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New treatment option for Shock, Cardiogenic
Official title Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care
ClinicalTrials.gov ID: NCT06832722
What this study is testing
What is AK1967 (Invobenitug also known as Procizumab)?
AK1967 (Invobenitug also known as Procizumab) is an investigational medicine, being studied as a potential treatment for shock, cardiogenic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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
You likely can't join 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.
See the full eligibility criteria
- 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
- 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...
- 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...
- Patients with untreated sepsis.
- Patients with valvular heart diseases as the primary cause of cardiogenic shock.
- Other known causes of shock, namely
- Hypovolemia
- Hemorrhage
- Anaphylaxis
- Intoxication (e.g., drug-induced shock)
- Dynamic left ventricular outflow tract obstruction
- Isolated right heart failure, including cardiac tamponade and/or pulmonary embolism
- Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture
- Inappropriate pacing or shock resulting from ICD malfunction
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Yerevan, Armenia
- Aalst, Belgium
- Brussels, Belgium
- Ghent, Belgium
- Pilsen, Czechia
- Prague, Czechia
- Bobigny, France
- Dijon, France
- Lille, France
- Limoges, France
- Nancy, France
- Paris, France
- Nijmegen, Netherlands
- Bialystok, Poland
- Katowice, Poland
- Poznan, Poland
- Wroclaw, Poland
- Belgrade, Serbia
- Kamenitz, Serbia
- Niš, Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yerevan, Armenia; Aalst, Belgium; Brussels, Belgium; Ghent, Belgium; Pilsen, Czechia; Prague, Czechia and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.