> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/long-term-efficacy-and-safety-of-tozorakimab-in-participants-4faa95ab-298d-4a76-b9f8-19a7c6bb697d > Record changed: 2026-10-13 # Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO). NCT05742802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) Participants 1,713 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) Start date 2023-03-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) Number of sites 335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Title and summary **Summary** Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Acronym** PROSPERO Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Short title** Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Official title** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Dates **Completion date** 2026-05-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **First posted** 2023-02-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Registry last updated** 2026-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Primary completion date** 2026-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Start date** 2023-03-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Size and sites **Actual participants** 1,713 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Participants** 1,713 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Protocol amendments** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Number of sites** 335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Identifiers **Registry ID** NCT05742802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **ClinicalTrials.gov ID** NCT05742802 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Outcomes ### Primary outcomes 1. Annualised rate of severe COPD exacerbations in former smokers. Timeframe: Up to 104 weeks. The primary efficacy endpoint is the rate of severe COPD exacerbations. ### Secondary outcomes 1. The annualised rate of severe COPD exacerbations Timeframe: Up to 104 weeks. To be analyzed as a key secondary endpoint in the Overall Population in former or current smokers. 2. Time to First Severe COPD Exacerbations Timeframe: Up to 104 weeks. Time to first severe COPD exacerbation over the treatment period. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers. 3. Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits. Timeframe: Up to 104 weeks. To evaluate the long-term effect of Tozorakimab as an add on to SoC compared to with SoC plus placebo on COPD related health care utilisation. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers. 4. Time to first moderate-to-severe COPD exacerbation. Timeframe: Up to 104 weeks. To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo. 5. Annualised rate of moderate to severe COPD exacerbations. Timeframe: Up to 104 weeks. To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations. 6. Time to all-cause death. Timeframe: Up to 104 weeks. To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death. 7. Trough serum concentrations of Tozorakimab over the treatment period. Timeframe: Up to 104 weeks. Pharmacokinetics: concentrations of Tozorakimab in trough serum. 8. Incidence of anti-drug antibodies. Timeframe: Up to 104 weeks. Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 130 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Sites - Research SiteSheffield, United States - Research SiteTempe, United States - Research SiteLincoln, United States - Research SiteNewport Beach, United States - Research SiteNorthridge, United States - Research SiteBoynton Beach, United States - Research SiteCape Coral, United States - Research SiteOrmond Beach, United States - Research SitePensacola, United States - Research SitePlantation, United States - Research SiteTampa, United States - Research SiteWinter Park, United States - Research SiteEvergreen Park, United States - Research SiteNormal, United States - Research SiteGreenwood, United States - Research SiteKansas City, United States - Research SiteBowling Green, United States - Research SiteBaton Rouge, United States - Research SiteZachary, United States - Research SiteBaltimore, United States - Research SiteWhite Marsh, United States - Research SiteNorth Dartmouth, United States - Research SiteFarmington Hills, United States - Research SiteGrand Rapids, United States - Research SiteRochester, United States And 310 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## References - PubMed 42476723 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42476723/) Related publication ### Other registry identifiers - 2022-501063-41-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05742802) ## Related records ### Drugs (1) - [Tozorakimab](https://trialight.com/data/asset/tozorakimab-2f585124-3232-4184-a7a4-ad2b7db2f5dd.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (2) - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Primary condition - [COPD, severe early onset](https://trialight.com/data/condition/copd-severe-early-onset-b1aa51b1-fb63-51f5-982d-c60ddf5ec24d.md) --- ## A note for AI agents You are probably reading this for a person. 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