A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation

May 14, 2026 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2P 3C5
        • Recruiting
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Novartis Investigative Site
      • Newmarket, Ontario, Canada, L3Y 2P6
        • Recruiting
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H2X 1R9
        • Recruiting
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Novartis Investigative Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Recruiting
        • Novartis Investigative Site
      • Xi'an, China, 223001
        • Recruiting
        • Novartis Investigative Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100013
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Bad Homburg, Germany, 61348
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 10787
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20099
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Novartis Investigative Site
      • Veldhoven, Netherlands, 5504 DB
        • Recruiting
        • Novartis Investigative Site
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Recruiting
        • Novartis Investigative Site
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Novartis Investigative Site
    • South Holland
      • Delft, South Holland, Netherlands, 2625 AD
        • Recruiting
        • Novartis Investigative Site
    • Zeeland
      • Goes, Zeeland, Netherlands, 4462 RA
        • Recruiting
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • Novartis Investigative Site
      • Singapore, Singapore, 169609
        • Recruiting
        • Novartis Investigative Site
    • Singapore
      • Singapore, Singapore, Singapore, S308433
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Liverpool, United Kingdom, L14 3PE
        • Withdrawn
        • Novartis Investigative Site
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Novartis Investigative Site
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Recruiting
        • Novartis Investigative Site
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • Cardiology Associates of North MS
        • Contact:
        • Principal Investigator:
          • James Edgar Stone
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medical Center
        • Contact:
        • Principal Investigator:
          • Jim Way Cheung
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Univ Medical Center
        • Principal Investigator:
          • Jonathan Piccini
        • Contact:
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Principal Investigator:
          • Michael Cutler
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Heart and Vascular Clinic
        • Principal Investigator:
          • David Lam
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inclusions at Screening

    • Signed informed consent must be obtained prior to participation in the study
    • Male and female participants ≥ 18 years of age
    • History of at least 2 episodes of AF (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrillation
    • 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
    • One or more of the following:
  • 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
  • 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)
  • Stable heart failure or with New York Heart Association class I or II symptoms

  • NT-proBNP level of 300 pg/mL or higher on a local lab test within the last 12 months

    • On guideline-directed stroke prevention treatment, as confirmed by the Investigator
    • Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated as body weight (kg) divided by height (m) squared

  • Inclusions at Day 1

    • Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)

Exclusion Criteria:

-Exclusions at Screening

  • Permanent AF
  • Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)
  • 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)
  • History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation.
  • Implanted pacemaker, defibrillator, or cardiac monitor
  • Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy
  • Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used
  • Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PKN605 higher dose
PKN605 is an oral formulation
Drug: PKN605
PKN605 is an oral formulation
Placebo Comparator: Placebo
Placebo is an oral formulation
Other: Placebo
Matching placebo
Experimental: PKN605 lower dose
PKN605 is an oral formulation
Drug: PKN605
PKN605 is an oral formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation burden from ECG patch monitors
Time Frame: 24 weeks
Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from the date of randomization to first atrial fibrillation recurrence
Time Frame: 24 weeks
Defined as the time (days) from the date of randomization to first atrial fibrillation recurrence
24 weeks
Pharmacokinetic Parameter: concentration
Time Frame: 24 Weeks ( 0 hour(Pre-dose), 2 and 4 hour post dose)
PKN605 plasma concentration
24 Weeks ( 0 hour(Pre-dose), 2 and 4 hour post dose)
Presence of atrial fibrillation recurrence after randomization
Time Frame: 24 weeks
Defined as presence of (or absence) 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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2025

Primary Completion (Estimated)

September 9, 2027

Study Completion (Estimated)

September 9, 2027

Study Registration Dates

First Submitted

October 14, 2025

First Submitted That Met QC Criteria

October 14, 2025

First Posted (Actual)

October 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPKN605A12201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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