A study to assess Astegolimab in participants with chronic obstructive pulmonary disease (COPD)
Résumé de l'étude
The aim of this study is to assess the efficacy and safety of Astegolimab compared to a placebo that looks like a medication but contains no active ingredients, in participants with COPD who are former or current smokers and have a history of more frequent exacerbations of symptoms. It is expected that approximately 1290 participants with COPD will be enrolled in the study worldwide. The study drug Astegolimab is a monoclonal antibody. Monoclonal antibodies are proteins of the immune system that are manufactured in the laboratory. Antibodies are naturally produced by your body and help the immune system recognize and mark disease-causing germs for destruction. Like the body's own antibodies, monoclonal antibodies also recognize specific targets. Astegolimab blocks the activity of interleukin-33 (IL-33), a protein released by airway cells in response to viral infections, allergens, irritants, and other triggers of COPD exacerbations. In this study, the pre-screening phase (to determine if you qualify for the study) lasts at least 7 days and up to 4 weeks. The treatment period is 50 weeks, followed by a 12-week safety follow-up period. The total duration of study participation is expected to be a maximum of 15 months or 66 weeks for each person.
(BASEC)
Intervention étudiée
After passing the pre-screening, participants will be randomly assigned, in a ratio of 1:1:1, to one of 3 treatment groups, where they will receive either Astegolimab (groups 1 and 2) or the placebo (group 3). The probability of being assigned to one of the 3 treatment groups is equal and is 33.3%. This is a blinded study, meaning that neither the patient nor the investigator will know which treatment the patient is receiving. The treatment regimens for each group are as follows: 1. Participants receive Astegolimab as a subcutaneous injection every 2 weeks 2. Participants receive Astegolimab as a subcutaneous injection every 4 weeks 3. Participants receive the placebo as a subcutaneous injection every 2 weeks. To ensure that all study participants follow the same visit schedule, participants assigned to treatment group 2 will receive alternating injections of Astegolimab and placebo, thus receiving Astegolimab every 4 weeks.
(BASEC)
Maladie en cours d'investigation
Chronic obstructive pulmonary disease (COPD)
(BASEC)
- Men or non-pregnant women aged 40-80 years at the 1st visit - Documented diagnosis of COPD for ≥ 12 months prior to the 1st visit - History of frequent exacerbations of symptoms, defined as 2 or more moderate or severe COPD exacerbations within 12 months prior to pre-screening - Forced expiratory volume in 1 second (FEV1) after bronchodilation ≥ 20% and < 80% of predicted at pre-screening - Forced expiratory volume in 1 second / forced vital capacity (FEV1 / FVC) after bronchodilation < 0.70 at pre-screening - Current cigarette smoker or former smoker with a smoking history of ≥ 10 pack-years (e.g., one pack of 20 cigarettes per day for 10 years or half a pack per day over a period of 20 years) (BASEC)
Critères d'exclusion
- Current documented diagnosis of asthma - Significant lung disease diagnosed by a physician in the medical history (other than COPD) - Diagnosis of alpha-1-antitrypsin deficiency - Long-term treatment with oxygen > 4.0 liters/minute in the medical history - Surgery or procedure to reduce lung volume within 12 months prior to pre-screening - Individuals participating in an intensive COPD rehabilitation program or scheduled for it (participants in the maintenance phase of a rehabilitation program are eligible) (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
F. Hoffmann-La Roche Ltd
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Peter Worff
+41 79 313 78 71
switzerland.clinical-research@clutterroche.comPPD Switzerland GmbH
(BASEC)
Informations générales
Hoffmann-La Roche,
888-662-6728
switzerland.clinical-research@clutterroche.com(ICTRP)
Informations générales
Hoffmann-La Roche
888-662-6728
switzerland.clinical-research@clutterroche.com(ICTRP)
Informations scientifiques
Hoffmann-La Roche,
888-662-6728
switzerland.clinical-research@clutterroche.com(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
15.08.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05595642 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (BASEC)
Titre académique
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease (ICTRP)
Titre public
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (ICTRP)
Maladie en cours d'investigation
Chronic Obstructive Pulmonary Disease (COPD) (ICTRP)
Intervention étudiée
Drug: AstegolimabDrug: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria
- Documented COPD diagnosis for = 12 months
- History of frequent exacerbations, defined as having had 2 or more moderate or
severe COPD exacerbations within 12 months prior to screening
- Post-bronchodilator FEV1 = 20% and < 80% of predicted at screening
- Post-bronchodilator FEV1/FVC < 0.70 at screening
- Modified Medical Research Council (dyspnea scale) (mMRC) score = 2
- Current tobacco smoker or former smoker with a history of smoking = 10 pack-years
- On optimized COPD maintenance therapy as defined below for = 12 months prior to
screening, and stable on current therapy for at least 4 weeks prior to screening:
Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting
muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
- Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or
chest X-ray during the screening period that confirms the absence of clinically
significant lung disease besides COPD
Exclusion Criteria
- Current documented diagnosis of asthma
- History of clinically significant pulmonary disease other than COPD
- Diagnosis of 1-antitrypsin deficiency
- History of long-term treatment with oxygen at > 4.0 liters/minute
- Lung volume reduction surgery or procedure within 12 months prior to screening
- Individuals participating in, or scheduled for, an intensive COPD rehabilitation
program (participants who are in the maintenance phase of a rehabilitation program
are eligible)
- History of lung transplant
- Any infection that resulted in hospital admission for = 24 hours and/or treatment
with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
- Upper or lower respiratory tract infection within 4 weeks prior to or during
screening
- Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of
study drug
- Initiation of or change in non-biologic immunomodulatory or immunosuppressive
therapy within 3 months prior to screening
- Unstable cardiac disease, myocardial infarction, or New York Heart Association Class
III or IV heart failure within 12 months prior to screening (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period (ICTRP)
Time to first moderate or severe COPD exacerbation during the 52-week treatment period;Absolute change from baseline in health-related quality of life (HRQoL) at Week 52 as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score;Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52;Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52;Proportion of participants with improvement in HRQoL at Week 52;Annualized rate of severe COPD exacerbations over the 52-week treatment period (ICTRP)
Date d'enregistrement
24.10.2022 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Clinical Trials;Reference Study ID Number: GB44332 https://forpatients.roche.com/, global-roche-genentech-trials@gene.com, 888-662-6728, Hoffmann-La Roche, (ICTRP)
ID secondaires
GB44332 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05595642 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible