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    Summary
    EudraCT Number:2010-022380-35
    Sponsor's Protocol Code Number:982
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-022380-35
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter, parallel-group,
    adaptive group-sequential phase II study, to determine the efficacy
    and safety of BT086 as an adjunctive treatment in severe community
    acquired pneumonia (sCAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, double-blind, placebo-controlled, multicenter, parallel-group,
    adaptive group-sequential phase II study, to determine the efficacy
    and safety of BT086 as an adjunctive treatment in severe pneumonia (sCAP) acquired outside the hospital
    A.3.2Name or abbreviated title of the trial where available
    CIGMA (Concentrated IgM for Application) Study
    A.4.1Sponsor's protocol code number982
    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 SponsorBiotest AG
    B.1.3.4CountryGermany
    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 supportBiotest AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiotest AG
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLandsteiner Str. 5
    B.5.3.2Town/ cityDreieich
    B.5.3.3Post code63303
    B.5.3.4CountryGermany
    B.5.4Telephone number+4961038012124
    B.5.5Fax number+496103801180
    B.5.6E-mailiris_bobenhausen@biotest.de
    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 nameIgM Concentrate
    D.3.2Product code BT086
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIgM Concentrate
    D.3.9.2Current sponsor codeBT086
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 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
    severe Community Acquired Pneumonia (sCAP)
    E.1.1.1Medical condition in easily understood language
    severe Pneumonia (sCAP) acquired outside the hospital
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main objective of this clinical phase II trial is to evaluate the efficacy (ventilator free days) of BT086 IgM concentrate in patients with sCAP (severe community acquired pneumonia)
    E.2.2Secondary objectives of the trial
    Secondary objectives of this clinical phase II trial are to demonstrate repeated dose safety, tolerability, pharmacodynamic and pharmacokinetics of BT086 intravenous administration.
    Pharmacodynamics: Evaluation of complement system (6 patients) and Procalcitonin and C-reactive protein (CRP)

    Pharmacokinetics (PK): Evaluation of IgM and serum concentration of IgM, IgA, IgG in approximately 20 patients

    Evaluation of safety and tolerability in terms of:
    • Infusion-related reactions
    • Adverse events (AEs)
    • Vital signs
    • Electrocardiogram (ECG)
    • Safety laboratory
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent:
    • given by the patient
    or
    • a legal/authorised representative of the patient
    or
    • a waiver for written informed consent due to emergency situation,
    in compliance with all local legal requirements.
    2. Male or female patients aged 18 years or older
    3. Patient receiving adequate antibiotic treatment for pneumonia
    4. Prior to endotracheal ventilation and therapy, the patient must have at least one
    of the following two signs of inflammation:
    • Fever/Hypothermia
    Fever defined as an oral, tympanic, oesophageal, or vesical temperature of >38°C, or rectal temperature of >38.5°C, or
    hypothermia (rectal temperature <35.5°C) (measurement with temperature probe or device)
    or
    • White blood cell (WBC) count >10,000/mm³ or WBC <4,500/mm³

    5. Patient must have at least one of the following signs and symptoms of
    pneumonia:
    • New or increased cough
    • Production of purulent sputum or change in sputum characteristics
    • Dyspnoea or tachypnoea (respiratory rate >20 breaths/minute)
    • Pleuritic chest pain
    • Auscultatory findings on pulmonary examination of rales and/or crackles and/or
    evidence of pulmonary consolidation (e.g. dullness on percussion, bronchial
    breath sounds, or egophony)
    6. Radiological (or other imaging technique) evidence of (an) infiltrate(s) consistent
    with bacterial pneumonia
    7. Pneumonia has been acquired outside the hospital. In hospital-admitted
    patients, pneumonia has been diagnosed a maximum of 72 hours after
    admission. Patients from nursing homes or similar institutions are eligible.
    8. Major sCAP criterion: need for endotracheal ventilation
    9. Treatment of patient with BT086 must start within 12 hours but not earlier
    than 1 hour after start of endotracheal ventilation
    E.4Principal exclusion criteria
    1. For incapacitated patients: any indication that the patient’s presumed will would
    be against inclusion in the trial
    2. Patients with suspected hospital-acquired pneumonia
    3. Severe lung diseases interfering with sCAP therapy e.g. patients with
    cystic fibrosis,
    4. Patients receiving Xigris® (drotrecogin alfa, activated Protein C) or medications
    not approved for sCAP (e.g. Dornase alpha) are excluded from inclusion in the
    study
    5. Patients on dialysis
    6. Presence of other severe diseases impairing life expectancy (e.g. patients are not
    expected to survive 28 days given their pre-existing uncorrectable medical
    condition).
    7. Patients unable to be treated due to obesity
    8. Selective, absolute IgA deficiency with known antibodies to IgA
    9. Patients with neutrophil count <1,000/mm³ or platelet count <50,000/mm³
    10. Pregnant or lactating women. A pregnancy test will be performed in all women
    aged <65 years and the result must be available at study inclusion.
    11. Known relevant intolerance to immunoglobulins, vaccines or other substances
    of human origin
    12. Participation in another interventional clinical trial within 30 days before
    entering the study or during the study, and/or previous participation in this
    study (participation in non-interventional trials is allowed).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the increase of ventilator free days (VFDs) measured in sCAP patients treated with adjunctive BT086 and the appropriate standard of care treatment compared to patients treated with placebo and the appropriate standard of care.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 28 days
    E.5.2Secondary end point(s)
    Furthermore the following secondary endpoints will be assessed.
    • VFDs in surviving patients
    • 28-day all cause mortality
    • 28-day pneumonia cause mortality
    • Time to discharge from ICU (intensive care unit)
    • Time to discharge from hospital
    • SOFA score
    • Glasgow coma score
    • Vasopressor-free days
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 28 days
    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 No
    E.6.10Pharmacogenetic No
    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
    adaptive group-sequential
    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 Yes
    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 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
    Last visit of last subject (chapter 13.2 of the study protocol)
    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 years4
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Unconscious due to mechanical ventilation
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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 Decision2013-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
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