Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-29 @ 10:57 PM
Study NCT ID:
NCT07284459
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 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'}, {'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 324}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute change in forced vital capacity (FVC) (mL)', 'timeFrame': 'From baseline to Week 26'}], 'secondaryOutcomes': [{'measure': 'To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE)', 'timeFrame': 'From baseline to Week 30'}, {'measure': 'Relative change in FVC (mL)', 'timeFrame': 'From baseline to Week 26', 'description': 'Additional assessment of disease progression through lung function measurements'}, {'measure': 'Proportion of subjects with a ≥10% absolute decline in percent predicted FVC (ppFVC)', 'timeFrame': 'From baseline to Weeks 12 and Week 26'}, {'measure': 'Time to first ≥10% absolute decline in ppFVC', 'timeFrame': 'From baseline to time of first ≥10% absolute decline, up to Week 26'}, {'measure': 'Absolute change in ppFVC', 'timeFrame': 'From baseline to Week 26', 'description': 'Additional assessment of disease progression through lung function measurements'}, {'measure': 'Relative change in ppFVC', 'timeFrame': 'From baseline to Week 26', 'description': 'Additional assessment of disease progression through lung function measurements'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic Pulmonary Fibrosis', 'PIPE 791', 'Pulmonary Fibrosis', 'IPF', 'ILD', 'Interstitial lung disease'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in subjects with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.', 'detailedDescription': 'This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and PK of PIPE-791 in subjects with a diagnosis of Idiopathic Pulmonary Fibrosis with or without background treatment. The treatment period is 26 weeks and full study duration is up to 36 weeks including Screening and Follow-Up. Approximately 324 subjects will be enrolled into one of three treatment arms, PIPE-791 Dose A, PIPE-791 Dose B, or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or female ≥ 40 years of age at the time of Randomization\n* A diagnosis of IPF within 7 years prior to Screening, based on the 2018 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT with verification of usual interstitial pneumonia\n* Percent predicted (pp) FVC ≥ 40% on Screening spirometry\n* Subjects may enter the study whether or not they are receiving background antifibrotic therapy, approved for the treatment of IPF (nintedanib or pirfenidone, but not both concurrently)\n\nKey Exclusion Criteria:\n\n* Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.\n* Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.\n* Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.\n* Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.\n\nAdditional inclusion and exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT07284459', 'briefTitle': 'Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Contineum Therapeutics'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'CTX-791-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PIPE-791 Dose A', 'interventionNames': ['Drug: PIPE-791 Dose A']}, {'type': 'EXPERIMENTAL', 'label': 'PIPE-791 Dose B', 'interventionNames': ['Drug: PIPE-791 Dose B']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PIPE-791 Dose A', 'type': 'DRUG', 'otherNames': ['PIPE-791'], 'description': 'Subjects will receive a daily oral dose of PIPE-791 in tablet form', 'armGroupLabels': ['PIPE-791 Dose A']}, {'name': 'PIPE-791 Dose B', 'type': 'DRUG', 'otherNames': ['PIPE-791'], 'description': 'Subjects will receive a daily oral dose of PIPE-791 in tablet form', 'armGroupLabels': ['PIPE-791 Dose B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will receive a daily oral dose of matching Placebo in tablet form', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N8X 5A6', 'city': 'Windsor', 'state': 'Ontaria', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Dr. Anil Dhar Medicine Professional Corporation', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'centralContacts': [{'name': 'Nikki Nepomuceno', 'role': 'CONTACT', 'email': 'nnepomuceno@contineum-tx.com', 'phone': '858-333-5280'}, {'name': 'Marietta Franco', 'role': 'CONTACT', 'email': 'mfranco@contineum-tx.com', 'phone': '650-450-6634'}], 'overallOfficials': [{'name': 'Mudiaga O Sowho, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Contineum Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Contineum Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}