NCT06832722

Brief Summary

The objective of this Phase 1b trial is to evaluate the safety and tolerability of 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 procizumab are evaluated to define the optimum phase 2 dose (P2D) of procizumab.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_1

Timeline
7mo left

Started Jul 2025

Geographic Reach
6 countries

20 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

Study Progress59%
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
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

February 7, 2025

Last Update Submit

April 21, 2026

Conditions

Shock, Cardiogenic

Keywords

Cardiogenic shockProcizumab

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 (3)

Invobenitug also known as Procizumab (AK1967) other dose regimen based on PK profile

ACTIVE COMPARATOR

Other dose regimen based on PK profile

Drug: AK1967 (Invobenitug also known as Procizumab)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Invobenitug also known as Procizumab (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 Procizumab (AK1967) 10mg/kg body weightInvobenitug also known as Procizumab (AK1967) other dose regimen based on PK profile

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.
  • 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.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

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

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

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

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

Central Study Contacts

Karakas Mahir, Prof. Dr. Dr.

CONTACT

+49 173 3060687karakas@4teen4.de

Gad Cotter, MD

CONTACT

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)

November 30, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

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