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    Summary
    EudraCT Number:2017-000575-88
    Sponsor's Protocol Code Number:SHP647-305
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-04-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-000575-88
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305)
    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 in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether
    they receive study drug or placebo)
    A.3.2Name or abbreviated title of the trial where available
    CARMEN CD 305
    A.4.1Sponsor's protocol code numberSHP647-305
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/281/2018
    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 pointChantal L. Letourneau
    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 Kingdom
    B.5.4Telephone number0017814820852
    B.5.5Fax number0017814822954
    B.5.6E-mailchantal.letourneau@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.3.1Product nameSHP647
    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 INNontamalimab
    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.3.1Product nameSHP647
    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 INNontamalimab
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's disease
    E.1.1.1Medical condition in easily understood language
    Long-term condition that results in inflammation of 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 20.0
    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 coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn's Disease (CD) in:
    Inducing clinical remission based on 2-item patient-reported outcome (PRO) (abdominal pain severity and very soft stool/liquid stool frequency)
    Inducing endoscopic response based on centrally read colonoscopy.
    E.2.2Secondary objectives of the trial
    The key secondary objectives are as follows:
    To evaluate the efficacy of ontamalimab in inducing clinical remission as measured by Crohn's Disease Activity Index (CDAI)
    To evaluate the efficacy of ontamalimab in inducing enhanced endoscopic response based on centrally read colonoscopy
    To evaluate the efficacy of ontamalimab in inducing clinical remission based on abdominal pain severity and very soft stool/liquid stool frequency (alternate thresholds)
    To evaluate the efficacy of ontamalimab in inducing clinical response based on patient-reported clinical signs and symptoms (as measured by 2-item PRO)
    To evaluate the efficacy of ontamalimab in inducing clinical remission based on patient-reported clinical signs and symptoms (as measured by 2-item PRO) as well as inducing endoscopic response based on centrally read colonoscopy in the same subject
    To evaluate the efficacy of ontamalimab in inducing endoscopic healing based on centrally read colonoscopy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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 be between ≥16 and ≤80 years of age at the time of the signing of the informed consent/assent form. Note: Subjects <18 years of age must weigh ≥40 kg and must have body mass index ≥16.5 kg/m2.
    4.Subjects must have active moderate to severe ileal (terminal ileum), ileocolic, or colonic CD at baseline (Visit 2) as defined by:
    a.CDAI score between 220 and 450 (inclusive) AND
    b.Presence of ulcerations that are characteristic to CD, as determined by a colonoscopy performed during screening, and as defined by the SES-CD >6 (SES-CD ≥4 for isolated ileitis) AND
    c.Meeting the following subscores in the 2-item PRO:
    i.Abdominal pain subscore ≥5 (average worst daily pain on the 11-point NRS) AND abdominal pain subscore > 2 (average daily pain on the 4point abdominal pain variable of CDAI) over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) AND/OR
    ii.Average of the daily stool frequency subscore ≥4 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous).
    AND
    c. Presence of ulcerations that are characteristic to CD, as determined by a colonoscopy performed during screening, and as defined by the SES-CD >6 (SES-CD ≥4 for isolated ileitis) Note that the subject must be confirmed as meeting the CDAI score and PRO subscore requirements before a colonoscopy is done.
    5.Subjects must have a documented diagnosis (endoscopic with histology) of CD for ≥3 months before screening. Documented diagnosis is defined as:
    A biopsy report in which the description of the histological findings is consistent with the CD diagnosis AND
    A report documenting disease duration based upon prior colonoscopy.
    Note: If a biopsy report is not available in the source document at the
    time of screening, a biopsy must be performed during the screening
    colonoscopy and the histology report should be consistent with the CD
    diagnosis. If the histology description does not support the CD diagnosis is
    not clear at this time point, the subject should not be randomized
    6.Subjects must be willing and able to undergo a colonoscopy during screening after all other inclusion criteria have been met.
    7.Subjects must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as sulfasalazine or mesalamine (5-ASA), glucocorticoids, immunosuppressants (AZA, 6-MP, or MTX), or anti-TNF (see to Appendix 4 of the protocol for guidance).
    Subjects who have had an inadequate response to sulfasalazine or mesalamine should have also failed at least 1 other conventional treatment such as glucocorticoids.
    8.Subjects receiving any treatment(s) for CD described in Section 5.2.1 of the protocol are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
    9. Subjects are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential. Males and females of reproductive potential who are sexually active must agree to use appropriate contraception (ie, highly
    effective methods for female and medically appropriate methods for male study subjects as described in in Section 4.4 of the protocol) for the duration of the study.
    E.4Principal exclusion criteria
    1.Subjects with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of ulcerative colitis.
    2.Subjects with colonic dysplasia or neoplasia. (Subjects with prior
    history of adenomatous polyps will be eligible if the polyps have been completely removed.)
    3.Subjects with past medical history or presence of toxic megacolon.
    4.Subjects with presence of enterovesical (ie, between the bowel and urinary bladder) or enterovaginal fistulae.
    5.Subjects with current symptomatic diverticulitis or diverticulosis.
    6.Subjects with clinically significant obstructive colonic stricture, or
    who have a history of bowel surgery within 6 months before screening,
    or who are likely to require surgery for CD during the treatment period. Subjects who have undergone
    previous colonic resection or
    ileocolectomy more than 6 months before screening must have at least 25 cm of colon remaining.
