This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL).
The research study involves the following study interventions:
* Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy)
* Axicabtagene Ciloleucel
* Emapalumab

开始日期2024-08-01

申办/合作机构

The General Hospital Corp.

[+1]

NCT06285825 / Recruiting临床2期IIT

A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia

To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART.

开始日期2024-07-05

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT06430788 / Recruiting临床2期IIT

Phase 2a/2b Study Emapalumab: A Window of Opportunity in Pediatric Aplastic Anemia

The purpose of this study is to find out whether upfront emapalumab treatment can help in sAA (Aplastic Anemia) treatment planning and increase the effectiveness of standard treatment options.

开始日期2024-05-21

申办/合作机构

Memorial Sloan Kettering Cancer Center

100 项与依马利尤单抗相关的临床结果

登录后查看更多信息

100 项与依马利尤单抗相关的转化医学

登录后查看更多信息

100 项与依马利尤单抗相关的专利（医药）

登录后查看更多信息

项与依马利尤单抗相关的文献（医药）

2024-09-27·MEDICINE

Emapalumab as a therapeutic intervention for Epstein–Barr virus-associated hemophagocytic lymphohistiocytosis: A case series

Article

作者: Yu, Li ; Pei, Fuyu ; Yuan, Xiao ; Wang, Wen

Rationale::

Epstein–Barr virus-associated hemophagocytic lymphohistiocytosis (EBV-HLH) is characterized by a severe cytokine storm, heightened inflammatory response, and immune-mediated damage to tissues and organs. Standard treatment protocols for hemophagocytic lymphohistiocytosis often fall short in effectively controlling EBV-HLH, leading to a need for novel therapeutic options. Emapalumab, a monoclonal antibody targeting interferon-gamma, has shown promise due to its targeted cytokine modulation capabilities and favorable safety profile. This study aimed to evaluate the efficacy and safety of emapalumab in pediatric patients with EBV-HLH.

Patient concerns::

The case series involved 4 pediatric patients diagnosed with EBV-HLH who did not achieve disease control despite receiving comprehensive treatment.

Diagnoses::

All 4 pediatric patients were diagnosed with EBV-HLH.

Interventions::

Emapalumab was introduced as an adjunctive therapeutic intervention alongside the HLH-94 or L-DEP regimens for these patients.

Outcomes::

Among the 4 patients, 1 experienced severe multiorgan dysfunction and opted to discontinue therapy. The remaining 3 patients showed controlled disease progression with significant clinical improvements following emapalumab administration. These improvements included reduced levels of inflammatory markers, normalization of blood counts and liver function, and decreased Epstein–Barr virus viral load.

Lessons::

The findings suggest that emapalumab may be an effective and safe treatment option for pediatric EBV-HLH. However, further research is necessary to confirm these outcomes, especially in critically ill patients.

2024-09-01·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Systemic T-cell activation and IFN-γ activity in indeterminate severe hepatitis are reminiscent of hemophagocytic lymphohistiocytosis: Implications for T-cell– and IFN-γ–directed therapies

Article

作者: Kapoor, Urvi ; Montminy, Taylor ; Chandrakasan, Shanmuganathan ; Prince, Chengyu ; Rytting, Heather B ; Satwani, Prakash ; Goldner, Dana ; Malik, Sakshi ; Remotti, Helen E. ; Nguyen, Thinh H. ; Marsh, Rebecca ; Fazlollahi, Ladan ; Romero, Rene ; Rytting, Heather B. ; Remotti, Helen E ; Nguyen, Thinh H ; Smiley, Kristi ; Martinez, Mercedes ; Kumar, Deepak

BACKGROUND:

Severe hepatitis cases in children are increasingly recognized, but the exact etiology remains unknown in a significant proportion of patients. Cases of indeterminate severe hepatitis (iSH) may progress to indeterminate pediatric acute liver failure (iPALF), so understanding its immunobiology is critical to preventing disease progression. Hemophagocytic lymphohistiocytosis (HLH) is a systemic hyperinflammatory disorder associated with T-cell and macrophage activation with liver injury.

