Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a Hi… (NCT06040086) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
United States1,454 participantsStarted 2023-09-22
Plain-language summary
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.
Who can participate
Age range40 Years – 130 Years
SexALL
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Inclusion criteria
✓. Participant must be ≥ 40 years of age and capable of giving signed informed consent.
✓. Documented diagnosis of COPD for at least one year prior to enrolment.
✓. Post BD FEV1/FVC \< 0.70 and post-BD FEV1 \>20% of predicted normal value
✓. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
✓. Documented optimised inhaled dual or triple therapy for at least 3 months prior to enrolment.
✓. Smoking history of ≥ 10 pack-years.
✓. CAT total score ≥ 10, with each of the phlegm (sputum) and cough items with a score ≥ 2
Exclusion criteria
✕. Clinically important pulmonary disease other than COPD.
✕. 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 randomisation. Radiological findings suggestive of acute infection.
✕. 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
✕. 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.
What they're measuring
1
Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
✕. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
✕. 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.
✕. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
✕. Significant COVID-19 illness within the 6 months prior to enrolment.