PKN605 for Atrial fibrillation

Inclusion criteria

• {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study"}
• {"criterion_text":"- Male and female participants > 18 years of age"}
• {"criterion_text":"- History of at least 2 episodes of AF"}
• {"criterion_text":"- At least one 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"}
• {"criterion_text":"- One or more of the following, at Screening: •\tAFB 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 •\tCHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack) •\tStable heart failure or with New York Heart Association class I or II symptoms •\tNT-proBNP level of 300 pg/mL or higher on a local lab test within the last 12 months"}
• {"criterion_text":"- On guideline-directed stroke prevention treatment, as confirmed by the investigator, at Screening"}
• {"criterion_text":"- Participants must have a body mass index (BMI) >18 kg/m2. BMI is calculated as body weight (kg) divided by height in (m) squared"}
• {"criterion_text":"- Sinus rhythm at Baseline as documented by a 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)"}

Exclusion criteria

• {"criterion_text":"- Permanent AF"}
• {"criterion_text":"- Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, alcohol use, sepsis- or infection-related AF, surgery-related AF, pulmonary embolism)"}
• {"criterion_text":"- Ongoing use of antiarrhythmic therapy (Vaughan Williams class l 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)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Implanted pacemaker, defibrillator, or cardiac monitor"}
• {"criterion_text":"- Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy"}
• {"criterion_text":"- Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening"}
• {"criterion_text":"- Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during the Screening period"}

Primary endpoints

• {"endpoint_text":"- AFB from ECG patch monitors, defined as the amount of time spent in AF as a proportion of the analyzable monitoring time","definition_or_measurement_approach":"Measured from ECG patch monitors; defined as the amount of time spent in atrial fibrillation expressed as a proportion of the analyzable monitoring time."}

Secondary endpoints

• {"endpoint_text":"- Time (d) from the date of randomization to first AF recurrence and presence (or absence) of AF recurrence after randomization detected by ECG patch monitor, 12-lead ECG, handheld ECG, or other protocol-approved method for ascertainment","definition_or_measurement_approach":"Time to first AF recurrence in days after randomization; detection by ECG patch monitor, 12-lead ECG, handheld ECG, or other protocol-approved methods."}
• {"endpoint_text":"- Adverse events, vital signs, 12-lead ECG parameters (including QTcF), and laboratory assessments","definition_or_measurement_approach":"Safety assessments including recording of adverse events, vital signs measurements, 12-lead ECG parameters (including QTcF) and laboratory test results."}
• {"endpoint_text":"- PKN605 plasma concentrations; Ctrough (pre-dose), C2h, C4h","definition_or_measurement_approach":"Pharmacokinetic sampling of PKN605 plasma concentrations at specified time points: trough (pre-dose), 2 hours post-dose (C2h) and 4 hours post-dose (C4h)."}

Germany

Earliest CTIS Part Ii Submission Date

17-10-2025

Latest Decision Or Authorization Date

19-11-2025

Processing Time Days

33

Number Of Sites

5

Number Of Participants

16

Netherlands

Earliest CTIS Part Ii Submission Date

17-10-2025

Latest Decision Or Authorization Date

28-11-2025

Processing Time Days

42

Number Of Sites

7

Number Of Participants

25

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

sponsorDuties codes: 12

Name

IQVIA Limited

Responsibilities

sponsorDuties codes: 1, 3 (including IRT responsibilities listed separately)

Name

Icon Clinical Research Limited / Icon Clinical Research LLC

Responsibilities

sponsorDuties codes: 1; Icon LLC duties include code 15 (Cardiac Assessment)

Name

Syneos Health Inc.

Responsibilities

sponsorDuties codes: 1

Name

Veeda Clinical Research Limited

Responsibilities

sponsorDuties codes: 4

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties codes: 7

Name

Icon Laboratory Services Inc.

Responsibilities

sponsorDuties codes: 4 (laboratory services)

Name

Medical Equipment Supplies And Management Limited

Responsibilities

sponsorDuties codes: 15 (Ancillary Supplies)

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 3","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"sponsorDuties codes: 15 (Cardiac Assessment)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited (IRT team)","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"sponsorDuties codes: 15 (Ancillary Supplies)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 1","organisation_type":"Pharmaceutical company"}