Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT07217067
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-10-14', 'studyFirstSubmitQcDate': '2025-10-14', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation burden from ECG patch monitors', 'timeFrame': '24 weeks', 'description': 'Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time'}], 'secondaryOutcomes': [{'measure': 'Time from the date of randomization to first atrial fibrillation recurrence', 'timeFrame': '24 weeks', 'description': 'Defined as the time (days) from the date of randomization to first atrial fibrillation recurrence'}, {'measure': 'Presence of atrial fibrillation recurrence after randomization', 'timeFrame': '24 weeks', 'description': 'Defined as presence of (or absense) of atrial fibrillation recurrence after randomization detected by ECG patch monitor, 12-lead ECG, handheld ECG, or other protocol approved method for ascertainment individually and as a composite'}, {'measure': 'Pharmacokinetic Parameter: concentration', 'timeFrame': '24 Weeks ( 0 hour(Pre-dose), 2 and 4 hour post dose)', 'description': 'PKN605 plasma concentration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Atrial fibrillation burden', 'Arrythmia'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation', 'detailedDescription': "A screening period of up to 90 days will be conducted to determine participants' eligibility. Once eligibility is confirmed, participants will be randomly assigned to receive either PKN605 or placebo. The treatment phase will last for 24 weeks, during which participants will visit the clinic approximately once a month. During the study, participants' atrial fibrillation will be monitored using various ECG devices. Approximately one month after the end of the treatment phase, participants will have a final safety follow-up visit. The primary purpose of the study is to monitor the effect PKN605 has on the amount of time participants spend in atrial fibrillation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusions at Screening\n\n * Signed informed consent must be obtained prior to participation in the study\n * Male and female participants ≥ 18 years of age\n * History of at least 2 episodes of AF\n * At least 1 of the AF episodes specified in inclusion #3 must be within the last 12 months (or during screening) and documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator\n * One or more of the following:\n* AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months\n* CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)\n* Stable heart failure or with New York Heart Association class I or II symptoms\n* NT-proBNP level of 300 pg/mL or higher on a local lab test within the last 12 months\n\n * On guideline-directed stroke prevention treatment, as confirmed by the Investigator\n * Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated as body weight (kg) divided by height (m) squared\n* Inclusions at Day 1\n\n * Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)\n\nExclusion Criteria:\n\n-Exclusions at Screening\n\n* Permanent AF\n* Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)\n* Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)\n* History of an AF ablation procedure within the last 6 months without a recurrence of AF at least 2 or more months after the ablation.\n* Implanted pacemaker, defibrillator, or cardiac monitor\n* Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy\n* Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening\n* Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening'}, 'identificationModule': {'nctId': 'NCT07217067', 'briefTitle': 'A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation Burden (AFB) as Well as the Safety, Tolerability, and Pharmacokinetics of Oral PKN605 in Participants With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CPKN605A12201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PKN605 lower dose', 'description': 'PKN605 is an oral fomulation', 'interventionNames': ['Drug: PKN605']}, {'type': 'EXPERIMENTAL', 'label': 'PKN605 higher dose', 'description': 'PKN605 is an oral formulation', 'interventionNames': ['Drug: PKN605']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo is an oral formulation', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'PKN605', 'type': 'DRUG', 'description': 'PKN605 is an oral formulation', 'armGroupLabels': ['PKN605 higher dose', 'PKN605 lower dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Penn Collins', 'role': 'CONTACT', 'email': 'gpc4001@med.cornell.edu'}, {'name': 'Jim Way Cheung', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paden Hansen', 'role': 'CONTACT', 'email': 'paden.hansen@imail.org'}, {'name': 'Michael Cutler', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Serena Risher', 'role': 'CONTACT', 'email': 'Serena.Risher@swedish.org', 'phone': '+1 206 386 6462'}, {'name': 'David Lam', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Swedish Heart and Vascular Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'L3Y 2P6', 'city': 'Newmarket', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2X 1R9', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '100013', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '20099', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '2625 AD', 'city': 'Delft', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'zip': '4462 RA', 'city': 'Goes', 'state': 'Zeeland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50417, 'lon': 3.88889}}, {'zip': 'S308433', 'city': 'Singapore', 'state': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '119074', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169609', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '1-888-669-6682'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'phone': '+41613241111'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}