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Evaluating Tozorakimab for COPD patients with a history of exacerbations

A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).

Phase 3 Interventional AstraZeneca · NCT05742802

This study is testing if Tozorakimab can help adults with COPD who often have flare-ups feel better and have fewer symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1596 (estimated)
Ages40 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsTozorakimab
Locations388 sites (Huntsville, Alabama and 387 other locations)
Trial IDNCT05742802 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is designed to assess the long-term efficacy and safety of Tozorakimab in adults aged 40 and older who have chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Participants who have previously completed the OBERON or TITANIA studies will be invited to join this multicenter, double-blind, randomized, placebo-controlled extension study. The trial will compare the effects of Tozorakimab against a placebo to determine its effectiveness in managing symptoms and reducing exacerbations in COPD patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with symptomatic COPD who have completed prior studies without premature discontinuation.

Not a fit: Patients with significant comorbidities or those who have been withdrawn from previous studies may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of COPD and reduce the frequency of exacerbations for patients.

How similar studies have performed: Previous studies have shown promise in similar approaches, but the specific efficacy of Tozorakimab in this context is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
2. Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
5. Capable of giving signed informed consent.

Exclusion Criteria:

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 make the participation of the participant inappropriate.
2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
4. Known history of:

   1. Severe allergic reaction to any monoclonal and polyclonal antibody.
   2. Allergy or reaction to any component of the IP formulation.
5. 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.
6. 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).
7. Participants who are not able to comply with the study requirements, procedures, and restrictions.

Where this trial is running

Huntsville, Alabama and 387 other locations

+338 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary DiseaseCOPDTozorakimabMEDI3506exacerbationsICSLABA/LAMA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.