Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-002544-25
    Sponsor's Protocol Code Number:MDX1100-06
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-07
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-002544-25
    A.3Full title of the trial
    A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis
    A.4.1Sponsor's protocol code numberMDX1100-06
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 nameMDX-1100
    D.3.2Product code MDX-1100
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMDX-1100
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 Yes
    D.3.11.13.1Other medicinal product typefully human monoclonal antibody
    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 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
    Active Ulcerative Colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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 objectives of this study are to: 1) determine the response rate [defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1] at Day 57 in subjects administered MDX-1100; and 2) assess the tolerability and safety of this MDX-1100 regimen in subjects with active Ulcerative Colitis (UC).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to: 1) determine the remission rate (defined as a total Mayo score of ≤ 2 points with no individual subscore exceeding 1 point and no blood in stool) at Day 57 in subjects administered MDX-1100; 2) assess Quality of Life (QoL) outcome using the Inflammatory Bowel Disease Questionnaire (IBDQ); 3) determine the mucosal healing score rate at Day 57 for subjects administered MDX-1100; 4) determine the peak and trough pharmacokinetic profile of MDX-1100; and 5) investigate the effects of MDX-1100 on CXCL-10 levels and CXCL-10 responsive markers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be 18 years of age or older;
    2. Subjects with active UC on stable doses of either 5-ASA, corticosteroids, AZA, and/or 6-MP;
    3. Mayo score of 6 to 10 points with moderate to severe disease on endoscopy (Mayo endoscopic score of at least 2) performed ≤ 14 days of study drug administration;
    4. Subjects on the following medications may be enrolled into the study if the medications were initiated according to the following schedules before study drug administration and if no dosing changes are anticipated during the study;
    a. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration);
    b. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration);
    c. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration);
    d. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug administration)
    - Subjects using rectal medications must have visible disease on sigmoidoscopy at ≥ 20 cm;
    5. Screening laboratory values must meet the following criteria:
    • Hemoglobin ≥ 9.5 gm/dL
    • WBC ≥ 3000/mm3
    • Neutrophils ≥1.5 x109/L
    • Platelets ≥125 x109/L
    • Prothrombin time (PT) ≤1.3 X control
    • Serum creatinine <2 mg/dL
    • AST ≤2 X upper limit of normal
    • ALT ≤2 X upper limit of normal
    6. Women must be postmenopausal (> 12 months without menses) or surgically sterile (i.e., by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (i.e., oral contraceptives, intrauterine device (IUD), double barrier method of condom and spermicide) for at least 4 weeks prior to study drug administration and agree to continue contraception for the duration of their participation in the study. Women of childbearing potential must agree to use contraception for 70 days after their last dose of study drug; and
    7. Sexually active male subjects must use a barrier method of contraception during the study and agree to the use of male contraception for at least 180 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. Anti-TNF therapy within 8 weeks before study drug administration;
    2. Any experimental therapy ≤ 4 weeks before study drug administration;
    3. Prior treatment with any monoclonal antibody or immunoglobulin-based fusion proteins ≤ 8 weeks prior to study treatment;
    4. Prior treatment with an anti-CXCL10 antibody;
    5. Presence of Cushing’s syndrome;
    6. Toxic megacolon or fulminant disease likely to require colectomy;
    7. Contraindication to colonoscopy or sigmoidoscopy;
    8. Primary or secondary immunodeficiency;
    9. Other autoimmune disease such as systemic lupus erythematosus or rheumatoid arthritis, with the exceptions of Sjogren’s Syndrome or organ-specific autoimmune diseases such as vitiligo or well controlled hypo- or hyper-thyroidism;
    10. Any history of malignancy, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ;
    11. Active major psychiatric disease (subjects with stable depression receiving appropriate medical management will be permitted in the study);
    12. Evidence of acute or chronic infection as evidenced by:
    • Stool culture positive for pathogens and/or Clostridium difficile toxin
    • Findings on Screening chest radiography such as pulmonary infiltrate(s) or
    adenopathy
    • Current treatment for tuberculosis infection, clinical or radiological
    evidence of active TB (if necessary, confirmed by expert consultation), or for subjects in North America, a positive PPD without prior prophylaxis
    • Herpes zoster ≤3 months prior to study drug administration
    • Active infectious disease requiring i.v. antibiotics within 4 weeks prior to
    study treatment or oral antibiotics at the time of enrollment
    • HIV or AIDS
    • Positive tests for HBV, or HCV indicating active or chronic infection
    13. Clinically significant cardiac disease requiring medication, unstable angina, myocardial infarction within 6 months before study drug administration, or congestive heart failure;
    14. Arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities;
    15. History of cerebrovascular disease requiring medication/treatment;
    16. Anticoagulation therapy (low-dose aspirin prophylaxis will be permitted) or a known bleeding disorder;
    17. Seizure disorder requiring active therapy;
    18. Known drug or alcohol abuse;
    19. Pregnant or nursing;
    20. Any underlying medical condition that in the Principal Investigator’s opinion will make the administration of study drug hazardous to the subject or would obscure the interpretation of study treatment efficacy or safety; or
    21. Inability or unwillingness to return for Follow-up visits and comply with study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the clinical response rate at Day 57. The clinical response is defined as a decrease from baseline (Screening) in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1. The clinical response rate is defined as proportion of subjects in each treatment group who had a clinical response. The clinical response rate will be summarized using descriptive statistics and analyzed using Fisher’s exact test between the treatment groups. The 95% confidence interval for difference in response rates will be presented.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 concerned8
    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
    The end of the trial is the last visit of the last subject undergoing the trial.
    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.1.1.1In 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 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 2008-01-07. Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 106
    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)
    Subjects may explore other treatment options as discussed with their physician after they end their participation in study MDX1100-06.
    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 Decision2008-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-14
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 11:34:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA