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    Summary
    EudraCT Number:2005-002857-29
    Sponsor's Protocol Code Number:5326-07
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-08-18
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-002857-29
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 mesylate, for the Induction of Clinical Response in Patients with Crohn’s Disease
    A.4.1Sponsor's protocol code number5326-07
    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 SponsorSynta Pharmaceutical Corporation
    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 Information not present in EudraCT
    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 nameSTA-5326 mesylate
    D.3.2Product code S38
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeSTA-5326 mesylate
    D.3.9.3Other descriptive nameSTA-6838, STA-5326 m, S38
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) 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) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCoated 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
    Moderate to severe, active Crohn’s disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 3.2
    E.1.2Level LLT
    E.1.2Classification code 10011401
    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 determine the proportion of patients who achieve clinical remission at Day 29, defined as a Crohn’s Disease Activity Index (CDAI) <150, and who achieve a clinical response, defined as a decrease in CDAI of 100 points or more from Baseline to Day 29 with STA-5326 mesylate compared with placebo.
    E.2.2Secondary objectives of the trial
    To determine the proportion of patients who achieve:
    • a clinical remission (CDAI <150) at Days 29 and 43
    • a clinical response (decrease in CDAI of 100 points or more) from Baseline to Day 29 and from Baseline to Day 43
    • a reduction in Crohn’s Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Score for Crohn’s Disease (SES-CD) from Baseline to Day 29
    • an increase in the Inflammatory Bowel Disease Questionnaire (IBDQ) score from Baseline to Days 29 and 43
    • a clinical remission or clinical response at Days 29 and 43 in the subset of patients with a high Screening C-reactive protein (CRP ≥10 mg/L).
    Exploratory Objectives: In addition to primary and secondary objectives, there are several exploratory objectives associated with the induction and maintenance of clinical response and remission, cell-surface markers and gene expression.
    Safety Objective: To further characterize the safety of STA-5326 mesylate in patients with active Crohn’s disease.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A patient is eligible for the study if all of the following criteria are met:
    1. Has given written informed consent prior to Screening.
    2. Is male or female aged 18 through 75 years.
    3. Has Crohn’s disease diagnosed definitively prior to Screening (based upon clinical, endoscopic, radiologic imaging, or histological assessments).
    4. Has a CDAI score of 220 to 450, inclusive at Baseline.
    5. If taking sulfasalazine or mesalamine, must have been using continuously for at least 2 months prior to randomization and at stable doses for at least 2 weeks prior to randomization.
    6. If taking azathioprine, 6-mercaptopurine, or methotrexate, must have been using continuously for at least 3 months prior to randomization and at stable doses for at least 1 month prior to randomization.
    7. If taking oral antibiotics chronically, must have been using continuously for at least 1 month prior to randomization and at stable doses for at least 2 weeks prior to randomization.
    8. If taking corticosteroids, must have been using prednisone ≤20 mg daily (or equivalents), or budesonide ≤9 mg daily for at least 2 months prior to randomization and at stable doses for at least 2 weeks prior to randomization.
    E.4Principal exclusion criteria
    Main criteria for exclusion:
    A patient is excluded from the study if any of the following criteria are met:
    General criteria
    1. Has any clinically significant disease (eg, renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the patient an unsuitable candidate for this study.
    2. Is a woman who has a positive pregnancy test, who is breast-feeding, or who is sexually active without using birth control during the course of the study and Follow-up period.
    3. Is a woman of childbearing potential or a man who does not agree to use 2 forms of contraception during the course of the study and Follow-up period.
    4. Has hypersensitivity to any of the components of STA 5326 mesylate drug product.
    5. Has any of the following clinical chemistry values:
    • Aspartate aminotransferase (AST) >2.0 x ULN
    • Alanine aminotransferase (ALT) >2.0 x ULN
    • Serum bilirubin >1.5 x ULN
    • Serum creatinine >1.5 x ULN
    • Alkaline phosphatase >2.5 x ULN
    6. Has a hemoglobin level <9 g/dL or hematocrit <30%.
    7. Has any of the following cell counts (cells/µL):
    • Platelets <100,000 or >800,000
    • White blood count <3,500
    • Neutrophils <2000
    8. Has a history of any infection requiring intravenous antibiotics, a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, pneumonia, septicemia) that occurred within 3 months of randomization.
    9. Has a history of cancer within the past 5 years, with the exception of excised basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ;
    10. Had a dependency for any illicit drug, chemical, or alcohol within the past 5 years;
    11. Has an abnormal chest x-ray determined to be clinically significant by the investigator
    12. Has a history of active tuberculosis, acute or chronic hepatitis B, hepatitis C, human immunodeficiency virus, or Listeria.
    Gastrointestinal criteria
    13. Has a current ileostomy or colostomy.
    14. Has a proctocolectomy or total colectomy.
    15. Has short bowel syndrome requiring enteral or parenteral nutrition supplementation or total parenteral nutrition.
    16. Has a stool sample positive for gastrointestinal infection (e.g. Clostridium difficile toxin, etc.) during Screening.
    17. Has a history or diagnosis of ulcerative or indeterminate colitis.
    18. Had bowel surgery in the previous 3 months.
    19. Had severe intestinal tract stenosis or fixed strictures causing symptomatic obstruction within 6 months prior to randomization.
    Prior medication criteria relative to randomization (see Section 10.5 for details)
    20. Received parenteral corticosteroids or corticotropin within 1 month prior to randomization.
    21. Has had regular use of aspirin or other non-steroidal anti-inflammatory drugs within 2 weeks prior to randomization (other than use of chronic low dose aspirin [80 mg per day] for cardioprotective effects).
    22. Received any investigational drug within 3 months prior to randomization.
    23. Received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 2 months prior to randomization.
    24. Received any biological product (eg, infliximab, adalimumab, natalizumab, etc.) within 3 months prior to randomization.
    25. Ever received treatment with STA-5326 free base or mesylate, anti-IL 12 antibodies, or other specific IL 12 inhibitors.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is that patients achieve clinical remission at Day 29, defined as a Crohn's Disease Activity Index (CDAI) <150, and that patients achieve a clinical response, defined as a decrease in CDAI of 100 points or more from Baseline to Day 29 with STA-5326 mesylate compared with placebo.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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
    Patients meeting group II criteria ( per protocol) at day 43 will cross over to an open label phase.
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 the trial is determined when the last subject undergoing the trial returns for a Follow-up visit on Day 197.

    Patients withdrawing from the study prior to Day 169 should complete all Day 169 assessments at the time of withdrawal. All patients who withdraw early should also return for a follow-up safety visit (Day 197 assessments) within 30 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-08-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 282
    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)
    Expected 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 Decision2006-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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