A study to assess Astegolimab in participants with chronic obstructive pulmonary disease (COPD)
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Zürich
(BASEC)
Sponsor
F. Hoffmann-La Roche Ltd
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Peter Worff
+41 79 313 78 71
switzerland.clinical-research@clutterroche.comPPD Switzerland GmbH
(BASEC)
Allgemeine Auskünfte
Hoffmann-La Roche,
888-662-6728
switzerland.clinical-research@clutterroche.com(ICTRP)
Allgemeine Auskünfte
Hoffmann-La Roche
888-662-6728
switzerland.clinical-research@clutterroche.com(ICTRP)
Wissenschaftliche Auskünfte
Hoffmann-La Roche,
888-662-6728
switzerland.clinical-research@clutterroche.com(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
15.08.2023
(BASEC)
ICTRP Studien-ID
NCT05595642 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (ICTRP)
Untersuchte Krankheit(en)
Chronic Obstructive Pulmonary Disease (COPD) (ICTRP)
Untersuchte Intervention
Drug: AstegolimabDrug: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
24.10.2022 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Clinical Trials;Reference Study ID Number: GB44332 https://forpatients.roche.com/, global-roche-genentech-trials@gene.com, 888-662-6728, Hoffmann-La Roche, (ICTRP)
Sekundäre IDs
GB44332 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05595642 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar