A Study to Investigate Efficacy and Safety of Tozorakimab Injections Compared With Placebo in Adu… (NCT06897748) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Investigate Efficacy and Safety of Tozorakimab Injections Compared With Placebo in Adult Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations and Elevated Eosinophils
Russia98 participantsStarted 2025-04-12
Plain-language summary
The purpose of this study is to investigate lung function parameters, composite endpoint for exacerbations in chronic obstructive pulmonary disease (COPDCompEx), symptoms and to provide safety information after tozorakimab or placebo administrations in participants with symptomatic chronic obstructive pulmonary disease (COPD) with history of exacerbations and high blood eosinophil counts.
Study details include the following:
* The maximum duration of the screening/run-in period is 5 weeks. An additional unscheduled visit may be performed prior to randomization to repeat safety assessments as deemed necessary by the investigator.
* Eligible patients will enter 12-week treatment (intervention) period with site visits and investigational product (IP) administration every 2 weeks.
* Participants who complete a treatment period, and have not been prematurely discontinued from IP, will enter a 10-week post-intervention follow-up period.
* The study duration will be 27 weeks at maximum for each participant.
Who can participate
Age range40 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% and \< 80% 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.
✓. All participants must have eosinophil blood count ≥ 150 cells/µL.
Exclusion criteria
✕. Clinically important pulmonary disease other than COPD.
✕
What they're measuring
1
Change From Baseline to Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV1) as Measured in Clinic
. 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.
✕. 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.
✕. Significant COVID-19 illness within the 6 months prior to enrolment.