OBJECTIVES:

We hypothesized that a high proportion of patients with iSH demonstrate systemic T-cell activation similar to HLH before developing iPALF and that the degree of T-cell activation in iSH might correlate with outcomes.

METHODS:

From 2019 to 2022, 14 patients with iSH and 7 patients with PALF of known, nonimmune etiology were prospectively enrolled. We compared immune signatures of iSH, HLH, known PALF, and healthy controls.

RESULTS:

We found that patients with iSH have increased CD8⁺ T-cell activation and high IFN-γ activity similar to HLH. The amplitude of CD8⁺ T-cell activation was predictive of iSH progression to iPALF. We also found that in patients with iSH, ferritin had only modest elevation. However, the ratio of age-normalized plasma soluble IL-2 receptor to ferritin level can distinguish iSH from known PALF and HLH. As proof of concept, we report that in 3 patients with steroid-refractory iSH, emapalumab, an IFN-γ blocking antibody used in combination with steroids, improved liver function and may have prevented progression to PALF.

CONCLUSIONS:

Flow-based T-cell activation markers could help in early identification and risk stratification for targeted intervention in patients with iSH.

2024-06-01·Rheumatology and therapy

Population Pharmacokinetics of the Anti-Interferon-Gamma Monoclonal Antibody Emapalumab: An Updated Analysis

Article

作者: Laveille, Christian ; Brossard, Patrick

INTRODUCTION:

Emapalumab is a fully human monoclonal antibody that targets free and receptor-bound interferon-gamma (IFNγ), neutralizing its biological activity. IFNγ levels differ by orders of magnitude between patients with primary hemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS; a form of secondary HLH) in systemic juvenile idiopathic arthritis (sJIA). Therefore, this study aimed to develop a population pharmacokinetic model for emapalumab across a patient population with a wide range of total (free and emapalumab-bound) IFNγ levels using observations from patients with primary HLH or MAS in sJIA in clinical trials.

METHODS:

Pharmacokinetic data were pooled (n = 58; 2709 observations) from studies enrolling patients administered emapalumab for primary HLH or MAS in sJIA. Patients with primary HLH were administered emapalumab 1 mg/kg (potentially increasing to 3, 6, and up to 10 mg/kg based on clinical response) every 3 days. Patients with MAS in sJIA were administered emapalumab 6 mg/kg, followed by 3 mg/kg every 3 days until day 15 and twice weekly until day 28. An earlier population PK model was re-parameterized using this data.

RESULTS:

The final model for emapalumab comprised a 2-compartment model with first-order elimination. Emapalumab clearance remains constant when the total IFNγ concentration (free and emapalumab-bound) is < ~ 10,000 pg/ml but increases proportionally to total IFNγ concentration above this threshold. Emapalumab clearance was estimated to be 0.00218, 0.00308, 0.00623 and 0.01718 l/h at total serum IFNγ concentrations of 10³, 10⁴, 10⁵ and 10⁶ pg/ml, respectively, with corresponding terminal half-lives of 19.2, 13.8, 7.18 and 3.12 days for a 1-year-old patient weighing 10 kg with primary HLH. The median terminal half-life for emapalumab in patients with MAS in sJIA was estimated to be 24.0 (range, 6.13-32.4) days, which is similar to observations in healthy volunteers.

CONCLUSIONS:

Emapalumab pharmacokinetics in patients with primary HLH and MAS in sJIA were described by a two-compartment model with fixed allometric exponents and an age-related effect. Differences in total IFNγ levels between patients with primary HLH and MAS may affect emapalumab pharmacokinetics, suggesting that each indication may require different dosing to rapidly control hyperinflammation.

TRIAL REGISTRATION:

Clinicaltrials.gov identifiers: NCT01818492, NCT03311854 and NCT02069899.

