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    Summary
    EudraCT Number:2009-013538-26
    Sponsor's Protocol Code Number:20080615
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-12
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-013538-26
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to
    Determine the Safety and Efficacy of AMG 853 in Subjects with Inadequately Controlled Asthma
    A.4.1Sponsor's protocol code number20080615
    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 SponsorAmgen Inc
    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 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 nameAMG 853
    D.3.2Product code AMG 853
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNAMG 853
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAMG 853
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 No
    D.IMP: 2
    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 nameAMG 853
    D.3.2Product code AMG 853
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNAMG 853
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAMG 853
    D.3.9.3Other descriptive namen/a
    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 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 No
    D.IMP: 3
    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 nameAMG 853
    D.3.2Product code AMG 853
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNAMG 853
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAMG 853
    D.3.9.3Other descriptive namen/a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 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
    Inadequately Controlled Asthma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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 is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from
    baseline to week 12.

    E.2.2Secondary objectives of the trial
    Evaluate the efficacy of AMG 853 as measured by:
    • Pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1),
    • AM and PM peak expiratory flow rate (PEFR),
    • Use of rescue short-acting β-agonist (SABA),
    • Daily symptom score (aggregate/night and individual symptoms; and symptom free
    days),
    • Asthma quality of life questionnaire (AQLQ).

    Exploratory Objectives:

    Evaluate the efficacy of AMG 853 as measured by:

    • Asthma exacerbations,
    • Patient global rating of change,
    • Total serum Immunoglobulin E (IgE),
    • Exhaled nitric oxide,
    • Sputum eosinophils (substudy),
    • Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ),
    • Sleep scale from Medical Outcomes Study (Sleep-MOS).

    Assess the pharmacokinetics of AMG 853.
    Investigate novel circulating biomarkers in the asthma setting.

    Safety Objectives:

    Evaluate the safety of AMG 853 as measured by:

    • Adverse events,
    • Changes in electrocardiogram (ECG),
    • Laboratory profiles,
    • Vital signs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males or females 18 to 65 years of age at the time of screening

    Percent of predicted FEV1 ≥ 50% and ≤ 80% at screening and baseline visits

    At least 12% reversibility over pre-bronchodilator FEV1 with SABA inhalation
    (up to 8 puffs) or nebulized equivalent (up to 2 treatments with 2.5 mg albuterol),
    demonstrated in the office during screening

    Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 μg/day fluticasone or equivalent.
    Stable ICS dose for ≥ 30 days before screening and must have used ICS for at
    least the last 3 consecutive months prior to screening. The ICS dose is expected
    to remain the same from screening through the end of study.

    Ongoing asthma symptoms with ACQ score ≥ 1.5 points, at screening and
    baseline

    If receiving allergen immunotherapy, a stable dose for > 3 months before
    screening and anticipated to remain stable for the duration of the study

    Nonsmoker or ex-smoker with < 10 pack-years (eg, 1 pack per day for 10 years)
    who stopped ≥ 1 year ago

    Signed the IRB-approved informed consent before any study-specific procedure
    E.4Principal exclusion criteria
    Acute asthma exacerbation requiring emergency room treatment or
    hospitalization within 2 months of screening

    History of endotracheal intubation for asthma-related exacerbation within 3 years
    of screening

    History of chronic obstructive pulmonary disease or other chronic pulmonary
    condition other than asthma

    Current diagnosis of sleep apnea with ongoing symptoms or requiring continuous
    positive airway pressure

    History of aspirin-sensitive asthma

    Any uncontrolled, clinically significant systemic disease, (eg, uncontrolled
    diabetes, liver disease)

    Any finding on the screening ECG that in the opinion of the investigator requires
    further cardiovascular evaluation

    Poorly controlled hypertension defined as resting blood pressure > 150/90 mmHg
    (assessed on two separate occasions during the screening period)

    Known malabsorption syndromes (eg, active duodenal ulceration, inflammatory
    bowel disease; history of small intestine surgery that involved resection or history
    of gastric bypass)

    Respiratory infection within 4 weeks of screening visit

    Any evidence of active infection at screening visit requiring systemic antibiotics

    Malignancy (other than resected cutaneous basal or cutaneous squamous cell
    carcinoma, or treated in situ cervical cancer considered cured) within 5 years of
    screening visit (if malignancy occurred > 5 years ago, subject is eligible with
    documentation of disease-free state since treatment)

    Systemic corticosteroids within 6 weeks before screening visit

    Received long-acting β-agonist, theophylline, inhaled anticholinergics, oral β-2
    agonists, or cromolyn therapeutics within 1 week of first run-in visit

    Leukotriene antagonists within 2 weeks before first run-in visit

    5-lipoxygenase inhibitors for asthma (eg, Zyflo®) within 1 week before first run-in
    visit

    Previous receipt of AMG 853

    Current receipt of any experimental or commercial biologic agent at screening

    Xolair® within 2 months before screening visit

    Known positive tuberculin skin test or recent (within 6 months) exposure to a
    person with active tuberculosis.

    Subjects with a known positive tuberculin skin test are allowed if:
    • They have completed treatment with appropriate chemoprophylaxis, or
    • They have a history of Bacillus Calmette-Guerin vaccination with a
    negative chest x-ray in the past year, and have no symptoms per the
    tuberculosis worksheet.

    Known to have tested positive for hepatitis B surface antigen, hepatitis C virus,
    human immunodeficiency virus

    Elevated AST/ALT ≥ 1.5 x the upper limit of normal at screening

    Creatinine clearance < 50 mL/min (based on the Cockroft-Gault formula,
    calculated by the central laboratory)

    Bilirubin ≥ 1.5 x the upper limit of normal at screening

    Laboratory abnormality, which, in the opinion of the investigator, will prevent the
    subject from completing the study or will interfere with the interpretation of the
    study results

    Subject is pregnant or breast feeding

    Subject is not willing to use highly effective birth control for the duration of the
    study including the 2-week follow-up period for women (except women at least
    2 years post menopausal or surgically sterile) and for up to 10 weeks after the
    last dose for men (except men whose female partners are at least 2 years post
    menopausal or surgically sterile).

    Highly effective methods of birth control are those which result in a low failure
    rate when used consistently and correctly such as implants, injectables,
    combined oral contraceptives, some intrauterine devices (IUDs), sexual
    abstinence or vasectomised partner. It is the responsibility of the physician and
    subject to decide together on the choice of an appropriate birth control method.

    Subject currently is enrolled in or has not yet completed at least 30 days since
    ending other investigational device or drug study(s), or subject is receiving other
    investigational agent(s)

    Other investigational procedures are excluded

    Any planned surgery (eg, elective cosmetic surgery) during the course of this
    study

    Subject will not be available for follow-up assessments

    Presence of any condition that could, in the opinion of the investigator,
    compromise the subject’s ability to participate in the study, such as history of
    substance abuse, alcoholism, or a psychiatric condition
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoint:

    • Change in ACQ scores from baseline to week 12
    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 Yes
    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 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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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 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
    The end of study is defined as the last visit of the last subject on the study.
    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.1.3Elderly (>=65 years) No
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 375
    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 Decision2010-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-13
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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