Procizumab (PCZ; AK1967) in Critical Cardiovascular Care
NCT ID: NCT06832722
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
130 participants
INTERVENTIONAL
2025-07-13
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Procizumab (AK1967) 10mg/kg body weight
10 mg/kg body weight
AK1967 (Procizumab)
DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
Procizumab (AK1967) other dose regimen based on PK profile
Other dose regimen based on PK profile
AK1967 (Procizumab)
DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
Placebo
Placebo
Placebo
Application of placebo
Interventions
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AK1967 (Procizumab)
DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
Placebo
Application of placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of CS due to ACS or CS of septic origin based on the following entry criteria:
1. Need for ongoing vasopressors to maintain a MAP ≥ 65 mm ≥ or SBP ≥ 90 mmHg
2. Serum lactate ≥ 2.0 mmol/L
3. Elevated DPP3 concentration
Exclusion Criteria
* Patients below the age of 18 or above 75 years.
* Patients receiving Ang II and/or Levosimendan.
* Patients receiving only inotropes for the treatment of CS.
* Patients with known allergies or hypersensitivity to the IMP or its excipients (including known lactose hypersensitivity) or any related medication.
* Stroke or transient ischemic attack within the last 3 months.
* SCAI Stage E or most severe SCAI D including circulatory collapse refractory to treatment and/or loss of consciousness.
* Patients with SOFA score 12 and above in Part 1; SOFA score 14 and above in Part 2/3.
* Patients on and with a high likelihood of requiring MCS within 12 hours of trial enrollment. MCS includes any type of mechanical support device including IAoBP, left ventricular assist device of any type or kind and renal replacement or mechanical support devices of any type or kind.
* Patients exceeding a maximum body weight of 120 kg.
* CPR lasting more than 15 minutes and the patient is not fully conscious at randomization.
* Primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease.
* Shock triggered primarily by a correctable causality such as significant arrhythmia (inclusive of atrial fibrillation as the main reason for admission), severe anemia, pulmonary embolism, exacerbation of chronic obstructive pulmonary disease, or device implantation, or over-diuresis as a cause of hypotension.
* Pericardial constriction or active pericarditis.
* Patients suffering from CS due to myocarditis.
* Significant ventricular arrhythmia prior to screening (such as sustained ventricular tachycardia or ventricular fibrillation) or ICD shock within the past month or history of sudden death within the last 6 months.
* CRT, ICD, or pacemaker implantation within the past month.
* Sustained SBP \> 120 mmHg during the hour prior to randomization.
* Cor pulmonale or other causes of isolated right-sided HF or not related to left ventricular dysfunction.
* Known severe renal disease before admission requiring dialysis or known eGFR prior to admission \< 20 ml/min/1.73 m2.
* Laboratory exclusions:
1. Hemoglobin \< 8.5 g/dl
2. Platelet count \< 30,000/µl for CS from septic origin
3. Platelet count \< 100,000/µl for CS from ACS origin
4. Serum potassium \> 5.7 mmol/L or \< 3.3 mmol/L
* Severe chronic pulmonary or thyroid disease.
* In those with CS due to ACS, patients with no attempt or failed attempts to coronary revascularization.
* Patients with untreated sepsis.
* Patients with severe valvular heart diseases. This includes any moderate or severe stenotic valvular disease, any moderate or severe aortic or pulmonary regurgitation and severe mitral or tricuspid regurgitation.
* Patients experiencing hemorrhagic, hypovolemic, obstructive, anaphylactic shock or shock related to intoxication or any other reason for shock besides ischemic or septic/ inflammatory causes.
* Patients who have undergone chemotherapy within 30 days prior to trial entry.
* Patients receiving chronic corticosteroid treatment equivalent to a prednisone dose of 10 mg or higher per day, or an equivalent dose of another corticosteroid or any other anti-inflammatory or inflammation suppressing medications such as interleukin blockers, methotrexate or other such therapies.
* Patients who have undergone any form of surgery in the last 7 days will be excluded from the trial or analysis, except 1) minor surgeries such as cosmetic surgeries, skin surgery and dental surgery and 2) primary post operative peritonitis, 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.
18 Years
75 Years
ALL
No
Sponsors
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4TEEN4 Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Alexandre Mebazaa, Professor
Role: PRINCIPAL_INVESTIGATOR
Hôpital Lariboisière, Paris France
Locations
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University Hospital Saint Pierre
Brussels, , Belgium
General University Hospital in Prague - FVN
Prague, , Czechia
Institute of Clinical and Experimental Medicine - IKEM
Prague, , Czechia
University Hospital Avicenne AP-HP
Bobigny, , France
University Hospital Lille - Institut Cœur Poumon
Lille, , France
University Hospital - Dupuytren Limoges
Limoges, , France
Regional University Hospital Nancy - Hopitaux de Brabois
Nancy, , France
Lariboisière Hospital AP-HP
Paris, , France
Radboud University Medical Center
Nijmegen, , Netherlands
Clinical University Hospital Poznań
Poznan, , Poland
J. Mikulicz Radecki Clinical University Hospital Wrocław
Wroclaw, , Poland
Countries
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Central Contacts
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Gad Cotter, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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2024-518450-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
CT-P1-002
Identifier Type: -
Identifier Source: org_study_id
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