Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT06878261
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622721', 'term': 'tezepelumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomised in a ratio of 1:1:1 to receive Dose 1 of tezepelumab, Dose 2 of tezepelumab or matching placebo.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 990}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-06-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualised rate of moderate or severe COPD exacerbations', 'timeFrame': 'Baseline up to 76 weeks', 'description': 'The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in post-BD FEV1', 'timeFrame': 'From baseline to Week 52', 'description': 'Change from baseline in post-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration'}, {'measure': 'Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)', 'timeFrame': 'From baseline to Week 52', 'description': 'Change from baseline in pre-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration'}, {'measure': "Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score", 'timeFrame': 'From baseline over 52 weeks', 'description': 'Change from baseline in the SGRQ total score over 52 weeks compared to placebo.\n\nSGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.'}, {'measure': 'Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit.', 'timeFrame': 'Baseline up to 76 weeks', 'description': 'The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo among participants with EOS ≥ 300 cells/µL collected during screening visit.'}, {'measure': 'Annualised rate of severe COPD exacerbations', 'timeFrame': 'Baseline up to 76 weeks', 'description': 'The annualised severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo'}, {'measure': 'Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation', 'timeFrame': 'Baseline up to 76 Weeks', 'description': 'The annualised rate of COPD exacerbation requiring ER visit and/or hospitalisation up to 76 weeks treatment period compared to placebo.'}, {'measure': "Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score", 'timeFrame': 'From baseline over 52 weeks', 'description': 'Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks.\n\nSGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.'}, {'measure': 'Change from baseline in the COPD assessment Test (CAT) total score', 'timeFrame': 'From baseline over 52 weeks', 'description': 'Change from baseline in the CAT total score over 52 weeks\n\nCAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.'}, {'measure': 'Clinical meaningful improvement in COPD Assessment Test (CAT) total score', 'timeFrame': 'From baseline over 52 weeks', 'description': 'Participants achieving a clinically meaningful improvement from baseline in CAT total score (2-point score decrease) over 52 weeks.\n\nCAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.'}, {'measure': 'Time to first moderate or severe COPD exacerbation', 'timeFrame': 'Baseline up to 76 weeks', 'description': 'Time to first occurrence of moderate or severe COPD exacerbation up to 76 weeks'}, {'measure': 'Time to first severe COPD exacerbation', 'timeFrame': 'Baseline up to 76 weeks', 'description': 'Time to first occurrence of severe COPD exacerbation up to 76 weeks'}, {'measure': 'Pharmacokinetics (PK): Serum trough concentrations', 'timeFrame': 'Baseline, Week 24, Week 36, Week 52', 'description': 'Serum trough concentrations'}, {'measure': 'Immunogenicity of anti-drug antibodies (ADA)', 'timeFrame': 'Baseline, Week 24, Week 36, Week 52', 'description': 'Incidence of anti-drug antibodies'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Moderate COPD', 'Severe COPD', 'Very Severe COPD', 'chronic obstructive pulmonary disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)', 'detailedDescription': 'This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥40 to ≤80 years old\n2. COPD diagnosis ≥1 year,\n3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \\<0.70 at screening\n4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1\n5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy\n6. EOS ≥ 150 cells/μL during screening\n7. CAT ≥15 at screening\n8. Former or current smokers ≥10 pack-years\n\nExclusion Criteria:\n\n1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD\n2. Asthma, incl. pediatric, or ACOS\n3. Any unstable disorder that can impact participants safety or study outcomes\n4. Tuberculosis requiring treatment within 12 months prior V2\n5. Malignancies current or past\n\n Concomitant therapies:\n * Macrolides (less than 6 months)\n * Systemic immuno-suppressive, -modulating medications\n6. LTOT \\>4.0 L/min or O2 saturation \\<89% despite LTOT'}, 'identificationModule': {'nctId': 'NCT06878261', 'acronym': 'JOURNEY', 'briefTitle': 'A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'D5241C00007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 of Tezepelumab', 'description': 'Tezepelumab, SC, Q4W', 'interventionNames': ['Biological: Tezepelumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 of Tezepelumab', 'description': 'Tezepelumab, SC, Q4W', 'interventionNames': ['Biological: Tezepelumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Matching placebo, SC, Q4W', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tezepelumab', 'type': 'BIOLOGICAL', 'description': 'Tezepelumab subcutaneous injection', 'armGroupLabels': ['Dose 1 of Tezepelumab', 'Dose 2 of Tezepelumab']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo subcutaneous injection', 'armGroupLabels': ['Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35055', 'city': 'Cullman', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85044', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 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