Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT01875003
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2013-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, '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': 'C561806', 'term': 'lebrikizumab'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 348}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2013-06-07', 'studyFirstSubmitQcDate': '2013-06-07', 'lastUpdatePostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) or Serious AEs', 'timeFrame': 'Baseline up to Week 124'}, {'measure': 'Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab', 'timeFrame': 'Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 76, 104, 112, and 124 or at early termination [up to 108 weeks])'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 second (FEV1) at Week 52', 'timeFrame': 'Baseline , Week 52'}, {'measure': 'Time to First Asthma Exacerbation', 'timeFrame': 'Baseline up to 52 weeks'}, {'measure': 'Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 52', 'timeFrame': 'Baseline , Week 52'}, {'measure': 'Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and Older (AQLQ + 12) at Week 52', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Change From Baseline in Asthma Rescue Medication Use at Week 52', 'timeFrame': 'Baseline, Week 52'}, {'measure': 'Rate of Urgent Asthma-Related Health Care Utilization', 'timeFrame': 'Baseline up to 52 weeks'}, {'measure': 'Injection Acceptability Questionnaire (IAQ) Score', 'timeFrame': 'Baseline up to Week 104'}]}, 'oversightModule': {'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '35846226', 'type': 'DERIVED', 'citation': 'Szefler SJ, Roberts G, Rubin AS, Zielen S, Kuna P, Alpan O, Anzures-Cabrera J, Chen Q, Holweg CTJ, Kaminski J, Putnam WS, Matthews JG, Kamath N. Efficacy, safety, and tolerability of lebrikizumab in adolescent patients with uncontrolled asthma (ACOUSTICS). Clin Transl Allergy. 2022 Jul 14;12(7):e12176. doi: 10.1002/clt2.12176. eCollection 2022 Jul.'}]}, 'descriptionModule': {'briefSummary': "This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthma diagnosis for greater than or equal to (\\>/=) 12 months prior to Visit 1\n* Bronchodilator response during screening\n* Pre-bronchodilator FEV1 of 40 percent (%) - 90% predicted at both Visits 2 and 3\n* On high dose ICS therapy for \\>/= 6 months prior to Visit 1\n* On an eligible second controller medication for 6 months prior to Visit 1\n* Uncontrolled asthma as defined by the protocol both during screening and at the time of randomization\n* Demonstrated adherence with controller medication during the screening period\n\nExclusion Criteria:\n\n* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection\n* Maintenance oral corticosteroid therapy within 3 months prior to Visit 1\n* Treatment with systemic (oral, intravenous \\[IV\\], or intramuscular \\[IM\\]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period\n* Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study\n* Infection that meets the following criteria: Any infection requiring hospital admission or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; any active infection that required treatment with oral antibiotics within 2 weeks prior to Visit 1 or during screening; upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening\n* History of active tuberculosis requiring treatment\n* Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection\n* Evidence of acute or chronic hepatitis or known liver cirrhosis\n* History of cystic fibrosis, bronchiectasis, and/or other clinically significant lung disease other than asthma\n* Diagnosis or history of malignancy or current evaluation for potential malignancy\n* Current smoker or former smoker with a history of greater than (\\>) 10 pack-years\n* History of alcohol or drug abuse\n* Past and/or current use of any anti- interleukin (IL) -13 or anti-IL-4/IL-13 therapy, including lebrikizumab\n* Use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives (whichever is longer) prior to Visit 1\n* Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening\n* History of bronchial thermoplasty'}, 'identificationModule': {'nctId': 'NCT01875003', 'briefTitle': 'A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'WB28183'}, 'secondaryIdInfos': [{'id': '2012-000180-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lebrikizumab High', 'description': 'Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 micrograms \\[mcg\\] of fluticasone propionate dry powder inhaler \\[DPI\\] or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (high dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period.', 'interventionNames': ['Drug: Lebrikizumab', 'Drug: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Lebrikizumab Low', 'description': 'Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab (low dose) Q4W for 52 weeks during placebo-controlled period and up to 76 weeks or 104 weeks for participants who will be willing to take part in optional active-treatment extension period.', 'interventionNames': ['Drug: Lebrikizumab', 'Drug: Standard of Care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants with uncontrolled asthma on ICS therapy (total daily dose of 500-2000 mcg of fluticasone propionate DPI or equivalent) and a second controller medication, will receive SC injection of lebrikizumab matching placebo Q4W for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at high or low dose will be administered from Weeks 52 to 76 or 104 to participants who are willing to take part in optional active-treatment extension period.', 'interventionNames': ['Drug: Lebrikizumab', 'Drug: Placebo', 'Drug: Standard of Care']}], 'interventions': [{'name': 'Lebrikizumab', 'type': 'DRUG', 'description': 'Lebrikizumab will be administered as SC injection at high or low dose Q4W.', 'armGroupLabels': ['Lebrikizumab High', 'Lebrikizumab Low', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Lebrikizumab matching placebo will be administered as SC injection Q4W.', 'armGroupLabels': ['Placebo']}, {'name': 'Standard of Care', 'type': 'DRUG', 'description': 'Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists \\[LABAs\\], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.', 'armGroupLabels': ['Lebrikizumab High', 'Lebrikizumab Low', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85716', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Allergy Associates of Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research Center', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Allergy & Asthma Consultants', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Dignity Health Medical Foundation', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95207', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'Bensch Research Associates', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Allergy & Asthma Medical Group; Clinical Research Division', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Colorado Children's Hospital; The Breathing Institute", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'IMMUNOe International Research Centers', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Asthma & Allergy; Associates, P.C.', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Medical and Research Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Abel and Buchheim', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research East, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Clinical Research', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Brookstone Clinical Res Ctr', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Pain Clinic', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62269', 'city': 'Shiloh', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Clinical Research Center', 'geoPoint': {'lat': 38.56144, 'lon': -89.89732}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children; Pediatric Nephrology', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '41042', 'city': 'Florence', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Abraham Research PLLC', 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'08904', 'city': 'New Jersey', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Parikh Institute for Research LLC'}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico; School of Med', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Parikh Institute for Research LLC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10459', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Urban Health Plan, Inc.', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': "Promedica Toledo Children's Hospital", 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'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'B6500BWQ', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro Médico Vitae', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1122AAK', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundación Faicep', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1125 ABE', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion Cidea', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1425BEN', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'INAER', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5500', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Instituto Respirar', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'M5500CCG', 'city': 'Mendoza, Mendoza City', 'country': 'Argentina', 'facility': 'INSARES'}, {'zip': '2000', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'Centro 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