An exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026 to assess safety, tolerability, and efficacy in patients with ST-Elevation Myocardial Infarction (STEMI)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

ResoTher Pharma A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

16 Sep 2024 → ongoing

Decision date (initial)

2024-05-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary safety objective: To evaluate the safety and tolerability of RTP-026 against placebo in multiple doses.
The primary efficacy objective: To evaluate the efficacy of RTP-026 against placebo in multiple doses.

Conditions and MedDRA coding

Patients with ST-Elevation Myocardial Infarction (STEMI)

Regulatory references

Scientific advice from competent authorities

Danish Medicines Agency

Plan to share IPD

No

IPD plan description

No plan available at present.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures
2. Men between 18-85 years of age and post-menopausal women up to 85 years of age (menstrual periods stopped at least 12 months ahead of the enrolment in the trial)
3. Acute onset of chest pain of < 12 hours duration
4. STEMI as characterized on ECG by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with a minimum of 1 mm concordant ST elevation or 1 mV ST elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior acute myocardial infarction (AMI)
5. Eligible for primary PCI
6. NLR in the range of 7-17 at hospital admission (measured in a point-of-care testing device). In patients with chest pain lasting > 3 - ≤ 6 hours at admission, the NLR should be in the range of 4.8-17 and for patients with chest pain lasting ≤ 3 hours at admission, the NLR should be in the range of 4.8-17, or the neutrophile count should be ≥ 9 x 10E9/L, irrespective of the lymphocyte count. For STEMI patients with an anterior or anterolateral infarction, the NLR should be ≥3. If it is not possible to measure NLR at admission, it must be measured before reflow is established.

Exclusion criteria 9

1. Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
2. Previous exposure to RTP-026
3. Time from symptoms onset to primary PCI > 12 hours
4. Previous CABG
5. Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
6. Ongoing treatment with immune suppressive compounds
7. Any condition that, in the view of the investigator, would suggest that the patient is unable to comply with the study protocol and procedures (e.g., psychiatric disorders, dementia)
8. Known contraindications to CMR
9. ORBI Risk Score > 12

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The primary safety endpoint: To compare the safety and tolerability of RTP-026 against placebo by evaluating adverse events (AEs), serious adverse events (SAEs), vital signs, ECGs, and laboratory abnormalities.
2. To compare the effect of RTP-026 against placebo by assessing the following by treatment group: Change in cTnT and CK-MB determined in samples taken at Baseline, 6 hrs, 12 hrs and 24 hours post-PCI

Secondary endpoints 12

1. Initial MSI defined as the ratio between IS and AAR determined within 48 hours post-PCI determined by CMR
2. MSI determined by CMR 90 days post-PCI
3. IS determined by CMR within 48 hours post-PCI
4. IS determined by CMR 90 days post-PCI
5. Myocardial oedema determined by CMR within 48 hours post-PCI
6. Change in IS from initial determination of IS within 48 hours post-PCI to 90 days post-PCI determined by CMR
7. Effects on LVEF determined by CMR 48 hours post-PCI
8. Effects on LVEF determined by CMR 90 days post-PCI
9. Changes in Pro-BNP, hsCRP and NLR determined in samples taken at Baseline, 6 hrs, 12 hrs and 24 hours post-PCI
10. The composite of death and MACE (defined as CV mortality, admission due to recurrent AMI or HF up to day 28 post-PCI
11. The composite of death and MACE up to day 90 post-PCI
12. Days to discharge from hospital

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

ResoTher Pharma A/S

Sponsor organisation

ResoTher Pharma A/S

Address

Dronninggaards Alle 136

City

Holte

Postcode

2840

Country

Denmark

Scientific contact point

Organisation

ResoTher Pharma A/S

Contact name

Thomas Jonassen

Public contact point

Organisation

ResoTher Pharma A/S

Contact name

Thomas Jonassen

Third parties 2

Locations

2 EU/EEA countries · 4 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 12 files

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

Application history

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