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    Summary
    EudraCT Number:2017-000574-11
    Sponsor's Protocol Code Number:SHP647-304
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-27
    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 ConcernedGreece - EOF
    A.2EudraCT number2017-000574-11
    A.3Full title of the trial
    A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)
    A.3.2Name or abbreviated title of the trial where available
    AIDA
    A.4.1Sponsor's protocol code numberSHP647-304
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03283085
    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 SponsorShire Human Genetic Therapies, Inc.
    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 supportShire Human Genetic Therapies, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Human Genetic Therapies, Inc.
    B.5.2Functional name of contact pointMelanie Ivarsson
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016175849253
    B.5.5Fax number0017814822954
    B.5.6E-mailmivarsson0@shire.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.3.2Product code SHP647
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-MAdCAM antibody
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.3.2Product code SHP647
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-MAdCAM antibody
    D.3.9.2Current sponsor codeSHP647
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis or Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Long-term condition that results in inflammation and ulcers of the colon and rectum or long-term condition that results in inflammation of the the gastrointestinal tract.
    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 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    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
    The primary objective of the study is to evaluate the safety and tolerability of long-term treatment with SHP647 in subjects with moderate to severe UC or CD.
    E.2.2Secondary objectives of the trial
    Secondary - Subjects with Ulcerative Colitis:
     To evaluate the effect of long-term SHP647 treatment on clinical outcomes (including remission over time
    based on composite score of patient-reported symptoms using daily diary and locally read endoscopy,
    Mayo-based remission over time, clinical remission over time, partial Mayo score over time).
     To evaluate the effect of long-term SHP647 treatment on endpoints related to endoscopic healing.
    Secondary - Subjects with Crohn’s Disease:
     To evaluate the effect of long-term SHP647 treatment on clinical outcomes (including 2 item PRO based
    clinical response over time, 2 item PRO based and CDAI-based clinical remission over time.
     To evaluate the effect of long-term SHP647 treatment on endpoints related to endoscopic outcomes
    (enhanced endoscopic response as well as endoscopic healing).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with Ulcerative Colitis
    1. Subjects and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
    2. Subjects must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
    3. Subjects must have been previously enrolled in study SHP647-301, SHP647 302, or SHP647-303, and reached 1 of the following clinical trial milestones:
    - Completed the Week 12 visit in induction study SHP647-301 or SHP647 302, and did NOT achieve a clinical response. Clinical response is defined as: 1) a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding ≥1 point or a subscore for rectal bleeding ≤1, OR 2) a decrease from the induction study (SHP647 301 or SHP647-302) baseline total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.
    - Completed the Week 52 visit in maintenance study SHP647-303.
    - Withdrew early from maintenance study SHP647-303 due to treatment failure, defined by an endoscopic subscore that has increased by at least 1 point over baseline in the maintenance study or a value ≥2 plus an increase in clinical subscore (stool frequency + rectal bleeding score) of at least 2 points. Centrally read endoscopic subscores will be used to determine treatment failure.
    4. Subjects receiving any treatment(s) for UC described in Section 5.2.1 are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

    Subjects with Crohn’s Disease
    1. Subjects and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
    2. Subjects must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
    3. Subjects must have been previously enrolled in study SHP647-305, SHP647 306, or SHP647-307, and reached 1 of the following clinical trial milestones:
    - Completed the Week 16 visit in induction study SHP647-305 or SHP647 306, and did NOT meet the efficacy criteria (clinical and/or endoscopic response/remission as appropriate) for entry into maintenance study SHP647-307.
    - Completed the Week 52 visit in maintenance study SHP647-307.
    - Withdrew early from maintenance study SHP647-307 due to treatment failure (or were considered to have failed treatment, at the time of the last visit in study SHP647-307), as defined in the SHP647-307 protocol.
    4. Subjects receiving any treatment(s) for CD described in Section 5.3.1, are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
    E.4Principal exclusion criteria
    Exclusion Criteria – Subjects with UC:
    Subjects are excluded from the study if any of the following criteria are met:
    1. Subjects who had major protocol deviation(s) (as determined by the sponsor) in previous studies.
    2. Subjects who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in previous studies.
    3. Subjects who are likely to require major surgery for UC/CD.
    4. Subjects are females who became pregnant during study SHP647-301, SHP647-302, or SHP647-303, females
    who are planning to become pregnant during the study period, or males or females of childbearing potential
    not agreeing to continue using appropriate contraception methods through the conclusion of study
    participation.
    5. Subjects who do not agree to postpone donation of any organ or tissue, including male subjects who are
    planning to bank or donate sperm and female subjects who are planning to harvest or donate eggs, for the
    duration of the study and through 16 weeks after last dose of investigational product.
    6. Subjects who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
    7. Subjects who have a newly-diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
    8. Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [eg, Felty’s syndrome], or local active infection/infectious illness) that, in the investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study.
    9. Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    10. Subjects with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in previous studies and who have been advised to require treatment for latent or active disease, but who are without a generally accepted course of treatment.

