Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a Hi… (NCT05166889) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
United States1,132 participantsStarted 2022-01-03
Plain-language summary
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 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 optimized inhaled dual or triple therapy at a stable dose 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.
✕. 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.