Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-28 @ 5:47 PM
Study NCT ID:
NCT01006161
Status:
WITHDRAWN
Last Update Posted:
2015-10-14
First Post:
2009-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)
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': 'C516686', 'term': '2-hydroxy-N,N-dimethyl-3-(2-((1-(5-methylfuran-2-yl)propyl)amino)-3,4-dioxocyclobut-1-enylamino)benzamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-12', 'studyFirstSubmitDate': '2009-10-30', 'studyFirstSubmitQcDate': '2009-10-30', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe asthma exacerbations, pulmonary function test data, and a change in symptoms', 'timeFrame': 'Measured over the duration of the trial.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race.\n\nExclusion Criteria:\n\n* Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).'}, 'identificationModule': {'nctId': 'NCT01006161', 'briefTitle': 'Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma', 'orgStudyIdInfo': {'id': 'P05109'}, 'secondaryIdInfos': [{'id': 'EUDRACT No.: 2008-004119-36'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose SCH 527123', 'interventionNames': ['Drug: SCH 527123']}, {'type': 'EXPERIMENTAL', 'label': 'Medium dose SCH 527123', 'interventionNames': ['Drug: SCH 527123']}, {'type': 'EXPERIMENTAL', 'label': 'High dose SCH 527123', 'interventionNames': ['Drug: SCH 527123']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: SCH 527123']}], 'interventions': [{'name': 'SCH 527123', 'type': 'DRUG', 'description': 'Low dose', 'armGroupLabels': ['Low dose SCH 527123']}, {'name': 'SCH 527123', 'type': 'DRUG', 'description': 'Medium dose', 'armGroupLabels': ['Medium dose SCH 527123']}, {'name': 'SCH 527123', 'type': 'DRUG', 'description': 'High dose', 'armGroupLabels': ['High dose SCH 527123']}, {'name': 'SCH 527123', 'type': 'DRUG', 'description': 'Placebo to match SCH 527123', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}