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    The EU Clinical Trials Register currently displays   44293   clinical trials with a EudraCT protocol, of which   7351   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-004222-25
    Sponsor's Protocol Code Number:AB11003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-004222-25
    A.3Full title of the trial
    A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors
    Prospektive, randomisierte, doppelblinde kontrollierte Multizentrenstudie der Phase 2b/3 mit vier parallelen Gruppen über 12 Wochen mit möglicher Verlängerung, zur Kontrolle der Wirksamkeit und Sicherheit von Masitinib gegenüber dem Placebo in der Behandlung eines moderaten Morbus Crohn bei Patienten mit einer Intoleranz oder unbefriedigenden Reaktion auf Immunsuppressiva und /oder TNF-Blocker - AB11003
    Een prospectief, gerandomiseerd, dubbelblind, gecontroleerd multicenteronderzoek in fase 2b/3 met 4 parallelle groepen en een looptijd van 12 weken met een mogelijke verlenging, om de werkzaamheid en de veiligheid van masitinib met een placebo te vergelijken, in de behandeling van een gematigde vorm van de ziekte van Crohn bij patiënten die geen immunosuppressieve geneesmiddelen en/of TNF-alfaremmers verdragen of er onvoldoende op reageren – AB11003

    A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease
    A.3.2Name or abbreviated title of the trial where available
    AB1010 in treatement of patients with moderate Crohn's disease
    A.4.1Sponsor's protocol code numberAB11003
    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 SponsorAB Science
    B.1.3.4CountryFrance
    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 supportAB Science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointCécile VISSAC-SABATIER
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0147207750
    B.5.5Fax number0147202411
    B.5.6E-mailcecile.vissac@ab-science.com
    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 nameMasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive namenot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive namenot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) 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 No
    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 placeboTablet
    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
    Crohn's disease
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Enhanced clinical response, defined as a decrease in CDAI (Crohn’s Disease Activity Index) ≥ 100 at W12
    E.2.2Secondary objectives of the trial
    • Clinical remission, defined as CDAI < 150 and absence of surgery at W4, W8 and W12
    • Clinical response defined as a decrease in CDAI ≥ 70 at W4, W8 and W12
    • Enhanced clinical response, defined as a decrease in CDAI ≥ 100 at W4 and W8
    • Cumulative clinical response
    • Cumulative enhanced clinical response
    • Cumulative clinical remission
    • C-reactive protein change at W4, W8 and W12
    • Faecal calprotectin level at W4, W8 and W12
    • Faecal lactoferrin level at W4, W8 and W12
    • Corticosteroids consumption at W4, W8, W9, W10, W11 and W12
    • Quality of Life
    o Absolute and relative change from baseline in IBDQ (Inflammatory Bowel Disease Questionnaire) scores at W8 and W12
    o Absolute and relative change from baseline in FACIT-Fatigue (Functional Assessment of Chronic IllnesTherapy-Fatigue) score at W8 and W12
    o Absolute and relative change from baseline in W12 IBD disability index (Inflammatory Bowel Disease disability index) at W8 and W12
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient with at least a 6-month history of Crohn’s disease (CD) from diagnosis.
    2.Patient with CD based on clinical history and radiologic or endoscopic findings within the previous 24 months. Patients with active disease following surgical resection must have radiological or endoscopic confirmation of CD post-surgery.
    3.Patient with a CDAI (Crohn’s disease activity index) score at baseline between 220 and 450 ([220;450]).
    4.Patient intolerant or with unsatisfactory response to [Azathioprine or 6-mercaptopurine or methotrexate] and/or TNF-inhibitors and/or Vedolizumab. Patient with unsatisfactory response is defined as patient with active Crohn’s disease (CDAI>=220) during at least 3 months under stable dose of treatment. Patient intolerant is defined as patient who have had to discontinue treatment at any time for tolerability or safety reason
    5.Patient with active Crohn’s disease confirmed by at least one of the following criteria:
    •level of C-reactive protein > 5 mg/L within 2 weeks prior to study treatment initiation
    •faecal calprotectin level > 250 µg within 2 weeks prior to study treatment initiation
    •ulcers demonstrated at colonoscopy within 12 weeks prior to study treatment initiation
    •small intestine or colonic inflammation defined as postcontrast parietal relative contrast enhancement after gadolinium injection and/or the presence of deep ulcerations on MRI or CT within 6 weeks prior to study treatment initiation
    6.Patient with adequate organ function:
    •Absolute neutrophils count (ANC) ≥ 2 x 109/L
    •Haemoglobin ≥ 10 g/dL
    •Platelets (PTL) ≥ 100 x 109/L
    •AST/ALT ≤ 2.5x ULN
    •Bilirubin ≤ 1.5x ULN
    •Creatinine clearance ≥ 60 mL/min
    •Albuminemia > 1 x LLN
    •Proteinuria < 30 mg/dL on the dipstick; in case of proteinuria ≥ 30 mg/dL, 24 hours proteinuria must be <1.5g/24 hours
    7.Male or female patient aged 18 to 75 years, weight > 50 kg, BMI between 18 and 35 kg/m²
    8. Contraception:
    •Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an acceptable method of contraception by her male partner during the study and for 3 months after the last treatment intake.