项与依马利尤单抗相关的新闻（医药）

2024-11-07

·GlobeNewswire-Health Care

Sobi to present new data across its immunology portfolio at the ACR Convergence 2024

WALTHAM, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of four abstracts that highlights data from its immunology portfolio at the ACR Convergence 2024 taking place in Washington, D.C. from November 14–19, 2024. Sobi’s commitment to delivering innovative treatments for people living with immunological diseases is seen in global studies spanning multiple disorders: Results from two Phase 3 trials evaluating the effect on patient-reported outcomes in patients with chronic refractory gout treated with SEL-212.Initial data on the effect of anti-drug antibodies on serum uric acid (sUA) reduction and safety in response to treatment with SEL-212.DISSOLVE 1 Phase 3 study: Results of a post hoc analysis of sustained sUA reduction and safety of SEL-212 in patients with chronic refractory gout living in the United States.Results from a Phase 3 Study and a pooled analysis of two prospective trials evaluating efficacy and safety of emapalumab in patients with Macrophage Activation Syndrome in Still’s disease. Key Sobi data to be presented at ACR Convergence 2024 Chronic Refractory GoutSEL-212Improvements in Patient-Reported Outcomes After Treatment with SEL-212 in Adults with Refractory Gout: Results from Two Randomized Phase 3 TrialsSession: Patient Outcomes, Preferences, & Attitudes Poster ISaturday, November 16; 10:30 AM - 12:30 PMImpact of Anti-drug Antibodies on the Efficacy of SEL-212 in Patients with Chronic Gout Refractory to Conventional TherapySafety and Efficacy of SEL-212 in the US and ex-US Subgroups: Results from the Phase 3 DISSOLVE StudiesSession: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster IIIMonday, November 18; 10:30 AM - 12:30 PM Macrophage Activation SyndromeEmapalumabEfficacy and Safety of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still’s disease: Results from a Phase 3 Study and a Pooled Analysis of Two Prospective TrialsLate-Breaking AbstractsNovember 19; Session Time: 8:00 AM - 9:30 AM; Presentation Time: 9:00 AM - 9:15 AM All abstracts can be accessed via the official ACR Convergence website. ContactsFor details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media, click here. About SEL-212SEL-212 is being developed as a novel once-monthly combination medicine that integrates targeted immunomodulation with uricase-based therapy and is being investigated for the treatment of chronic refractory gout . SEL-212 consists of pegadricase, a proprietary pegylated uricase, co-administered with nanoencapsulated sirolimus. About Chronic Refractory GoutGout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 160,000 people in the United States suffer from chronic refractory gout (CRG), where patients are resistant to conventional medicines and symptoms are more persistent. CRG is a painful and debilitating condition in people with persistent raised serum uric acid (sUA) levels, which may result in several flares per year and the development of nodular masses of uric acid crystals known as tophi. About emapalumab-lzsgEmapalumab-lzsg is a fully human, anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity. In the US, emapalumab-lzsg is indicated for pediatric (newborn and older) and adult primary hemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab-lzsg is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval in 2018 was based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).For the treatment of HLH, Emapalumab is indicated for administration through twice per week until hematopoietic stem cell transplantation (HSCT). The efficacy and safety of emapalumab are currently being evaluated. Emapalumab is currently under investigation (phase 3) in patients with MAS in Still’s disease or systemic lupus erythematosus (SLE) (EMERALD; NCT05001737). U.S. Indication for Gamifant® (emapalumab-lzsg)Gamifant® (emapalumab-lzsg) is an interferon gamma (IFNγ)–blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy. Important Safety InformationInfectionsBefore initiating Gamifant, patients should be evaluated for infection, including latent tuberculosis (TB). Prophylaxis for TB should be administered to patients who are at risk for TB or known to have a positive purified protein derivative (PPD) test result or positive IFNγ release assay. During Gamifant treatment, patients should be monitored for TB, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2 weeks and as clinically indicated. Patients should be administered prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections prior to Gamifant administration. Increased Risk of Infection With Use of Live VaccinesDo not administer live or live attenuated vaccines to patients receiving Gamifant and for at least 4 weeks after the last dose of Gamifant. The safety of immunization with live vaccines during or following Gamifant therapy has not been studied. Infusion-Related ReactionsInfusion-related reactions, including drug eruption, pyrexia, rash, erythema, and hyperhidrosis, were reported with Gamifant treatment in 27% of patients. In one-third of these patients, the infusion-related reaction occurred during the first infusion. Adverse ReactionsIn the pivotal trial, the most commonly reported adverse reactions (≥10%) for Gamifant included infection (56%), hypertension (41%), infusion-related reactions (27%), pyrexia (24%), hypokalemia (15%), constipation (15%), rash (12%), abdominal pain (12%), CMV infection (12%), diarrhea (12%), lymphocytosis (12%), cough (12%), irritability (12%), tachycardia (12%), and tachypnea (12%). Additional selected adverse reactions (all grades) that were reported in less than 10% of patients treated with Gamifant included vomiting, acute kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal hemorrhage, epistaxis, and peripheral edema. Please see the full Prescribing Information for Gamifant. About Sobi North AmericaAs the North American affiliate of international biopharmaceutical company Sobi, the Sobi North America team is committed to Sobi’s vision of being a leader in providing innovative treatments that transform lives for individuals with rare diseases. Our product portfolio includes multiple approved treatments focused on immunology, hematology and specialty care. With U.S. headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. More information is available at https://www.sobi.com/usa or at www.sobi.com. About Sobi®Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of hematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. Brian Castellibrian.castelli@sobi.com

临床3期临床结果上市批准免疫疗法疫苗

2024-10-30

·PRNewswire

New data for emapalumab in the treatment of macrophage activation syndrome to be presented at the ACR conference

STOCKHOLM, Oct. 30, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) today announced that new research showing the effect of emapalumab in patients with macrophage activation syndrome (MAS) in Still's disease, including systemic juvenile idiopathic arthritis (sJIA) and adult-onset still's disease (AOSD) who had an inadequate response to high-dose glucocorticoids (GCs) will be presented at the American College of Rheumatology (ACR) Convergence in Washington D.C. The data were pooled from two open-label, single-arm interventional studies, the phase 3 NI-0501-14 study [EMERALD; NCT05001737] and NI-0501-06 [NCT03311854], including 39 patients with MAS. Key results: Complete response at week 8: At week 8, 21 patients (53.8%) achieved a complete response (95% confidence interval (CI): 37.2–69.9%). Complete response at any time: 33 patients (85%) achieved a complete response at any time during the studies. Glucocorticoid tapering: Weekly mean glucocorticoid doses were reduced by 70.1% after 2 weeks of treatment. By week 8, glucocorticoids were tapered to a clinically meaningful dose of ≤1 mg/kg/day in 28 patients (72%) and to ≤0.5 mg/kg/day in 17 patients (44%). Safety: No new safety concerns were identified during the studies. "MAS in Still's disease is a severe condition characterised by intense hyperinflammation and multiple organ failure. Those affected, including young children, often experience high fevers, liver and spleen enlargement, severe cytopenias, and neurological symptoms," said Lydia Abad-Franch, MD, Head of Research & Development and Medical Affairs and Chief Medical Officer at Sobi. "The results to be presented at ACR indicate that emapalumab could potentially provide a new therapeutic option, offering effective control of MAS symptoms and possibly reducing the need for high-dose glucocorticoids. This represents an important development in the treatment landscape for MAS." Additional key results: Overall response (OR) by week 8: 32 patients (82.4%) achieved an overall response by week 8. OR was observed as early as day 5, with a median time to first OR of 2.3 weeks. Clinical MAS remission: 32 patients (82.1%) achieved investigator-assessed clinical MAS remission at any time , with a median time to clinical remission of 3.3 weeks. Survival rate: 37 patients (94.9%) were alive at week 8. Emapalumab is a monoclonal antibody that neutralises interferon gamma (IFNγ), a key cytokine which contributes to the inflammation and tissue damage seen in MAS. The purpose of these two prospective studies is to assess the efficacy and safety of emapalumab in controlling MAS in patients with Still's disease, including sJIA and AOSD, who had an inadequate response to high-dose glucocorticoids. In May 2024, the US FDA granted emapalumab fast track designation as a potential therapeutic option in patient with MAS. Sobi plans to submit an sBLA for this indication to the FDA in 2024. The data will be presented by Alexei A. Grom, MD, Professor of Paediatrics, Research Director Division of Rheumatology, Cincinnati Children's Hospital Medical Centre, in a session entitled "Efficacy and Safety of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still's disease: Results from a phase 3 study and a pooled analysis of two prospective trials" on Tuesday, 19 November at ACR Convergence. About macrophage activation syndrome (MAS) Macrophage activation syndrome (MAS) is a severe complication of rheumatic diseases, most frequently systemic juvenile idiopathic arthritis (sJIA) – a rare systemic disorder of auto-inflammatory nature with common clinical manifestations such as daily spiking fever, typical transient cutaneous rash, arthritis, lymphadenopathy, hepatosplenomegaly and serositis. MAS is characterised by fever, hepatosplenomegaly, liver dysfunction, cytopenias, coagulation abnormalities and hyperferritinaemia, possibly progressing to multiple organ failure and death. MAS is classified as a secondary form of haemophagocytic lymphohistiocytosis (HLH). About emapalumab Emapalumab (Gamifant®) is an anti-interferon gamma (IFNγ) monoclonal antibody that binds to and neutralises IFNγ. In the USA, emapalumab is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Gamifant is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). About Sobi® Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download: SOURCE Swedish Orphan Biovitrum AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期快速通道上市批准

