Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-10 @ 2:00 PM
Study NCT ID:
NCT05349760
Status:
WITHDRAWN
Last Update Posted:
2023-01-19
First Post:
2022-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'IRT and unblinded pharmacists'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2:1 randomization of active to placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'to focus resources on other studies', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-17', 'studyFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-emergent adverse events', 'timeFrame': 'Week 24', 'description': 'Frequency and severity of reported treatment-emergent adverse events will be graded per CTCAE 5-point scale'}], 'secondaryOutcomes': [{'measure': 'Pulmonary Function', 'timeFrame': 'Week 28', 'description': 'Change in forced vital (FVC) capacity in liters'}, {'measure': 'Pharmacodynamics via CSF1', 'timeFrame': 'Week 28', 'description': 'Plasma CSF1 assessment and other exploratory biomarkers'}, {'measure': "ST GEORGE'S RESPIRATORY QUESTIONNAIRE IDIOPATHIC PULMONARY FIBROSIS (SGRQ-I)", 'timeFrame': 'Week 28', 'description': "Change in health-related quality of life, as measured by St. George's Respiratory Questionnaire (SGRQ-I)"}, {'measure': 'Cmax', 'timeFrame': 'Week 24', 'description': 'Peak Plasma Concentration (Cmax) measurement'}, {'measure': 'AUC', 'timeFrame': 'Week 24', 'description': 'Area under the plasma concentration versus time curve (AUC) measurement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic Pulmonary Fibrosis', 'IPF'], 'conditions': ['IPF']}, 'descriptionModule': {'briefSummary': 'AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects ≥40 years old.\n2. History of confirmed diagnosis of IPF\n3. Chest HRCT at Screening\n4. Subjects who are either:\n\n * Not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) or\n * Being treated with approved IPF therapies (i.e., nintedanib or pirfenidone)\n5. Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted\n6. Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70\n7. Has adequate hematologic, hepatic, and renal function\n\nExclusion Criteria:\n\n1. Prior investigational drug use within 30 days or 5 half-lives\n2. Presence of emphysema exceeding the extent of fibrosis\n3. Active or anticipated need for lung transplant\n4. Treatment with prednisone\n5. Active cancer\n6. Active or chronic infection with HCV, HBV, or HIV\n7. Known active tuberculosis\n8. History of or current immunosuppressive condition\n9. IPF exacerbation within 12 weeks\n10. Lower respiratory-tract infection requiring antibiotic therapy\n11. Smoking\n12. Other forms of interstitial lung disease\n13. History of lung volume reduction surgery or lung transplant\n14. Contraindications for forced expiratory maneuvers during spirometry\n15. Unstable cardiac or pulmonary disease (other than IPF)\n16. Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)\n17. History of drug or alcohol abuse -'}, 'identificationModule': {'nctId': 'NCT05349760', 'briefTitle': 'A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AmMax Bio, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'AMB-053-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMB-05X', 'description': 'AMB-05X will be administered every 4 weeks for 24 weeks (for 6 treatments in total).', 'interventionNames': ['Biological: AMB-05X']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be administered every 4 weeks for 24 weeks (for 6 treatments in total).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AMB-05X', 'type': 'BIOLOGICAL', 'description': 'A fully human monoclonal immunoglobulin (IgG2) directed against c-fms', 'armGroupLabels': ['AMB-05X']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline/D5W', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dorothy Nguyen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AmMax Bio, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AmMax Bio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}