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    Summary
    EudraCT Number:2016-001684-36
    Sponsor's Protocol Code Number:GED0507-UC-001
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-07-26
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2016-001684-36
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS
    A.4.1Sponsor's protocol code numberGED0507-UC-001
    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 SponsorPPM SERVICES SA
    B.1.3.4CountrySwitzerland
    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 supportPPM Services SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles
    B.5.2Functional name of contact pointDaniel Szabo, MD
    B.5.3 Address:
    B.5.3.1Street AddressBudafoki u. 91-93
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1117
    B.5.3.4CountryHungary
    B.5.4Telephone number+3630 967 1212
    B.5.6E-maildaniel.szabo@quintiles.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 nameGED-0507-34-Levo
    D.3.2Product code GED0507
    D.3.4Pharmaceutical form Gastro-resistant 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 INN(S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
    D.3.9.2Current sponsor codeGED-0507-34-Levo
    D.3.9.3Other descriptive nameGED-0507-34-LEVO
    D.3.9.4EV Substance CodeSUB182278
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 placeboGastro-resistant 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
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021184
    E.1.2Term IBD
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10045366
    E.1.2Term Ulcerative colitis, unspecified
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    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 primary objective of the study is to evaluate the clinical efficacy of GED-0507-34-Levo (80 mg BID and 160 mg BID), compared with placebo, in subjects with active UC.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the safety and tolerability of GED-0507-34-Levo (80 mg BID and 160 mg BID), compared with placebo, in subjects with active UC.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A PK sub-study will be conducted at selected sites to evaluate the PK profile of GED-0507-34-Levo (parent compound) and N-Acetyl-GED-0507-34-Levo (metabolite) in subjects with active UC and to explore the relationship between GED-0507-34-Levo PK exposures and key efficacy endpoints. The target for the PK sub-study is to achieve participation of approximately 50% of the randomized subjects. A separate consent will be signed for this assessment at the Screening Visit.
    E.3Principal inclusion criteria
    Subjects must satisfy the following criteria to be enrolled in the study:
    1. Male or female aged 18 and over at the time of signing the informed consent.
    2. Must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
    3. Must be able to adhere to the study visit schedule and other protocol requirements.
    4. Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.
    5. MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study
    • SFS ≥ 1 and RBS = 1 or 2
    • Mayo endoscopic sub-score > 1 and < 3 prior to randomization in the study
    6. Subjects are required to have a colonoscopy if one has not been performed within 12 months prior to the Screening Visit.
    7. Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day.
    8. Must meet the following laboratory criteria:
    • WBC count ≥ 3000/mm3 and < 14,000/mm3
    • Platelet count ≥ 100,000/mm3
    • Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
    • AST (SGOT) and ALT (SGPT) ≤ 2 upper limit of normal (ULN). If initial test shows ALT or AST > 2 ULN, 1 repeat test is allowed during the screening period
    • Total bilirubin ≤ 2 mg/dL (≤ 34 mol/L) and albumin > lower limit of normal (LLN). If initial albumin test result is < 2 g/dL, 1 repeat test is allowed during the screening period
    • Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L)
    9. FCBP must have a negative pregnancy test at screening and the Baseline Visit. While on IP and for at least 28 days after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options
    10. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception while on investigational product and for at least 28 days after the last dose of investigational product.
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from enrollment:
    1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis.
    2. UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).
    3. Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
    4. Clinical signs suggestive of fulminant colitis or toxic megacolon.
    5. Evidence of pathogenic enteric infection.
    6. History of colorectal cancer or colorectal dysplasia.
    7. Prior use of any TNF inhibitor (or any biologic agent).
    8. Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.
    9. Subjects who have relapsed on maintenance therapy with doses of 5-ASA > 2.4 g/day will be excluded from the study. If a subject had a recent 5-ASA dose reduction from > 2.4g/day to ≤ 2.4 g/day and relapsed within 2 weeks of that dose reduction.
    10. Oral aminosalicylates are not permitted during the study treatment period (from visit 2 until visit 7 or ET visit).
    11. Use of budesonide-MMx within the last 8 weeks.
    12. Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.
    13. Use of immunosuppressants (azathioprene [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) within 8 weeks of the Screening Visit.
    14. Use of topical treatment with 5-ASA or corticosteroid enemas or suppositories within 2 weeks of the Screening Visit.
    15. History of any clinically significant neurological, renal, hepatic, GI, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease or any other medical condition that, in the Investigator's opinion, would preclude participation in the study.
    16. Prior history of suicide attempt at any time in the subject’s lifetime prior to randomization in the study or major psychiatric illness requiring hospitalization within 3 years of study randomization.
    17. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study.
    18. Pregnant or breast feeding.
    19. History of any of the following cardiac conditions within 6 months of screening: myocardial infarction, acute coronary syndrome, unstable angina, new onset atrial fibrillation, new onset atrial flutter, second- or third-degree atrioventricular block, ventricular fibrillation, ventricular tachycardia, heart failure, cardiac surgery, interventional cardiac catheterization (with or without a stent placement), interventional electrophysiology procedure, or presence of implanted defibrillator.
    20. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with IV or oral antibiotics within 4 weeks of screening.
    21. Subjects with active hepatitis B infection, as described in Appendix D of the protocol, are ineligible for the study. Subjects without current hepatitis B infection, as described in Appendix E of the protocol, may participate in the study.
    22. Subjects who are positive for the hepatitis C antibody are not eligible for the study.
    23. History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
    24. History of malignancy, except for:
    a. Treated (ie, cured) basal cell or squamous cell in situ skin carcinomas
    b. Treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
    25. Any condition that could affect oral drug absorption, including gastric resections, gastroparesis, or bariatric surgery, such as gastric bypass.
    26. Subjects who have received any investigational drug or device within 3 months of study randomization.
    27. History of alcohol, drug, or chemical abuse within the 6 months prior to screening.
    28. Known hypersensitivity to GED-0507-34-Levo or any excipients in the formulation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the proportion of subjects achieving a clinical remission in the Modified Mayo score (MMS) at Week 8, defined as an MMS of ≤ 2, with individual sub-scores (stool frequency [SF] and Endoscopy) ≤ 1 and Rectal Bleeding sub-score (RBS) = 0
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 8
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are the following:
    • The proportion of subjects achieving clinical response at Week 8, defined as a decrease from baseline in the MMS of at least 2 points and at least 25%, along with a reduction in the RBS of at least 1 point or an absolute RBS of ≤ 1
    • The proportion of subjects achieving endoscopic remission at Week 8, defined as a Mayo endoscopic sub-score = 0
    • The proportion of subjects achieving endoscopic response at Week 8, defined as a decrease from baseline of at least 1 point in the Mayo endoscopic sub-score
    • The proportion of subjects achieving an RBS ≤ 1 at Week 8
    Secondary Safety Endpoints
    • Type, frequency, severity, and relationship of AEs to investigational product (IP)
    • Number of subjects who discontinue IP due to any AE
    • Frequency of clinically significant changes in vital signs and/or laboratory findings
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 8
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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
    Bulgaria
    Canada
    France
    Hungary
    Italy
    Latvia
    Poland
    Slovakia
    Spain
    Ukraine
    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 End of Trial is defined as either the date of the last visit of the last subject to complete the study or the date of receipt of the last data point from the last subject that is required for primary, secondary, and/or exploratory analysis, as pre-specified in the protocol and/or the Statistical Analysis Plan (SAP), whichever is the later date.
    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 months1
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days18
    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: 196
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 207
    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)
    Once subject has ended the participation in the trial he will return to normal treatment.

    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 Decision2016-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-07-31
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