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Long-term Efficacy and Safety of Tozorakimab in Participants with Chronic Obstructive Pulmonary Disease with a History of Exacerbations.
EU CTIS ID: 2022-501063-41-00
What this study is testing
To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of severe COPD exacerbations in former smokers.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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- Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.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.
You likely can't join if
- 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 makes 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: (a) Severe allergic reaction to any monoclonal and polyclonal antibody. (b) 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).
See the full eligibility 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.
- 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 makes 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: (a) Severe allergic reaction to any monoclonal and polyclonal antibody. (b) 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).
- Participants who are not able to comply with the study requirements, procedures, and restrictions.
The study team makes the final eligibility decision.
Where it's taking place
- Philippines
- United States
- Canada
- Argentina
- India
- Mexico
- Brazil
- Vietnam
- Japan
- Taiwan
- Chile
- Colombia
- Australia
- China
- Turkey
- United Kingdom
- Peru
- Israel
- Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philippines; United States; Canada; Argentina; India; Mexico and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.