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

Sponsor
AstraZeneca
Study ID
NCT07566195
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
May 4, 2026
Start date
May 5, 2026
Status verified
Jul 2026
Primary completion
Dec 29, 2028
Completion
Dec 29, 2028

Study Design

Enrollment
59 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tozorakimab Dose Regimen 1
    Subcutaneous injection of Tozorakimab via a pre-filled syringe.
  • Experimental: Tozorakimab Dose Regimen 2
    Subcutaneous injection of Tozorakimab via a pre-filled syringe.

Primary Outcome Measure

Adverse events [ Time Frame: 2-3 years ]

Central Contacts

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