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    Summary
    EudraCT Number:2013-002857-32
    Sponsor's Protocol Code Number:GLPG0634-CL-211
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-03
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-002857-32
    A.3Full title of the trial
    Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration
    A.4.1Sponsor's protocol code numberGLPG0634-CL-211
    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 SponsorGalapagos NV
    B.1.3.4CountryBelgium
    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 supportGalapagos NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalapagos NV
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGeneraal De Wittelaan L11A3
    B.5.3.2Town/ cityMechelen
    B.5.3.3Post code2800
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 15 342 900
    B.5.5Fax number+32 15 342 901
    B.5.6E-mailrd@glpg.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 nameGLPG0634
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNFILGOTINIB
    D.3.9.1CAS number 1206161-97-8
    D.3.9.2Current sponsor codeGLPG0634
    D.3.9.4EV Substance CodeSUB31297
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboFilm-coated tablet
    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
    Crohn’s Disease With Evidence of Mucosal Ulceration
    E.1.1.1Medical condition in easily understood language
    Crohn’s 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 18.1
    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 demonstrate efficacy in terms of the percentage of subjects achieving clinical remission (CD Activity Index [CDAI] score < 150) following 10 weeks treatment with GLPG0634 200 mg q.d. versus placebo in patients with active CD with evidence of mucosal ulceration.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy in terms of percentage of subjects achieving clinical response, clinical remission, endoscopic response, endoscopic remission and mucosal healing with GLPG0634 given once daily compared to placebo.

    To assess the effect of GLPG0634 (compared to placebo) on subject’s quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ).

    To evaluate the safety and tolerability of GLPG0634 given to CD subjects.

    To characterize the pharmacokinetics (PK) of GLPG0634 and its metabolite (G254445) in CD subjects.

    To assess the effects of GLPG0634 on selected pharmacodynamic (PD)/biomarkers (eg, C-reactive protein [CRP], faecal calprotectin, serum analytes/miRNA, whole blood gene expression/miRNA, faecal microbiota).

    To evaluate the effect of GLPG0634 on histopathological features of the intestinal mucosa.

