更新于：2024-04-26
Ziltivekimab
更新于：2024-04-26
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
序列信息
Sequence Code 19342433H
来源: *****
Sequence Code 19342434L
来源: *****
关联
19
项与 Ziltivekimab 相关的临床试验ARTEMIS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Patients With Acute Myocardial Infarction
Specifying the Anti-inflammatory Effects of Ziltivekimab With Diverse Imaging Modalities and In-depth Cellular Phenotyping
Effects of Ziltivekimab Versus Placebo on Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
100 项与 Ziltivekimab 相关的临床结果
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100 项与 Ziltivekimab 相关的转化医学
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100 项与 Ziltivekimab 相关的专利（医药）
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12
项与 Ziltivekimab 相关的文献（医药）2024-01-01Journal of the American Society of Nephrology
Effect of Ziltivekimab on Determinants of Hemoglobin in Patients with CKD Stage 3–5: An Analysis of a Randomized Trial (RESCUE)
Article
作者: Pergola, Pablo E ; Davidson, Michael ; Andreas Schytz, Philip ; Perkovic, Vlado ; Mohseni Zonoozi, Amir A ; Raj, Dominic S ; Jensen, Camilla ; Tuttle, Katherine R
Significance Statement:
Systemic inflammation in CKD can lead to anemia. Ziltivekimab, a fully human monoclonal antibody targeting the IL-6 ligand, has been shown to reduce systemic inflammation in patients with CKD. It has also been shown to increase serum albumin in patients on hemodialysis with inflammation and hyporesponsiveness to treatment with erythropoiesis-stimulating agents. This exploratory analysis of the RESCUE clinical trial found that among patients with CKD stage 3–5 and systemic inflammation, ziltivekimab treatment significantly increased hemoglobin (Hb) levels after 12 weeks compared with placebo. Ziltivekimab was also associated with significant increases in serum iron levels, total iron-binding capacity, and transferrin saturation. No major safety concerns were reported. Further clinical trials are warranted to study ziltivekimab's potential for anemia management in patients with CKD.
Background:
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.
Methods:
This was an analysis of exploratory end points from the RESCUE trial (NCT03926117), which included 264 adults with CKD stage 3–5 and high-sensitivity C-reactive protein ≥2 mg/L. Participants received placebo or subcutaneous ziltivekimab (7.5, 15, or 30 mg) (1:1:1:1) once every 4 weeks, up to 24 weeks. End points for this analysis were changes in Hb and biomarkers of iron homeostasis from baseline to week 12.
Results:
The trial was terminated early due to the coronavirus disease 2019 pandemic, and thus, data up to week 12 are presented. Hb levels significantly increased from baseline to week 12 with ziltivekimab 7.5, 15, and 30 mg (treatment differences versus placebo: +0.57 g/dl [95% confidence interval, 0.27 to 0.86], +1.05 g/dl [0.76 to 1.33], and +0.99 g/dl [0.70 to 1.28], respectively, all P < 0.001). Ziltivekimab was associated with significant increases in serum iron levels, total iron-binding capacity, and transferrin saturation from baseline to week 12 (P < 0.05 versus placebo for all doses and comparisons). Cases of sustained thrombocytopenia, sustained neutropenia, anemia, and iron deficiency anemia were infrequent and similar across all groups.
Conclusions:
Anti-inflammatory therapy with ziltivekimab improved the markers of anemia and iron homeostasis in people with stage 3–5 CKD and systemic inflammation, suggesting a possible role in anemia management.
2023-11-01Clinical Therapeutics
An Update on Inflammation in Atherosclerosis: How to Effectively Treat Residual Risk
Review
作者: El Messaoudi, S ; Opstal, T S J ; Cornel, J H ; Bax, W A ; Mohammadnia, N
PURPOSE:
This study reviewed the contribution of inflammation to atherosclerotic cardiovascular disease (ASCVD), which has gained widespread recognition in recent years.
METHODS:
This critical review evaluated how recent publications and ongoing clinical trials in atherosclerotic inflammation will affect clinical care.
FINDINGS:
Key trials, including CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcomes Study) with canakinumab (interleukin-1β inhibition), and COLCOT (Colchicine Cardiovascular Outcomes Trial) and LoDoCo2 (Low Dose Colchicine 2) with colchicine, have shown that suppressing inflammation can improve outcomes in ASCVD. Cholesterol crystals play an important role in activating the NOD-, LRR-, and pyrin domain-containing protein 3 inflammasome and subsequent cytokine cascade. Inflammation contributes to significant residual risk after optimal lipid-lowering therapy. High-sensitivity C-reactive protein is a recognized biomarker of residual risk, and newer biomarkers such as the neutrophil to lymphocyte ratio may add additional information. The role of lipoprotein(a) as a proinflammatory agent or possible inflammatory biomarker is under investigation. The contribution of clonal hematopoiesis of indeterminate potential and trained immunity are in the early stages of investigation. Ongoing clinical trials of suppressing inflammation with NOD-, LRR-, and pyrin domain-containing protein 3 inflammasome inhibition (colchicine) and alternative approaches with downstream interleukin-6 ligand inhibition (ziltivekimab) will expand the evidence base for the use of anti-inflammatory agents in ASCVD.
