Chronic Obstructive Pulmonary Disease, COPD
Conditions
Keywords
Tozorakimab, MEDI3506, Chronic Obstructive Pulmonary Disease, COPD, Exacerbations, Safety, Biologic, Biologic Treatment
Brief summary
ROMEO is a Phase III, multicentre, open-label, chronic-dosing extension study evaluating the long-term safety of two dose regimens of tozorakimab in participants with COPD and a history of exacerbations. Eligible participants must have completed one of the predecessor studies.
Interventions
DRUGTozorakimab Dose Regimen 1
Participants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen
DRUGTozorakimab Dose Regimen 2
Participants previously randomised in the TITANIA or PROSPERO predecessor studies will receive Tozorakimab in ROMEO according to this dose regimen
Sponsors
AstraZeneca
Clinact, Multihealth Group
Contract Research Organization
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label, long-term extension study with two treatment arms corresponding to two dose regimens of tozorakimab, based on allocation in the predecessor studies
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Participants previously randomized in predecessor studies. 2. Participants should be affiliated with the French Social Security system. 3. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor studies. 4. Capable of giving signed informed consent.
Exclusion criteria
1. Clinically important pulmonary disease other than COPD. 2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor. 3. Current alcohol, drug or chemical abuse. 4. Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO. 5. Known history of: 1. Severe allergic reaction to any monoclonal and polyclonal antibody. 2. Allergy or reaction to any component of the IMP formulation. 6. Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO. 7. Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO. 8. 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. 9. 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. 10. 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. 11. Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration). 12. Participation 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. 13. 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). 14. Participants who are not able to comply with the study requirements, procedures, and restrictions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 2-3 years | Assessments related to AEs include: Occurrence/frequency, Relationship to IMP as assessed by Investigator, Intensity, Seriousness, Death, AEs leading to discontinuation of IMP, Other significant AEs. Medically significant abnormal laboratory results will be reported as AEs. |
Countries
France
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed