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    Summary
    EudraCT Number:2021-002045-15
    Sponsor's Protocol Code Number:GB43311
    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:2021-11-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-002045-15
    A.3Full title of the trial
    A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease
    Een fase IIb, gerandomiseerd, dubbelblind, placebogecontroleerd onderzoek in meerdere centra ter beoordeling van de werkzaamheid en veiligheid van Astegolimab bij patiënten met Chronische Obstructieve Longziekte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease (COPD)
    Een onderzoek ter beoordeling van de werkzaamheid en veiligheid van Astegolimab bij patiënten met Chronische Obstructieve Longziekte (COL)
    A.4.1Sponsor's protocol code numberGB43311
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05037929
    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 SponsorGenentech, 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 supportGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameAstegolimab
    D.3.2Product code RO7187807
    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 INNAstegolimab
    D.3.9.1CAS number 2173054-79-8
    D.3.9.2Current sponsor codeRO7187807
    D.3.9.3Other descriptive nameanti-ST2 (IgG2) human monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 Yes
    D.3.11.13.1Other medicinal product typehuman immunoglobulin (Ig) G2 monoclonal antibody
    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
    Chronic Obstructive Pulmonary Disease (COPD)
    Chronische Obstructieve Longziekte (COL)
    E.1.1.1Medical condition in easily understood language
    COPD is a chronic lung disease that causes increasing airflow obstruction in the lungs, resulting in breathlessness and cough, and in some people causing disease flares or exacerbations.
    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 LLT
    E.1.2Classification code 10077773
    E.1.2Term Chronic obstructive pulmonary disease exacerbation
    E.1.2System Organ Class 100000004855
    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 astegolimab compared with placebo, on annualized rate of moderate and severe acute exacerbations of COPD over 52 weeks of treatment
    E.2.2Secondary objectives of the trial
    •To evaluate the effect of astegolimab compared with placebo on time to first moderate or severe COPD exacerbation
    •To evaluate the effect of astegolimab compared with placebo on St George’s Respiratory Questionnaire
    •To evaluate the effect of astegolimab compared with placebo on post-bronchodilator forced expiratory volume in 1 second (FEV1)
    •To evaluate the effect of astegolimab compared with placebo on Evaluating Respiratory Symptoms in COPD (E-RS:COPD)
    •To evaluate the effect of astegolimab compared with placebo on annualized rate of severe COPD exacerbations
    •To evaluate the effects of astegolimab compared with placebo on safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Signed Informed Consent Form
    •Age 40-90 years at time of signing Informed Consent Form
    •Ability to comply with the study protocol
    •Documented physician diagnosis of COPD made at least 12 months prior to screening
    •History of frequent exacerbations, defined as having had two or more moderate or severe
    exacerbations occurring within a 12-month period in the 24 months prior to screening. Exacerbations should have been treated with systemic corticosteroids and/or antibiotics. A moderate COPD exacerbation is defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) that lead to treatment (duration => 3 days) with systemic corticosteroids (oral, IV, or IM) at a dose of >10 mg/day prednisolone equivalent and/or antibiotics. Prior use of antibiotics alone does not qualify as a moderate exacerbation, unless the use was specifically for the treatment of worsening symptoms of COPD. A severe COPD exacerbation is defined as new or increased COPD symptoms that lead to hospitalization (duration >24 hours) or lead to or death.
    •Post-bronchodilator FEV1 =>20 and <80% of predicted normal value at screening, as verified by over-reader
    •Post-bronchodilator FEV1/FVC < 0.70 at screening, as verified by over-reader
    •mMRC score => 2 at screening
    •Current smoker or former smoker with a minimum of 10 pack-year history (e.g., 20 cigarettes/day for 10 years) A former smoker is defined as meeting the criteria above but has not used inhaled tobacco products or inhaled marijuana within 6 months prior to screening, through use of cigarettes, cigars, electronic cigarettes, vaporizing devices, or pipe. Note that at screening, patients who meet the protocol definition of current smoker will receive smoking cessation counseling.
    •History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) => 500 mcg/day fluticasone propionate dose-equivalent plus long-acting beta-agonist (LABA). – Long-acting muscarinic antagonist (LAMA) plus LABA. – ICS => 500 mcg/day fluticasone propionate dose-equivalent plus LAMA plus LABA
    •Demonstrated ability to use and comply with electronic diary (eDiary) requirements, defined as completion of all questions on at least 5 out of 7 consecutive days within the 14 days after the screening visit Patients unable to demonstrate compliance with the eDiary within the first 2 weeks of screening will be screen failed. Patients will have the opportunity to demonstrate eDiary compliance if re-screened.
    •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for 12 weeks after the final dose of Astegolimab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (=> 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
    •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 12 weeks after the final dose of Astegolimab to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence.
