Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Novo Nordisk A/S
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing ziltivekimab to see if it can help people with heart failure and inflammation by reducing inflammation and improving heart function.
Is Ziltivekimab a promising drug for heart failure?The provided research articles do not contain information about Ziltivekimab or its effectiveness for heart failure. Therefore, we cannot determine if Ziltivekimab is a promising drug for heart failure based on the given data.236813
What safety data is available for Ziltivekimab in heart failure treatment?The provided research does not contain specific safety data for Ziltivekimab or its other names (COR-001, MEDI-5117, etc.) in the context of heart failure treatment. The articles focus on other treatments and drugs for heart failure, such as omecamtiv mecarbil, anakinra, and vericiguat, but do not mention Ziltivekimab or its associated names.57101112
What data supports the idea that the drug Ziltivekimab for Heart Failure is an effective treatment?The available research does not provide specific data supporting the effectiveness of Ziltivekimab for treating heart failure. Instead, it mentions a study where Ziltivekimab was used to reduce inflammation in patients with chronic kidney disease, not heart failure. Other studies focus on different treatments for heart failure, like Anakinra and Celacade, but not Ziltivekimab. Therefore, there is no direct evidence from the provided information that Ziltivekimab is effective for heart failure.1491214
Do I need to stop my current medications for the trial?The trial information does not specify if you need to stop your current medications. However, it is common for clinical trials to have specific guidelines about medication use, so it's best to discuss this with the trial coordinators.
Eligibility Criteria
This trial is for people with heart failure and inflammation. They must have a certain level of left atrial volume, high levels of C-reactive protein, and meet specific criteria related to heart function documented by echocardiography or hospital visits. It's not for those who've had recent major cardiac events/surgery, planned procedures, specific cardiomyopathies, extremely high blood pressure or abnormal heart rates.Inclusion Criteria
I have been diagnosed with heart failure and it affects my daily activities.
I was hospitalized for heart failure and needed IV treatment in the last 9 months, and my NT-proBNP levels are high.
My heart pumps well, with an LVEF over 40% in the last year.
My hs-CRP level is 2 mg/L or higher, indicating inflammation related to heart disease.
I have been diagnosed with heart failure and it affects my daily activities.
Exclusion Criteria
I am scheduled for a procedure to improve blood flow to my heart or other areas during the screening period.
I haven't had a heart attack, stroke, severe chest pain, mini-stroke, or been hospitalized for heart failure in the last 30 days.
I am scheduled for a heart device placement or a procedure to correct heart rhythm issues.
I have not had major surgery in the last 60 days and do not plan any soon.
Treatment Details
The study tests if Ziltivekimab can treat heart failure with inflammation compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo and monitored up to 4 years through clinic visits and an app that tracks injections and questionnaires.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZiltivekimabExperimental Treatment1 Intervention
Participants will receive ziltivekimab subcutaneous (s.c.) injection once-monthly and added standard of care for up to 4 years.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive ziltivekimab placebo s.c. injection once-monthly and added standard of care for up to 4 years.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Baptist Health HardinElizabethtown, KY
Novo Nordisk Investigational SiteSan Diego, CA
Novo Nordisk Investigational SiteGreensboro, NC
Novo Nordisk Investigational SiteCharlottesville, VA
More Trial Locations
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Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
References
Broad modulation of tissue responses (immune activation) by celacade may favorably influence pathologic processes associated with heart failure progression. [2007]Immune activation and inflammation contribute to the progression of chronic heart failure (CHF), but therapeutic approaches directed against these processes have been largely unsuccessful. This clinical study evaluated a novel, nonpharmacologic immune modulation therapy, shown experimentally to reduce inflammatory and increase anti-inflammatory cytokines. A total of 75 patients with New York Heart Association (NYHA) functional class III or IV CHF were randomized to receive either Celacade (immune modulation therapy) or placebo (n = 38 and n = 37, respectively) in a double-blind trial for 6 months, during which standard therapy for CHF was maintained. Patients were evaluated using the 6-minute walk test, changes in NYHA class, cardiac function, and quality-of-life assessments, and were observed for the occurrence of death and hospitalization. There was no between-treatment difference in the 6-minute walk test results, but 15 Celacade-treated patients (compared with 9 placebo-treated patients) improved NYHA classification by > or = 1 class (p = 0.140). Kaplan-Meier survival analysis showed that Celacade significantly reduced the risk of death (p = 0.022) and hospitalization (p = 0.008). Analysis of a clinical composite score demonstrated a significant between-group difference (p = 0.006). There was no difference in left ventricular ejection fraction between groups, but there was a trend toward improved quality of life favoring the Celacade-treated group (p = 0.110). These preliminary findings are consistent with the hypothesis that immune activation is important in the pathogenesis of CHF, and they establish the basis for a phase 3 trial to define the benefit of Celacade in CHF.
The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent. [2015]This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions.
Zarxio (Filgrastim-sndz): The First Biosimilar Approved by the FDA. [2020]Zarxio (filgrastim-sndz), a biosimilar for the treatment of severe chronic neutropenia.
Interleukin-1 Blockade in Recently Decompensated Systolic Heart Failure: Results From REDHART (Recently Decompensated Heart Failure Anakinra Response Trial). [2018]An enhanced inflammatory response predicts worse outcomes in heart failure (HF). We hypothesized that administration of IL-1 (interleukin-1) receptor antagonist (anakinra) could inhibit the inflammatory response and improve peak aerobic exercise capacity in patients with recently decompensated systolic HF.
New perspectives and future directions in the treatment of heart failure. [2021]The management of heart failure has changed significantly over the last 30 years, leading to improvements in the quality of life and outcomes, at least for patients with a substantially reduced left ventricular ejection fraction (HFrEF). This has been made possible by the identification of various pathways leading to the development and progression of heart failure, which have been successfully targeted with effective therapies. Meanwhile, many other potential targets of treatment have been identified, and the list is constantly expanding. In this review, we summarise planned and ongoing trials exploring the potential benefit, or harm, of old and new pharmacological interventions that might offer further improvements in treatment for those with HFrEF and extend success to the treatment of patients with heart failure with preserved left ventricular ejection fraction (HFpEF) and other heart failure phenotypes.
A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects. [2020]FKB327 is a biosimilar of the adalimumab reference product (RP). The primary objective was to assess the relative bioavailability of FKB327 after a single subcutaneous (SC) dose via prefilled syringe (PFS), auto-injector (AI), or vial with a disposable syringe (vial), in healthy subjects.
Recently Approved and Under Investigation Drugs for Treating Patients with Heart Failure. [2021]Heart Failure (HF) represents a leading cause of morbidity and mortality worldwide. Despite the recent advances in the treatment of this condition, patients´ prognosis remains unfavorable in most cases. Sacubitril/valsartan and ivabradine have been recently approved to improve clinical outcomes in patients with HF with reduced ejection fraction. Drugs under investigation for treating patients with HF encompass many novel mechanisms including vasoactive peptides, blocking inflammatory- mediators, natriuretic peptides, selective non-steroidal mineralocorticoid-receptor antagonists, myocardial β3 adrenoreceptor agonists, inhibiting the cytochrome C/cardiolipin peroxidase complex, neuregulin-1/ErbB signaling and inhibiting late inward sodium current. The aim of this manuscript is to review the main drugs under investigation for the treatment of patients with HF and give perspectives for their implementation into clinical practice.
Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study. [2022]To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence (BE) of MYL-1601D biosimilar with originator, NovoLog (Ref-InsAsp-US), and NovoRapid (Ref-InsAsp-EU).
Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week. [2023]With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.
Safety and efficacy of omecamtiv mecarbil for heart failure: A systematic review and meta-analysis. [2022]To assess the safety and efficacy of omecamtiv mecarbil compared with placebo in heart failure (HF) patients.
Vericiguat and Health-Related Quality of Life in Patients With Heart Failure With Reduced Ejection Fraction: Insights From the VICTORIA Trial. [2022]We examined the effects of vericiguat compared with placebo in patients with heart failure with reduced ejection fraction enrolled in VICTORIA (Vericiguat Global Study in Patients With Heart Failure With Reduced Ejection Fraction) on health status outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and evaluated whether clinical outcomes varied by baseline KCCQ score.
Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study. [2023]Heart failure (HF) is a global leading cause of mortality despite implementation of guideline directed therapy which warrants a need for novel treatment strategies. Proof-of-concept clinical trials of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, have shown promising results in patients with HF.
Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double-blind Study in Healthy Subjects. [2023]ABP 654 is a proposed biosimilar to ustekinumab reference product (RP) which works through antagonism of interleukin-12 and interleukin-23. Ustekinumab RP is used for the treatment of chronic inflammatory conditions, including some forms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. A randomized, double-blinded, single-dose, 3-arm, parallel-group study was conducted to assess the pharmacokinetic (PK) similarity of ABP 654 with ustekinumab RP sourced from the United States (US) and the European Union (EU); the PK similarity of ustekinumab US versus ustekinumab EU; and the comparative safety, tolerability, and immunogenicity of all 3 products. A total of 238 healthy subjects were randomized 1:1:1 and stratified by gender and ethnicity (Japanese versus non-Japanese) to receive a single 90 mg subcutaneous injection of ABP 654 or ustekinumab US or ustekinumab EU. PK similarity was established based on 90% confidence intervals (CIs) for the primary endpoints of area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf ) and maximum observed serum concentration (Cmax ) being contained within the prespecified margin of 0.8-1.25. No clinically meaningful differences in immunogenicity were found among the 3 products. Adverse events were similar between treatment groups and consistent with the safety profile of ustekinumab RP. Results indicate that ABP 654, ustekinumab US and ustekinumab EU share similar PK and safety profiles.
Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3-5: An Analysis of a Randomized Trial (RESCUE). [2023]In the phase 2 RESCUE clinical trial, ziltivekimab, a fully human monoclonal antibody against the IL-6 ligand, significantly reduced the biomarkers of inflammation compared with placebo, in patients with CKD and systemic inflammation (high-sensitivity C-reactive protein ≥2 mg/L). The aim of this subanalysis of RESCUE trial data was to assess the effect of ziltivekimab on Hb and iron homeostasis in this patient population.