Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations (ROMEO)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; COPD
• Intervention / Treatment: Drug: Tozorakimab Dose Regimen 1; Drug: Tozorakimab Dose Regimen 2

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• France
  • Aix-en-Provence, France, 13100
    • Not yet recruiting
    • Research Site
  • Brest, France, 29200
    • Recruiting
    • Research Site
  • Colmar, France, 68024
    • Withdrawn
    • Research Site
  • Epagny Metz Tessy, France, 74370
    • Recruiting
    • Research Site
  • Grenoble, France, 38043
    • Recruiting
    • Research Site
  • Lyon, France, 69317
    • Recruiting
    • Research Site
  • Marseille, France, 13015
    • Not yet recruiting
    • Research Site
  • Montpellier, France, 34090
    • Recruiting
    • Research Site
  • Pessac, France, 33600
    • Not yet recruiting
    • Research Site
  • Quimper, France, 29107
    • Not yet recruiting
    • Research Site
  • Saint-Herblain, France, 44800
    • Recruiting
    • Research Site
  • Toulouse, France, 31400
    • Not yet recruiting
    • Research Site
  • Villefranche-sur-Saône, France, 69655
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tozorakimab Dose Regimen 1; Subcutaneous injection of Tozorakimab via a pre-filled syringe.	Drug: Tozorakimab Dose Regimen 1; Participants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen
Experimental: Tozorakimab Dose Regimen 2; Subcutaneous injection of Tozorakimab via a pre-filled syringe.	Drug: Tozorakimab Dose Regimen 2; Participants previously randomised in the TITANIA or PROSPERO predecessor studies will receive Tozorakimab in ROMEO according to this dose regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2-3 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Clinact, Multihealth Group; Contract Research Organization

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2026
• Primary Completion (Estimated): December 29, 2028
• Study Completion (Estimated): December 29, 2028

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Safety; COPD; Biologic; Chronic Obstructive Pulmonary Disease; MEDI3506; Exacerbations; Tozorakimab; Biologic Treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D9180C00015; 2025-523690-41-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at :

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes