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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518450-16-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Invobenitug also known as Invobenitug (AK1967) 10mg/kg body weight | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK1967 (Invobenitug also known as Procizumab) | Drug | DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reported number of treatment-emergent adverse events from start of Invobenitug administration up until the last follow-up visit after Invobenitug administration | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics defined as plasma-time concentration of invobenitug | 30 days | |
| Pharmacodynamics defined as cDPP3 concentration | 30 days | |
| Pharmcodynamics defined as cDPP3 activity |
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Inclusion Criteria:
Signed informed consent.
Diagnosis of CS based on the following entry criteria:
Etiology of CS must be one of the following: ACS, septic or adHF origin
Exclusion Criteria:
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.
Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score >30), known severe chronic pulmonary disease (including COPD classification GOLD4 and/or chronic oxygen therapy and/or restrictive chronic pulmonary disease and/or severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR < 20 ml/min/1.73 m2 or chronic dialysis.
Patients with untreated sepsis.
Patients with valvular heart diseases as the primary cause of cardiogenic shock.
Other known causes of shock, namely
Patients who have severe immune suppression such as recent (<3 months) chemotherapy and/or severe neutropenia (neutrophil count <500 cells/mm3) and/or chronic high glucocorticoid dose (≥0.5 mg/kg per day of prednisone equivalent) and/or recent (<3 months) organ transplantation
Patients who have undergone any form of surgery in the last 7 days, except 1) minor surgeries such as cosmetic surgeries, skin surgery, dental surgery and impella implantation 2) surgery for peritonitis with adequate source control, which are allowed.
Women who are pregnant or breastfeeding.
Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization
US only: Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karakas Mahir, Prof. Dr. Dr. | Contact | +49 173 3060687 | karakas@4teen4.de | |
| Peter Szecsödy, MD | Contact | +46 707878737 | szecsoedy@4teen4.de |
| Name | Affiliation | Role |
|---|---|---|
| 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) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yerevan medical scientific center | Not yet recruiting | Yerevan | 0014 | Armenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42165327 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Placebo | Drug | Application of placebo |
|
| 30 days |
| Erebouni Mwdical Center | Not yet recruiting | Yerevan | 0087 | Armenia |
|
| Heart Center Aalst, AZORG | Recruiting | Aalst | Belgium |
|
| University Hospital Saint Pierre | Recruiting | Brussels | Belgium |
|
| Ghent University Hospital | Not yet recruiting | Ghent | Belgium |
|
| University Hospital and Medical Faculty of Pilsen | Recruiting | Pilsen | Czechia |
|
| Charles University Motol University Hospital | Recruiting | Prague | Czechia |
|
| General University Hospital in Prague - FVN | Recruiting | Prague | Czechia |
|
| Institute of Clinical and Experimental Medicine - IKEM | Recruiting | Prague | Czechia |
|
| University Hospital Avicenne AP-HP | Recruiting | Bobigny | France |
|
| Département d'anesthésie-réanimation | Not yet recruiting | Dijon | 21000 | France |
|
| University Hospital Lille - Institut Cœur Poumon | Recruiting | Lille | France |
|
| University Hospital - Dupuytren Limoges | Recruiting | Limoges | France |
|
| Regional University Hospital Nancy - Hopitaux de Brabois | Recruiting | Nancy | France |
|
| Hôpital Pitié Salpêtrière | Not yet recruiting | Paris | 75651 | France |
|
| Lariboisière Hospital AP-HP | Recruiting | Paris | France |
|
| Radboud University Medical Center | Recruiting | Nijmegen | Netherlands |
|
| Uniersytecki Szpital Kliniczny w Białystoku | Recruiting | Bialystok | Poland |
|
| Uniwersytecki Szpital Kliniczny w Białymstoku | Not yet recruiting | Bialystok | Poland |
|
| Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach | Recruiting | Katowice | Poland |
|
| Clinical University Hospital Poznań | Recruiting | Poznan | Poland |
|
| J. Mikulicz Radecki Clinical University Hospital Wrocław | Recruiting | Wroclaw | Poland |
|
| Clinical Hospital Center Bezanijska Kosa | Not yet recruiting | Belgrade | Serbia |
|
| Institute for Cardiovascular Diseases of Vojvodina | Not yet recruiting | Kamenitz | Serbia |
|
| Clinical Center Niš | Not yet recruiting | Niš | Serbia |
|
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
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| ID | Term |
|---|---|
| C000717530 | procizumab |
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