IMPLICATIONS:
Based on current evidence and ongoing clinical trials, targeting inflammation alongside optimal lipid lowering is likely to be central to the future treatment of ASCVD. (Clin Ther. 2023;45:XXX-XXX) © 2023 Elsevier HS Journals, Inc.
2023-10-01Journal of cardiology
Efficacy and safety of interleukin-6 inhibition with ziltivekimab in patients at high risk of atherosclerotic events in Japan (RESCUE-2): A randomized, double-blind, placebo-controlled, phase 2 trial.
Article
作者: Wada, Yukihiro ; Honda, Hirokazu ; Zonoozi, Amir Abbas Mohseni ; Meyer, Anna Sina Pettersson ; Jensen, Camilla
BACKGROUND:
Despite optimal treatment, a residual inflammatory risk often remains in patients with atherosclerotic cardiovascular disease. In a US-based phase 2 trial, ziltivekimab, a fully human monoclonal antibody targeting the interleukin-6 ligand, significantly reduced biomarkers of inflammation compared with placebo in patients at high atherosclerotic risk. Here, we report the efficacy and safety of ziltivekimab in Japanese patients.
METHODS:
RESCUE-2 was a randomized, double-blind, 12-week, phase 2 trial. Participants aged ≥20 years with stage 3-5 non-dialysis-dependent chronic kidney disease and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L were randomized to receive placebo (n = 13) or subcutaneous ziltivekimab 15 mg (n = 11) or 30 mg (n = 12) at Weeks 0, 4, and 8. The primary endpoint was percentage change in hsCRP levels from baseline to end of treatment (EOT; mean of Week 10 and Week 12 values).
RESULTS:
At EOT, median hsCRP levels were reduced by 96.2 % in the 15 mg group (p < 0.0001 versus placebo), by 93.4 % in the 30 mg group (p = 0.002 versus placebo), and by 27.0 % in the placebo group. Serum amyloid A and fibrinogen levels were also reduced significantly. Ziltivekimab was well tolerated and did not affect total cholesterol to high-density lipoprotein cholesterol ratios. There was a small, but statistically significant increase in triglyceride levels with ziltivekimab 15 mg and 30 mg compared with placebo.
CONCLUSIONS:
The efficacy and safety results support the development of ziltivekimab for secondary prevention and the treatment of patients at high atherosclerotic risk.
CLINICALTRIALS:
gov identifier, NCT04626505.
100 项与 Ziltivekimab 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 心脏衰竭 | 临床3期 | 希腊 更多 | |
| 炎症 | 临床3期 | 新加坡 更多 | |
| 动脉粥样硬化 | 临床3期 | 中国台湾 更多 | |
| 慢性心力衰竭 | 临床3期 | 中国台湾 更多 | |
| 慢性肾病 | 临床3期 | 马来西亚 更多 |
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临床结果
临床结果
适应症
分期
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临床2期 | 慢性肾病 high-sensitivity C-reactive protein | 264 | 願鏇願壓糧廠獵夢齋願(憲製醖膚憲積製築醖壓) = 鏇遞膚範獵簾鑰鑰衊壓 夢範積獵範積遞鹽遞顧 (淵顧鹽積艱鹽選淵積淵 ) | 积极 | 2024-01-01 | ||
願鏇願壓糧廠獵夢齋願(憲製醖膚憲積製築醖壓) = 鏇窪鏇觸憲窪壓艱壓蓋 夢範積獵範積遞鹽遞顧 (淵顧鹽積艱鹽選淵積淵 ) | |||||||
临床2期 | 264 | (Placebo) | 淵築簾遞膚淵鏇獵壓鹹(淵糧蓋窪鏇淵齋鏇鏇築) = 構獵築簾網構構選憲鹽 齋遞鬱壓鹹遞網顧糧窪 (蓋選夢選糧顧鹽網糧選, 窪衊願選鏇獵廠鏇齋淵 ~ 願醖憲淵憲蓋繭醖淵顧) 更多 | - | 2023-08-09 | ||
(Ziltivekimab 7.5 mg) | 淵築簾遞膚淵鏇獵壓鹹(淵糧蓋窪鏇淵齋鏇鏇築) = 製構窪憲憲鏇衊範觸廠 齋遞鬱壓鹹遞網顧糧窪 (蓋選夢選糧顧鹽網糧選, 鑰範淵構鹽鬱鬱餘鏇憲 ~ 遞構簾窪積範廠鏇鏇衊) 更多 | ||||||
临床1/2期 | 61 | Placebo (Placebo) | 壓築積壓網網鹹範獵衊(窪繭築餘願繭製鑰鹹鑰) = 範夢鏇膚廠廠願鏇齋網 壓淵廠餘積繭齋艱選淵 (遞夢選範網鏇鏇範鑰觸, 艱夢構範顧簾膚膚膚獵 ~ 窪觸構鬱網構繭襯糧範) 更多 | - | 2021-07-30 | ||
(COR-001) | 餘廠簾憲蓋觸鹹醖窪築(願築餘鹽壓艱製製齋繭) = 糧衊積糧齋餘壓鑰獵積 窪醖憲簾齋醖膚築蓋顧 (淵獵衊範壓衊鬱鏇選網, 壓鹹築製選願夢糧鏇淵 ~ 獵鏇觸網鹽獵夢壓構壓) |
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