NCT06832722|RecruitingPhase 1DMCFDA Drug

Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care

PROCARD 2a

Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1b/2a Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Invobenitug Also Knows as Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations

4TEEN4 Pharmaceuticals GmbH ClinicalTrials.gov

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2 other identifiers

CT-P1-0022024-518450-16-00

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredFeb 2025

StartedJul 2025

CompletionDec 2026

Brief Summary

The objective of this Phase 1b/2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as procizumab), a monoclonal antibody under development for the treatment of cardiogenic shock (CS). CS is a life-threatening hypoperfusion of vital organs that frequently results in death. In addition to safety and tolerability, pharmacokinetics and pharmacodynamics of invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

5mo left

Started Jul 2025

Geographic Reach

7 countries

25 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Progress73%

Jul 2025Dec 2026

First Submitted

Initial submission to the registry

February 7, 2025

Completed

11 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed

5 months until next milestone

Study Start

First participant enrolled

July 13, 2025

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

February 7, 2025

Last Update Submit

July 8, 2026

Conditions

Shock, Cardiogenic

Keywords

Cardiogenic shockProcizumabinvobenitug

Outcome Measures

Primary Outcomes (1)

Reported number of treatment-emergent adverse events from start of Invobenitug administration up until the last follow-up visit after Invobenitug administration
30 days

Secondary Outcomes (3)

Pharmacokinetics defined as plasma-time concentration of invobenitug
30 days
Pharmacodynamics defined as cDPP3 concentration
30 days
Pharmcodynamics defined as cDPP3 activity
30 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Invobenitug also known as Invobenitug (AK1967) 10mg/kg body weight

ACTIVE COMPARATOR

Drug: AK1967 (Invobenitug also known as Procizumab)

Interventions

PlaceboDRUG

Application of placebo

Placebo

AK1967 (Invobenitug also known as Procizumab)DRUG

DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

Invobenitug also known as Invobenitug (AK1967) 10mg/kg body weight

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed informed consent.
Diagnosis of CS based on the following entry criteria:
Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg
Lactate ≥ 2.0 mmol/L
High cDPP3 concentration ≥ 30 ng/mL
Etiology of CS must be one of the following: ACS, septic or adHF origin

You may not qualify if:

Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP.
Patients being longer than 24 hours in the ICU at the time of randomization.
Patients below the age of 18 or above 80 years.
Patients receiving Ang II and/or levosimendan.
Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication.
Stroke or transient ischemic attack within the last 3 months.
SCAI Shock Stage E.
Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset).
Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death.
Only for Part 1: Patients on cannula-based MCS (including VV and VA-ECMO, impella or left ventricular assist device of any type (excluding IABP)) or on renal replacement therapy. Patients who are treated by impella and/or ECMO but have no evidence of hemolysis during screening can be enrolled in the trial.
Patients exceeding a maximum body weight of 120 kg (US: 150 kg).
CPR lasting more than 15 minutes and/or the patient is not conscious at randomization.
Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease.
Pericardial constriction
Sustained SBP \> 120 mmHg during the hour prior to randomization.
+17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

4TEEN4 Pharmaceuticals GmbHlead

Study Sites (25)

Yerevan medical scientific center

Yerevan, 0014, Armenia

NOT YET RECRUITING

Erebouni Mwdical Center

Yerevan, 0087, Armenia

NOT YET RECRUITING

Heart Center Aalst, AZORG

Aalst, Belgium

RECRUITING

University Hospital Saint Pierre

Brussels, Belgium

RECRUITING

Ghent University Hospital

Ghent, Belgium

NOT YET RECRUITING

University Hospital and Medical Faculty of Pilsen

Pilsen, Czechia

RECRUITING

Charles University Motol University Hospital

Prague, Czechia

RECRUITING

General University Hospital in Prague - FVN

Prague, Czechia

RECRUITING

Institute of Clinical and Experimental Medicine - IKEM

Prague, Czechia

RECRUITING

University Hospital Avicenne AP-HP

Bobigny, France

RECRUITING

Département d'anesthésie-réanimation

Dijon, 21000, France

NOT YET RECRUITING

University Hospital Lille - Institut Cœur Poumon

Lille, France

RECRUITING

University Hospital - Dupuytren Limoges

Limoges, France

RECRUITING

Regional University Hospital Nancy - Hopitaux de Brabois

Nancy, France

RECRUITING

Hôpital Pitié Salpêtrière

Paris, 75651, France

NOT YET RECRUITING

Lariboisière Hospital AP-HP

Paris, France

RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

RECRUITING

Uniersytecki Szpital Kliniczny w Białystoku

Bialystok, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, Poland

NOT YET RECRUITING

Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach

Katowice, Poland

RECRUITING

Clinical University Hospital Poznań

Poznan, Poland

RECRUITING

J. Mikulicz Radecki Clinical University Hospital Wrocław

Wroclaw, Poland

RECRUITING

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

NOT YET RECRUITING

Institute for Cardiovascular Diseases of Vojvodina

Kamenitz, Serbia

NOT YET RECRUITING

Clinical Center Niš

Niš, Serbia

NOT YET RECRUITING

Related Publications (1)

van Lier D, Mourisse L, Hollander H, Santos K, Bergmann A, van Herwaarden AE, Kox M, Pickkers P. Safety, tolerability, and pharmacokinetics/-dynamics of the dipeptidyl peptidase 3-inhibiting antibody Procizumab in a first-in-human trial. MAbs. 2026 Dec;18(1):2671468. doi: 10.1080/19420862.2026.2671468. Epub 2026 May 21.
PMID: 42165327DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

procizumab

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

Alexandre Mebazaa, Professor
Hôpital Lariboisière, Paris France
PRINCIPAL INVESTIGATOR
David A. Morrow, MD, MPH
TIMI study Group (An ARO of Brigham & Women's Hospital and an Affiliate of Harvard Medical School)
PRINCIPAL INVESTIGATOR

Central Study Contacts

Karakas Mahir, Prof. Dr. Dr.

CONTACT

+49 173 3060687 karakas@4teen4.de

Peter Szecsödy, MD

CONTACT

+46 707878737 szecsoedy@4teen4.de

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 18, 2025

Study Start

July 13, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing: Will not share

Locations

SE(3)CZ(4)BE(3)NL(1)PL(5)FR(7)AR(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Placebo

Invobenitug also known as Invobenitug (AK1967) 10mg/kg body weight

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations