Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 1:22 AM
Study NCT ID:
NCT01018550
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2009-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'France', 'Germany', 'Italy', 'Spain', 'United Kingdom', 'United States']}, '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': 'C573852', 'term': 'vidupiprant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'dispFirstSubmitDate': '2016-02-23', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2009-11-19', 'dispFirstSubmitQcDate': '2016-02-23', 'studyFirstSubmitQcDate': '2009-11-19', 'dispFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.', 'timeFrame': 'Baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA)', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days)', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR)', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ)', 'timeFrame': 'Baseline to Week 12'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '23174659', 'type': 'BACKGROUND', 'citation': 'Busse WW, Wenzel SE, Meltzer EO, Kerwin EM, Liu MC, Zhang N, Chon Y, Budelsky AL, Lin J, Lin SL. Safety and efficacy of the prostaglandin D2 receptor antagonist AMG 853 in asthmatic patients. J Allergy Clin Immunol. 2013 Feb;131(2):339-45. doi: 10.1016/j.jaci.2012.10.013. Epub 2012 Nov 20.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females 18 to 65 years of age\n* Percent of predicted FEV1 ≥ 50% and ≤ 80%\n* At least 12% reversibility over pre-bronchodilator FEV1\n* Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent.\n* Ongoing asthma symptoms with ACQ score ≥ 1.5 points\n\nExclusion Criteria:\n\n* History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma\n* Any uncontrolled, clinically significant systemic disease\n* Respiratory infection within 4 weeks of the screening visit'}, 'identificationModule': {'nctId': 'NCT01018550', 'briefTitle': 'AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma', 'orgStudyIdInfo': {'id': '20080615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 853', 'interventionNames': ['Drug: AMG 853']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AMG 853', 'type': 'DRUG', 'description': 'AMG 853 5 mg (BID)', 'armGroupLabels': ['AMG 853']}, {'name': 'AMG 853', 'type': 'DRUG', 'description': 'AMG 853 200 mg (QD)', 'armGroupLabels': ['AMG 853']}, {'name': 'AMG 853', 'type': 'DRUG', 'description': 'AMG 853 25 mg (BID)', 'armGroupLabels': ['AMG 853']}, {'name': 'AMG 853', 'type': 'DRUG', 'description': 'AMG 853 100 mg (BID)', 'armGroupLabels': ['AMG 853']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}