    •Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an acceptable method of contraception by his female partner during the study and for 3 months after the last treatment intake or who agrees to use an acceptable method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake.
    •Highly effective methods of contraception include:
    - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
    - Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
    - Intrauterine device (IUD)
    - Intrauterine hormone-releasing system (IUS)
    - Bilateral tubal occlusion
    - Vasectomized male (azoospermia assessed medically)
    - Sexual abstinence (Its reliability should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
    •Acceptable methods of contraception include:
    - Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
    - Male or female condom with or without spermicide
    - Cap, diaphragm, or sponge with spermicide
    9. Female patient of childbearing potential must have a negative pregnancy test at screening and baseline
    10.Patient able and willing to comply with study procedures as per protocol
    11.Patient able to understand, and willing to sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
    12.Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity
    E.4Principal exclusion criteria
    1.Patient with less than 3 months exposure to Azathioprine or 6-mercaptopurine or methotrexate.
    2.Patient treated with biological agents (natalizumab, ...) as anti-TNF alpha or Vedolizumab
    3.Patient with known active or draining fistula.
    4.Patient currently receiving nasogastric/nasoenteric tube feeding, an elemental/polymeric diet or total parenteral nutrition e.g. liquid diet and oral supplements, must remain stable during the treatment phase (baseline to week 4).
    5.Patient likely to require emergency surgery for persistent intestinal obstruction, bowel perforation, uncontrolled bleeding or abdominal abscess infection, in the investigator’s opinion and patients who have undergone bowel surgery within the 3 months prior to study treatment initiation.
    6.Patient with previous proctocolectomy or with symptomatic stricture or with abscess
    7.Patient with a clinically relevant short bowel syndrome, in the opinion of the investigator.
    8.Patient whose symptoms are believed to be largely due to the presence of fixed fibrotic strictures in the opinion of the investigator.
    9.Patient with a history of malignant neoplastic diseases of the bowel including diseases occurring more than 5 years before the inclusion in the study.
    10.Patient with active infection (HBV, HCV, HIV, EBV, CMV)
    11.Patient presenting with cardiac disorders defined by at least one of the following conditions:
    •Patient with recent cardiac history (within 6 months) of:
    -Acute coronary syndrome
    -Acute heart failure (class III or IV of the NYHA classification)
    -Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
    •Patient with cardiac failure class III or IV of the NYHA classification
    •Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
    •Syncope without known aetiology within 3 months
    •Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
    12.Patient with life expectancy < 6 months
    13.Patient with history of primary malignancy < 5 years; except treated basal cell skin cancer or cervical carcinoma in situ
    14.Patient with a severe and/or uncontrolled medical condition according to judgment of the investigator
    15.Pregnant or lactating female patient
    16.Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
    17.Patient with Body Mass Index (BMI) strictly above 35.
    E.5 End points
    E.5.1Primary end point(s)
    Enhanced clinical response, defined as a decrease in CDAI (Crohn’s Disease Activity Index) ≥ 100 at W12
    E.5.1.1Timepoint(s) of evaluation of this end point
    W12
    E.5.2Secondary end point(s)
    •Clinical remission, defined as CDAI < 150 and absence of surgery at W4, W8 and W12
    •Clinical response defined as a decrease in CDAI ≥ 70 at W4, W8 and W12
    •Enhanced clinical response, defined as a decrease in CDAI ≥ 100 at W4 and W8
    •Cumulative clinical response
    •Cumulative enhanced clinical response
    •Cumulative clinical remission
    •C-reactive protein change at W4, W8 and W12
    •Faecal calprotectin level at W4, W8 and W12
    •Faecal lactoferrin level at W4, W8 and W12
    •Corticosteroids consumption at W4, W8, W9, W10, W11 and W12
    Quality of Life
    oAbsolute and relative change from baseline in IBDQ (Inflammatory Bowel Disease Questionnaire) scores at W8 and W12
    oAbsolute and relative change from baseline in FACIT-Fatigue (Functional Assessment of Chronic IllnesTherapy-Fatigue) score at W8 and W12
    oAbsolute and relative change from baseline in W12 IBD disability index (Inflammatory Bowel Disease disability index) at W8 and W12
    •Safety profile
    •Ancillary study (optionally and in some defined sites only): Lesions though ileo-colonoscopy between baseline and W12 with CDEIS and SES-CD scores
    •Pharmacogenomic assessment: relationship between genomic data, efficacy variables (Enhanced clinical response) and safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    W4, W8, W12
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial4
    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 EEA70
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Central African Republic
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Slovakia
    South Africa
    Spain
    Switzerland
    Tunisia
    United Kingdom
    United States
    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
    After 24 weeks on treatment, in case there is a clinical benefit, the patients can stay in the study and continue receiving the 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 450
    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)
    NONE
    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 Decision2013-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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