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    EudraCT Number:2010-022382-10
    Sponsor's Protocol Code Number:CCX114151
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2010-022382-10
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease.
    A.4.1Sponsor's protocol code numberCCX114151
    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 Ltd
    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 supportGSK R & D 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
    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.3.9.2Current 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Moderately-to-Severely Active 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 14.0
    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
    • To assess the efficacy of GSK1605786A compared with placebo as an induction
    therapy in subjects with moderately-to-severely active Crohn’s disease over 12
    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 healthcare 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 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 variants and GSK1605786A efficacy and safety endpoints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged ≥18 years
    2. Written informed consent prior to any of the screening procedures including
    discontinuation of prohibited medications
    3. A diagnosis of Crohn’s disease for > 4 months duration with small bowel and/or
    colonic involvement
    4. Confirmation of Crohn’s disease established by visualisation of the gastrointestinal
    tract within the 12 months prior to screening or by screening endoscopy at study
    entry. Acceptable methods for gastrointestinal tract visualisation include, but are not
    limited to endoscopy, capsule endoscopy, MRI or barium X-ray. Subjects without
    visualisation of the gastrointestinal tract within 12 months of screening must be
    willing to undergo endoscopy within the screening period
    5. History of inadequate response and/or intolerance/adverse event leading to
    discontinuation of at least one of the following treatments for Crohn’s disease:
    corticosteroids, immunosuppressants
    6. Current evidence of moderately-to-severely active disease characterised by a CDAI
    score of ≥220 to ≤450 at Baseline (Week 0) [Criterion for Randomisation]
    7. Confirmation of current active Crohn’s disease by either of the following [Criterion for Randomisation]:
    a. Luminal ulceration visualised by Screening endoscopy and as adjudicated by central endoscopy reader, or
    b. Elevated CRP (≥ 3 mg/L, the upper limit of normal (ULN) for the highly sensitive CRP test) plus elevated faecal calprotectin (> 200 μg/g stool) at Screening
    8. Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn’s disease. Please refer to Section 5.5.1 Permitted Medications and Non Drug Therapies.
    9. Demonstrated ability to comply with Crohn’s disease symptom recording using the IVRS; to be eligible for randomisation subject must complete recording of symptoms for at least 8 consecutive days prior to the randomisation/baseline visit (Week 0).
    10. 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. A serum pregnancy test is required of all FCBP at Screening. In addition, a urine pregnancy test will be performed
    at the Randomisation visit (Week 0) and at Weeks 4, 8, 12 and at the Early Withdrawal or Follow-up visits if applicable.
    Country specific inclusion criterion for 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. Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for coeliac disease (elevated anti- tissue transglutaminase antibodies)
    3. Diagnosis of ulcerative or indeterminate colitis
    4. Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period
    5. Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for CD during the study period
    6. Extensive colonic resection, subtotal or total colectomy
    7. Presence of ileostomies, colostomies or rectal pouches
    8. Fixed symptomatic stenoses of small bowel or colon
    9. History of more than 3 small bowel resections or diagnosis of short bowel syndrome
    10. Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medication
    11. Use of prohibited medications, including enteral feeding or elemental diet, within their specified timeframes and throughout the study (Section 5.5.2 Prohibited Medications and Non Drug Therapies). Biologic use: Use of any TNF inhibitor (eg. infliximab, adalimumab or certolizumab) or natalizumab within 10 weeks prior to randomisation Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to screening Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to screening. For further information please view protocol pages 31-32
    12. Positive immunoassay for C. difficile [Subjects who test positive and receive antibiotic treatment may be re-screened after 4 months if the re-test is negative]
    13. Known HIV infection
    14. Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
    15. Subjects who have received immunisation with a live vaccine e.g. measles, mumps, rubella (each as in MMR vaccine), oral polio, varicella, yellow fever, within 4 weeks of screening and throughout the study, with the exception of influenza vaccine
    16. Active or latent tuberculosis (TB) infection: All subjects will be tested with QuantiFERON TB Gold test and those with a positive test result will be excluded. Please view protocol page 31 for further information.
    17. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks
    18. Previous infections characterised by opportunistic pathogens, and/or dissemination suggestive of clinically significant immunocompromise
    19. The subject has congenital or acquired immunodeficiency or has evidence of immunocompromise manifested by current opportunistic infection
    20. 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). Please view protocol page 32 for further information.
    21. A positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test or positive Hepatitis C test result at screening*
    22. QTc ≥450 msec (≥480 msec for those with Bundle Branch Block)
    a. either QTcb or QTcf, machine or manual overread, males or females. The QT correction formula used to determine exclusion and discontinuation should be the same throughout the study
    b. based on single or average QTc value of an ECG obtained over a brief recording period
    23. The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematologic, or neurological condition or mental impairment)
    24. History or evidence of adenomatous colonic polyps that have not been removed
    25. History of evidence of colonic mucosal dysplasia
    26. The subject has current evidence of, or has been treated for, a malignancy within the past five years (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or any cancer in situ that has been resected)
    27. Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B)
    28. Medical history of sensitivity to any of the components of GSK1605786A (microcrystalline cellulose, crospovidone, sodium stearyl fumarate)
    29. Use of any investigational product within 30 days prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects achieving clinical response, defined by CDAI decrease from baseline of ≥100 points, at Week 12

    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 and post 4 week follow-up at Week 16, if subject does not enrol in follow on study. 12 lead ECG at Screening and Week 12. CDAI assessments at Week 0, 4, 8, 12, and post 4 week follow-up at Week 16, 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, defined as a CDAI score of <150 points, at Week 12

    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety assessments at Week 0, 4, 8, 12 and post 4 week follow-up at Week 16, if subject does not enrol in follow on study. 12 lead ECG at Screening and Week 12. CDAI assessments at Week 0, 4, 8, 12, and post 4 week follow-up at Week 16, if subject does not enrol in follow on study.
    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. 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 EEA13
    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
    Czech Republic
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 280
    F.4.2.2In the whole clinical trial 600
    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)
    Subjects who are a responder (CDAI decrease =>100 points) or in remission (CDAI < 150 points) at the Week 12 are eligible to enter a 52 week maintenance study (Study CCX114157). Other subjects who complete the Week 12 assessment are eligible for the open-label extension study (Study CCX114644). Subjects who do not enter either CCX114157 or CCX114644 will return for a follow-up visit at Week 16. 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 Decision2011-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-09
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