Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT03782532
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2018-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-23', 'studyFirstSubmitDate': '2018-12-05', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pre-bronchodilator forced expiratory volume (FEV1)', 'timeFrame': 'Baseline to Week 12', 'description': 'Absolute change from baseline in pre-bronchodilator FEV1 at Week 12'}], 'secondaryOutcomes': [{'measure': 'Annualized rate of severe exacerbation events', 'timeFrame': 'During the 24-week placebo-controlled treatment period', 'description': 'Annualized rate of severe exacerbation events during the 24-week placebo-controlled treatment period'}, {'measure': 'Percent change from baseline in pre-bronchodilator FEV1', 'timeFrame': 'Baseline to Week 12', 'description': 'Percent change from baseline in pre-bronchodilator FEV1 at Week 12'}, {'measure': 'Annualized rate of loss of asthma control (LOAC) event', 'timeFrame': 'During the 24-week placebo-controlled treatment period', 'description': 'Annualized rate of LOAC event during the 24-week placebo-controlled treatment period'}, {'measure': 'Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit', 'timeFrame': 'During the 24-week placebo-controlled treatment period', 'description': 'Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 24-week placebo-controlled treatment period'}, {'measure': 'Time to first severe exacerbation event', 'timeFrame': 'During the 24-week placebo-controlled treatment period', 'description': 'Time to first severe exacerbation event during the 24-week placebo-controlled treatment period'}, {'measure': 'Time to first LOAC', 'timeFrame': 'During the 24-week placebo-controlled treatment period', 'description': 'Time to first LOAC during the 24-week placebo-controlled treatment period'}, {'measure': 'Change from baseline in Asthma Control Questionnaire (ACQ)-5 score', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline in ACQ-5 score at Week 24'}, {'measure': 'Change from baseline in ACQ-7 score', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline in ACQ-7 score at Week 24'}, {'measure': 'Morning/evening asthma symptom score (e-diary)', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline at Week 24 in morning/evening asthma symptom score (e-diary)'}, {'measure': 'Nocturnal awakenings (e-diary)', 'timeFrame': 'Baseline to week 24', 'description': 'Change from baseline at Week 24 in nocturnal awakenings (e-diary)'}, {'measure': 'Use of daily puffs of rescue medication', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline at Week 24 in use of daily puffs of rescue medication'}, {'measure': 'Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) with Standardized Activities (≥12 years) (AQLQ+12)', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline in AQLQ with Standardized Activities (≥12 years) (AQLQ+12) at Week 24'}, {'measure': 'Change from baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L)', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline in EQ-5D-5L at Week 24'}, {'measure': 'Assessment of adverse events (AEs)', 'timeFrame': 'Baseline to week 36', 'description': 'Number of participants with adverse events (AEs)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '39988927', 'type': 'DERIVED', 'citation': 'Zhang Q, Zhong N, Dhooria S, Fu X, Fang H, Lin J, Zhu S, Laws E, Wang Y, Li V, Hu CC, Maloney J, Abdulai RM, Robinson LB. Dupilumab Efficacy and Safety in Patients With Persistent Asthma: Asia-Pacific Region. Clin Exp Allergy. 2025 Aug;55(8):691-700. doi: 10.1111/cea.70005. Epub 2025 Feb 23.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002375-11/results', 'label': '2022-002375-11 EudraCT results'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo evaluate the efficacy of dupilumab in patients with persistent asthma\n\nSecondary Objectives:\n\n* To evaluate the safety and tolerability of dupilumab\n* To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life\n* To evaluate dupilumab systemic exposure and immunogenicity', 'detailedDescription': 'The total duration of study per patient is approximately 40 weeks, including 3 to 5 weeks of screening period, 24 weeks of treatment period and 12 weeks of post-treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Adults and adolescent patients (≥12 years of age) with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma 2017 Guidelines and the following criteria:\n* Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1).\n* Patients requiring maintenance oral corticosteroids (OCS) with a stable dose ≤10 mg/day prednisone or equivalent will be allowed; OCS should be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1).\n* Pre-bronchodilator FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization.\n* Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization.\n* For patients not requiring maintenance OCS, screening blood eosinophil count ≥150 cells/μL or Fractional Exhaled Nitric Oxide (FENO) ≥25 parts per billion (ppb); for patients requiring maintenance OCS, there is no minimum requirement for blood eosinophil count and FENO level.\n\nExclusion criteria:\n\n* Patients \\<12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, patient recruitment will be restricted to those who are ≥18 years of age).\n* Weight is less than 30 kg at the screening visit (Visit 1) or the randomization visit (Visit 2).\n* Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis) which may impair lung function.\n* A patient who experiences a severe asthma exacerbation (defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, treatment with systemic steroids, or treatment with systemic steroid at least twice the previous dose for patients on OCS maintenance) at any time from 1 month prior to the screening visit (Visit 1) up to and including the randomization visit (Visit 2).\n* Evidence of lung disease(s) other than asthma, either clinical or imaging evidence (eg, chest X-ray, computed tomography, and magnetic resonance imaging) within 3 months prior to the screening visit (Visit 1) as per local standard of care.\n* Current smoker or cessation of smoking within 6 months prior to the screening visit (Visit 1).\n* Previous smoker with a smoking history \\>10 pack-years.\n* Comorbid disease that might interfere with the evaluation of investigational medicinal product (IMP).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03782532', 'briefTitle': 'Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma', 'orgStudyIdInfo': {'id': 'EFC13995'}, 'secondaryIdInfos': [{'id': 'U1111-1175-0772', 'type': 'OTHER', 'domain': 'UTN'}, {'id': '2022-002375-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dupilumab', 'description': 'For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2', 'interventionNames': ['Drug: Dupilumab SAR231893', 'Drug: Asthma Controller Therapies (include prednisone/prednisolone)', 'Drug: Asthma Reliever Therapies']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo for dupilumab', 'description': 'For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose', 'interventionNames': ['Drug: Placebo', 'Drug: Asthma Controller Therapies (include prednisone/prednisolone)', 'Drug: Asthma Reliever Therapies']}], 'interventions': [{'name': 'Dupilumab SAR231893', 'type': 'DRUG', 'description': 'Pharmaceutical form: Solution\n\nRoute of administration: Subcutaneous', 'armGroupLabels': ['Dupilumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: Solution\n\nRoute of administration: Subcutaneous', 'armGroupLabels': ['Placebo for dupilumab']}, {'name': 'Asthma Controller Therapies (include prednisone/prednisolone)', 'type': 'DRUG', 'description': 'Pharmaceutical form: Aerosol, capsules, tablets, oral solution\n\nRoute of administration: Inhalation, oral', 'armGroupLabels': ['Dupilumab', 'Placebo for dupilumab']}, {'name': 'Asthma Reliever Therapies', 'type': 'DRUG', 'description': 'Pharmaceutical form: Nebulized, aerosol\n\nRoute of administration: Inhaled', 'armGroupLabels': ['Dupilumab', 'Placebo for dupilumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '014010', 'city': 'Baotou', 'country': 'China', 'facility': 'Investigational Site Number :1560013', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'zip': '100020', 'city': 'Beijing', 'country': 'China', 'facility': 'Investigational Site Number :1560016', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'Investigational Site Number :1560029', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Beijing', 'country': 'China', 'facility': 'Investigational Site Number :1560015', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, 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Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}