[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"4TEEN4 Pharmaceuticals GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100580086","phase-1-invobenitug-also-known-as-procizumab-pcz-ak1967-in-critical-cardiovascular-care-100580086",false,"NCT06832722","Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care","Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1b\u002F2a Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Invobenitug Also Knows as Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations","PROCARD 2a","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Diagnosis of CS based on the following entry criteria:\n\n   1. Need for ongoing vasopressors and\u002For inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg\n   2. Lactate ≥ 2.0 mmol\u002FL\n   3. High cDPP3 concentration ≥ 30 ng\u002FmL\n3. Etiology of CS must be one of the following: ACS, septic or adHF origin\n\n   Exclusion Criteria:\n4. Patients who will be receiving vasopressors and\u002For inotropes for more than 16 hours prior to receiving the IMP.\n5. Patients being longer than 24 hours in the ICU at the time of randomization.\n6. Patients below the age of 18 or above 80 years.\n7. Patients receiving Ang II and\u002For levosimendan.\n8. Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication.\n9. Stroke or transient ischemic attack within the last 3 months.\n10. SCAI Shock Stage E.\n11. Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset).\n12. Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death.\n13. 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\u002For ECMO but have no evidence of hemolysis during screening can be enrolled in the trial.\n14. Patients exceeding a maximum body weight of 120 kg.\n15. CPR lasting more than 15 minutes and\u002For the patient is not conscious at randomization.\n16. Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease.\n17. Pericardial constriction\n18. Sustained SBP \\> 120 mmHg during the hour prior to randomization.\n19. Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score \\>30), known severe chronic pulmonary disease (including COPD classification GOLD4 and\u002For chronic oxygen therapy and\u002For restrictive chronic pulmonary disease and\u002For severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR \\\u003C 20 ml\u002Fmin\u002F1.73 m2 or chronic dialysis.\n20. Patients with untreated sepsis.\n21. Patients with valvular heart diseases as the primary cause of cardiogenic shock.\n22. Other known causes of shock, namely\n\n    1. Hypovolemia\n    2. Hemorrhage\n    3. Anaphylaxis\n    4. Intoxication (e.g., drug-induced shock)\n    5. Dynamic left ventricular outflow tract obstruction\n    6. Isolated right heart failure, including cardiac tamponade and\u002For pulmonary embolism\n    7. Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture\n    8. Inappropriate pacing or shock resulting from ICD malfunction\n23. Patients who have severe immune suppression such as recent (\\\u003C3 months) chemotherapy and\u002For severe neutropenia (neutrophil count \\\u003C500 cells\u002Fmm3) and\u002For chronic high glucocorticoid dose (≥0.5 mg\u002Fkg per day of prednisone equivalent) and\u002For recent (\\\u003C3 months) organ transplantation\n24. 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.\n25. Women who are pregnant or breastfeeding.\n26. Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization","ALL","18 Years","80 Years",{"count":21,"type":22},130,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","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.",[29],"Shock, Cardiogenic",[31,32],"Cardiogenic shock","Procizumab","RECRUITING","2026-04-21",{"date":36,"type":37},"2026-04-23","ACTUAL",{"date":39,"type":37},"2025-07-13",{"date":41,"type":22},"2026-12-01",{"name":43,"class":44},"4TEEN4 Pharmaceuticals GmbH","INDUSTRY",20,""]