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

NCT07566195 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-05-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Clinact, Multihealth Group

    collaborator UNKNOWN

  • Contract Research Organization

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-05
Primary Completion
2028-12-29
Completion
2028-12-29
FDA Drug
Yes

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566195 on ClinicalTrials.gov