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Recruiting NCT07566195

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

Phase III Interventional Chronic Obstructive Pulmonary Disease COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tozorakimab Dose Regimen 1, Tozorakimab Dose Regimen 2.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease, COPD. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

  • Drug Tozorakimab Dose Regimen 1
    Participants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen
  • 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

Primary outcome measures

  • Adverse events [Time frame: 2-3 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • Participants who are not able to comply with the study requirements, procedures, and restrictions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 13 centers
  • Research Site — Aix-en-Provence
  • Research Site — Brest
  • Research Site — Colmar
  • Research Site — Gleizé
  • Research Site — Grenoble
  • Research Site — Lyon
  • Research Site — Marseille
  • Research Site — Montpellier
  • … and 5 more centers

Identifiers

NCT: NCT07566195 · D9180C00015 · 2025-523690-41-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