Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT05742802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2023-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1710}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2023-01-17', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualised rate of severe COPD exacerbations in former smokers.', 'timeFrame': 'Up to 104 weeks.', 'description': 'The primary efficacy endpoint is the rate of severe COPD exacerbations.'}], 'secondaryOutcomes': [{'measure': 'The annualised rate of severe COPD exacerbations', 'timeFrame': 'Up to 104 weeks.', 'description': 'To be analyzed as a key secondary endpoint in the Overall Population in former or current smokers.'}, {'measure': 'Time to First Severe COPD Exacerbations', 'timeFrame': 'Up to 104 weeks.', 'description': '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.'}, {'measure': 'Annualised rate of COPD exacerbations requiring hospitalisation and/or ER/ED visits.', 'timeFrame': 'Up to 104 weeks.', 'description': '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.'}, {'measure': 'Time to first moderate-to-severe COPD exacerbation.', 'timeFrame': 'Up to 104 weeks.', 'description': 'To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo.'}, {'measure': 'Annualised rate of moderate to severe COPD exacerbations.', 'timeFrame': 'Up to 104 weeks.', 'description': '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.'}, {'measure': 'Time to all-cause death.', 'timeFrame': 'Up to 104 weeks.', 'description': 'To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.'}, {'measure': 'Trough serum concentrations of Tozorakimab over the treatment period.', 'timeFrame': 'Up to 104 weeks.', 'description': 'Pharmacokinetics: concentrations of Tozorakimab in trough serum.'}, {'measure': 'Incidence of anti-drug antibodies.', 'timeFrame': 'Up to 104 weeks.', 'description': 'Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'COPD', 'Tozorakimab', 'MEDI3506', 'exacerbations', 'ICS', 'LABA/LAMA'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Participants who have completed the study treatment period and have not been prematurely discontinued from IP in one of the predecessor studies, 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 efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and with a history of exacerbations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.\n2. 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.\n3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.\n4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.\n5. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. 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.\n2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.\n3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.\n4. Known history of:\n\n 1. Severe allergic reaction to any monoclonal and polyclonal antibody.\n 2. Allergy or reaction to any component of the IP formulation.\n5. 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.\n6. 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).\n7. Participants who are not able to comply with the study requirements, procedures, and restrictions.'}, 'identificationModule': {'nctId': 'NCT05742802', 'acronym': 'PROSPERO', 'briefTitle': 'Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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).', 'orgStudyIdInfo': {'id': 'D9180C00008'}, 'secondaryIdInfos': [{'id': '2022-501063-41-00', 'type': 'REGISTRY', 'domain': 'EU CT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tozorakimab Dose 1', 'description': 'Injection subcutaneously Tozorakimab via pre-filled syringe.', 'interventionNames': ['Combination Product: Tozorakimab 1']}, {'type': 'EXPERIMENTAL', 'label': 'Tozorakimab Dose 2', 'description': 'Injection subcutaneously Tozorakimab via pre-filled syringe.', 'interventionNames': ['Combination Product: Tozorakimab 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.', 'interventionNames': ['Combination Product: Placebo']}], 'interventions': [{'name': 'Tozorakimab 1', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.', 'armGroupLabels': ['Tozorakimab Dose 1']}, {'name': 'Tozorakimab 2', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.', 'armGroupLabels': ['Tozorakimab Dose 2']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': 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