Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-28 @ 6:49 AM
Study NCT ID:
NCT06959095
Status:
RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
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'], 'maskingDescription': 'This is a double-blind study neither the participants the caregivers the researchers nor the people assessing the outcomes know which treatment is being given to whom.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a placebo-controlled, multicenter trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 981}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Rate of Moderate/Severe Exacerbations', 'timeFrame': 'From Baseline up to Week 104', 'description': 'Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \\[\\>=\\] 24 hours) or result in death. The frequency of moderate/ severe exacerbations expressed as an annualized exacerbation rate will be evaluated.'}], 'secondaryOutcomes': [{'measure': 'Time to First Moderate/Severe Exacerbation', 'timeFrame': 'From Baseline up to Week 104', 'description': 'Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \\[\\>=\\] 24 hours) or result in death.'}, {'measure': 'Change From Baseline in St. Georges Respiratory Questionnaire (SGRQ) Total Score at Week 52', 'timeFrame': 'From Baseline up to Week 52', 'description': "The SGRQ total score will be measured using the SGRQ for COPD \\[SGRQ-C\\]. The SGRQ-C is a 40-item participant questionnaire designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participant's current state (questions 8-14). The questions are designed to be self-completed by the participant. The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health."}, {'measure': 'Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) Total Score at Week 52', 'timeFrame': 'From Baseline up to Week 52', 'description': 'E-RS:COPD consists of 11 items from the 14-item Exacerbations of Chronic Pulmonary Disease Tool - Patient Reported Outcomes (EXACT) instrument. E-RS: COPD is intended to capture information related to the respiratory symptoms of COPD, i.e., breathlessness, cough, sputum production, chest congestion, and chest tightness. The ERS: COPD has a scoring range of 0 to 40, higher scores indicate more severe symptoms.'}, {'measure': 'Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization', 'timeFrame': 'From Baseline up to Week 104', 'description': 'Annualized rate of exacerbations requiring ED Visit or Hospitalization (For pooled analysis across studies 222714 and 222725) will be assessed.'}, {'measure': 'Annualized Rate of Severe Exacerbations', 'timeFrame': 'From Baseline up to Week 104', 'description': 'Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (i.e., greater than or equal to \\[\\>=\\] 24 hours) or result in death. Annualized rate of severe exacerbations (For pooled analysis across studies 222714 and 222725) will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depemokimab', 'GSK3511294', 'Eosinophilic phenotype', 'Chronic obstructive pulmonary disease', '(COPD)', 'Moderate COPD', 'Severe COPD', 'Uncontrolled Moderate to Severe Chronic Obstructive Pulmonary Disease', 'Exacerbations', 'Placebo', 'Type 2 inflammation'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be greater than or equal to (\\>=) 40 to less than or equal to (\\<=) 80 years of age, at the time of signing the informed consent.\n* Elevated blood eosinophil count (BEC).\n* Moderate to severe COPD with frequent exacerbations, defined as:\n* A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year\n* A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (\\<) 0.70 and a post- bronchodilator FEV1 \\>30 percent (%) and \\<= 80% predicted normal values\n* A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening\n* COPD assessment test (CAT) score \\>=10 at Visit 1.\n* Smoking status: Current or former cigarette smokers with a history of cigarette smoking of \\>=10 pack-years.\n* Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1.\n* Body mass index (BMI) \\>=16 kilogram per square meter (kg/m\\^2).\n* Male or eligible female participants.\n\nExclusion Criteria:\n\nThe following subjects are excluded:\n\n* Participants with a current or prior physician diagnosis of asthma.\n* Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.\n* Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.\n* Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.\n* Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1.\n* Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day.\n* Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension\n* Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure \\[BiPAP\\] or Continuous Positive Airway Pressure \\[CPAP\\]).\n* Unstable cardiovascular disease or arrhythmia.\n* Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).'}, 'identificationModule': {'nctId': 'NCT06959095', 'acronym': 'ENDURA -1', 'briefTitle': 'Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab In Adult Participants With COPD With Type 2 Inflammation', 'orgStudyIdInfo': {'id': '222714'}, 'secondaryIdInfos': [{'id': '2024-520418-22', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Depemokimab', 'description': 'Participants will be administered depemokimab along with standard of care (SoC).', 'interventionNames': ['Drug: Depemokimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be administered placebo along with SoC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Depemokimab', 'type': 'DRUG', 'otherNames': ['GSK3511294'], 'description': 'Depemokimab as a sterile liquid formulation will be administered.', 'armGroupLabels': ['Depemokimab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo as a sterile 0.9 percent (%) sodium chloride solution will be administered.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33470', 'city': 'Loxahatchee Groves', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Neal Warshoff', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.68368, 'lon': -80.27977}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Guillermo Somodevilla', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Michael Denenberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '75110', 'city': 'Corsicana', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'John D Updegrove', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.09543, 'lon': -96.46887}}, {'zip': '410015', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Yingqun Zhu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Xiao Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610041', 'city': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'fuqiang Wen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '510150', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Liping Wei', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '310000', 'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Limin Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '529000', 'city': 'Jiangmen', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Mingjiang Lin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.58333, 'lon': 113.08333}}, {'city': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 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'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Dongbo Guangdong Tian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 23.7, 'lon': 113.03333}}, {'zip': '643036', 'city': 'Zigong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Zhiping Deng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.34162, 'lon': 104.77689}}, {'zip': '140-8522', 'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Centre', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 8990 4466'}, {'name': 'Masaharu Shinkai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'US GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '877-379-3718'}, {'name': 'EU GSK Clinical Trials Call Center', 'role': 'CONTACT', 'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '+44 (0) 20 89904466'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gsk.com/en-gb/innovation/trials/data-transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.', 'ipdSharing': 'YES', 'description': 'Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\\_GSK\\_Patient\\_Level\\_Data\\_Sharing\\_Final\\_13July2023.pdf', 'accessCriteria': 'Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}