25. Known hypersensitivity to apremilast or any excipients in the formulation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the proportion of subjects achieving a clinical remission in the TMS at Week 12, defined as a TMS of ≤ 2, with no individual subscore > 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    -The proportion of subjects achieving clinical response at Week 12, defined as a
    decrease from baseline in the TMS of at least 3 points and at least 30%, along with a
    reduction in the rectal bleeding subscore (RBS) of at least 1 point or an absolute RBS
    of ≤ 1
    - The proportion of subjects achieving endoscopic remission at Week 12, defined as a
    Mayo endoscopic subscore of 0
    - The proportion of subjects achieving endoscopic response at Week 12, defined as a
    decrease from baseline of at least 1 point in the Mayo endoscopic subscore
    - The proportion of subjects achieving a RBS ≤ 1 at Week 12
    - The proportion of subjects achieving clinical remission in the modified Mayo Score
    (range: 0 to 9, based on stool frequency (SFS), RBS and endoscopy) at Week 12,
    defined as a score of 2 points or lower, with no individual subscore exceeding 1 point
    - The proportion of subjects achieving clinical response in the modified Mayo Score at
    Week 12, defined as a decrease from baseline at least 2 points and at least 25%, along
    with a reduction in the RBS of at least 1 point or an absolute RBS of ≤ 1 point
    - The proportion of subjects achieving clinical remission at Week 12 defined as a PMS
    of ≤ 2, with no individual subscore > 1
    - The proportion of subjects achieving clinical response at Week 12 defined as a
    decrease from baseline in the PMS of at least 2 points and at least 25%, along with a
    reduction in the RBS of at least 1 point or an absolute RBS of ≤ 1 point

    The following safety parameters will be evaluated for the duration of the study:
    - Type, frequency, severity, and relationship of AEs to IP
    - Number of subjects who discontinue IP due to any AE
    - Frequency of clinically significant changes in physical examination, vital signs,
    and/or laboratory findings

    Exploratory efficacy endpoints
    - The proportion of subjects who are in clinical remission per the TMS, PMS, or modified Mayo score, as applicable, over time, except at Week 12
    - The proportion of subjects who are in clinical response per the TMS, PMS, or modified Mayo score, as applicable, over time, except at Week 12.
    - The proportion of subjects achieving a RBS ≤ 1 over time, except at Week 12
    - The proportion of subjects achieving SFS ≤ 1 over time
    - The proportion of subjects achieving a physician’s global assessment (PGA) ≤ 1 Week 2 through Week 52
    - The proportion of subjects who achieve corticosteroid-free clinical remission at Week 52 among subjects receiving oral corticosteroids at baseline
    - The change from baseline in the PMS at Week 2 through Week 52
    - The change from baseline in the TMS at Week 12 and Week 52
    - The change from baseline in the SF-12v2 score over time


    PK Endpoint:
    - The population-based PK estimates of apremilast
    - The estimates to reflect the relationship of apremilast exposure and key efficacy
    endpoints

    PD/Biomarker Endpoints:
    - The change from baseline in hsCRP concentration over time
    - The change from baseline in FCP concentration over time
    - The correlation between FCP/hsCRP and clinical outcomes over time
    - The change from baseline in PD markers from intestinal mucosa at Week 12, such as, but not limited to, hematoxylin and eosin (H&E) staining to measure the degree of cellular inflammatory infiltrate and of tissue destruction, and gene expression (messenger ribonucleic acid [mRNA] for the inflammatory mediators TNF-α, IL-12, IL-23, IFN-γ, IL-5, IL-13, IL-17, and matrix metalloproteinase-3 [MMP-3])


    PG Endpoint:
    - The association of PG markers with the efficacy of apremilast in subjects with active
    UC
    E.5.2.1Timepoint(s) of evaluation of this end point
    The Secondary end points will be evaluated for the duration of the study
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    dose-ranging study
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Netherlands
    New Zealand
    Poland
    United Kingdom
    United States
    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
    The End of Trial is defined as either the date of the last visit of the last subject to complete the study, or the date of receipt of the last data point from the last subject that is required for primary, secondary, and/or exploratory analysis, as pre-specified in the protocol and/or the Statistical Analysis Plan, whichever is the later date.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 165
    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)
    Subjects who complete the Double-blind Placebo-controlled Phase, as
    well as subjects who prematurely discontinue from the study will enter
    the Post-treatment Observational Follow-up Phase, the 4-week period
    after the last dose of investigational product (IP).
    The long term care of the participant will remain the responsibility of
    the primary treating physician once the trial has ended.
    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 Decision2015-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-03
    The status of studies in GB is no longer updated from 1.1.2021
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