    Exclusion Criteria – Subjects with CD:
    Subjects are excluded from the study if any of the following criteria are met:
    1. Subjects who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-305,
    SHP647-306, or SHP647-307.
    2. Subjects who permanently discontinued investigational product because of an adverse event (AE), regardless
    of relatedness to investigational product, in study SHP647-305, SHP647-306, or SHP647-307.
    3. Subjects who are likely to require major surgery for CD or developed acute severe complications of CD (with
    or without fulfilling the treatment failure criteria in the maintenance study) that required immediate
    intervention (eg, need for immediate biologic treatment with proven effect) and/or CDAI score >450.
    4. Subjects are females who became pregnant during study SHP647-305, SHP647-306, or SHP647-307, females
    who are planning to become pregnant during the study period, or males or females of childbearing potential
    not agreeing to continue using appropriate contraception methods through the conclusion of study
    participation.
    5. Subjects who do not agree to postpone donation of any organ or tissue, including male subjects who are
    planning to bank or donate sperm and female subjects who are planning to harvest or donate eggs, for the
    duration of the study and through 16 weeks after last dose of investigational product.
    6. Subjects who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with
    study procedures.
    7. Subjects who have a newly-diagnosed malignancy or recurrence of malignancy (other than resected cutaneous
    basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated
    with no evidence of recurrence).
    8. Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (eg,
    renal, hepatic, hematologic, gastrointestinal [except disease under study], endocrine, cardiovascular,
    pulmonary, immunologic [eg, Felty’s syndrome], or local active infection/infectious illness) that, in the
    investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is assessment of safety as measured by: incidence and severity of AEs; incidence and nature of serious infections; actual values and change from baseline, as well as the incidence of abnormalities in laboratory tests, ECGs, and vital signs; and antidrug antibodies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to section “Study Schedules” of the Protocol
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints – Subjects with Ulcerative Colitis:
    The secondary efficacy endpoints are as follows:
    • Remission based on composite score, assessed yearly and at end of study. Remission is defined as a composite score of patient-reported symptoms using daily diary and locally read endoscopy as follows: stool frequency subscore of 0 or 1 with at least a 1-point change from induction study (SHP647-301 or SHP647-302) baseline AND rectal bleeding subscore of 0 AND locally-read endoscopic subscore of 0 or 1 (modified, excludes friability).
    • Remission, based on total Mayo score, assessed yearly and at end of study. Remission is defined as a total Mayo score ≤ 2 with no individual subscore (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician’s global assessment) exceeding 1.
    • Clinical remission as defined by stool frequency subscore of 0 or 1 with at least a 1-point change from induction study (SHP647-301 or SHP647-302) baseline in stool frequency subscore, and rectal bleeding subscore of 0, assessed yearly and at end of study.
    • Partial Mayo score of ≤2 with no individual subscore >1 over time. The partial Mayo score does not include the endoscopy subscore.
    • Endoscopic remission, as defined by locally read endoscopic subscore 0 or 1 (modified, excludes friability), assessed yearly and at end of study.

    Secondary Efficacy Endpoints – Subjects with Crohn’s Disease:
    The secondary efficacy endpoints are as follows:
    • Clinical remission over time. Clinical remission is defined by 2-item PRO CD daily e-diary subscore of average worst daily abdominal pain ≤3 (based on 11-point NRS over the 7 most recent days) and average daily stool frequency ≤2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days.
    • Enhanced endoscopic response, assessed yearly and at end of study, as measured by a decrease in SES-CD of at least 50% from induction study (SHP647-305 or SHP647-306) baseline.
    • Clinical remission over time as measured by CDAI <150.
    • Clinical remission over time as defined by the following: CD daily e-diary subscores of average worst daily abdominal pain ≤1 (based on the 4-point scale) over the 7 most recent days and average daily stool frequency ≤3 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days.
    • Both clinical remission by 2-item PRO and enhanced endoscopic response over time (composite endpoint).
    • Complete endoscopic healing at end of study, defined as SES-CD=0-2.
    All efficacy analyses will be performed using the full-analysis set.
    Secondary efficacy endpoints will be summarized by treatment group using descriptive statistics at each assessment visit. Summaries may be presented by the status at entry into the study (eg, induction non-responder, maintenance SHP647 completer, etc). Statistical summaries will include number of subjects and percentages, and 95% confidence intervals.
    E.5.2.1Timepoint(s) of evaluation of this end point
    assessed every 24 weeks, yearly, at end of study, or a combination, as detailed in E.5.1
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    25 mg or 75 mg SHP647
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA167
    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
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Colombia
    Croatia
    Czech Republic
    Estonia
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Mexico
    Netherlands
    New Zealand
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    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
    The Study Completion Date is defined as the date the final subject, across all sites, completes their final protocol-defined assessment. Please note that this includes the follow-up visit or contact, whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    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 Yes
    F.1.1Number of subjects for this age range: 247
    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: 247
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescents (16-17 years)
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 967
    F.4.2.2In the whole clinical trial 2453
    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)
    At the end of this study patients will return to standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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