Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Acesion Pharma ApS

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

6 Oct 2025 → ongoing

Decision date (initial)

2025-10-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the effect of AP31969 on atrial fibrillation (AF) burden.

Secondary objectives 4

1. To assess the effect of AP31969 on other measures of AF.
2. To assess the effect of AP31969 on signs and symptoms of AF.
3. To assess the effect of AP31969 on quality of life (QoL) and patient-reported outcomes (PRO).
4. To evaluate the safety of AP31969.

Conditions and MedDRA coding

Atrial fibrillation

Study design 4 periods

Regulatory references

Scientific advice from competent authorities

Danish Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Willing and able to provide written informed consent.
2. Age 18 or older.
3. ECG documented diagnosis of AF.
4. AF history at screening indicating an expected AF burden of 1-90%.
5. If currently in AF, the episode must be of < 7 days duration at screening.
6. AF burden of ≥ 1% and ≤ 90% assessed with an ECG patch device.
7. Agreement to avoid non-trial related rhythm control intervention for the duration of the trial.
8. Willing to have a loop recorder implanted.
9. Female participants must not be pregnant or breastfeeding. Female participants of childbearing potential who have a fertile male sexual partner must agree to use highly effective contraception and not donate ova from 4 weeks prior to the first trial drug administration and until the follow-up visit. Male participants, if not surgically sterilized, who have a female sexual partner of childbearing potential, must agree to use a condom and not donate sperm from the screening visit until the follow-up visit.

Exclusion criteria 25

1. Prior AF ablation procedure (treatment that uses heat or cold energy to create tiny scars in an area of the heart).
2. QTc interval > 450 ms for males and > 470 ms for females.
3. QRS duration >120 ms at screening.
4. Sick sinus syndrome (heart rhythm disorder).
5. Atrioventricular block or complete bundle branch block (heart rhythm disorders).
6. Reduced kidney function.
7. Increase of liver enzymes.
8. Thyroid-stimulating hormone below 0.5 or above 5.0 mIU/L
9. Potassium below 3.5 or above 5.3 mmol/L.
10. Use of antiarrhythmic drug class I and/or III within 7 days or, for amiodarone, within 3 months prior to screening.
11. Use of QT-prolonging drug within 7 days prior to screening.
12. Significant cardiovascular events.
13. Use of a moderate or strong inhibitor of cytochrome P450 (CYP) 3A4 within 7 days prior to screening.
14. Received non-marketed or drug in a clinical trial within 30 days or 5 half-lives prior to screening.
15. Administration of AP31969 at any time prior to screening.
16. History of significant mental, renal or hepatic disorder, or other significant disease.
17. Planned or expected major cardiovascular or other procedure for the duration of the trial.
18. Cardiac pacing device, e.g., pacemaker.
19. Uncontrolled high blood pressure.
20. Heart failure.
21. Left ventricular ejection fraction (how much blood is pumped from the heart < 40%.
22. Clinically significant heart valve disease.
23. Personal or 1st degree family history of certain heart diseases.
24. History of drug addiction and/or alcohol abuse.
25. Any malignant cancer (except for in-situ non-melanoma skin cancer, breast ductal carcinoma in-situ and in-situ cervical cancer) within 2 years prior to screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. AF burden from week 2 to week 12.

Secondary endpoints 4

1. • Number of AF episodes from week 2 to week 12 • Mean duration of AF episodes from week 2 to week 12 • Time to first AF episode > 5 hours (for participants in sinus rhythm [SR] at randomisation)
2. • Change from baseline in Modified European Heart Rhythm Association (mEHRA) score at week 12
3. • Change from baseline in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire at week 12 • Change from baseline in EQ-5D-5L score at week 12 • Patient Global Assessment of Change (PGI-C) score at week 12
4. • Adverse events (AE) • Number of ventricular tachycardia episodes > 30 seconds of duration from week 0 to week 12 • Change from baseline in QTcF at week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Acesion Pharma ApS

Sponsor organisation

Acesion Pharma ApS

Address

Nordre Fasanvej 215

City

Frederiksberg

Postcode

2000

Country

Denmark

Scientific contact point

Organisation

Acesion Pharma ApS

Contact name

Birgitte Vestbjerg

Public contact point

Organisation

Acesion Pharma ApS

Contact name

Birgitte Vestbjerg

Third parties 8

Locations

7 EU/EEA countries · 38 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 91 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications