Actively Recruiting
Multi-center, Randomized, Placebo-controlled, Double-blind Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Procizumab (AK1967) in Cardiogenic Shock Patients with High cDPP3 Levels
Led by 4TEEN4 Pharmaceuticals GmbH · Updated on 2026-04-23
130
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating procizumab, a monoclonal antibody, in a Phase 1b/2a trial to assess its safety, tolerability, and how it behaves in the body for treating cardiogenic shock (CS). CS is a severe condition where vital organs do not receive enough blood, often leading to death. This study aims to determine the best dose for future trials by monitoring pharmacokinetics and pharmacodynamics of procizumab in patients with elevated circulating DPP3 levels. Participants receive either procizumab at different dose regimens based on pharmacokinetic profiles or a placebo, with treatment assigned randomly in a double-blind manner. The trial includes a 30-day follow-up period during which safety and drug activity are closely monitored. The study involves multiple centers and compares the investigational antibody against placebo to evaluate treatment-emergent adverse events and biological effects. During the study, participants will be carefully assessed for adverse events, blood levels of the drug, and changes in DPP3 concentration and activity. The primary measure is the number of treatment-related adverse events up to 30 days after dosing. Researchers also evaluate pharmacokinetic and pharmacodynamic parameters at regular intervals. The trial runs until December 2026 and involves detailed monitoring to establish the safety profile and optimal dosing of procizumab in adults with cardiogenic shock.
CONDITIONS
Brief Title
Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosis of cardiogenic shock needing vasopressors and/or inotropes to maintain mean arterial pressure ≥ 65 mmHg or systolic blood pressure ≥ 90 mmHg
- Blood lactate level ≥ 2.0 mmol/L
- High circulating dipeptidyl peptidase 3 (cDPP3) concentration ≥ 30 ng/mL
- Cardiogenic shock due to acute coronary syndrome, sepsis, or acute decompensated heart failure
- Age between 18 and 80 years
You will not qualify if you...
- Receiving vasopressors and/or inotropes for more than 16 hours before the study drug
- In intensive care unit for more than 24 hours at randomization
- Receiving angiotensin II or levosimendan
- Known allergy or hypersensitivity to study drug or related medications
- Stroke or transient ischemic attack within last 3 months
- SCAI Shock Stage E
- Life expectancy less than 6 months due to other illnesses
- Very severe frailty or moribund condition indicating imminent death
- On cannula-based mechanical circulatory support or renal replacement therapy (with some exceptions)
- Body weight over 120 kg
- Cardiopulmonary resuscitation lasting more than 15 minutes or unconscious at randomization
- Certain heart diseases like primary hypertrophic cardiomyopathy or congenital heart disease
- Pericardial constriction
- Sustained systolic blood pressure over 120 mmHg during hour before randomization
- Severe chronic liver, lung, thyroid, or kidney disease
- Untreated sepsis
- Primary valvular heart disease causing cardiogenic shock
- Other causes of shock such as hypovolemia, hemorrhage, anaphylaxis, intoxication, right heart failure, mechanical heart complications, or device malfunction
- Severe immune suppression or recent organ transplantation
- Recent surgery within 7 days except minor or controlled surgeries
- Pregnant or breastfeeding women
- Participation in another clinical trial within one month prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive the study drug or placebo to investigate safety, tolerability, and pharmacokinetics in cardiogenic shock patients.
Multiple visits during treatment period
Duration - Up to 30 days after treatment
Participants are monitored for treatment-emergent adverse events and pharmacokinetic outcomes after treatment ends.
1 to 2 follow-up visits
Trial Site Locations
Total: 20 locations
1
Yerevan medical scientific center
Yerevan, Armenia, 0014
Not Yet Recruiting
2
Erebouni Mwdical Center
Yerevan, Armenia, 0087
Not Yet Recruiting
3
Heart Center Aalst, AZORG
Aalst, Belgium
Actively Recruiting
4
University Hospital Saint Pierre
Brussels, Belgium
Actively Recruiting
5
University Hospital and Medical Faculty of Pilsen
Pilsen, Czechia
Actively Recruiting
6
Charles University Motol University Hospital
Prague, Czechia
Actively Recruiting
7
General University Hospital in Prague - FVN
Prague, Czechia
Actively Recruiting
8
Institute of Clinical and Experimental Medicine - IKEM
Prague, Czechia
Actively Recruiting
9
University Hospital Avicenne AP-HP
Bobigny, France
Actively Recruiting
10
Département d'anesthésie-réanimation
Dijon, France, 21000
Not Yet Recruiting
11
University Hospital Lille - Institut Cœur Poumon
Lille, France
Actively Recruiting
12
University Hospital - Dupuytren Limoges
Limoges, France
Actively Recruiting
13
Regional University Hospital Nancy - Hopitaux de Brabois
Nancy, France
Actively Recruiting
14
Hôpital Pitié Salpêtrière
Paris, France, 75651
Not Yet Recruiting
15
Lariboisière Hospital AP-HP
Paris, France
Actively Recruiting
16
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
17
Uniersytecki Szpital Kliniczny w Białystoku
Bialystok, Poland
Actively Recruiting
18
Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach
Katowice, Poland
Actively Recruiting
19
Clinical University Hospital Poznań
Poznan, Poland
Actively Recruiting
20
J. Mikulicz Radecki Clinical University Hospital Wrocław
Wroclaw, Poland
Actively Recruiting
Research Team
K
Karakas Mahir, Prof. Dr. Dr.
G
Gad Cotter, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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