A Phase III, Multicentre, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (Oberon)
- Conditions
- (Chronic Obstructive Pulmonary Disease)chronic bronchitisCOPD10024967
- Registration Number
- NL-OMON54370
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 38
1. Participant must be >= 40 years of age and capable of giving signed informed
consent.
2. Documented diagnosis of COPD for at least one year prior to enrolment.
3. Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.
4. Documented history of >= 2 moderate or >= 1 severe COPD exacerbations within
12 months prior to enrolment.
5. Documented optimized dual or triple treatment with COPD and at a stable dose
for at least 3 months prior to enrolment.
6. Smoking history of >= 10 pack-years.
7. CAT total score >=10, with each of the phlegm (sputum) and cough items >= 2.
1. Clinically important pulmonary disease other than COPD.
2. Radiological findings suggestive of a respiratory disease other than COPD
that is significantly contributing to the participant*s respiratory symptoms.
3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD
overlap. Childhood history of asthma is allowed and defined as asthma diagnosed
and resolved before the age of 18.
4. Any unstable disorder, including, but not limited to, cardiovascular,
gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious,
endocrine, metabolic, haematological, psychiatric disorder, major physical
and/or cognitive impairment that could affect safety, study findings or
participants ability to complete the study.
5. COPD exacerbation, within 2 weeks prior to randomization, that was treated
with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
6. Active significant infection within the 4 weeks prior to randomization,
pneumonia within 6 weeks prior to randomization, or medical condition that
predisposes the participant to infection.
7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
8. Significant COVID-19 illness within the 6 months prior to enrolment.
9. Unstable cardiovascular disorder.
10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right
ventricular failure.
11. History of known immunodeficiency disorder, including a positive test for
HIV-1 or HIV 2.
12. Medical history or treatment for hepatitis B or hepatitis C, except for
cured hepatitis C.
13. Evidence of active liver disease, including jaundice during screening.
14. Malignancy, current or within the past 5 years, except for adequately
treated non-invasive basal cell and squamous cell carcinoma of the skin and
cervical carcinoma-in-situ treated with apparent success more than one year
prior to enrolment. Suspected malignancy or undefined neoplasms.
15. Participants who have evidence of active TB.
16. Participants that have previously received Tozorakimab.
17. Any clinically significant abnormal findings in physical examination, vital
signs, ECG, or laboratory testing during the screening period, which in the
opinion of the investigator may put the participant at risk because of their
participation in the study, or may influence the results of the study, or the
participant*s ability to complete the entire duration of the study.
18. Active vaping of any products or using smoked marijuana within the 6 months
prior to randomization and during the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the effect of 2 dose regimens of Tozorakimab as add on to SoC<br /><br>compared with SoC plus placebo on the rate of moderate to severe COPD<br /><br>exacerbations in former smokers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key Secondary Endpoints:<br /><br>- To evaluate the effect of 2 dose regimens of Tozorakimab as add on to SoC<br /><br>compared with SoC plus placebo on the rate of moderate to severe COPD<br /><br>exacerbation in former and current smokers.<br /><br>- To evaluate the effect of 2 dose regimens of Tozorakimab as add on to SoC<br /><br>compared with SoC plus placebo on change in pre-BrochoDilator lung function.<br /><br>- To evaluate the effect of 2 dose regimens of Tozorakimab as add on to SoC<br /><br>compared with SoC plus placebo on respiratory symptoms.<br /><br>- To evaluate the effect of 2 dose regimens of Tozorakimab as add on to SoC<br /><br>compared with SoC plus placebo on respiratory health status/health-related<br /><br>quality of life.</p><br>