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    Summary
    EudraCT Number:2006-004303-19
    Sponsor's Protocol Code Number:BSX - 001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-02-20
    Trial 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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-004303-19
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    BSX-001
    A.4.1Sponsor's protocol code numberBSX - 001
    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 SponsorCerimon Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Simulect
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBasiliximab
    D.3.4Pharmaceutical form Powder 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.3.9.3Other descriptive nameBasiliximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    Steroid-refractory ulcerative colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy:
    Assess the efficacy, relative to placebo, of 40 mg basiliximab given intravenously, at 2 week intervals for a total of 3 doses, with concomitant oral corticosteroids, in subjects with steroid-refractory, moderate to severe Ulcerative Colitis. A total of 3 doses will be administered during the 8 week duration of the trial.


    Safety:
    Evaluate the overall safety of this multiple-dose regimen in this patient population.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess:
    • Efficacy, relative to placebo, of basiliximab 20 mg, given with concomitant
    oral corticosteroids, according to the same schedule
    • Safety of basiliximab 20 mg multiple-dose regimen
    • Pharmacokinetics of both basiliximab regimens in this population
    • Immunogenicity of multiple doses of basiliximab through measurement of
    formation of antibodies to basiliximab, and monitoring for hypersensitivity
    reactions
    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 complete description of these studies is included within the protocol BSX-001, Amendment 4, dated 28th January 2008

    Pharmacodynamics

    An optional substudy will be conducted in approximately 100 subjects at selected sites. This substudy will assess basiliximab pharmacodynamics through the following analyses:
    • Saturation and/or depletion of circulating CD25 receptors will be assessed via a Fluorescence Activated Cell Sorting (FACS) lymphocyte subset analysis of whole blood collected from consenting subjects at the Day 1, Week 4, and Week 8 study visits. A total CD3 count will also be determined.
    • In the same subjects, saturation and/or depletion of tissue CD25 receptors will be assessed via immunohistochemical analysis of rectal biopsy tissue obtained during the Screening, Week 4, and the Week 8 endoscopic procedure.
    The results of these analyses will also be correlated with serum basiliximab trough levels in the subjects from the active treatment groups.

    Steroid Resistance Biomarker Evaluation

    An optional substudy will be conducted in approximately 30 adult subjects at selected sites in the U.K. The following evaluations will be performed at the Biomarker Substudy Laboratory (University of Bristol, UK):
    • Dexamethasone inhibition of lymphocyte proliferation, with and without autologous serum (Creed, 2003)
    • Assessment of CD25+ cell subsets
    • Assessment of DNA polymorphisms linked to steroid sensitivity. Stored DNA (from white cells) will not be used for any other purpose.
    Any cells not used in the above assays may be stored for additional related cell signaling studies.
    E.3Principal inclusion criteria
    Subjects must satisfy all of the following inclusion criteria to be eligible for the study:
    1. Male or female subjects, age ≥18 years and ≤75 years
    2. Weight of 40 kg or greater
    3. Signed a current IRB/IEC-approved informed consent form
    4. Diagnosis of ulcerative colitis confirmed through screening endoscopy performed no more than 3 days prior to day of randomization (Day -2 to Day 0, with randomization on Day 1). At the time of endoscopy, a rectal biopsy will be obtained and reviewed by a local pathologist to confirm histopathology compatible with the diagnosis of ulcerative colitis. Randomization can proceed without the screening biopsy result if a previous biopsy result compatible with ulcerative colitis is documented and available in the subject’s medical record.
    5. Extent of disease must involve at least the left colon (i.e., greater than 15
    cm beyond the anal verge as the endoscope is withdrawn)
    6. Moderate to severe disease, defined as a total Mayo score of 6 points or
    greater, including an endoscopic subscore of 2 points or greater. Systemic
    features of tachycardia, fever, and/or significant anemia should not be
    present
    7. Steroid-refractory disease, defined as moderate to severe disease,
    without systemic features , despite treatment with prednisone 40 – 50
    mg/day (or other oral steroid at equivalent dose) orally for a minimum of
    14 days immediately preceding study entry
    8. Concomitant azathioprine or 6-mercaptopurine treatment is permitted
    during the study if initiated at least 12 weeks before study entry, and if
    the dose has not been changed or stopped for at least 8 weeks before
    study entry.
    9. Concomitant oral aminosalicylate treatment is permitted during the study if
    initiated at least 4 weeks before study entry, and if the dose has not been
    changed or stopped during this time.
    10. Females of childbearing potential must use an effective birth control
    method, and be willing to continue birth control during the study, and for 4
    months after the last dose of study drug.
    11. Females of non-childbearing potential should be surgically sterile (bilateral
    tubal ligation with surgery at least 6 months before study entry,
    hysterectomy, or bilateral oophorectomy at least 2 months before study
    entry) or post-menopausal for at least 2 years.
    E.4Principal exclusion criteria
    Presence of any of the following conditions will exclude the subject from eligibility for the study:
    1. Prior treatment with basiliximab or daclizumab at any time
    2. Prior treatment with cyclosporine, tacrolimus, methotrexate, or any anti-
    TNF agent within 3 months before study entry
    3. Prior treatment with parenteral corticosteroids within 14 days before
    study entry
    4. History of partial colectomy or total proctocolectomy
    5. Initiation of azathioprine or 6-mercaptopurine treatment less than 12
    weeks before study entry, or discontinuation or change of dose less than
    8 weeks before study entry
    6. Initiation of oral aminosalicylate treatment , or change of dose, or
    discontinuation less than 4 weeks before study entry
    7. Rectally administered medications containing corticosteroids or
    aminosalicylates within 2 weeks before screening endoscopy
    8. If currently taking a nonsteroidal anti-inflammatory agent (NSAID), the
    inability to discontinue NSAID use during study participation
    9. Intolerance or inability to continue oral corticosteroids during the trial
    10. Stool studies that show presence of ova and parasites, significant
    bacterial pathogens, or C. difficile toxin
    11. Baseline endoscopic finding of disease isolated to the rectum (proctitis), fistulas, strictures, skip areas, or small bowel inflammation not consistent with backwash ileitis, or findings of multiple epithelial granulomas on biopsy
    12. Presence of toxic megacolon
    13. Severely ill patients as evidenced by greater than 6 episodes of loose
    stools, all of them bloody, during a 24-hour period within the screening
    window, concurrent with any of the following systemic features:
    -Heart rate >90 beats/min at rest
    -Temperature >37.8 degrees C
    -Hemoglobin <10.5 g/dL
    14. Laboratory values as follows:
    -Hemoglobin <8.5 g/dL
    -WBC <3.0 x 10E9/L
    -Neutrophils <1.5 x 10E9 /L
    -Lymphocytes <0.5 x 10E9 /L
    -Platelets <100 x 10E9 /L
    -AST (SGOT) >3 times upper limit of normal
    -ALT (SGPT) >3 times upper limit of normal
    15. Pregnant or breast-feeding female patients
    16. Chest radiograph abnormalities consistent with an infectious process
    17. HIV infection
    18. Known viral Hepatitis B or C infection
    19. History of or exposure to tuberculosis within 6 months before study entry
    20. History of central nervous system demyelinating disorder
    21. History of colonic dysplasia
    22. History of malignancy during the previous 5 years or current malignancy,
    with exception of adequately treated non-melanoma skin cancer or in situ
    carcinoma of the cervix
    23. History of varicella, herpes zoster, or severe viral infection within 6 weeks
    before study entry, exposure to varicella within 21 days before study
    entry, or vaccination with live virus within 4 weeks before study entry
    24. Any ECG abnormalities unless approved by the Medical Monitor
    25. Treatment with an investigational drug or device within 30 days before
    study entry
    26. Treatment with an investigational biologic within 6 months before study
    entry
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be clinical remission at week 8.

    Secondary efficacy endpoints will include:

    • Clinical remission at week 4
    • Clinical response at weeks 4 and 8
    • Mucosal healing at weeks 4 and 8
    • Use of rescue medication
    • Hospitalization or colectomy
    • Concomitant steroid use (median dose over time and cumulative dose)
    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 Yes
    E.6.13.1Other scope of the trial description
    1)Immunogenicity and 2)Steroid Resistance Biomarker Evaluation
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    End of trial is defined as last visit by the last subject
    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 months6
    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 months6
    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) 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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 69
    F.4.2.2In the whole clinical trial 181
    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)
    Qualifying patients will be offered the opportunity to participate in the Study BSX-002. If the subject does not qualify or chooses not to participate in BSX-002, they will revert to standard care after their participation in the trial has ended.
    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 Decision2007-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-08-25
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