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    Summary
    EudraCT Number:2015-000319-41
    Sponsor's Protocol Code Number:RPC01-3101
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-12
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-000319-41
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction
    and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety Study of RPC1063 in Ulcerative Colitis
    A.4.1Sponsor's protocol code numberRPC01-3101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02435992
    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 International II Sàrl (CIS II)
    B.1.3.4CountrySwitzerland
    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 International II Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene International II Sàrl
    B.5.2Functional name of contact pointTruenorth Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address3033 Science Park Road, Suite 300
    B.5.3.2Town/ citySan Diego, California
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18442669299
    B.5.6E-mailtruenorth@quintiles.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 name0.25mg RPC103
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.3Other descriptive name(S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 name1.0 mg RPC103
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.3Other descriptive name(S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboCapsule, hard
    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
    ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    ulcerative colitis
    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 20.1
    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
    INDUCTION THERAPY
    Demonstrate the efficacy of RPC1063 versus placebo on induction of clinical remission in adults.

    MAINTENANCE THERAPY
    To demonstrate the efficacy of RPC1063 versus placebo maintenance therapy on clinical remission in adults.
    E.2.2Secondary objectives of the trial
    INDUCTION THERAPY

    Demonstrate the efficacy of RPC1063 versus placebo
    - on induction of clinical response in adults.
    - achieving endoscopic improvement in adults.
    - on achieving histologic remission in adults.
    Demonstrate the safety and tolerability of RPC1063 induction therapy in all patients.

    MAINTENANCE THERAPY
    Demonstrate the efficacy of RPC1063 versus placebo
    - in maintaining clinical response in adults.
    - on achieving endoscopic improvement in adults.
    - on durability of clinical remission in adults.
    - on maintaining clinical remission among patients who achieved remission during induction therapy in adults.
    - in achieving corticosteroid-free remission among patients receiving corticosteroids at entry into the Maintenance Period in adults.
    Demonstrate the safety and tolerability of RPC1063 maintenance therapy in all patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must meet one of the following criteria:
    - Male or female adult patients aged 18 to 75 years (at Screening), inclusive for
    Cohort 1 or Cohort 2, or
    - Male or female adolescent patients aged 12 to < 18 years (at Screening) with a body weight ≥ 45 kg for Cohort 3.
    Note: Countries or sites with local restrictions that prohibit enrollment of adolescents (aged 12 to<18 years) will only enroll patients who are aged 18 to 75 years, inclusive. Enrollment of adolescent patients will only begin after the applicable regulatory requirements for studying patients in that age group have been satisfied and the necessary health authority agreements have been granted.
    2. Have had UC diagnosed at least 3 months prior to first investigational drug administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report (note: endoscopy and histopathology may be performed at Screening if no prior report is readily available)
    3. Evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy)
    4. Have active UC defined as a complete Mayo score of 6 to 12 inclusive, with endoscopic subscore of ≥ 2, a rectal bleeding score of ≥ 1, and a stool frequency score ≥ 1
    5. Must be currently receiving treatment with at least 1 of the following therapies and must continue on these therapies during Induction:
    - Oral aminosalicylates at a therapeutic dose for their disease (eg, mesalamine, sulfasalazine, olsalazine, balsalazide), with the dose stable for at least 3 weeks, prior to Screening endoscopy
    - Prednisone (doses ≤ 20 mg per day) or equivalent receiving a stable dose for at least 2 weeks prior to Screening endoscopy
    - Budesonide MMX therapy receiving a stable dose for at least 2 weeks prior to Screening endoscopy
    6. Have undergone colonoscopy (or are willing to undergo colonoscopy during Screening):
    - within the past 2 years, to screen for dysplasia (unless otherwise recommended by local and national guidelines) if the patient has had left-sided colitis of > 12 years duration or total/extensive colitis of > 8 years duration
    - within the past 5 years, to screen for polyps if the patient age is > 45 years
    - If oral aminosalicylates or corticosteroids have been recently discontinued, they must have been stopped for at least 2 weeks prior to the endoscopy used for Baseline Mayo score
    7. Females of childbearing potential (FCBP):
    Must agree to practice a highly effective method of contraception throughout the trial until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly. Acceptable methods of birth control in the trial are the following:
    combined hormonal (oestrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
    progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
    placement of an intrauterine device (IUD)
    placement of an intrauterine hormone-releasing system (IUS)
    bilateral tubal occlusion
    vasectomized partner
    complete sexual abstinence

    Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception.
    8. Must provide written informed consent/assent and have the ability to be compliant with the schedule of protocol assessments. The parent/legal guardian of the adolescent must sign an informed consent form. In addition, adolescent patients must also agree to participate in the study by signing an assent.
    9. Patients must have documentation of positive Varicella zoster virus (VZV) immunoglobulin G (IgG) antibody status or complete VZV vaccination at least 30 days prior to randomization
    E.4Principal exclusion criteria
    1. Have severe extensive colitis as evidenced by:
    • Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of Baseline • Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation
    2. Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease or microscopic colitis or radiation colitis or ischemic colitis
    3. Have positive stool examination for pathogens (ova and parasites, bacteria) or positive test for toxin producing Clostridium difficile (C. difficile) at Screening. PCR (polymerase chain reaction) examination of the stool for C. difficile may be used to exclude false positives. If positive, patients may be treated and retested. Documentation of a negative test result for pathogens (ova and parasites, bacteria) is required within 60 days of Day 1
    4. Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during Screening
    5. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the trial difficult or that would put the patient at risk by participating in the trial
    6. Clinically relevant cardiovascular conditions, including history or presence of:
    • Recent (within the last 6 months) occurrence of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea
    • For Adult patients: Prolonged Fridericia’s corrected QT interval (QTcF; QTcF > 450 msec for males, > 470 msec for females), or at additional risk for QT interval prolongation
    • For Adolescent patients: Prolonged Fridericia’s corrected QT interval (QTcF; QTcF >450 msec for both males and females), or at additional risk for QT interval prolongation
    • Resting HR <55 bpm when taking vital signs as part of a physical exam at Screening
    7. History of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with glycosylated Hb (HbA1c) > 9%, or diabetic patients with significant comorbid conditions such as retinopathy or nephropathy
    8. History of uveitis (within the last year) or macular edema
    9. Subject has a known active bacterial, viral, or fungal infection [excluding fungal infection of nail beds, minor upper respiratory tract infections, and minor skin infections] a mycobacterial infection (including tuberculosis[TB] or atypical mycobacterial disease),or any major episode of infection that required hospitalization or treatment with intravenous (IV) antibiotics within 30 days of Screening or oral antibiotics within 14 days of Screening
    10. History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or uterine cervix that have been excised and resolved) or colonic mucosal dysplasia
    11. History of alcohol or drug abuse within 1 year prior to randomization
    12. History of treatment with a biologic agent within 8 weeks or 5 elimination half-lives (whichever is less) of that agent prior to randomization
    13. History of treatment with an investigational agent within 5 elimination half-lives of that agent prior to randomization
    14. History of treatment with topical rectal 5-aminosalicylic acid or topical rectal steroids within 2 weeks of Screening endoscopy or anti-motility medications during Screening
    15. Receipt of a live vaccine or live attenuated vaccine within 4 weeks prior to randomization
    16. Planned concurrent treatment with immunosuppressive agents (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate) after randomization. Patients receiving AZA, 6-MP, or methotrexate at Screening must discontinue treatment with these agents prior to randomization
    17. Treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with two or more agents in combination known to prolong PR interval
    18. Patients who were primary non-responders to 2 or more biologic agents approved for the treatment of UC (eg anti-TNF agents or vedolizumab)
    19. Serum creatinine > 1.4 mg/dL for females or > 1.6 mg/dL for males
    20. Liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN), or direct bilirubin > 1.5 times the ULN
    26. ECG showing any clinically significant abnormality
    27. Forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) < 70% of predicted values at screening
    28. Patient receiving treatment with breast cancer resistance protein (BCRP) inhibitors (eg cyclosporine, eltrombopag)
    30. Adolescent patients with delayed growth or delayed pubertal development and who will not maintain a stable dose of corticosteroids through Week 10.
    31-39 Abnormal lab results
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy endpoints will be formally examined with statistical hypothesis tests conducted on the efficacy results obtained from adult patients randomized and dosed in Cohort 1. Cohort 2 is open-label and does not contain a control group,therefore all of the efficacy endpoints will be summarized and described without statistical hypothesis testing. The analysis of adolescent patients (aged 12 up to < 18 years; Cohort 3) will be performed independently from the analysis of adult patients. Efficacy results in the Induction Period will be evaluated for similar efficacy trends between Cohort 1 and Cohort 3. No formal hypothesis testing is planned for Cohort 3 data.

    INDUCTION PERIOD Cohort 1
    - The proportion of adult patients in clinical remission at Week 10.

    INDUCTION PERIOD Cohort 2
    Cohort 2 is open label; therefore no formal analysis of efficacy endpoints will be conducted.
    All efficacy endpoints will be summarized and described without hypothesis testing and reported using descriptive statistics.

    MAINTENANCE PHASE Cohort 1 and Cohort 2 in Adult Patients
    Primary Efficacy Endpoint:
    - The proportion of adult patients in clinical remission at 52 weeks
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 10 weeks (Induction Visit I4/Week 10)
    At 52 weeks (Maintenance Visit M5/Week 42)
    E.5.2Secondary end point(s)
    INDUCTION PERIOD Cohort 1
    - The proportion of adult patients with a clinical response at Week 10
    - The proportion of adult patients with endoscopic improvement at Week 10
    - The proportion of adult patients with mucosal healing at Week 10

    MAINTENANCE PHASE
    Key Secondary Efficacy Endpoints:
    - The proportion of adult patients with a clinical response at 52 weeks
    - The proportion of adult patients with endoscopic improvement at 52 weeks
    - The proportion of adult patients with durable clinical remission
    - The proportion of adult patients in clinical remission at 52 weeks in the subset of patients who were
    in remission at Week 10
    - The proportion of adult patients with corticosteroid-free remission
    - The proportion of adult patients with mucosal healing at 52 weeks

    OTHER ENDPOINTS
    Safety
    Pharmacokinetic and pharmacodynamic
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 10 weeks (Induction Visit I4/Week 10)
    At 52 weeks (Maintenance Visit M5/Week 42)
    From the list of Other efficacy endpoints during maintenance phase (not
    primary or secondary) some endpoints are evaluated at 28 weeks (Maintenance Visit M3/Week 18), 40 weeks (Maintenance Visit M3/Week 30) and 52 weeks (Maintenance Visit M3/Week 42).
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Induction (Coh1 & 3: Random PlaceboContr; Coh2: OpenLabel; ); Maintenance (PlaceboContr)
    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 trial4
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA117
    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
    Argentina
    Australia
    Belarus
    Belgium
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Georgia
    Germany
    Greece
    Hungary
    Israel
    Italy
    Korea, Republic of
    Latvia
    Moldova, Republic of
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Ukraine
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    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 Yes
    F.1.1Number of subjects for this age range: 150
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 863
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state68
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 430
    F.4.2.2In the whole clinical trial 1050
    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)
    Patients may roll-over into an open-label extension study.
    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 Decision2015-08-31
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-17
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