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    Summary
    EudraCT Number:2021-001654-65
    Sponsor's Protocol Code Number:PDY16967
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-04
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-001654-65
    A.3Full title of the trial
    A Phase 2a, open label, two-part study to evaluate the mechanism of action of itepekimab (anti-IL-33 mAb) on airway inflammation in patients with chronic obstructive pulmonary disease (COPD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mechanistic study of the effect of itepekimab on airway inflammation in patients with COPD
    A.4.1Sponsor's protocol code numberPDY16967
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1255-5322
    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 SponsorSanofi-Aventis Recherche & Developpement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenzyme Europe BV
    B.5.2Functional name of contact pointTeam manager
    B.5.3 Address:
    B.5.3.1Street AddressPaasheuvelweg 25
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 BP
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031202454000
    B.5.5Fax number0031202453952
    B.5.6E-mailstartup.nl@sanofi.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 nameItepekimab
    D.3.2Product code SAR440340
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNItepekimab
    D.3.9.2Current sponsor codeSAR440340
    D.3.9.3Other descriptive nameREGN3500
    D.3.9.4EV Substance CodeSUB182669
    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
    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
    E.1.1.1Medical condition in easily understood language
    Chronic Obstructive Pulmonary Disease
    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
    Part A:
    • Generate an airway gene expression signature for itepekimab treatment using Ribonucleic Acid (RNA) sequencing in former smokers with COPD

    Part B:
    • Validate the airway gene expression signature from Part A in former smokers with COPD in Part B
    E.2.2Secondary objectives of the trial
    Part A:
    Evaluate in former smokers with COPD the
    • effect of itepekimab treatment on prespecified gene expression signatures
    • effect of itepekimab on blood eosinophil counts
    • safety and tolerability of itepekimab
    • immunogenicity to itepekimab in serum

    Part B:
    Evaluate in former smokers with COPD the:
    • effect of itepekimab on airway gene expression by RNA sequencing (pooled Part A and B)
    • effect of itepekimab on blood eosinophil counts
    Evaluate in current smokers with COPD the:
    • effect of itepekimab on airway gene expression by RNA sequencing
    Evaluate in former smokers and current smokers with COPD the:
    • differences in the effect of itepekimab on airway gene expression by RNA sequencing
    • differences in airway gene expression by RNA sequencing with COPD prior to treatment with itepekimab
    • effect of itepekimab treatment on prespecified gene expression signatures
    • safety and tolerability of itepekimab
    • immunogenicity to itepekimab in serum
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be 40 to 70 years of age inclusive
    - Physician diagnosis of COPD for at least 1 year (based on the Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).
    - Smoking history of ≥10 pack-years
    -- For former smokers: Participants who report that they are not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1) with an intention to quit permanently.
    -- For current smokers (not eligible for Part A): Participants who report that they are currently smoking tobacco (participant smoked at least 5 cigarettes per day on average during the past 7 days) at Screening (Visit 1) and at Baseline, and who are not currently participating in, or planning to initiate, a smoking cessation intervention at Screening (Visit 1) or during the screening period.
    - Participant-reported history of signs and symptoms of chronic bronchitis (chronic productive cough for at least 3 months in the year before screening in a participant in whom other causes of chronic cough [eg, inadequately treated gastroesophageal reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] have been excluded).
    - Documented or self-reported history of exacerbation having had ≥1 moderate or severe exacerbation within the 5 years prior to Screening (Visit 1), with at least 1 exacerbation treated with systemic corticosteroids:
    -- Moderate exacerbations are defined as an acute worsening of respiratory symptoms that requires either systemic corticosteroids (intramuscular [IM], intravenous [IV], or oral) and/or antibiotics.
    -- Severe exacerbations are defined as AECOPD that require hospitalization or observation for >24 hours in emergency department/urgent care facility.
    - Participants treated with SoC controller therapy for ≥3 months before Screening (Visit 1) and at a stable dose and regimen of controller therapy for at least 1 month before the screening visit AND during the screening period, including either: triple therapy with LAMA + LABA + ICS, or double therapy with ICS + LABA or LABA + LAMA or ICS + LAMA, or monotherapy with LABA or LAMA.
    - Participants who have received appropriate vaccination according to local recommendations against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), administered a minimum of 1 week prior to Screening (Visit 1).
    - Body mass index (BMI) ≥18 kg/m2
    - A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    -- Not a women of child-bearing potential (WOCBP) or
    -- A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 20 weeks after the last dose of study intervention.
    E.4Principal exclusion criteria
    - Current diagnosis or previously confirmed diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines unless asthma resolved before 18 years of age and has not recurred
    - Former smokers (Parts A and B): Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit1, V1) or during the screening period
    For current smokers (PartB): vaping of any products (eg nicotine,THC) within 6 months prior to Screening (V1) or during the screening period
    - Participants who are expected to be regularly exposed to environmental (ie,"second hand") tobacco smoke in an indoor setting during the screening or treatment periods (former smokers only)
    - Clinically significant new abnormal electrocardiogram within 6 months before or at Screening (V1) that may affect the participant’s participation in the study
    - Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α-1 anti-trypsin deficiency, or another diagnosed pulmonary disease
    - Diagnosis of cor pulmonale, evidence of right cardiac failure, or moderate-to-severe pulmonary hypertension
    - Participants who require more than 2L/min of long-term treatment with oxygen at rest. Participants who use up to 4L/min of supplemental oxygen during exercise may enroll. Oxygen during sleep is allowed
    - Hypercapnia that requires bi-level positive airway pressure (BiPAP)
    - Moderate or severe exacerbation of COPD (AECOPD) within 8 weeks prior to Screening (V1) or during the screening period
    - Prior history of pneumonectomy, lobectomy, segmentectomy, or therapeutic bronchoscopy procedure (including bronchoscopic volume reduction). Note: Prior history of surgical lung biopsy or wedge resection are not exclusion criteria
    - Any surgery or major procedures (including those requiring conscious sedation) planned to occur during the study. Minor skin procedures are allowed.
    - Unstable ischemic heart disease, including acute myocardial infarction within 1 year before Screening (V1) or unstable angina within 6 months before Screening (V1) or during the screening period
    - Cardiac arrhythmias, including paroxysmal (eg, intermittent) atrial fibrillation
    Participants with isolated premature ventricular contractions (PVC) or premature atrial contractions (PAC) may be considered for inclusion
    - Cardiomyopathy, as defined by Stage III-IV (New York Heart Association) cardiac failure, or other relevant cardiovascular disorder that that may affect the participant’s participation in the study
    - Any underlying disease requiring the use of prophylaxis for endocarditis.
    - Uncontrolled hypertension (ie, systolic blood pressure [BP]>180 mmHg or diastolic BP>110 mmHg with or without use of antihypertensive therapy)
    - Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection (TBI) or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette Guérin-vaccination within 12 weeks before Screening (V1)
    - History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (V1)
    - Suspicion of, or confirmed, coronavirus disease 2019 (COVID19) infection or contact with known exposure to COVID19 at Screening (V1) or during the screening period; known history of COVID19 infection within 6 weeks before Screening (V1); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID19 within 12 months before Screening (V1); participants who have had a COVID19 infection before Screening (V1) who have not yet sufficiently recovered to participate in the procedures of a clinical trial
    - Evidence of acute or chronic infection requiring systemic treatment with antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 6 weeks before Screening (V1) or during the screening period, significant viral infections within 6 weeks before Screening (V1) or during the screening period that may not have been treated with antiviral treatment (eg influenza receiving only symptomatic treatment)
    - Participants with active autoimmune disease or participants taking immunosuppressive therapy for autoimmune disease (eg rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis)
    - History of malignancy within 5 years before Screening (V1) or during the screening period, except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin
    - Symptomatic herpes zoster within 3 months prior to screening
    - Previous use of itepekimab
    The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    1 - Part A: Log2 relative change from baseline in gene expression in endobronchial biopsies at Week 12 ; As measured by RNA Sequencing, in former smokers with COPD
    2 - Part B: Change from baseline in itepekimab treatment normalized enrichment score (NES) developed in Part A in endobronchial biopsies at Week 12 ; As measured by RNA Sequencing, in former smokers with COPD
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 2 - Baseline to Week 12
    E.5.2Secondary end point(s)
    Part A :
    1 - Change from baseline in IL-33 treated eosinophil and mast cell-derived NES in endobronchial biopsies at Week 12 ; As measured by RNA Sequencing, in former smokers with COPD
    2 - Change from baseline in preclinical mouse models-derived NES in endobronchial biopsies at Week 12 ; As measured by RNA Sequencing, in former smokers with COPD
    3 - Change from baseline in bronchial allergen challenge-derived NES in endobronchial biopsies at Week 12 ; As measured by RNA Sequencing, in former smokers with COPD
    4 - Change from baseline in blood eosinophil count at Week 12 ; In former smokers with COPD
    5 - Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation ; In former smokers with COPD
    6 - Incidence of potentially clinically significant abnormalities in clinical laboratory tests, vital signs and electrocardiogram (ECG) in the treatment-emergent period ; In former smokers with COPD
    7 - Incidence of treatment-emergent anti-itepekimab antibody responses throughout the study ; In former smokers with COPD

