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    Summary
    EudraCT Number:2015-000319-41
    Sponsor's Protocol Code Number:RPC01-3101
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-05
    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 ConcernedHungary - National Institute of Pharmacy
    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 Sárl (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 Sárl (CIS II)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReceptos Services, LLC
    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 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.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 20.0
    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
    INDUCTION THERAPY
    Demonstrate the efficacy of RPC1063 versus placebo on induction of clinical remission.

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

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

    MAINTENANCE THERAPY
    Demonstrate
    -the efficacy of RPC1063 versus placebo in maintaining clinical response
    -the efficacy of RPC1063 versus placebo on achieving endoscopic improvement
    -the efficacy of RPC1063 versus placebo on durability of clinical remission
    -the efficacy of RPC1063 versus placebo on maintaining clinical remission among patients who achieved remission during induction therapy
    -the efficacy of RPC1063 versus placebo, in achieving corticosteroid-free remission among patients receiving corticosteroids at entry into the Maintenance Period
    -the safety and tolerability of RPC1063 maintenance therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 18 to 75 years (at screening), inclusive
    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 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
    - 7. If oral aminosalicylates or corticosteroids have been discontinued, they must have been stopped for at least 2 weeks prior to
    the endoscopy used for Baseline Mayo score
    8. Female patients of childbearing potential:
    Must agree to practice a highly effective method of contraception
    throughout the trial until completion of the 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
    vasectomised partner
    sexual abstinence
    Male patients:
    Must agree to use a latex condom during sexual contact with women of
    childbearing potential while participating in the study until completion of
    the safety follow-up visit.
    All patients:
    Periodic abstinence (calendar, symptothermal, post-ovulation methods),
    withdrawal (coitus interruptus), spermicides only, and lactational
    amenorrhoea method are not acceptable methods of contraception.
    Female condom and male condom should not be used together.
    9. Must provide written informed consent and have the ability to be compliant with the schedule of protocol assessments.
    10. Patients must have documentation of positive Varicella zoster virus IgG antibody status or complete Varicella zoster virus vaccination at least 30 days prior to randomization
    E.4Principal exclusion criteria
    Exclusions Related to General Health:
    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
    • Prolonged Fridericia’s corrected QT interval (QTcF; QTcF > 450 msec for males, > 470 msec for females), or at additional risk for QT interval prolongation (eg, hypokalemia, hypomagnesemia, congenital long QT syndrome)
    • 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. Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infections and minor skin infections]) or any major episode of infection that required hospitalization or treatment with intravenous 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
    Exclusions Related to Medications:
    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 or anti-motility medications (such as diphenoxylate/atropine) during screening
    15. Receipt of a live 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. Serum creatinine > 1.4 mg/dL for females or > 1.6 mg/dL for males
    19. 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
    20. Platelet count < 100,000/uL
    21. Hemoglobin < 8.5 g/dL
    22. Neutrophils < 1500 ¬/uL
    23. Absolute white blood cell count < 3500/uL
    24. Absolute lymphocyte count < 800/uL
    25. ECG showing any clinically significant abnormality
    26. Forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) < 70% of predicted values at screening
    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 patients randomized and dosed in Cohort 1. Cohort 2 is open-label and does not contain a control group

    INDUCTION PHASE Cohort 1
    Primary Efficacy Endpoint:
    - The proportion of patients in clinical remission at Week 10.

    INDUCTION PHASE 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.

    MAINTENANCE PHASE
    Primary Efficacy Endpoint:
    - The proportion of 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 PHASE
    Key Secondary Efficacy Endpoints:
    - The proportion of patients with a clinical response at Week 10
    - The proportion of patients with endoscopic improvement at Week 10
    - The proportion of patients with mucosal healing at Week 10

    MAINTENANCE PHASE
    Key Secondary Efficacy Endpoints:
    - The proportion of patients with a clinical response at 52 weeks
    - The proportion of patients with endoscopic improvement at 52 weeks
    - The proportion of patients with durable clinical remission
    - The proportion of patients in clinical remission at 52 weeks in the subset of patients who were
    in remission at Week 10
    - The proportion of patients with corticosteroid-free remission
    - The proportion of 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
    2 phases. Induction (Cohort1: Random PlaceboContr; Cohort2: 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA93
    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
    Austria
    Belarus
    Belgium
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    New Zealand
    Poland
    Russian Federation
    Slovakia
    South Africa
    Ukraine
    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 years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 873
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state86
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 427
    F.4.2.2In the whole clinical trial 900
    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 Decision2015-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-17
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    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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