A 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) (TITANIA)

  • STATUS
    Recruiting
  • End date
    Aug 28, 2025
  • participants needed
    1272
  • sponsor
    AstraZeneca
Updated on 27 October 2022

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.

Details
Condition Chronic Obstructive Pulmonary Disease (COPD)
Treatment Placebo, Tozorakimab (MEDI3506) Dose 1, Tozorakimab (MEDI3506) Dose 2, Tozorakimab
Clinical Study IdentifierNCT05158387
SponsorAstraZeneca
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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 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
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
Unstable cardiovascular disorder
Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure
History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2\
History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
Evidence of active liver disease, including jaundice during screening
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
Participants who have evidence of active TB
Participants that have previously received tozorakimab
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
Active vaping of any products within the 6 months prior to randomization and during the study
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