    7.Subjects with past medical history of multiple small bowel resections resulting in clinically significant short bowel syndrome.
    8.Subjects requiring total parenteral nutrition.
    9.Subjects with past medical history of bowel surgery resulting in an existing or current stoma. Subjects who had a j-pouch are excluded as a j-pouch could result in a stoma.
    10.Subjects have had prior treatment with ontamalimab (formerly PF00547659;
    SHP647).
    11.Subjects with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
    12.Subjects have received any nonbiologic treatment
    with immunomodulatory properties (other than AZA, 6-MP, or MTX) or
    continuous antibiotics (>2 weeks) for the treatment of CD within 30 days before baseline (Visit 2).
    13.Subjects have received anti-TNF treatment within 60 days before baseline (Visit 2).
    14.Subjects have received any biologic with
    immunomodulatory
    properties (other than anti-TNFs) within 90 days before baseline (Visit 2).
    15.Subjects have ever received anti integrin/adhesion
    molecule treatment (eg, natalizumab, vedolizumab, efalizumab, etrolizumab,
    or any other investigational anti-integrin/adhesion
    molecule).
    16.Subjects have received lymphocytes apheresis or selective monocyte
    granulocytes apheresis within 60 days before baseline (Visit 2).
    17.Subjects have received enteral nutrition treatment within 30 days before baseline (Visit 2).
    18.Subjects have received parenteral or rectal glucocorticoids or rectal
    5-ASA within 14 days before screening colonoscopy.
    19.Subjects have taken >20 mg/day of prednisone, >9 mg/day of budesonide, or equivalent oral systemic corticosteroid dose within
    14 days before baseline (Visit 2) or have taken ≥40 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 6 weeks before
    baseline (Visit 2).
    20.Subjects have participated in other investigational studies
    within either 30 days or 5 half-lives of investigational product used in the study
    (whichever is longer) before screening (Visit 1).
    21.Subjects have received a live (attenuated) vaccine within 30 days before baseline (Visit 2).
    22.Subjects with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis [subjects with C. difficile infection at screening may be allowed retest after treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as
    histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the subjects to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before baseline (Visit 2).
    23. Subjects with abnormal chest x-ray or other imaging findings at screening (Visit 1), such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy. (A chest x-ray, computed tomography scan, etc., performed up to 12 weeks before study entry [screening, Visit 1] may be used if available; documentation of the official reading
    must be located and available in the source documentation).
    E.5 End points
    E.5.1Primary end point(s)
    The coprimary efficacy endpoints are:
     Clinical remission at the Week 16 visit as defined by the following: 2-item PRO
    subscores 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. The 7 most recent
    days may or may not be contiguous during the 10 days of data collection before
    colonoscopy preparation, depending on days to be excluded because of missing data.
    If fewer than 7 days are available, the endpoint will be calculated on all available most
    recent 6 or 5 days. If fewer than 5 days are available, the endpoint will be treated as
    missing.
     Endoscopic response at Week 16 as measured by a decrease in SES-CD of at least 25%
    from baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints are as follows:
     Clinical remission at the Week 16 visit as measured by a CDAI score of <150.
     Enhanced endoscopic response at Week 16 as measured by a decrease in SES-CD of at
    least 50% from baseline.
     Clinical remission at the Week 16 visit as defined by the following: 2-item PRO
    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. The 7 most recent
    days may or may not be contiguous during the 10 days of data collection before
    colonoscopy preparation, depending on days to be excluded because of missing data.
    If fewer than 7 days are available, the endpoint will be calculated on all available most
    recent 6 or 5 days. If fewer than 5 days are available, the endpoint will be treated as
    missing.
     Clinical response at the Week 16 visit as measured by the 2-item PRO and defined as
    meeting at least 1 of the following 2 criteria:
    o A decrease of ≥30% and at least 2 points from baseline in the average daily worst
    abdominal pain over the 7 most recent days*, with the average daily stool frequency
    of type 6/7 (very soft stools/liquid stools) either:
    (a) Not worsening from baseline
    and/or
    (b) Meeting the criteria for clinical remission, ie, 2-item PRO subscore of 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*
    o A decrease of ≥30% from baseline in the average daily stool frequency of type 6/7
    (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*,
    with the average daily worst abdominal pain either:
    (a) Not worsening from baseline
    and/or
    (b) Meeting the criteria for clinical remission, ie, 2-item PRO subscore of average
    worst daily abdominal pain ≤3 (based on 11-point NRS) over the 7 most recent days
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    25 mg or 75 mg ontamalimab
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA107
    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
    Austria
    Brazil
    Croatia
    Czech Republic
    Germany
    Israel
    Italy
    Japan
    Lithuania
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    Serbia
    South Africa
    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. 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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 103
    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: 103
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 909
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 816
    F.4.2.2In the whole clinical trial 1032
    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 the 16-week treatment period, subjects will be offered the opportunity to participate in either a
    double-blind maintenance study (SHP647-307; for subjects who fulfill the entry criteria) or a long-term safety
    extension (LTS) study (SHP647-304; for subjects who do not fulfill the entry criteria for Study SHP647-307).
    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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-28
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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