MAS-825(MAS-825) - 药物靶点：IL-18 x IL-1β_在研适应症：冠状动脉疾病，化脓性汗腺炎，婴幼儿小肠结肠炎自身炎症_专利_临床

概要

基本信息

药物类型

双特异性抗体

别名

靶点

IL-18 x IL-1β

作用方式

抑制剂

作用机制

IL-18抑制剂(白细胞介素18抑制剂)、IL-1β抑制剂(白细胞介素-1β抑制剂)

治疗领域

免疫系统疾病感染心血管疾病+ [5]

在研适应症

冠状动脉疾病化脓性汗腺炎婴幼儿小肠结肠炎自身炎症+ [2]

非在研适应症

新型冠状病毒感染呼吸功能不全

原研机构

Novartis Pharmaceuticals Corp.

在研机构

Novartis Pharmaceuticals Corp.

Novartis AG

非在研机构-

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

6

项与 MAS-825 相关的临床试验

NCT06097663

/ Completed临床2期

A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in an Adult Population With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)

This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, or a single s.c. dose of MAS825, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 28 people with known coronary heart disease and TET2 or DNMT3A CHIP (VAF ≥2%).

开始日期2024-02-15

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT06309823

/ Completed临床3期IIT

A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency

MAS825 is a bi-specific IgG1 monoclonal antibody that simultaneously targets IL-1 beta and IL-18, thereby neutralizing both cytokines that are thought to be integral to the pathogenesis of XLP-2. Clinical trials are currently examining its efficacy in other diseases associated with elevations of these cytokines, including NLRC4-associated disease and hidradenitis suppurativa. This study proposes to assess the effectiveness of MAS825 in a single patient with XLP-2, who has previously demonstrated response to blockade of IL-1 beta and IL-18. Given the lack of alternative pharmaceutical options for XLP-2, this represents the only known medication option that avoids the toxicity associated with high-dose corticosteroids and the morbidity associated with hematopoietic stem cell transplantation.

开始日期2023-02-08

申办/合作机构

The Hospital for Sick Children

NCT04641442

/ Active, not recruiting临床2期

A Three-period Multicenter Study, With a Randomized-withdrawal, Double-blind, Placebo-controlled Design to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations

This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations.

开始日期2020-12-18

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与 MAS-825 相关的临床结果

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100 项与 MAS-825 相关的转化医学

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100 项与 MAS-825 相关的专利（医药）

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4

项与 MAS-825 相关的文献（医药）

2025-03-01·Rheumatology

Long-term efficacy of MAS825, a bispecific anti-IL1β and IL-18 monoclonal antibody, in two patients with systemic JIA and recurrent episodes of macrophage activation syndrome

Article

作者: Rosina, Silvia ; Natoli, Valentina ; Ravelli, Angelo ; Palmeri, Serena ; Corcione, Anna ; Gattorno, Marco ; Penco, Federica ; Matucci-Cerinic, Caterina ; Caorsi, Roberta ; Papa, Riccardo ; Viola, Stefania ; Consolaro, Alessandro ; Volpi, Stefano ; Bertoni, Arinna ; Malattia, Clara

AbstractIntroductionSystemic JIA (sJIA), a multifaceted autoinflammatory disorder, can be complicated by life-threatening conditions such as macrophage activation syndrome (MAS) and interstitial lung disease. The management of these conditions presents a therapeutic challenge, underscoring the need for innovative treatment approaches.ObjectivesTo report the possible role of MAS825, a bispecific anti-IL1β and IL-18 monoclonal antibody, in the treatment of multi-drug-resistant sJIA.MethodsWe report two patients affected by sJIA with severe and refractory MAS and high serum IL-18 levels, responding to dual blockade of IL-1β and IL-18.ResultsThe first patient is a 20-year-old man, presenting a severe MAS complicated by thrombotic microangiopathy, following SARS-CoV-2 infection. He was treated with MAS825, with quick improvement. Eighteen months later, the patient is still undergoing biweekly treatment with MAS825, associated with MTX, ciclosporin and low-dose glucocorticoids, maintaining good control over the systemic features of the disease. The second patient, a 10-year-old girl, presented a severe MAS case, complicated by posterior reversible encephalopathy syndrome, following an otomastoiditis. The MAS was not fully controlled despite treatment with i.v. high-dose glucocorticoids, anakinra and ciclosporin. She began biweekly MAS825, which led to a prompt amelioration of MAS parameters. After 10 months, the patient continues to receive MAS825 and is in complete remission.ConclusionIn light of the pivotal role of IL-1β and IL-18 in sJIA, MAS and interstitial lung disease, MAS825 might represent a possible valid and safe option in the treatment of drug-resistant sJIA, especially in the presence of high serum IL-18 levels.

2024-04-02·Rheumatology

Experience of anti-IL-1β and anti-IL-18 combined therapy (MAS825) in recurrent and recalcitrant macrophage activation syndrome

Article

作者: Sözeri, Betül ; Ulu, Kadir ; Çağlayan, Şengül

2023-10-13·Clinical and experimental immunology

Efficacy and safety of MAS825 (anti-IL-1β/IL-18) in COVID-19 patients with pneumonia and impaired respiratory function.

Article

作者: Hakim, Alex D ; O'Neal, Hollis R ; Awili, Mustafa ; Yu, Lili ; Junge, Guido ; Overcash, Jeffrey S ; Jenkins, Janet ; Sengupta, Tirtha ; Watts, Jen ; Lee, Richard ; Rowlands, Marianna ; Stein, Richard R ; Bendrick-Peart, Jamie ; Chauffe, Ann ; Siddiqi, Omar ; Matthews, Jesse ; Patel, Bela ; Waters, Michael ; Koo, Philip ; Pachori, Alok ; Kiffe, Michael ; Hammond, Terese C ; Pinck, Anne ; Jaffrani, Naseem ; Levitch, Rafael ; Waldron-Lynch, Frank ; Criner, Gerard J

MAS825, a bispecific IL-1β/IL-18 monoclonal antibody, could improve clinical outcomes in COVID-19 pneumonia by reducing inflammasome-mediated inflammation. Hospitalized non-ventilated patients with COVID-19 pneumonia (n = 138) were randomized (1:1) to receive MAS825 (10 mg/kg single i.v.) or placebo in addition to standard of care (SoC). The primary endpoint was the composite Acute Physiology and Chronic Health Evaluation II (APACHE II) score on Day 15 or on the day of discharge (whichever was earlier) with worst-case imputation for death. Other study endpoints included safety, C-reactive protein (CRP), SARS-CoV-2 presence, and inflammatory markers. On Day 15, the APACHE II score was 14.5 ± 1.87 and 13.5 ± 1.8 in the MAS825 and placebo groups, respectively (P = 0.33). MAS825 + SoC led to 33% relative reduction in intensive care unit (ICU) admissions, ~1 day reduction in ICU stay, reduction in mean duration of oxygen support (13.5 versus 14.3 days), and earlier clearance of virus on Day 15 versus placebo + SoC group. On Day 15, compared with placebo group, patients treated with MAS825 + SoC showed a 51% decrease in CRP levels, 42% lower IL-6 levels, 19% decrease in neutrophil levels, and 16% lower interferon-γ levels, indicative of IL-1β and IL-18 pathway engagement. MAS825 + SoC did not improve APACHE II score in hospitalized patients with severe COVID-19 pneumonia; however, it inhibited relevant clinical and inflammatory pathway biomarkers and resulted in faster virus clearance versus placebo + SoC. MAS825 used in conjunction with SoC was well tolerated. None of the adverse events (AEs) or serious AEs were treatment-related.

100 项与 MAS-825 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
婴幼儿小肠结肠炎自身炎症	临床2期	法国	Novartis Pharmaceuticals Corp.	2020-12-18
婴幼儿小肠结肠炎自身炎症	临床2期	捷克	Novartis Pharmaceuticals Corp.	2020-12-18
婴幼儿小肠结肠炎自身炎症	临床2期	意大利	Novartis Pharmaceuticals Corp.	2020-12-18
婴幼儿小肠结肠炎自身炎症	临床2期	英国	Novartis Pharmaceuticals Corp.	2020-12-18
婴幼儿小肠结肠炎自身炎症	临床2期	西班牙	Novartis Pharmaceuticals Corp.	2020-12-18
婴幼儿小肠结肠炎自身炎症	临床2期	日本	Novartis Pharmaceuticals Corp.	2020-12-18
婴幼儿小肠结肠炎自身炎症	临床2期	美国	Novartis Pharmaceuticals Corp.	2020-12-18
自身炎症性疾病	临床2期	美国	Novartis Pharmaceuticals Corp.	2020-12-18
新型冠状病毒感染	临床前	美国	Novartis Pharmaceuticals Corp.	2020-06-11
呼吸功能不全	临床前	美国	Novartis Pharmaceuticals Corp.	2020-06-11

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04382651 (MAS825, Pubmed \| Clin Exp Immunol)	临床2期	呼吸功能不全 C-reactive protein (CRP) \| SARS-CoV-2 presence \| inflammatory markers	138	MAS825	淵鑰艱窪窪廠顧窪壓獵(網築積觸簾簾構餘鹹簾) = None of the adverse events (AEs) or serious AEs were treatment-related 網糧積觸廠衊構繭範鑰 (觸襯艱選築築製網範憲 ) 更多	积极	2023-10-13
				Placebo
NCT04382651 (MAS-COVID \| MAS825, CTgov)	临床2期	新型冠状病毒感染 \| 呼吸功能不全	140	Standard of Care (SoC)+MAS825 (MAS825 + SoC)	餘壓構鑰繭蓋選鬱憲齋(鏇築製鬱鹹築衊鬱夢選) = 鹽醖壓鹽淵襯憲糧觸夢廠鬱觸鬱獵衊顧鹽餘鬱 (膚構選壓網鹹獵遞選積, 製夢製壓鬱獵願壓積鹹 ~ 襯醖蓋遞醖遞蓋鏇齋願) 更多	-	2022-04-20
				Placebo (Placebo + SoC)	餘壓構鑰繭蓋選鬱憲齋(鏇築製鬱鹹築衊鬱夢選) = 製齋鬱憲餘鑰鹽膚鏇積廠鬱觸鬱獵衊顧鹽餘鬱 (膚構選壓網鹹獵遞選積, 願窪鹽繭顧齋憲淵鹹鬱 ~ 鏇壓築鹹繭鹹膚艱範衊) 更多