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    Summary
    EudraCT Number:2014-001893-32
    Sponsor's Protocol Code Number:GLPG1205-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:2014-10-22
    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 number2014-001893-32
    A.3Full title of the trial
    Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis
    A.4.1Sponsor's protocol code numberGLPG1205-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+3215342900
    B.5.5Fax number+3215342901
    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 nameGLPG1205
    D.3.2Product code G321605
    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 codeG321605
    D.3.9.3Other descriptive nameGLPG1205
    D.3.9.4EV Substance CodeSUB121444
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the efficacy of GLPG1205 versus placebo in UC subjects by use of the Mayo score comparing results at Week 8 to baseline.
    E.2.2Secondary objectives of the trial
    -To explore the efficacy of GLPG1205 versus placebo in UC subjects by use of the partial Mayo score comparing results to baseline.
    - To explore the efficacy of GLPG1205 versus placebo in UC subjects by use of the histopathological Geboes index comparing results at Week 8 to baseline.
    -To evaluate the safety and tolerability of GLPG1205 given to moderate to severe UC subjects for 12 weeks compared to placebo.
    -To characterize the PK of GLPG1205 in UC subjects.
    -To explore the effects of GLPG1205 on selected biomarkers (e.g., fecal calprotectin, myeloperoxidase (MPO), C-reactive protein [CRP]).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between 18 and 75 years of age inclusive, on the day of signing the informed consent form.
    2. Documented history of UC (at least 6 months prior to baseline) as assessed by endoscopy and supported by histological assessment.
    3. Allowed current UC treatment:
    a. 5-ASAs (mesalazine, olsalazine, or sulfasalazine) for at least 12 weeks and at a stable dosage for > 4 weeks and will be maintained at this dosage throughout the study or discontinued for > 4 weeks prior to baseline
    AND/OR
    b. Immunosuppressants (azathioprine or 6-mercaptopurine) if initiated and at a stable dosage > 3 months prior to baseline and will be maintained at this dosage throughout the study
    AND/OR
    c. Oral steroids, if the dosage of ≤ 30 mg prednisolone equivalent/day has been stable for at least 2 weeks prior to baseline and will be maintained at this dosage throughout the study.
    4. Tumor necrosis factor alpha (TNFα) inhibitor–naive subjects should have failed at least 1 prior conventional therapy (e.g., ASAs, steroids, and/or immunomodulators).
    5. Presence of active UC for a minimum period of 14 days prior to screening and spread beyond the rectum (inflammation extending ≥ 15 cm from anal verge) as evidenced by clinical signs and endoscopy.
    6. Mayo score ≥ 6 with rectal bleeding score ≥ 1 and endoscopy score ≥ 2 (confirmed by Core Imaging Laboratory).
    7. Absence of infectious colitis as evidenced by negative stool culture for enteric pathogens, negative Clostridium difficile cytotoxin assay, and negative microscopic stool examination for intestinal parasites.
    8. Absence of current active or history of tuberculosis (TB) infection as determined by a negative QuantiFERON TB Gold test at screening.
    9. Female subjects 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 being confirmative for menopause (see Section 5.4.2 of the protocol).
    10. Subjects will have 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 2 effective contraceptive methods as listed in Section 4.2.4 of the protocol. Female subjects who use contraception must have done so for at least 14 days prior to the first dose of the study drug.
    b. Non-vasectomized male subjects with female partners of childbearing potential must be willing to use a condom in addition to having their female partner use another form of contraception as listed in Section 4.2.4 of the protocol.
    11. Able and willing to give voluntary written informed consent and meet all of the inclusion criteria 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.
    E.4Principal exclusion criteria
    1. History of sensitivity to any component of the study drug, or a history of drug or other allergy that, in the investigator’s opinion, contraindicates the subject’s participation in the study.
    2. Any concurrent illness, condition, disability, or clinically significant abnormality (including laboratory tests) that, in the investigator’s opinion, represents a safety risk for the subject’s participation in the study, may affect the interpretation of clinical safety or efficacy data, or may prevent the subject from safely completing the assessments required by the protocol, including:
    a. Hb < 8.5 g/dL
    b. WBC count < 3.0 x 10^9 cells/L
    c. Neutrophil count < 1.5 x 10^9 cells/L
    d. Platelet count < 100 x 10^9 cells/L
    e. Serum ALT or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN)
    f. Total bilirubin level > 1.5 x ULN, except in the case of documented Gilbert’s syndrome
    g. Creatinine clearance < 60 mL/min using the Cockroft formula.
    3. Positive serology for human immunodeficiency virus (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.
    4. History of active infections requiring intravenous antibiotics within the past 4 weeks prior to screening.
