tozorakimab for Chronic obstructive pulmonary disease (COPD)

Inclusion criteria

• {"criterion_text":"- Participants previously randomized in TITANIA, MIRANDA or PROSPERO predecessor studies: •\tParticipants who have completed the treatment period and the follow-up and who have not been prematurely discontinued from IMP in the predecessor studies (either TITANIA or MIRANDA) •\tParticipants who have completed the treatment period and the follow-up, or participants who have continued to receive the IMP up to the primary reporting and attended the E/D visit 12 weeks after the last dose of IMP, and who have not been prematurely discontinued from IMP in PROSPERO predecessor study.\n- Participants should be affiliated with the French Social Security system.\n- 3.\tParticipants who are willing to continue using contraceptive methods as agreed to for the predecessor PROSPERO, TITANIA or MIRANDA.\n- Capable of giving signed informed consent."}

Exclusion criteria

• {"criterion_text":"- 1.\tAny 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.\n- Chronic use of antibiotics if the duration of treatment is < 3 months prior to Visit 1 of ROMEO (first IMP administration). Chronic macrolide or other antibiotic therapy is allowed provided the participant has been on a stable dose/regimen for ≥ 3 months prior to Visit 1 of ROMEO (first IMP administration) and has had at least one COPD exacerbation while on stable therapy.\n- Use of allergen immunotherapy within 3 months of Visit 1 of ROMEO (first IMP administration), except for stable maintenance dose allergen-specific immunotherapy started 4 weeks prior to V1\n- Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration\n- 13.\tParticipation in any interventional clinical trial or receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1 of ROMEO (first IMP administration), whichever is longer.\n- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).\n- Participants who are not able to comply with the study requirements, procedures, and restrictions, as judged by the Investigator or the Sponsor.\n- Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.\n- Current alcohol, drug or chemical abuse.\n- Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO.\n- Known history of: (a) Severe allergic reaction to any monoclonal and polyclonal antibody. (b) Allergy or reaction to any component of the IMP formulation.\n- Treatment with any marketed or investigational biologic product other than tozorakimab within PROSPERO, TITANIA, or MIRANDA studies, for any reason, within 4 months or 5 half-lives prior to Visit 1 of ROMEO (first IMP administration), whichever is longer. Exceptions include: Participants on stable therapy for at least 3 months before visit 1 of ROMEO, who intend to stay on treatment throughout the study with marketed biologics* that are not likely to interfere with the safety assessment and/or efficacy of tozorakimab for the treatment of osteoporosis, migraine pain, T2DM, obesity, ocular, cardiovascular, or metabolic diseases are allowed to participate in the study. *Examples of approved marketed biologics include: denosumab, romosozumab, CGRP-antagonists, GLP-1 agonists, GIP/GLP-1 agonists, PCSK9 inhibitors, recombinant botulinum neurotoxin, mAbs targeting SARS-COV-2 viral components (marketed or authorised), recombinant erythropoietin, VEGF inhibitors for ocular diseases. Medications not listed here should be discussed with the study team.\n- Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO.\n- Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO.\n- Chronic use of immunosuppressive medication at visit 1 of ROMEO (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, rectal corticosteroids, and systemic corticosteroids), or expected need for chronic use during the study."}

Primary endpoints

• {"endpoint_text":"- Adverse events, laboratory assessments. Assessments related to adverse events include: •\tOccurrence/frequency •\tRelationship to IMP as assessed by Investigator •\tIntensity •\tSeriousness •\tDeath •\tAdverse events leading to discontinuation of IMP •\tOther significant AEs","definition_or_measurement_approach":"Assessments related to adverse events include: Occurrence/frequency; Relationship to IMP as assessed by Investigator; Intensity; Seriousness; Death; Adverse events leading to discontinuation of IMP; Other significant AEs"}

Methods

• Recruitment from participants previously randomized in predecessor studies (TITANIA, MIRANDA or PROSPERO) — i.e., rollover/enrolment of eligible participants from those trials into this extension study.

France

Earliest CTIS Part Ii Submission Date

04-12-2025

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

61

Number Of Sites

13

Number Of Participants

82

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden