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    Summary
    EudraCT Number:2011-004812-40
    Sponsor's Protocol Code Number:D2211C00001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-29
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2011-004812-40
    A.3Full title of the trial
    A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

    A.4.1Sponsor's protocol code numberD2211C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportMedImmune Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryPoland
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryCzech Republic
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportMedImmune Ltd
    B.4.2CountryNetherlands
    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 nametralokinumab
    D.3.2Product code CAT-354
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNtralokinumab
    D.3.9.1CAS number 1044515-88-9
    D.3.9.2Current sponsor codeCAT-354
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) 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 Yes
    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
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel disease
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 assess the effect of tralokinumab compared with placebo in patients with active UC by assessment of clinical response, as defined by the Mayo score, at week 8.
    E.2.2Secondary objectives of the trial
    *To assess change in Mayo score from baseline to week 8.
    *To assess mucosal healing at week 8.
    *To assess change in partial Mayo score from baseline to week 4, 8, 12, 16, 20, and 24.
    *To assess the proportion of patients in clinical remission, as defined by the Mayo score, after 8 weeks.
    *To assess histology in biopsies from colonic mucosa at baseline and week 8.
    *To assess markers of disease activity and intestinal leakiness in serum and faeces at baseline, week 4, 8, 12, 16, 20, and 24.
    *To assess the pharmacokinetics and immunogenicity of tralokinumab.
    *To evaluate the safety and tolerability of tralokinumab by assessment of reported Adverse Events (AEs), safety laboratory values, electrocardiograms, vital signs, weight, and physical examination findings.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosed ulcerative colitis at least 90 days prior randomisation.
    2. Men or women age18 - 75 years.
    3. Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalisylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization
    4. Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1.
    5. Nonsterilized males or sterilized males who are ≤ 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception.
    E.4Principal exclusion criteria
    1. Pregnant or breastfeeding women.
    2. History of colostomy.
    3. Current diagnosis of indeterminate colitis, Crohn’s disease, ischemic colitis, fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited to the rectum (ulcerative proctitis).
    4. Hepatitis B, C or HIV.
    5. History of cancer.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical response (defined as a decrease in Mayo score from baseline of at least 3 points and at least 30% with an accompanying decrease in the sub score for rectal bleeding of at least 1 point or absolute sub score for rectal bleeding of 0 or 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 8.
    E.5.2Secondary end point(s)
    * Change in Mayo score (calculated as the sum of the four sub-scores: stool frequency rectal bleeding, endoscopy findings and the physician’s overall assessment of the same in addition to abdominal discomfort and patient's general sense of well-being).
    * Mucosal healing (defined as an improvement of the endoscopy sub-score (from the Mayo score) at week 8 from 3 or 2 to ≤1 point, or from 1 to 0 points).
    * Change in partial Mayo score (calculated as the sum of the scoring from the three sub-score areas: stool frequency, rectal bleeding and the physician's global assessment).
    * Clinical remission (defined as Mayo score of 2 or lower with no individual sub-score exceeding 1 point)
    * Histologic disease activity (assessment based on the modified Riley score).
    * Markers of disease activity (CRP, calprotectin) and intestinal leakiness (albumin).
    * Immunogenicity: incidence of anti-drug antibodies (ADA) to tralokinumab in serum.
    * Tralokinumab serum concentration.
    * Safety and tolerability of tralokinumab in terms of adverse events, safety laboratory values, electrocardiograms, vital signs, weight, and physical examination findings.
    E.5.2.1Timepoint(s) of evaluation of this end point
    * From baseline to week 8.
    * At week 8.
    * From baseline to week 4, 8, 12, 16, 20, and 24.
    * After 8 weeks.
    * At baseline and week 8.
    * At baseline, week 4, 8, 12, 16, 20, and 24.
    * Pre-dose sampling at baseline, week 8, 12, 16, and 24.
    * Pre-dose sampling at baseline, week 4, 8, 12, 16, 20, and 24.
    * From baseline to week 24
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    Immunogencity
    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 trial2
    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 No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months2
    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 months2
    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.1.2.1Number of subjects for this age range: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 110
    F.4.2.2In the whole clinical trial 110
    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 Decision2012-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-24
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