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Study to assess efficacy, safety, and tolerability of Tozorakimab in patients with symptomatic chronic obstructive pulmonary disease (COPD) with a history of exacerbations.
EU CTIS ID: 2023-503572-24-00
What this study is testing
To evaluate the effect of 2 dose regimens of tozorakimab as addon to standard of care compared with standard of care plus placebo on the rate of moderate to severe exacerbations in former smokers.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.
- 6. Smoking history of ≥ 10 pack-years.
You likely can't join if
- 1. Clinically important pulmonary disease other than COPD.
- 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. History of positive test 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.
See the full eligibility criteria
- 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 inhaled dual or triple therapy 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 with a score ≥ 2
- 1. Clinically important pulmonary disease other than COPD.
- 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. History of positive test 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.
- 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, without appropriate follow up prior to randomization. Radiological findings suggestive of acute infection.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- China
- United States
- Colombia
- Australia
- Chile
- Peru
- United Kingdom
- Thailand
- Brazil
- Taiwan
- Israel
- Philippines
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; United States; Colombia; Australia; Chile; Peru and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.