Summary:
Phase III, Multicentre, Randomised, 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 (TITANIA)
Criteria:
- Participant must be ≥ 40 years of age at the time of signing the ICF
- 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 (as assessed by central spirometry at screening)
- Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations 1 within 12 months prior to enrolment:
(a) An exacerbation is considered moderate if it required treatment with systemic corticosteroids and/or antibiotics or resulted in ER visit < 24 hours requiring intensive treatment; and did not result in hospitalization or death. An exacerbation is considered severe if it required hospitalization (defined as an inpatient admission ≥ 24 hours in the hospital, in an observation area, emergency department, or other equivalent healthcare facility depending on the country and healthcare system).
(b) At least one qualifying exacerbation should have been treated with systemic corticosteroids.
(c) Events treated with antibiotics alone qualify as a moderate exacerbation only when antibiotic was specifically prescribed for worsening of COPD symptoms.
(d) Previous exacerbations should be confirmed to have occurred while the participant was on stable dual or triple (ICS/LABA/LAMA) maintenance inhaled therapy for COPD and not as a result of a gap or step down in the treatment.
(e) At least one qualifying exacerbation should have occurred while on the most recent stable uninterrupted therapy (see inclusion criterion 5(a) and section 6.5.2) prior to enrollment.
- Documented optimized treatment with COPD inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) and at a stable dose for at least 3 months prior to enrolment; Smoking history of ≥ 10 pack-years
- Able to read and use electronic devices.
Qualified Participants May Receive:
$75 per completed visit in clinic
Additional reimbursement for mileage and meals for each visit provided via direct deposit