    Part B :
    8 - Log2 relative change from baseline in gene expression in endobronchial biopsies at Week 12 in former smokers with COPD (pooled Part A and B) ; As measured by RNA Sequencing, in former smokers with COPD (pooled Part A and B)
    9 - Log2 relative change from baseline in gene expression in endobronchial biopsies at Week 12 in current smokers ; As measured by RNA Sequencing, in current smokers with COPD
    10 - Log2 relative change from baseline in gene expression in endobronchial biopsies at Week 12 in former and current smokers with COPD ; As measured by RNA Sequencing, in former smokers and current smokers with COPD
    11 - Gene expression in endobronchial biopsies at Baseline ; As measured by RNA Sequencing, in former smokers and current smokers with COPD
    12 - Change from baseline in IL-33 treated eosinophil and mast cell-derived NES in endobronchial biopsies at Week 12 ; As measured by RNA Sequencing, in former smokers and current smokers with COPD
    13 - Change from baseline in preclinical mouse models-derived NES in endobronchial biopsies at Week 12 ; As measured by RNA Sequencing, in former smokers and current smokers with COPD
    14 - Change from baseline in bronchial allergen challenge-derived NES in endobronchial biopsies at Week 12 ; As measured by RNA Sequencing, in former smokers and current smokers with COPD
    15 - Change from baseline in blood eosinophil count at Week 12 ; In former smokers with COPD
    16 - Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation ; In former smokers and current smokers with COPD
    17 - Incidence of potentially clinically significant laboratory tests, vital signs and ECG abnormalities in the treatment-emergent period ; In former smokers and current smokers with COPD
    18 - Incidence of treatment-emergent anti-itepekimab antibody responses throughout the study; In former smokers and current smokers with COPD
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3, 4, 8, 9, 10, 12, 13, 14, 15 : Baseline to Week 12
    5, 6 ,7, 16, 17, 18 : Baseline up to end of study (Week 32)
    11 : Week 0 (Baseline)
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA11
    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
    United States
    Netherlands
    Germany
    Belgium
    Denmark
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days16
    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: 73
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 109
    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 Decision2021-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-17
    P. End of Trial
    P.End of Trial StatusOngoing
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