Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00971035
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2009-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary', 'Poland', 'Russia', 'South Africa', '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': 'C561806', 'term': 'lebrikizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2011-06-30', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-25', 'studyFirstSubmitDate': '2009-09-01', 'dispFirstSubmitQcDate': '2011-06-30', 'studyFirstSubmitQcDate': '2009-09-02', 'dispFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in forced expiratory volume in 1 second (FEV1)', 'timeFrame': 'Baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Change in pre-bronchodilator FEV1', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Change in quality of life and symptom scores', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Change in peak flow', 'timeFrame': 'Baseline to Week 1'}, {'measure': 'Rate of asthma exacerbations', 'timeFrame': 'During the 24-week treatment period'}, {'measure': 'Change in rescue medication use', 'timeFrame': 'From baseline to Week 1'}, {'measure': 'Frequency and severity of adverse events', 'timeFrame': 'From the first study-specific procedure through the last observation visit'}, {'measure': 'Incidence of human anti-therapeutic antibodies (ATA)', 'timeFrame': 'Baseline to Week 32'}]}, 'conditionsModule': {'keywords': ['MILR1444A'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body weight ≥ 50 kg and ≤ 150 kg at Visit 1\n* Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality\n* Stable asthma\n\nExclusion Criteria:\n\n* Asthma exacerbation during screening\n* Known malignancy\n* Known immunodeficiency\n* Pre-existing lung disease other than asthma\n* Uncontrolled clinically significant medical disease\n* Current smoker\n* History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator\n* Prior allergic reaction to a monoclonal antibody\n* Patients (men and women) of reproductive potential who are not willing to use contraception\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT00971035', 'acronym': 'MOLLY', 'briefTitle': 'A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)', 'orgStudyIdInfo': {'id': 'ILR4660g'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: lebrikizumab (MILR1444A)']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: lebrikizumab (MILR1444A)']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'interventionNames': ['Drug: lebrikizumab (MILR1444A)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'lebrikizumab (MILR1444A)', 'type': 'DRUG', 'description': 'Subcutaneous repeating dose', 'armGroupLabels': ['A']}, {'name': 'lebrikizumab (MILR1444A)', 'type': 'DRUG', 'description': 'Subcutaneous repeating dose', 'armGroupLabels': ['B']}, {'name': 'lebrikizumab (MILR1444A)', 'type': 'DRUG', 'description': 'Subcutaneous repeating dose', 'armGroupLabels': ['C']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subcutaneous repeating dose', 'armGroupLabels': ['D']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michelle Freemer, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}