Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-07-06 @ 2:06 AM
Study NCT ID:
NCT03694158
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2018-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Dupilumab's Effect in Asthma by Genotype
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind, placebo controlled.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a genotype stratified, double-blind, randomized, placebo-controlled, parallel-group, phase IV clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2018-10-01', 'studyFirstSubmitQcDate': '2018-10-01', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of asthma exacerbations', 'timeFrame': '48 week treatment period', 'description': 'An exacerbation is an asthma attack for which a clinician prescribed a course of systemic steroids, whether or not the patient took the steroids.'}], 'secondaryOutcomes': [{'measure': 'Change in pre-bronchodilator lung function', 'timeFrame': 'average of week 4,12, 24,36 and 48 week', 'description': 'the change in pre-bronchodilator FEV1% predicted from baseline'}, {'measure': 'Change in CASI score', 'timeFrame': 'average of 4,12, 24, 36, and 48 week', 'description': 'The change in CASI score from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '28943468', 'type': 'BACKGROUND', 'citation': 'Lai PS, Massoud AH, Xia M, Petty CR, Cunningham A, Chatila TA, Phipatanakul W. Gene-environment interaction between an IL4R variant and school endotoxin exposure contributes to asthma symptoms in inner-city children. J Allergy Clin Immunol. 2018 Feb;141(2):794-796.e3. doi: 10.1016/j.jaci.2017.08.023. Epub 2017 Sep 21. No abstract available.'}, {'pmid': '27479084', 'type': 'BACKGROUND', 'citation': 'Massoud AH, Charbonnier LM, Lopez D, Pellegrini M, Phipatanakul W, Chatila TA. An asthma-associated IL4R variant exacerbates airway inflammation by promoting conversion of regulatory T cells to TH17-like cells. Nat Med. 2016 Sep;22(9):1013-22. doi: 10.1038/nm.4147. Epub 2016 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'The Goal of this study is to investigate if individuals ages 12 years and older, carrying the IL-4RαR576 gene variant, will have a greater response to therapy acting directly on the anti-IL-4R. This will be conducted by examining the effect of a 48 week therapy with dupilumab on the rate of asthma exacerbations.', 'detailedDescription': 'This is a double-blind, randomized, placebo-controlled parallel-group phase 4 clinical trial.\n\nPatients will be genotyped and categorized as those with: 1) the wild type allele (Q576/Q576), 2) heterozygous allele (Q576/R576), or 3) homozygous mutant allele (R576/R576); the genotype associated with more severe disease.\n\nAfter a run-in period of 2-12 weeks to determine asthma control, subjects who fulfill all inclusion/exclusion criteria will be randomized to receive either subcutaneous Dupilumab or placebo (1:1 randomization allocation ratio).\n\nThis study addresses fundamental mechanisms by which the IL-4Rα-R576 variant drives the TH2/TH17 disease endotype and the influence of this variant on response to Dupilumab therapy. It brings together individuals with deep clinical and scientific expertise in allergic diseases, including epidemiology, genetics, inflammation, and tolerance mechanisms to investigate, in a coordinated strategy, the hypothesis that the IL-4Rα-R576 variant drives TH2/TH17 cell inflammation by subverting allergen-specific iTreg cells into TH17 cells. Asthmatics bearing this endotype will be particularly likely to favorably respond to Dupilumab therapy by virtue of its prevention of iTreg cell reprogramming into TH17-like cells, potentially leading to their long-term stability and potential for sustained immune tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 12 years and older\n2. Ability to provide informed consent\n3. Ability to perform pulmonary function tests\n4. Female participants of childbearing potential must have a negative urine pregnancy test upon study entry\n5. Female participants with reproductive potential must agree to use FDA-approved methods of birth control for the duration of the study2\n6. Participant-reported physician or licensed medical practitioner diagnosis of asthma\n7. Treatment with medium to high dose ICS (400 mcg to maximum of 2000 mcg per day of fluticasone propionate or equivalent) for at least 3 months with a stable dose ≥1 month prior to screening OR used a biologic medication for asthma within the past 8 weeks\n8. History of asthma exacerbation in the past year\n\nAn exacerbation is an asthma attack for which a clinician prescribed a course of systemic (oral, IV, IM) steroids whether or not the patient took the steroids OR An increase of \\>50% of baseline inhaled corticosteroid dose for ≥3 days OR An unscheduled visit for acute asthma attack (licensed medical practitioner/nurse office, urgent care intervention, emergency department, or hospitalization)\n\nExclusion Criteria:\n\n1. Chronic lung disease other than asthma, which may impair lung function\n2. Current smoker or cessation of smoking ≤6 months prior to Visit 0 screening\n3. Current use of any electronic (e) "vaping" device (e.g., e-cigarette, e-cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods) or cessation ≤ 6 months prior to screening\n4. Pregnant or breast feeding\n5. Any other condition or abnormality that, in the opinion of the Principal Investigator, would compromise the safety of the patient or quality of data\n6. Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures\n7. Planning to relocate away from the clinical center area before study completion\n8. Currently participating in an investigational drug trial or participated in one within 30 days before screening\n9. Currently being treated with immunosuppressive/immunomodulatory or other investigational agents or biologics for conditions other than asthma, or used a biologic for a non-asthma indication within the past 6 months\n10. History of respiratory illness requiring antibiotics or systemic corticosteroids, including asthma exacerbations, within the past 4 weeks (evaluated at time of screening visit)\n11. History of alcohol or illicit substance abuse within 6 months of screening\n12. Neutropenia (\\<1,000/mm3) or thrombocytopenia (\\<100,000/mm3) or hemoglobin \\< 100 g/L (10 g/dL) or blood eosinophils \\> 1500/mm3 at screening\n13. Administration of a live vaccine within 4 weeks of screening\n14. Currently receiving allergen immunotherapy (food or aeroallergen) other than an established maintenance regimen implemented continuously for a minimum of 2 months. Individuals receiving aeroallergen immunotherapy must be willing to stay on it for the duration of the study.'}, 'identificationModule': {'nctId': 'NCT03694158', 'acronym': 'IDEA', 'briefTitle': "Investigating Dupilumab's Effect in Asthma by Genotype", 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Effect of IL-4RαR576 Polymorphism on Response to Dupilumab in Asthma, a Genotype-stratified, Randomized, Placebo- Controlled Trial', 'orgStudyIdInfo': {'id': 'P00029072'}, 'secondaryIdInfos': [{'id': 'U01AI143514', 'link': 'https://reporter.nih.gov/quickSearch/U01AI143514', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Dupilumab (Dupixent®) administered subcutaneously every two weeks. An initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week.', 'interventionNames': ['Drug: Dupilumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo (preparation, administration, packaging, and labeling all equivalent to the treatment) administered subcutaneously every two weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Dupilumab', 'type': 'DRUG', 'otherNames': ['Dupixent®'], 'description': 'anti-IL4 receptor antagonist', 'armGroupLabels': ['Treatment group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo for Dupilumab (packaged/administered the same as the active drug)', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'IDEA Study Recruiter', 'role': 'CONTACT', 'email': 'asthma@childrens.harvard.edu', 'phone': '857-218-5336'}, {'name': 'Wanda Phipatanakul, MD.MS.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angeles Cinelli', 'role': 'CONTACT', 'email': 'mcinelli@bwh.harvard.edu'}, {'name': 'Eliot Israel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'IDEA Study Recruiter', 'role': 'CONTACT', 'email': 'ideaasthma@hfhs.org', 'phone': '313-207-2453'}, {'name': 'Haejin Kim, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hemraj Komal, MPH', 'role': 'CONTACT', 'email': 'Hemraj.komal@einsteinmed.edu', 'phone': '718-839-7562'}, {'name': 'Sunit Jariwala, MD', 'role': 'CONTACT', 'email': 'SJARIWAL@montefiore.org', 'phone': '609-937-1023'}, {'name': 'Sunit Jariwala, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Einstein Clinical Research Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Kaelber, MD.PHD. MPH.', 'role': 'CONTACT', 'email': 'dkaelber@metrohealth.org', 'phone': '216-780-3722'}, {'name': 'Hailey Chesnick, BSN.RN', 'role': 'CONTACT', 'email': 'hchesnick@metrohealth.org', 'phone': '216-778-7478'}, {'name': 'David Kaelber, MD.PHD.MPH.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MetroHealth System', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Beothy', 'role': 'CONTACT', 'email': 'eabeothy@pennmedicine.upenn.edu', 'phone': '215-549-5023'}, {'name': 'Audreesh Banerjee, MD', 'role': 'CONTACT', 'email': 'Audreesh.Banerjee@pennmedicine.upenn.edu', 'phone': '215-549-5023'}, {'name': 'Audreesh Banerjee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Wanda Phipatanakul, MD, MS', 'role': 'CONTACT', 'email': 'Wanda.Phipatanakul@childrens.harvard.edu', 'phone': '857-218-5336'}, {'name': 'Research Manager', 'role': 'CONTACT', 'email': 'asthma@childrens.harvard.edu', 'phone': '857-218-5336'}], 'overallOfficials': [{'name': 'Wanda Phipatanakul, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'HealthBeacon Plc', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Wanda Phipatanakul', 'investigatorAffiliation': 'Harvard Medical School (HMS and HSDM)'}}}}