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    Summary
    EudraCT Number:2008-004919-36
    Sponsor's Protocol Code Number:M10-222
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-11-10
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-004919-36
    A.3Full title of the trial
    A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT − 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease
    A.4.1Sponsor's protocol code numberM10-222
    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 SponsorAbbott
    B.1.3.4CountryGermany
    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 nameABT-874
    D.3.2Product code ABT-874
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 339308-60-0
    D.3.9.2Current sponsor codeABT-874
    D.3.9.3Other descriptive nameJ695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous 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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to compare the efficacy, safety, and pharmacokinetics of
    200, 400 or 700 mg IV dosing every four weeks of ABT-874 to placebo in
    subjects who have moderately to severely active Crohn's disease.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The optional exploratory substudy will be conducted under the same protocol and will require documentation of informed consent separate from the informed consent to participate in the main study. The objective of the substudy is to evaluate the correlation between the response to ABT-874 and pharmacogenomic and pharmacogenetic analysis.
    E.3Principal inclusion criteria
    1. Diagnosis of Crohn's disease for greater than 4 months confirmed by endoscopy or
    radiologic evaluation.
    2. CDAI score of greater than or equal to 220 and less than or equal to 450 at Week 0.
    3. Males and females greater than or equal to 18 years and less than 75 years of age at the Screening visit.
    4. Females are eligible to participate in the study if the result of the serum pregnancy
    performed during the Screening period is negative and the woman meets one of the
    following criteria:
    ● Females of childbearing potential must undergo monthly pregnancy testing
    during the study and agree to use two methods of
    contraception throughout the study and for 60 days after the last dose of study
    drug.
    ● Females who are postmenopausal (for at least one year), sterile, or
    hysterectomized;
    ● Females who have undergone tubal ligation will be required to undergo
    monthly pregnancy testing during the duration of the study and agree to use a
    second form of contraception.
    5. Judged to be in generally good health as determined by the Investigator based
    upon the results of medical history, laboratory profile, physical examination, chest
    X-ray (CXR), and 12-lead electrocardiogram (ECG) performed during the
    Screening period.
    6. Able and willing to give written informed consent and to comply with the
    requirements of this study protocol.
    E.4Principal exclusion criteria
    1. Current diagnosis of colitis other than Crohn's disease.
    2. Symptomatic known strictures.
    3. Surgical bowel resections within the past 6 months or is planning any resection at
    any time point while enrolled in the study.
    4. Ostomy or ileoanal pouch.
    5. Short bowel syndrome as determined by the investigator.
    6. Evidence of dysplasia or a history of malignancy other than a successfully treated
    non-metastatic cutaneous squamous cell, basal cell carcinoma or localized
    carcinoma in situ of the cervix.
    7. History of moderate to severe congestive heart failure (NYHA class III or IV),
    recent cerebrovascular accident and any other condition that, in the opinion of the
    investigator, would put the subject at risk by participating in the study.
    8. Infection or risk factors for severe infections.
    9. Abscess or suspicion of abscess.
    10. Diagnosed with dysplasia of the gastrointestinal tract.
    11. History of clinically significant drug or alcohol abuse in the last 12 months.
    12. Females who are pregnant or considering becoming pregnant during the study, or breast-feeding.
    13. Screening laboratory analysis shows any abnormal results as specified in the protocol.
    14. Positive C. difficile stool assay at the Screening visit.
    15. Received total parenteral nutrition within 2 weeks prior to the Week 0 visit.
    16. Not on stable amounts of enteral nutrition for at least 4 weeks prior to Week 0
    visit.
    17. Previous exposure to systemic or biologic anti-IL-12 therapy, including ABT-874.
    18. History of an allergic reaction or significant sensitivity to constituents of study
    drug.
    19. Received any investigational agent within 30 days or 5 half-lives prior to the
    Week 0 visit (whichever is longer) or within a duration of its known
    pharmacological activity.
    20. Subjects who have initiated or discontinued Imuran® (azathioprine), 6-MP, or
    MTX therapy within 12 weeks of the Week 0 visit. Subjects taking these
    medications who have undergone a change in dosage within 4 weeks prior to the
    Week 0 visit.
    21. Subjects who have initiated or discontinued aminosalicylates, mesalamine,
    sulfasalazine, or Crohn's-related antibiotics within 4 weeks of the Week 0 visit. In
    addition, subjects taking these medications who have undergone a change in
    dosage within 4 weeks prior to the Week 0 visit.
    22. Undergone therapeutic enemas within 14 days prior to the Week 0 visit.
    23. On prednisolone > 40 mg/day (or equivalent) and subjects who were not on stable
    doses for 2 weeks prior to Week 0. In addition, subjects who discontinued
    prednisolone (or equivalent) within 2 weeks of the Week 0 visit.
    24. On cyclosporine (IV, oral), tacrolimus (any form) or Mycophenolate mofetil
    within 8 weeks of the Week 0 visit.
    25. On budesonide > 9 mg/day and subjects who are not on stable doses of budesonide
    for at least 2 weeks prior to the Week 0 visit. In addition, subjects who
    discontinue budesonide within 2 weeks of the Week 0 visit.
    26. Received Tysabri within 4 months of the Week 0 visit.
    27. Received Kineret® (anakinra) within two days of the Week 0 visit.
    28. Received an anti-TNF therapy within 8 weeks of the Week 0 visit.
    29. Received an anti-TNF therapy that is currently investigational.
    30. Received a transfusion of any blood product or has lost 550 mL or more of blood
    due to a hemorrhage within an interval of time judged by the investigator to be
    unacceptable for study participation.
    31. The Investigator considers the subject, for any reason, to be unacceptable for study participation.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving clinical remission, defined as CDAI score of < 150 points, at Week 6.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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 EEA30
    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 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's last visit, or date of the last follow up contact, whichever is longer. (Study sites will contact all subjects at least 45 days after the last dose of study drug.)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 225
    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)
    See protocol.
    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 Decision2009-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-03-18
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