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    Summary
    EudraCT Number:2022-002441-18
    Sponsor's Protocol Code Number:D6582C00001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2022-002441-18
    A.3Full title of the trial
    A Phase IIa Randomised, Double Blind, Placebo Controlled, Parallel Arm, Multi-Centre Study to Evaluate the Efficacy and Safety of Mitiperstat (AZD4831), for 12-24 Weeks, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD
    A.3.2Name or abbreviated title of the trial where available
    CRESCENDO
    A.4.1Sponsor's protocol code numberD6582C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05492877
    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
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street Address1800 Concord Pike
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number1877240 9479
    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.3.1Product nameMitiperstat (AZD4831) film-coated tablet 5 mg
    D.3.2Product code Mitiperstat (AZD4831)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNNot available
    D.3.9.1CAS number 1933460-19-5
    D.3.9.2Current sponsor codeMitiperstat (AZD4831)
    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) 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 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 placeboFilm-coated tablet
    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
    Chronic Obstructive Pulmonary Disease (COPD)
    E.1.1.1Medical condition in easily understood language
    COPD is a serious lung condition that cause the airways to narrow and become obstructive and inflamed, which in turn makes breathing difficult.
    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 26.1
    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 evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first COPDCompEx event in patients with moderate to
    severe COPD.
    E.2.2Secondary objectives of the trial
    - To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD.
    - To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe COPD exacerbation.
    - To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-BD FEV1 in patients with moderate to severe COPD.
    - To assess the effect of mitiperstat (AZD4831) compared with placebo on respiratory symptoms in patients with moderate to severe COPD.
    - To assess the effect of mitiperstat (AZD4831) compared with placebo on disease impact in patients with moderate to severe COPD.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Cough Monitoring Substudy
    Date and Version: Not applicable (part of the main protocol)
    Objective 1: To assess the effects of mitiperstat (AZD4831) compared to placebo on change in cough frequency measured over a 24-hour period between start of treatment and Week 12.
    Objective 2: To investigate whether cough frequency is associated with lung function (eg. PEF, FEV1), cough/COPD symptom scores (eg. BCSS, CAT and Cough VAS) and sputum/blood biomarkers (eg. MPO
    concentration, neutrophil activation markers).
    E.3Principal inclusion criteria
    1. Confirmed primary diagnosis of moderate to severe COPD as per FEV1/FVC < 0.7, and post-BD FEV1 ≥ 25% predicted)
    2. Current or ex-smokers with a tobacco history of ≥ 10 pack-years
    3. High risk of exacerbations as defined by any one of the following:
    (a) 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 hospitalisation for reason of AECOPD in the 24 months prior to screening or
    (b) Frequent productive cough, defined as a positive response to both of the following questions:
    • Over the past 3 months, I have coughed at least several days a week
    • Over the past 3 months, I have brought up phlegm (sputum) at least several days a week, or
    (c) Post-BD FEV1 < 50% predicted.
    4. Clinically stable and free from an exacerbation of COPD for 1 month prior to SV1 (screening) and prior to Day 1.
    5. Participants who are at least 70% compliant with each of the following: morning e-Diary, evening e-Diary, and PEF measurements during the 14 days preceding SV3 based on the e-Diary.
    6. Participants who have a documented stable regimen of triple therapy or dual therapy for ≥ 3 months prior to enrolment. Triple therapy may consist of an appropriate combination of ICS + LABA + LAMA. Dual therapy consists of either inhaled ICS/LABA or LABA + LAMA where the treating physician deems the participant unsuitable for ICS (eg, blood eosinophil count ≤ 100 cells/µL on 2 separate occasions, or on the basis of previous or perceived risk of significant AEs from ICS-based therapy, such as previous episodes of pneumonia or significant oral candidiasis).
    E.4Principal exclusion criteria
    1. Current diagnosis of asthma or past diagnosis of asthma which persisted beyond the age of 25 years
    2. Active malignancy requiring treatment (with the exception of basal cell or squamous cell carcinomas of the skin and stable prostate cancer)
    3. Evidence of untreated active TB:
    Participants currently receiving treatment for active TB may be considered after completion of an appropriate course of therapy.
    4. Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up.
    5. Current diagnosis of hyperthyroidism, uncontrolled hypothyroidism (including but not limited to TSH ≥ 10 mIU/L), or any clinically significant thyroid disease.
    6. Participant who is going to start or finish intensive COPD rehabilitation program at anytime during study period. Participants can be recruited immediately following the completion of their COPD rehabilitation program.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first COPDCompEx event. COPDCompEx events include changes in COPD symptoms, lung function testing, COPD exacerbations, study dropout due to lack of efficacy, and use of reliever medication.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable as this is an event driven endpoint.
    E.5.2Secondary end point(s)
    - Plasma mitiperstat (AZD4831) concentration-time profiles during the intervention and follow-up periods, and PK parameters.
    - Time to first COPD exacerbation event.
    - Change from baseline in post-BD FEV1 after 12 weeks.
    - Change from baseline in EXACT, BCSS score, and cough VAS at Week 12 and Week 24.
    - Change from baseline in Total CAT measured in clinic at Week 12.
    - Safety and tolerability evaluations using AEs, SAEs, AESIs (skin reactions, including maculopapular rash, and infections, including pneumonia), vital sign measures, clinical laboratory assessments (clinical chemistry, haematology, and urinalysis), and ECG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - To assess the PK of mitiperstat (AZD4831) in patients with moderate to severe COPD (timepoint not applicable)
    - To evaluate the effect of mitiperstat (AZD4831) as compared to placebo on the time to first moderate or severe COPD exacerbation (timepoint not applicable)
    - To assess the effects of mitiperstat (AZD4831) as compared to placebo on post-BD FEV1 in patients with moderate to severe COPD (week 12)
    - To assess the effect of mitiperstat (AZD4831) compared with placebo on respiratory symptoms in patients with moderate to severe COPD (week 12 and week 24)
    - To assess the effect of mitiperstat (AZD4831) compared with placebo on disease impact in patients with moderate to severe COPD (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 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 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 EEA42
    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
    Argentina
    Canada
    Mexico
    South Africa
    United Kingdom
    United States
    Bulgaria
    Denmark
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Türkiye
    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
    A participant is considered to have completed the study if he/she has completed all phases of the study including SV8.
    The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the protocol 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial days1
    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: 203
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 203
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 191
    F.4.2.2In the whole clinical trial 406
    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)
    Return to standard of care.
    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 Decision2023-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-27
    P. End of Trial
    P.End of Trial StatusOngoing
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