Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-04-17 @ 1:23 AM
Study NCT ID:
NCT01653756
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2a, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects
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': 'C586691', 'term': 'duvelisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2012-07-19', 'studyFirstSubmitQcDate': '2012-07-26', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in one second (FEV1)', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose', 'timeFrame': 'Day 14'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety', 'timeFrame': 'From signing of informed consent through 21 days following study drug administration'}, {'measure': 'Change in C-reactive Protein (CRP) levels', 'timeFrame': 'Screening and/or Day 1 of each treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Allergen Challenge'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung function in mild asthmatic subjects following allergen challenge.', 'detailedDescription': 'This is a phase 2a, randomized, double-blind, placebo-controlled, multi-dose, 2-way cross-over study designed to examine the effect of IPI-145 on lung function and inflammatory indices in mild, allergen-reactive asthmatic subjects undergoing allergen challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults between 18 and 60 years of age\n* Diagnosis of asthma (mild) for at least 6 months prior to Screening\n* Forced expiratory volume in one second (FEV1) ≥70% of predicted value at Screening\n* A positive skin prick test to test allergen\n\nExclusion Criteria:\n\n* Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor other than IPI-145 in a previous clinical study\n* Acute asthma exacerbations within 6 weeks prior to Screening\n* Use of any medication for the treatment of asthma other than a short-acting β2 agonist (as needed) within the 4 weeks prior to Screening\n* Participation in another clinical study within minimum of 30 days prior to study Screening\n* A positive screen result for active or latent tuberculosis\n* A history of cardiovascular disease\n* The concomitant use of acid-reducing agents and cholinesterase inhibiting medication\n* Inadequate hepatic function defined by Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) greater than 1.5 times greater limit of normal (ULN)\n* Inadequate renal function defined by serum creatinine greater than 2.0 milligrams/dL'}, 'identificationModule': {'nctId': 'NCT01653756', 'briefTitle': 'A Phase 2a, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'SecuraBio'}, 'officialTitle': 'A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose, Cross-Over, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects Undergoing Allergen Challenge', 'orgStudyIdInfo': {'id': 'IPI-145-03'}, 'secondaryIdInfos': [{'id': '2012-001729-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IPI-145', 'description': 'Capsules', 'interventionNames': ['Drug: IPI-145, a PI3K Inhibitor', 'Drug: Placebo to match IPI-145']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Capsules', 'interventionNames': ['Drug: IPI-145, a PI3K Inhibitor', 'Drug: Placebo to match IPI-145']}], 'interventions': [{'name': 'IPI-145, a PI3K Inhibitor', 'type': 'DRUG', 'description': 'Active drug', 'armGroupLabels': ['IPI-145', 'Placebo']}, {'name': 'Placebo to match IPI-145', 'type': 'DRUG', 'description': 'Comparator', 'armGroupLabels': ['IPI-145', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Investigational Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Investigational Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'Hagop Youssoufian, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Verastem, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SecuraBio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}