    To develop an exposure-response model between GLPG0634/G254445 exposure and selected pharmacodynamic (PD)/biomarkers or efficacy markers.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic study
    E.3Principal inclusion criteria
    1. Male or female subjects between the ages of 18 and 75 years, on the day of signing informed consent
    2. Documented history of ileal, colonic, or ileocolonic CD (at least 3 months prior screening) as assessed by colonoscopy, and supported by histological assessment
    3. Crohn’s Disease Activity Index (CDAI) score during screening ≥ 220 to ≤ 450
    4. Evidence of active inflammation at screening as demonstrated by endoscopic confirmation of active disease (based on central reading) with evidence of ulceration corresponding to a score of 1 in at least 1 of the 5 ileocolonic segments on the Presence of Ulcers subscore of the Simplified Endoscopy Score for CD (SES CD) and total score of at least 7
    5. Treatment with oral steroids (≤ 30 mg prednisolone equivalent/day or budesonide dose ≤ 9 mg/day) is allowed, if at a stable dose since at least 2 weeks prior to the first dose of study drug
    6. Subjects previously not exposed to anti-TNF treatment (eg, TNF-naïve) or subjects previously exposed to anti-TNF therapy (infliximab, adalimumab or certolizumab pegol) at a dose registered for the treatment of CD that has been discontinued at least 8 weeks prior to Baseline. Subjects deemed by the treating physician as a primary or secondary non-responder or intolerant to anti-TNF treatment or responders to anti-TNF treatment, where treatment was stopped for other reasons (TNF experienced) can also be included).
    7. Subjects are allowed to continue on concurrent treatment with the following agents:
    a) Mesalazine and olsalazine if stable dosage for at least 4 weeks prior to Screening (same dosage to be maintained throughout the study). Previous exposure to sulfasalazine is permitted but must be discontinued at least 4 weeks prior to Screening in male subjects
    b) Crohn’s Disease-related antibiotics if stable dosage for at least 4 weeks prior to Screening and no discontinuation in the 14 days prior to the first dose of study drug
    c) Probiotics if stable dosage for 2 weeks prior to the first dose of study drug
    8. Previous exposure to immunomodulators (e.g. thiopurines and methotrexate) is permitted, but must be discontinued (and agreed by the subject) at least 25 days prior to the first dose of the study drug. Subjects whose immunomodulators (e.g. thiopurines and methotrexate) were discontinued prior to Screening are also permitted to participate. In these cases documented evidence for the reasons of discontinuation should be provided.
    9. The results of the following laboratory tests during screening must be as specified below:
    a) Haemoglobin ≥ 9 g/dL (International System of Units [SI]: ≥ 90 g/L)
    b) White blood cells (WBCs) ≥ 3.0 x 10^9 cells/L
    c) Neutrophils ≥ 2.0 x 10^9 cells/L
    d) Lymphocytes ≥ 0.5 x 10^9 cells/L
    e) Platelets ≥ 100 x 10^9 cells/L
    f) Serum alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 1.5 x ULN
    g) Total bilirubin level ≤ 1.5 x ULN
    h) Alkaline phosphatase ≤1.5 x ULN
    i) Lipase ≤ 1.5 x ULN and amylase ≤ 1.5 x ULN
    j) Creatinine clearance > 60 mL/min. Creatinine clearance will be calculated using the Cockroft-Gault formula
    10. Women of childbearing potential must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy, or have been postmenopausal for at least 1 year (12 consecutive months without menses); in case of doubt a determination of serum follicle-stimulating hormone (FSH) can be done with FSH levels > 35 mIU/mL confirming menopause status
    11. Subjects willing to use highly effective contraceptive methods prior to the first dose of the study drug, during the study and for at least 12 weeks after the last dose of the study drug
    a. If the subject is a sexually active woman of childbearing potential, she and her male partner are required to simultaneously use two effective contraceptive methods. Female subjects who wish to use non-hromonal contraception must have done so for at least 14 days prior to the first dose of the study medication
    b. Non-vasectomized males with female partners of child bearing potential must be willing to use a condom in addition to having their female partner using another form of contraception
    12. Able and willing to give voluntary written informed consent and meet all of the inclusion and none of the exclusion criteria before being enrolled in the study. The subjects must sign the informed consent form prior to any study related procedures and agree to the schedule of assessments (including 2 colonoscopies)
    13. Judged to be in good health, except for their CD, as determined by the Investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray, and a 12-lead electrocardiogram (ECG) performed during Screening
    E.4Principal exclusion criteria
    1. Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
    2. Stoma, gastric or ileanal pouch, proctocolectomy or total colectomy, symptomatic stenosis or obstructive strictures, abscess or suspected abscess, history of bowel perforation.
    3. Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
    4. Subject who has short bowel syndrome.
    5. Subject who is receiving tube feeding, defined formula diets, or total parenteral alimentation.
    6. Subjects with positive Clostridium difficile toxin stool assay or test positive for stool culture of enteric pathogens, ova or parasites during the screening period.
    7. Subject has received nonsteroidal anti-inflammatory drugs within 14 days prior to Screening or during screening period.
    8. Subject has received therapeutic enema or suppository, other than required for colonoscopy, within 7 days prior to or during screening period.
    9. Subject has received intravenous corticosteroids within 14 days prior to Screening or during screening period.
    10. If nonsystemic steroids are being used for other conditions than CD, subjects may be included at the discretion of the Investigator after discussion with the Medical Monitor.
    11. Treatment with cyclosporine, mycophenolate mofetil, tacrolimus, or interferon within 10 weeks prior to Screening or during screening period.
    12. Any prior treatment with lymphocyte-depleting agents. Subjects who have previously received either lymphocyte apheresis or selective monocyte granulocyte apheresis within 12 months prior to Screening or during screening period.
    13. Subjects who have previously received fecal microbiota transplants or stem cell transplantation.
    14. Subjects who have received previous treatment with investigational chemical agents within 4 weeks prior to Screening or during screening period.
    15. Subjects who have previously received treatment with biological IMPs including murine, chimeric or humanized monoclonal antibodies or a chemokine receptor blocker within less than 5 half-lives prior to Baseline. Previous treatment with a janus kinase inhibitor is prohibited.
    16. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis requiring hospitalization.
    17. Subject with a previous history of dysplasia of the GI tract (high or low grade, flat or raised including discrete adenoma-like dysplasia or indefinite dysplasia) or found to have above described dysplasia in any biopsy performed during the screening colonoscopy.
    18. Concurrent GI malignancy or a history of cancer elsewhere (other than basal cell carcinoma or carcinoma in situ of the cervix successfully treated more than 5 years prior to the initial study drug administration).
    19. History of, or signs and symptoms suggestive of, lymphoproliferative disease including lymphadenopathy or splenomegaly.
    20. Positive serology for HIV 1 or 2 or hepatitis B or C, or any history of HIV or hepatitis from any cause with the exception of hepatitis A.
    21. Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of the Screening visit or completion of oral anti-infectives within 2 weeks of the Screening visit (except Crohn's disease related antibiotics). Immunocompromised subjects who are at an unacceptable risk for participating in the study.
    22. Previous history of symptomatic herpes zoster or herpes simplex infection within 12 weeks prior to Screening or have a history of disseminated/complicated herpes zoster infection.
    23. History of invasive infection or currently on any therapy for chronic infection.
    24. Significant blood loss or transfusion of any blood product within 4 weeks prior to Screening.
    25. History of active or latent tuberculosis (TB) infection within 3 months prior to Screening or at Screening with evidence of current active TB or old inactive TB.
    26. Administration of a live vaccine within 90 days or an attenuated vaccine within 30 days prior to the initial study drug administration.
    27. Drug or alcohol abuse within the previous 1 year according to the opinion of the investigator.
    28. Currently pregnant or breastfeeding or not willing to maintain birth control methods for at least 12 weeks after last study drug administration.
    29. Inability to give informed consent, to comply with the requirements of the study protocol, or complete the study.
    30. Any concurrent illness, disability, or clinically significant abnormality that may affect the interpretation of clinical safety or efficacy data or prevent the subject from safely completing the assessments required by the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission defined as CDAI < 150 at Week 10.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 10
    E.5.2Secondary end point(s)
    Clinical remission, clinical response, endoscopic response, endoscopic remission and mucosal healing, changes from baseline in CDAI score, SES-CD score, histopathology scores, IBDQ score, and in CDAI subscores (pain, liquid stools, and general well-being), and the time to first response with GLPG0634 given once daily in comparison to placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each visit.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 trial7
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Belgium
    Czech Republic
    France
    Germany
    Hungary
    Poland
    Romania
    Russian Federation
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 145
    F.4.2.2In the whole clinical trial 180
    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)
    None, treatment will revert to the 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 Decision2014-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-30
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