    E.4Principal exclusion criteria
    Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug. Women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test on Day 1 prior to initiation of study drug.
    •Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
    •History of clinically significant pulmonary disease other than COPD (e.g., pulmonary, fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency)
    •Clinically significant abnormalities requiring clinical follow-up as indicated by chest X-ray or chest CT scan performed within 6 months prior to screening Chest X-ray must be performed at screening if results from a chest X-ray or chest CT scan performed within 6 months prior to screening are not available.
    •Presence of risk factors for aspiration pneumonia (e.g., neurologic disease such as uncontrolled epilepsy) in the opinion of the investigator
    •History of long-term treatment with oxygen at > 4.0 liters/minute. While breathing supplemental oxygen, patient should demonstrate an oxyhemoglobin saturation of => 89%.
    •History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the study drug
    •Lung volume reduction surgery or procedure within 12 months prior to screening
    •Participation in or planned participation in a new pulmonary rehabilitation program within 4 weeks prior to screening and throughout the study treatment period. Patients who are in the maintenance phase of a rehabilitation program are eligible.
    •History of lung transplant
    •Occurrence of protocol-defined moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of => 24 hours duration within 4 weeks prior to initiation of study drug
    •Any prior treatment with Astegolimab
    •Treatment with oral, IV, or IM corticosteroids (>10 mg/day prednisolone equivalent) within 4 weeks prior to initiation of study drug
    •Treatment with investigational therapy within 3 months or 5 drug-elimination half-lives (whichever is longer) prior to screening
    •Treatment with a licensed biologic agent (e.g., omalizumab, dupilumab, and/or anti-IL-5 therapies) within 3 months or 5 drug-elimination half-lives (whichever is longer) prior to screening
    •Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks prior to screening
    •Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening
    •Treatment that is considered palliative (e.g., for life expectancy <12 months)
    •Use of any of the following treatments within 4 weeks prior to screening, or any condition that is likely to require such treatment during the course of the study, unless the treatment is deemed acceptable by the investigator, in consultation with the Medical Monitor: – Treatment with immunoglobulin or blood products. – Treatment with any live or attenuated vaccine (including any approved, live SARS-CoV-2 vaccine) within 4 weeks prior to screening or during the screening period, or anticipated need for live, attenuated vaccine during the course of the study, unless the vaccine is deemed medically necessary and no inactivated vaccine alternatives are available.
    •Administration of non-live SARS-CoV-2 vaccine (with full marketing authorization or temporary), including those delivered by non-replicating viral vectors, within 7 days prior to initiation of study drug
    •Planned surgical intervention during the study
    •Positive hepatitis C virus (HCV) antibody test result accompanied by a positive HCV RNA test at screening
    •Unacceptable test results for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and total hepatitis B core antibody (HBcAb) at screening, defined as meeting either of the following criteria: – Positive HBsAg test at screening. – Negative HBsAg test at screening, with negative HBsAb test accompanied by positive total HBcAb test, followed by quantitative hepatitis B virus (HBV) DNA => 20 IU/mL.
    Inability to perform HBV DNA test is exclusionary. Patients with a negative HBsAg test and positive HBsAb test are eligible.
    •Known immunodeficiency including, but not limited to, HIV infection
    •Known evidence of active or untreated latent tuberculosis
    •Substance abuse, as determined by the investigator, within 12 months prior to screening
    •History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, or ductal carcinoma in situ
    E.5 End points
    E.5.1Primary end point(s)
    1.Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Week 52
    E.5.2Secondary end point(s)
    1. Time to first moderate or severe COPD exacerbation during the 52-week treatment period
    2. Absolute change from baseline in HRQoL at Week 52, as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score
    3. Proportion of patients with improvement in HRQoL, defined as a decrease from baseline of >/=4 points in SGRQ-C total score, at Week 52
    4. Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52
    5. Absolute change from baseline in E-RS:COPD total score at Week 52
    6. Annualized rate of severe COPD exacerbations over the 52-week treatment period
    7. Incidence and severity of adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to Week 52
    2-5. Baseline to Week 52
    6. Up to Week 52
    7. Up to Week 62
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and Biomarker
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA122
    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
    Chile
    Hong Kong
    Israel
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    South Africa
    United States
    Austria
    Belgium
    Bulgaria
    Denmark
    France
    Germany
    Netherlands
    Poland
    Romania
    Spain
    Sweden
    United Kingdom
    Czechia
    Argentina
    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
    last patient, last visit (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 465
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 465
    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 455
    F.4.2.2In the whole clinical trial 930
    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)
    Patients may be eligible for an Open Label Extension (OLE) with 1 year of treatment with Astegolimab following the end of the study if the OLE is open and available in their country. If participation in the OLE is not available for any reason, the subject would be switched back to their COPD 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 Decision2021-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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