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    Summary
    EudraCT Number:2010-019558-42
    Sponsor's Protocol Code Number:104UC201
    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:2010-10-27
    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 number2010-019558-42
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis
    A.4.1Sponsor's protocol code number104UC201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBiogen Idec 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameBaminercept
    D.3.2Product code BG9924
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeBG9924
    D.3.9.3Other descriptive nameBaminercept
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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 this study is to assess the potential of baminercept as an agent for inducing clinical response at Week 12 in subjects with moderate to severe UC.
    E.2.2Secondary objectives of the trial
    To assess the potential of baminercept for achieving clinical remission at Week 24 in this study population.
    To determine the safety and tolerability of baminercept in this study population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
    2. Aged 18 to 65 years old, inclusive, at the time of informed consent.
    3.Must have an established diagnosis of UC for at least 3 months and have at least 1 previous relapse.
    4. Must have a flexible sigmoidoscopy (or colonoscopy if required) indicative of active UC as close to randomization as possible.
    5. Must have >15 cm of active disease at Screening endoscopy.
    6. Subjects diagnosed with UC for >10 years must have had a colonoscopy within 12 months of Week 0 to exclude dysplasia and neoplasia.
    7. Must have active UC with a Total Mayo Score of 6 to 10 points and moderate to severe disease on endoscopy (Mayo endoscopic subscore of at least 2).
    8. Subjects must complete a UC symptom collection diary as assessed during the Screening period.
    9. Must have high sensitivity C-reactive protein (hsCRP) ≥2.87 mg/L.
    10. All male subjects and female subjects of child bearing potential must be willing and able to continue contraception for 6 months after their last dose of study treatment.
    E.4Principal exclusion criteria
    1.Subjects with a diagnosis of indeterminate colitis or Crohn’s disease.
    2. Subjects with an imminent need for surgery.
    3. Subjects with toxic megacolon.
    4. Subjects with primary sclerosing cholangitis.
    5. Subjects with known colonic stricture.
    6. Subjects with a history of colonic or small bowel obstruction or resection.
    7. Stool culture positive with confirmatory re-test, for enteric infection, including parasitic infection, and C. difficile toxin
    8. Subjects with a history of malignant disease, including solid tumors and hematologic malignancies
    9. History of severe allergic or anaphylactic reactions
    10. History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease
    11. Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with antibiotics within 4 weeks of Week 0.
    12. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 6 months prior to Week 0.
    13. Subjects with any laboratory test result at Screening considered clinically important (as determined by the Investigator) or:•alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥2.0 × upper limit of normal (ULN) •Hemoglobin ≤8.5 g/dL •Neutrophils <1.5 × 103/µL •Platelet count <150,000 cells/µL
    14. Known history of, or positive test result for hepatitis B or C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb])
    15. Primary or secondary immunodeficiency (history of or currently active), including known history of human immunodeficiency virus (HIV) infection
    16. History of tuberculosis (TB) or positive PPD (positive Mantoux test defined as 10 mm of induration [size of raised lump, not redness]), or equivalent positive TB test result as per country clinical standards during the screening period.
    17. Clinically important chest x-ray abnormality at Screening
    18. If receiving corticosteroid treatment orally, subjects must have been on a stable dose (≤20 mg prednisolone or equivalent per day) for at least 1 week prior to Mayo Score screening procedures, and must be willing to maintain the stable dose regimen through Week 12.
    19. If receiving 6-mercaptopurine or azathioprine (≤2.5 mg/kg) treatment orally, subjects must have been on a stable dose for at least 8 weeks prior to Mayo Score screening procedures, and must be willing to maintain the stable dose regimen through Week 24.
    20. If receiving 5-aminosalicylic acid (5-ASA) treatment orally, subjects must be on a stable dose for at least 1 week prior to Mayo Score screening procedures, and must be willing to maintain the stable dose regimen through Week 12.
    21. Treatment with another investigational product or approved therapy for investigational use within 8 weeks prior to Week 0.
    22. Exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins within 12 weeks prior to Week 0.
    23. Treatment with an anti-TNF agent (including anti-TNF agents as part of an investigational study)
    24. Treatment with methotrexate, cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 4 weeks prior to Week 0.
    25. Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) other than low-dose aspirin (<325 mg) within 4 weeks prior to Week 0.
    26. Use of oral antibiotics for any reason within 2 weeks prior to Week 0.
    27. Receipt of live or attenuated immunization/vaccination within 8 weeks prior to Week 0 or planned to occur during the study period.
    28. Treatment with rectally administered corticosteroids or rectally administered medications containing 5 ASA within 2 weeks prior to Screening.
    29. Use of antidiarrheal agents within 5 days of start of UC Symptom Diary (limited use only allowed prior to this time).
    30. Previous treatment with baminercept.
    31. Previous randomization into this study.
    32. Blood donation (1 unit or more) within 2 months prior to Week 0.
    33. Female subjects who are pregnant or who wish to become pregnant during the study, or who are lactating.
    34. History of drug or alcohol abuse within 1 year prior to Week 0.
    35. Current enrollment in any disease study
    36. Inability to comply with study requirements
    37. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response at Week 12 will be evaluated by the proportion of subjects with a decrease from baseline in the Total Mayo Score by at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 0 or 1
    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 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) 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
    Randomised, Double-Blind, Placebo-Controlled Pilot Study
    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.8.3 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 EEA39
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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 study is last patient, 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 months10
    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 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.1.1.1In 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.1.3Elderly (>=65 years) No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 100
    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 Decision2011-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-03-17
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