Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary D… (NCT05742802) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
United States1,713 participantsStarted 2023-03-06
Plain-language summary
Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.
Who can participate
Age range40 Years – 130 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
✓. Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
✓. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
✓. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
✓. Capable of giving signed informed consent.
Exclusion criteria
✕. Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.
✕. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
✕. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
✕. Known history of:
✕. Severe allergic reaction to any monoclonal and polyclonal antibody.
What they're measuring
1
Annualised rate of severe COPD exacerbations in former smokers.
. Allergy or reaction to any component of the IP formulation.
✕. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
✕. Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).