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    EudraCT Number:2020-000789-40
    Sponsor's Protocol Code Number:D9181C00001
    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:2020-07-17
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-000789-40
    A.3Full title of the trial
    A Phase II, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MEDI3506 in Adult Participants with Uncontrolled Moderate-to-severe Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Efficacy and Safety of MEDI3506 in Adults with Uncontrolled Moderate-to-severe Asthma
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD9181C00001
    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.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 supportAstraZeneca AB
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    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.3.2Product code MEDI3506
    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.3.9.1CAS number 2376858-66-9
    D.3.9.2Current sponsor codeMEDI3506
    D.3.9.3Other descriptive namehuman immunoglobulin (Ig) G1 monoclonal antibody (mAb)
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Uncontrolled moderate-to-severe asthma
    E.1.1.1Medical condition in easily understood language
    Uncontrolled moderate-to-severe asthma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma.
    E.2.2Secondary objectives of the trial
    1. The pharmacokinetics (PK) of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma.
    2. The immunogenicity of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma.
    3. The effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe asthma.
    4. The effect of MEDI3506 compared with placebo on health status in adult participants with uncontrolled moderate-to-severe asthma.
    5. To further assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma.
    6. The effect of MEDI3506 compared with placebo on composite endpoint for severe exacerbations of asthma (CompEx) in adult participants with uncontrolled moderate-to-severe asthma.
    7. The effect of MEDI3506 compared with placebo on concentration of fractional exhaled nitric oxide (FeNO) in adult participants with uncontrolled moderate-to-severe asthma.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploratory measures of airway function and structure.
    E.3Principal inclusion criteria
    • Aged 18 to < 65 years of age inclusive.
    • History of ≥ 1 asthma exacerbation in previous 12 months.
    • Treated with medium to high dose ICS defined as total daily dose of > 250 g fluticasone dry powder or equivalent, for at least 12 months and on a stable dose for ≥ 3 months.
    • Stable LABA therapy for ≥ 3 months.
    • An ACQ-6 score ≥ 1.5.
    • Morning pre-BD FEV1 ≥ 40% predicted normal and > 1 L.
    • Morning pre-BD FEV1 < 85% predicted normal.
    • Participants with documented evidence of asthma as demonstrated by either:
    - BD reversibility, within 12 months, or at screening, or
    - Positive methacholine challenge test within 12 months.
    • Bodyweight ≥ 40 kg and BMI < 35 kg/m2.
    • For female participants, a negative pregnancy test.
    • Abide by contraception requirements for males and females
    • Provide informed consent
    E.4Principal exclusion criteria
    • Participants with a positive diagnostic nucleic acid test for SARS-CoV-2.
    • Participants with a significant COVID-19 illness within 6 months of enrolment;
    • Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or HIV.
    • Evidence of active or latent TB;
    • NT-proBNP level greater than the upper limit of the laboratory reference range during screening.
    • An LVEF < 45% measured by echocardiogram during screening.
    • A family history of heart failure.
    • Current smokers or recent ex smokers i.e., have quit e-cigarettes or other inhaled tobacco products ≤ 6 months prior to SV1.
    • Ex-smokers with a total smoking history of > 10 pack years.
    • As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason (prior to randomisation) that in the investigator’s opinion makes it undesirable for the participant to participate in the study.
    • Any clinically important pulmonary disease other than asthma.
    • Any other clinically relevant abnormal findings on physical examination or laboratory testing, that in the opinion of the investigator or medical monitor might compromise the safety of the participant in the study or interfere with evaluation of the study intervention.
    • A known history of severe reaction to any medication including biologic agents or human gamma globulin therapy.
    • History of, or a reason to believe, a participant has a history of, drug or alcohol abuse within the past 2 years.
    • Current diagnosis of cancer.
    • History of cancer, except if treated with apparent success with curative therapy (response duration of > 5 years).
    • History of allogeneic bone marrow transplant.
    • A helminth parasitic infection diagnosed within 6 months prior to SV4 (randomisation) that has not been treated, or has not responded to SOC therapy.
    • An asthma exacerbation within 8 weeks.
    • Receiving any prohibited concomitant medications or therapies as specified in the protocol.
    • Known history of allergy or reaction to any component of the study intervention formulation, including hereditary fructose intolerance.
    E.5 End points
    E.5.1Primary end point(s)
    The effect of MEDI3506 compared with placebo on lung function, as measured in clinic, change from baseline to Week 16 in pre-BD FEV1 (L).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    1. Serum MEDI3506 concentration-time profiles during the intervention and follow-up periods.
    2. Anti-drug antibody during the intervention and follow-up periods.
    3. Change from baseline to Week 16 in asthma control questionnaire-6 (ACQ-6) score. Proportion of participants with a decrease in ACQ-6 score of ≥ 0.5 from baseline to Week 16. Proportion of participants achieving ACQ-6 well controlled status (defined as ACQ-6 score ≤ 0.75 at Week 16).
    4. Change from baseline to Week 16 in St George’s respiratory questionnaire score (SGRQ). Proportion of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16.
    5. The effect of MEDI3506 compared with placebo on lung function as measured in clinic, change from baseline to Weeks 8 and 16 in post-BD FEV1 (L).
    6. Time to first CompEx event based on the period from baseline to Week 16. CompEx annualised event rate.
    7. Percent change from baseline to Week 16 in concentration of FeNO in exhaled breath.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Serum MEDI3506 concentration - During the intervention and follow-up periods
    2. Anti-drug antibody - During the intervention and follow-up periods
    3. ACQ-6 - Week 16
    4. SGRQ - Week 16
    5. FEV1 - Week 8 and Week 16
    6. CompEx - Week 16
    7. FeNO - Week 16
    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 Yes
    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
    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. 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 trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    South Africa
    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
    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 months9
    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 months9
    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: 228
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 228
    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)
    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 Decision2020-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-06
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