A Study to evaluate the long-term safety and tolerability of tozorakimab in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

4 May 2026 → ongoing

Decision date (initial)

2025-12-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacoeconomic, Safety, Therapy

To describe the long-term safety and tolerability of tozorakimab as an add on to standard of care.

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease (COPD)

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants previously randomized in TITANIA, MIRANDA or PROSPERO predecessor studies: • Participants who have completed the treatment period and the follow-up and who have not been prematurely discontinued from IMP in the predecessor studies (either TITANIA or MIRANDA) • Participants who have completed the treatment period and the follow-up, or participants who have continued to receive the IMP up to the primary reporting and attended the E/D visit 12 weeks after the last dose of IMP, and who have not been prematurely discontinued from IMP in PROSPERO predecessor study.
2. Participants should be affiliated with the French Social Security system.
3. 3. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor PROSPERO, TITANIA or MIRANDA.
4. Capable of giving signed informed consent.

Exclusion criteria 15

1. 1. Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment, which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise makes the participation of the participant inappropriate.
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: (a) Severe allergic reaction to any monoclonal and polyclonal antibody. (b) Allergy or reaction to any component of the IMP formulation.
6. Treatment with any marketed or investigational biologic product other than tozorakimab within PROSPERO, TITANIA, or MIRANDA studies, for any reason, within 4 months or 5 half-lives prior to Visit 1 of ROMEO (first IMP administration), whichever is longer. Exceptions include: Participants on stable therapy for at least 3 months before visit 1 of ROMEO, who intend to stay on treatment throughout the study with marketed biologics* that are not likely to interfere with the safety assessment and/or efficacy of tozorakimab for the treatment of osteoporosis, migraine pain, T2DM, obesity, ocular, cardiovascular, or metabolic diseases are allowed to participate in the study. *Examples of approved marketed biologics include: denosumab, romosozumab, CGRP-antagonists, GLP-1 agonists, GIP/GLP-1 agonists, PCSK9 inhibitors, recombinant botulinum neurotoxin, mAbs targeting SARS-COV-2 viral components (marketed or authorised), recombinant erythropoietin, VEGF inhibitors for ocular diseases. Medications not listed here should be discussed with the study team.
7. Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO.
8. Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO.
9. Chronic use of immunosuppressive medication at visit 1 of ROMEO (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, rectal corticosteroids, and systemic corticosteroids), or expected need for chronic use during the study.
10. 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.
11. 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
12. Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration
13. 13. 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.
14. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
15. Participants who are not able to comply with the study requirements, procedures, and restrictions, as judged by the Investigator or the Sponsor.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Adverse events, laboratory assessments. Assessments related to adverse events include: • Occurrence/frequency • Relationship to IMP as assessed by Investigator • Intensity • Seriousness • Death • Adverse events leading to discontinuation of IMP • Other significant AEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

Delphine LEYNAUD

Public contact point

Organisation

AstraZeneca AB

Contact name

Myriam WERENNE

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications