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    Summary
    EudraCT Number:2010-022383-12
    Sponsor's Protocol Code Number:CCX114157
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-03-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-022383-12
    A.3Full title of the trial
    A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease
    A.4.1Sponsor's protocol code numberCCX114157
    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 SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClincial Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 44 66
    B.5.5Fax number+44208990 12 34
    B.5.6E-mailGSKClincialSupportHD@gsk.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 nameGSK1605786A
    D.3.2Product code GSK1605786A
    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 INNGSK1605786A
    D.3.9.2Current sponsor codeGSK1605786A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Subjects with Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Crohn’s disease Inflammatory bowel disease
    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 14.1
    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
    • To assess the efficacy of GSK1605786A compared with placebo in maintaining
    clinical remission in subjects with Crohn’s disease over 52 weeks.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of GSK1605786A compared with placebo
    • To investigate the effect of GSK1605786A compared with placebo on health-related quality of life
    • To investigate the effect of GSK1605786A compared with placebo on health-related resource utilisation
    • To investigate the effect of GSK1605786A compared with placebo on work productivity and activity impairment
    • To investigate the effect of GSK1605786A compared with placebo on unemployment and disability rates
    • To investigate the effect of GSK1605786A compared with placebo on biomarkers of inflammation [C-reactive protein (CRP) and faecal calprotectin]
    • To explore the dose relationships between GSK1605786A plasma concentration and Clinical response endpoints
    • To explore potential relationships between genetic variations and GSK1605786A efficacy and safety endpoints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects achieving clinical response (CDAI decrease ≥ 100points) and/or remission (CDAI <150) upon completion of treatment in Study CCX114151 or Study CCX114643
    2. Written informed consent prior to any CCX114157 specific study procedures.
    3.Females of child-bearing potential (FCBP) must be sexually inactive or commit to use of contraceptive methods with a failure rate of < 1% per year when used consistently and correctly and, when applicable, in accordance with the product label, for the duration of this study as defined by the following:
    Contraceptive Methods with a Failure Rate of < 1%
    • Abstinence from penile-vaginal intercourse, when this is the female’s preferred and usual lifestyle
    • Oral contraceptive, either combined or progestogen alone
    • Injectable progestogen
    • Implants of etonogestrel or levonorgestrel
    • Estrogenic vaginal ring
    • Percutaneous contraceptive patches
    • Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label
    • Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject. The information on the male sterility can come from the site personnel’s: review of subject’s medical records; medical examination of the subject and/or semen analysis; or interview with the subject on his medical history.
    • Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository)
    • Male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository)
    These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The Investigator is responsible for ensuring subjects understand how to properly use these methods of contraception. This list does not apply to FCBP with same sex partners, when this is their preferred and usual lifestyle.
    Female subjects should not be enrolled if they are pregnant or lactating or if they plan to become pregnant during the time of study participation. For women of child-bearing potential, a urine pregnancy test will be performed at repeated intervals throughout the study and at the Early Withdrawal or Follow-up visits if applicable.
    4. Any medications being currently received for Crohn’s disease must remain stable throughout the study period with the exception of tapering of corticosteroids and dose reductions of immunosuppressants for the management of toxicity. Please refer to Study Procedures Manual for more detailed information on permitted medications.
    5. Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose tapering.
    Note: Country-specific requirement for French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    E.4Principal exclusion criteria
    1. If female, is pregnant, has a positive pregnancy test or is breast-feeding
    2. Subjects with known or suspected coeliac disease or a positive screening test (antitissue transglutaminase (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive result
    3 Fixed symptomatic stenoses of small bowel or colon.
    4. Enterocutaneous , abdominal or pelvic fistulae likely to require surgery during the study period
    5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks
    6. Use of prohibited medications at baseline and throughout the study (Section 5.5.3 of the protocol).
    7. The subject exhibits evidence of hepatic dysfunction, viral hepatitis, or exhibits serum ALT (SGPT) and/or AST (SGOT) values ≥2 times the upper limit of normal; has a total bilirubin value >1.5 times the upper limit of normal (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); has alkaline phosphatase >1.5 times the upper limit of normal; has current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH); has known hepatic or biliary abnormalities with the exception of Gilbert’s syndrome or asymptomatic gallstones
    Note: At randomisation into the study, liver function tests results from the final visit in the preceding induction study will not be available . Subjects who have abnormalities as per the exclusion above will need to be withdrawn.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy endpoints:

    Proportion of subjects in clinical remission (CDAI score <150 points) at both Weeks 28 and 52 of the 52-week treatment period

    Safety Endpoints:
    • Incidence of adverse events/serious adverse events
    • Change from baseline in vital signs: heart rate and blood pressure
    • Change from baseline in haematology and clinical chemistry parameters
    • Change from baseline in liver function test parameters
    • Change from baseline in 12 lead ECG abnormalities
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety assessments at Week 0, 4, 8, 12, 20, 28, 36, 44, 52
    and post 4 week follow-up at Week 56, if subject does not enrol in follow on study.
    12 lead ECG at Week 0, 28, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study.
    CDAI assessments at Week 0, 4, 8, 12, 20, 28, 36, 44, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study.
    E.5.2Secondary end point(s)
    Key Secondary efficacy endpoint:
    Proportion of subjects in clinical remission (CDAI score <150 points) and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 28 and 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA165
    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
    Austria
    Brazil
    Bulgaria
    Chile
    Denmark
    Estonia
    Greece
    Hong Kong
    Ireland
    Israel
    Italy
    Korea, Republic of
    New Zealand
    Portugal
    Russian Federation
    Slovakia
    Spain
    Switzerland
    Taiwan
    Turkey
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    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: 718
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 750
    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)
    The investigator is responsible for maintaining the post study care of a patient’s medical condition. Subjects, on completion of the study after 52 weeks, may be eligible for an open-label study with GSK1605786A (study CCX114644). Subjects who do not enter study CCX114644 will not receive further treatment provided by GSK but will return for a Follow-up visit at Week 56. Subsequent treatment for Crohn's disease will be at the discretion of the investigator.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-09-04
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