    5. History of malignancy within the past 5 years (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been treated with no evidence of recurrence).
    6. History of bowel surgery within 6 months prior to screening Visit 1.
    7. Presence or history of intestinal malignancy (if any unexpected lesion/dysplasia is observed during screening endoscopy, additional biopsies should be taken for histopathological assessment in the local laboratory, and recruitment into the study must be deferred until the results are available).
    8. History of colon resection with < 30 cm of the colon remaining.
    9. Suspicion of Crohn’s disease, indeterminate colitis, microscopic colitis, ischemic colitis, diverticular disease–associated colitis, or radiation-induced colitis, based on medical history, endoscopy, and/or histological findings.
    10. A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, GI (other than UC), pulmonary, or metabolic disease.
    11. Treatment with:
    a. TNFα inhibitor within 8 weeks prior to baseline
    b. Vedolizumab within 12 weeks prior to baseline
    c. 6-Thioguanine within 4 weeks prior to baseline
    d. Methotrexate within 4 weeks prior to baseline
    e. Natalizumab or biologic agent that depletes B or T cells within 12 months prior to baseline
    f. Cyclosporine, mycophenolate, tacrolimus, or interferon within 10 weeks prior to baseline
    g. Topical corticosteroids, unless they are being used for other chronic inflammatory conditions, in which case, the subject may be included at the discretion of the investigator after discussion with the medical monitor
    h. Rectally-applied medications (including 5-ASA) within 14 days before screening.
    12. Regular use of probiotic or prebiotic preparations, if initiated or changed within 4 weeks prior to screening.
    13. Regular daily use of oral nonsteroidal anti-inflammatory drugs, except low-dose aspirin (≤ 200 mg/day) for cardioprotection, within 7 days prior to screening.
    14. Participation in another experimental therapy study within 90 days or 5 times the half-life of the experimental therapy, whichever is longer, prior to screening for this study or current enrollment in any other study.
    15. History within the previous 2 years or current evidence of drug or alcohol abuse at the discretion of the investigator.
    16. Pregnant or lactating women.
    17. Medical, psychiatric, cognitive, or other conditions that, according to investigator’s medical judgment, compromise the subject's ability to understand the subject information, give informed consent, comply with the requirements of the study protocol (that is likely to affect the subject’s return for visits on schedule), or complete the study.
    18. If applicable to national or local legislation, a history of being admitted to an institution under an administrative or court order.
    E.5 End points
    E.5.1Primary end point(s)
    -Actual values, changes from baseline, and percent changes from baseline.
    -Percentage of subjects achieving Mayo clinical remission at Week 8 as measured by Mayo score in the GLPG1205 group versus the placebo group (Mayo score ≤ 2 with no individual subscore exceeding 1 point and rectal bleeding score of 0). Change in Mayo of GLPG1205 vs placebo at Week 8 compared to baseline .
    -Percentage of subjects achieving Mayo clinical response at Week 8 as measured by Mayo score in the GLPG1205 group versus the placebo group (reduction from baseline Mayo score of 30% or ≥ 3 points, with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point).
    -Endoscopic response rate at Week 8, defined as proportion of subjects with endoscopy score (i.e., Mayo endoscopy subscore) decreased by ≥ 1 point in comparison with baseline.
    -Mucosal healing rate at Week 8, defined as proportion of subjects with endoscopy score (i.e., Mayo endoscopy subscore) of 0 or 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    Safety endpoints:
    - Frequency of Serious adverse events in GLPG1205 versus placebo group.
    - Frequency of Adverse events in GLPG1205 versus placebo group.
    - Changes in physical examinations, vital signs, 12-lead ECG and laboratory parameters over the duration of the study in GLPG1205 versus placebo group.

    Efficacy endpoints:
    - Partial Mayo at week 4, 8, 12

    PK parameters:
    GLPG1205 in blood at week 4, 8, 12

    PD assessments:
    - serum CRP in blood samples at baseline, week 4, 8 and 12 and FU
    - fecal calprotectin in stool samples at screening, baseline, week 4, 8 and 12
    - MPO in biopsy samples at baseline and week 8
    - Geboes Index at week 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 4,8,12 and week 2 for safety
    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 No
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    exploratory proof-of-concept
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Germany
    Hungary
    Poland
    Russian Federation
    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 contact with the last subject in the study
    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 months5
    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 months8
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 60
    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
    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 Decision2015-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-22
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