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

NCT07566195 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: D9180C000152025-523690-41-00
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

Tozorakimab; MEDI3506; Chronic Obstructive Pulmonary Disease; COPD; Exacerbations; Safety; Biologic; Biologic Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tozorakimab Dose Regimen 1

EXPERIMENTAL

Subcutaneous injection of Tozorakimab via a pre-filled syringe.

Drug: Tozorakimab Dose Regimen 1

Tozorakimab Dose Regimen 2

EXPERIMENTAL

Subcutaneous injection of Tozorakimab via a pre-filled syringe.

Drug: Tozorakimab Dose Regimen 2

Interventions

Tozorakimab Dose Regimen 1 DRUG

Participants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen

Tozorakimab Dose Regimen 1

Tozorakimab Dose Regimen 2 DRUG

Participants previously randomised in the TITANIA or PROSPERO predecessor studies will receive Tozorakimab in ROMEO according to this dose regimen

Tozorakimab Dose Regimen 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Clinact, Multihealth Group: collaborator
• Contract Research Organization: collaborator
• AstraZeneca: lead

Study Sites (13)

Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix- Pertuis

Aix-en-Provence, 13100, France

Location

Centre Hospitalier Regional Et Universitaire De Brest

Brest, 29200, France

Location

Centre Hospitalier de Colmar

Colmar, 68024, France

Location

Centre Hospitalier Annecy Genevois

Epagny Metz-Tessy, 74370, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38043, France

Location

Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Centre Hospitalier Regional De Marseille

Marseille, 13015, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34090, France

Location

Centre Hospitalier Universitaire de Bordeaux

Pessac, 33600, France

Location

Centre Hospitalier Intercommunal De Cornouaille

Quimper, 29107, France

Location

Centre Hospitalier Universitaire De Nantes

Saint-Herblain, 44800, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31400, France

Location

Les Hopitaux Nord-Ouest

Villefranche-sur-Saône, 69655, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 4, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 29, 2028
• Study Completion (Estimated): December 29, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

FR (13)