Chronic Obstructive Pulmonary DiseasePhase 3ROMEONCT07566195
Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations
A Phase 3 study testing Tozorakimab Dose Regimen 1 and Tozorakimab Dose Regimen 2 in people with Chronic Obstructive Pulmonary Disease and COPD, run by AstraZeneca at 13 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Tozorakimab Dose Regimen 1 and Tozorakimab Dose Regimen 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 13 sitesFrance
- Study dates
- 5 May 2026to 29 Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants previously randomized in predecessor studies.
- Participants should be affiliated with the French Social Security system.
- Participants who are willing to continue using contraceptive methods as agreed to for the predecessor studies.
- Capable of giving signed informed consent.
Who cannot join
- Clinically important pulmonary disease other than COPD.
- Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
- Current alcohol, drug or chemical abuse.
- Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO.
- Known history of:
- Severe allergic reaction to any monoclonal and polyclonal antibody.
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- Allergy or reaction to any component of the IMP formulation.
- Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO.
- Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO.
- 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.
- 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.
- 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.
- Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration).
- 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.
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
13 sites in 1 country
France13 sites, 5 recruiting
- Active, not recruiting
Research Site
Aix-en-Provence, 13616
- Active, not recruiting
Research Site
Brest, 29609
- Withdrawn
Research Site
Colmar, 68024
- Active, not recruiting
Research Site
Gleizé, 69400
- Recruiting
Research Site
Grenoble, 38043
- Recruiting
Research Site
Lyon, 69317
- Recruiting
Research Site
Marseille, 13015
- Recruiting
Research Site
Montpellier, 34295
- Recruiting
Research Site
Pessac, 33600
- Active, not recruiting
Research Site
Pringy, 74374
- Active, not recruiting
Research Site
Quimper, 29000
- Active, not recruiting
Research Site
Saint-Herblain, 44800
- Active, not recruiting
Research Site
Toulouse, 31000
About this study
Official title: A Phase III, Multicentre, Open-Label, Chronic Dosing, Extension Study to Evaluate the Long-term Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (ROMEO)
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.
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- Tozorakimab Dose Regimen 1, Tozorakimab Dose Regimen 2
- Keywords
- Tozorakimab, MEDI3506, Chronic Obstructive Pulmonary Disease, COPD, Exacerbations, Safety, Biologic, Biologic Treatment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tozorakimab Dose Regimen 1Drug
Participants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen
Tozorakimab Dose Regimen 2Drug
Participants previously randomised in the TITANIA or PROSPERO predecessor studies will receive Tozorakimab in ROMEO according to this dose regimen
| Study group | Role | What they receive |
|---|---|---|
| Tozorakimab Dose Regimen 1 | Experimental | Subcutaneous injection of Tozorakimab via a pre-filled syringe. Receives: Drug: Tozorakimab Dose Regimen 1 |
| Tozorakimab Dose Regimen 2 | Experimental | Subcutaneous injection of Tozorakimab via a pre-filled syringe. Receives: Drug: Tozorakimab Dose Regimen 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
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.
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start5 May 2026
- Primary completion29 Dec 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact, Multihealth Group, Contract Research Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566195
- Sponsor's protocol ID
- D9180C00015
- Other IDs
- 2025-523690-41-00, 2025
- Acronym
- ROMEO
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.