Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-29 @ 4:05 AM
Study NCT ID:
NCT06836232
Status:
RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010493', 'term': 'Pericarditis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of VTX2735', 'timeFrame': 'Day 1 of treatment period through study completion, up to 26 weeks', 'description': 'Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation'}], 'secondaryOutcomes': [{'measure': 'Effect of VTX2735 on pericardial pain', 'timeFrame': 'Day 1 of treatment period to Week 6 of treatment period', 'description': 'Change from baseline in Numeric Pain Rating Scale (NRS) over time through Week 6'}, {'measure': 'Effect of VTX2735 on inflammation', 'timeFrame': 'Day 1 of treatment period to Week 6 of treatment period', 'description': 'Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP) over time through Week 6'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ventyx', 'Zomagen', 'Recurrent Pericarditis', 'VTX2735', 'NLRP3 Inhibitor', 'NLRP3', 'Inflammasome'], 'conditions': ['Recurrent Pericarditis']}, 'descriptionModule': {'briefSummary': 'This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP).\n\nCohort A will include up to 30 participants and will consist of the following:\n\n* A 30-day Screening Period (to see if a participant qualifies for the study)\n* A 6-week Open Label Treatment Period - participant receives VTX2735 Dose A\n* A 7-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose A\n* An 11-week Once Daily Treatment Period (if a participant meets criteria for this treatment period) - participant receives VTX2735 Dose B\n* A 14-day Follow-Up Period\n\nCohort B will include up to 20 participants and will consist of the following:\n\n* A 30-day Screening Period (to see if a participant qualifies for the study)\n* A 6-week Open Label Treatment Period - participant receives VTX2735 Dose B or C\n* An 18-week Extension Treatment Period (if a participant meets criteria for extension treatment) - participant receives VTX2735 Dose B or C\n* A 14-day Follow-Up Period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants are male or female ≥ 18 years up to ≤ 75 years of age.\n* Capable of giving signed informed consent and able to comply with the protocol\n* Previously had an index (first) episode of pericarditis which met the criteria for an acute pericarditis event\n* Ongoing symptomatic episode of pericarditis, or may have an episode of recurrent pericarditis in the next 4 weeks.\n* CRP by local laboratory assessment prior to first dose of study treatment (participants with CRP ≤ 10 mg/L must be receiving corticosteroid treatment for RP and have evidence of pericardial inflammation)\n* Pericarditis pain score ≥ 4 based on the 11-point NRS.\n* Stable doses of NSAIDs, colchicine, and/or oral corticosteroids (if receiving these treatments)\n\nExclusion Criteria:\n\n* Current or prior diagnosis of pericarditis that is secondary to specific prohibited causes, including but not limited to tuberculosis, blunt trauma, tumor, myocarditis, or systemic autoimmune diseases.\n* History of clinically significant immunosuppressive disorder, autoimmune/autoinflammatory disorder, or primary or secondary immunodeficiency.\n* Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment."}, 'identificationModule': {'nctId': 'NCT06836232', 'briefTitle': 'An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zomagen Biosciences Ltd.'}, 'officialTitle': 'A Phase 2a, Open-Label Pilot Study to Evaluate the Safety/Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of VTX2735 in Participants With Recurrent Pericarditis', 'orgStudyIdInfo': {'id': 'VTX2735-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A', 'interventionNames': ['Drug: VTX2735']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B Treatment Group B1', 'interventionNames': ['Drug: VTX2735']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B Treatment Group B2', 'interventionNames': ['Drug: VTX2735']}], 'interventions': [{'name': 'VTX2735', 'type': 'DRUG', 'description': 'Dose A, daily', 'armGroupLabels': ['Cohort A']}, {'name': 'VTX2735', 'type': 'DRUG', 'description': 'Dose B, Daily', 'armGroupLabels': ['Cohort A', 'Cohort B Treatment Group B1']}, {'name': 'VTX2735', 'type': 'DRUG', 'description': 'Dose C, daily', 'armGroupLabels': ['Cohort B Treatment Group B2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840012', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840014', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '32086', 'city': 'Saint Augustine', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840016', 'geoPoint': {'lat': 29.89469, 'lon': -81.31452}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840008', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840002', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Site #840011', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840010', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840005', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840017', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840019', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840001', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840013', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840018', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840004', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Local Site #840021', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Ventyx Clinical Trial Contact', 'role': 'CONTACT', 'email': 'ClinicalTrials@ventyxbio.com', 'phone': '888-411-5176', 'phoneExt': 'ext 108'}], 'overallOfficials': [{'name': 'Henrik Sonnergren, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ventyx Biosciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zomagen Biosciences Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}