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    Summary
    EudraCT Number:2020-000571-20
    Sponsor's Protocol Code Number:D9180C00002
    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:2020-10-06
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-000571-20
    A.3Full title of the trial
    A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants with Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis
    II. fázisú, randomizált, kettős vak, placebokontrollos vizsgálat a MEDI3506 hatásosságának, biztonságosságának és tolerálhatóságának felmérésére középsúlyos-súlyos krónikus obstruktív tüdőbetegségben és krónikus bronchitisben szenvedő betegeknél (FRONTIER 4)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants with COPD and Chronic Bronchitis
    II. fázisú, randomizált, kettős vak, placebokontrollos vizsgálat a MEDI3506 hatásosságának, biztonságosságának és tolerálhatóságának felmérésére középsúlyos-súlyos krónikus obstruktív tüdőbetegségben és krónikus bronchitisben szenvedő betegeknél (FRONTIER 4)
    A.3.2Name or abbreviated title of the trial where available
    FRONTIER4
    A.4.1Sponsor's protocol code numberD9180C00002
    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.1.3.4CountrySweden
    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.4.2CountrySweden
    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 AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.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.3.2Product 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.3.8INN - Proposed INNTozorakimab
    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.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 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
    Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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 effects of MEDI3506 compared with placebo on pulmonary function in participants with COPD and chronic bronchitis.
    E.2.2Secondary objectives of the trial
    1. To assess the PK of MEDI3506 in participants with COPD and chronic bronchitis.

    2. To assess the immunogenicity of MEDI3506 compared with placebo in participants with COPD and chronic bronchitis.

    3. To assess the effect of MEDI3506 on COPDCompEx event in participants with COPD and chronic bronchitis

    4. To assess the effect of MEDI3506 compared with placebo on respiratory symptoms in participants with COPD and chronic bronchitis.

    5. To assess the effect of MEDI3506 compared with placebo on disease impact in participants with COPD and chronic bronchitis.

    6. To assess the effect of MEDI3506 compared with placebo on airway resistance and reactance in participants with COPD and chronic bronchitis.

    7. To evaluate the effect of MEDI3506 compared with placebo on objective cough measures in participants with COPD and chronic bronchitis.

    8. To evaluate the effect of MEDI3506 or placebo on lung function by extent of baseline emphysema on CT scan
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Provision of informed consent

    • Participant must be 40 to 80 years of age inclusive, at the time of signing the ICF.

    • Participants who are current or ex-smokers with a tobacco history of ≥ 10 pack-years.

    • Participants who have a documented history of COPD for at least 1 year.

    • Participants who have a post-BD FEV1/FVC < 0.70 and a post-BD FEV1 > 20% and < 80% predicted normal value at screening. Centralized spirometry will be used for this criteria assessment.

    • Participants who have a physician confirmed participant history of chronic bronchitis as defined as presence of cough and sputum on most days for ≥ 3 months/year in at least the 2 year period immediately prior to SV1 (screening).

    • Participants who have an average BCSS score of ≥ 2 in cough and ≥ 2 in sputum domains assessed over 14 days preceding SV3

    • Participants who have a documented stable regimen of dual therapy or triple therapy for ≥ 3 months prior to enrolment; there should have been no change in treatment after the previous exacerbation prior to entering into the study. Where dual therapy consists of ICS + LABA or LABA + LAMA, and triple therapy consists of ICS + LABA + LAMA.

    • Participants who have a documented history of ≥ 1 moderate or severe AECOPD requiring systemic corticosteroids and/or antibiotics for at least 3 days duration (or 1 injection of depot formulation), or hospitalization for reason of AECOPD in the previous 24 months.

    • Body mass index within the range 18 to 40 kg/m2 (inclusive).

    • Female participants of childbearing potential, must have negative pregnancy tests at SV1.

    • Female participants of childbearing potential who are sexually active with a male partner must agree to use a highly effective method of contraception from screening until the end of the follow-up period at SV14 of the study.
    E.4Principal exclusion criteria
    • Participants with a positive diagnostic nucleic acid test for SARS-CoV-2 at screening. Subjects with mild or asymptomatic disease could be rescreened.

    • Participants with a significant COVID-19 illness within 6 months of enrolment
    • As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason which in the investigator's opinion makes it undesirable for the participant to participate in the study.
    • Asthma as a current or as a past diagnosis unresolved by age 25
    • Clinically important pulmonary disease other than COPD, radiological findings, and/or laboratory findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms.
    • Increased pre-BD FEV1 at randomization visit (SV3) compared to Screening SV1 of ≥ 400 mL or ≥ 25% of SV1 FEV1.
    • Any other clinically relevant abnormal findings on physical examination, laboratory testing; or chest CT scan, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant’s ability to participate in the study.
    • A family history of heart failure.
    • A LVEF < 45% measured by echocardiogram.
    • History of a clinically significant infection (viral, bacterial, or fungal) within 4 weeks.
    • History of, or a reason to believe a participant has a history of, drug or alcohol abuse within the past 2 years prior to screening.
    • .Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening
    •. A positive test for HIV and known to have tested positive for HIV.
    • Evidence of active or untreated latent TB.
    • Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up.
    • Participants currently receiving background therapy that is not approved by regulatory authorities in the country of study for COPD are not eligible for the study.
    • History of treatment with cardiotoxic medications (eg, as part of cancer therapy) including thiazolidinediones.
    • Treatment with broad spectrum antibiotic within 4 weeks prior to randomization (Day 1).
    • Receiving any of the prohibited concomitant medications as specified in the CSP.
    • Inability to perform technically acceptable spirometry.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Week 12 in pre BD FEV1 measured in clinic.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    1. Serum MEDI3506 concentration-time profiles during the intervention and follow-up periods.

    2. Anti-drug antibodies during the intervention and follow-up periods.

    3. Time to first COPDCompEx event based on the period from baseline to 4 weeks after last dose (Week 28)

    4. Change from baseline to Week 12 in:
    • E-RS:COPD
    • Mean BCSS score (over the previous 4 weeks)
    • Cough VAS item

    5.
    • Change from baseline to Week 12 in SGRQ total score
    • Proportion of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 12

    6. Change from baseline to Week 12 in Airway Oscillometry parameters:
    • R5-R20
    • R5
    • R20
    • AX

    7. At Week 12, ratio to baseline in:
    • Daily (ie, 24 hour) cough frequency
    • Night time cough frequency
    • Awake time cough frequency

    8.
    • Change from baseline in pre-BD and post-BD FEV1 through Week 28
    • Change from baseline in pre-BD and post BD FVC through Week 28
    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 antibodies - During the intervention and follow-up periods

    3. COPDCompEx - Week 28

    4. E-RS:COPD, Mean BCSS score (over the previous 4 weeks) and Cough VAS item - Week 12

    5. SGRQ - Week 12

    6. AO parameters - Week 12

    7. Cough frequency - Week 12

    8. Pre-BD and post-BD FEV1 and FVC - Week 28
    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 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) 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 trial2
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Australia
    Canada
    Israel
    South Africa
    United States
    Czechia
    Denmark
    Germany
    Hungary
    Poland
    Spain
    United Kingdom
    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 study is defined as the date of last scheduled procedure as shown in the schedule of activities/SoA for the last participant in the study globally.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 144
    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 Decision2020-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-13
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