2024-10-24

·PRNewswire

Sobi Q3 2024 report: Strong growth and significant pipeline momentum

STOCKHOLM, Oct. 24, 2024 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi®) today announced its report for the third quarter 2024 Third Quarter 2024 Total revenue increased 33 per cent, 39 per cent at constant exchange rates, (CER)1, to SEK 6,894 M (5,168) Haematology revenue increased 18 per cent at CER to SEK 4,000 M (3,484), mainly driven by strong sales of Doptelet® of SEK 1,039 M (650), sales of Aspaveli®/Empaveli® of SEK 270 M (169) and launch sales of Altuvoct® of SEK 129 M (—) Immunology revenue increased 96 per cent at CER to SEK 2,583 M (1,400), driven by strong Beyfortus® royalty of SEK 1,478 M (263) and sales of Kineret® of SEK 699 M (600) Revenue from medicines in the strategic portfolio* grew by 113 per cent at CER to SEK 3,830 M (1,924) The adjusted EBITA margin1,2 was 43 per cent (30), excluding items affecting comparability (IAC)2. EBITA was SEK 2,923 M (1,443), corresponding to a margin of 42 per cent (28). EBIT was SEK 2,038 M (547) Earnings per share (EPS) before dilution was SEK 4.27 (0.30). Adjusted EPS before dilution1 was SEK 4.36 (0.54). Cash flow from operating activities was SEK 1,201 M (1,058) In August, Sobi and Apellis Pharmaceuticals announced positive topline results from the Phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN Outlook 2024 - Updated Revenue is anticipated to grow by a mid-teens percentage at CER (previously low double-digit) The adjusted EBITA margin is anticipated to be in the mid-30s percentage of revenue (unchanged) Click here for the Financial Summary. Alternative Performance Measures (APMs). Items affecting comparability (IAC). * The strategic portfolio includes Sobi's medicines Altuvoct, Aspaveli/Empaveli, Doptelet, Gamifant®, Vonjo® and Zynlonta®, and royalty on Sanofi's sales of Altuviiio® and Beyfortus. Investors, analysts, and the media are invited to a conference call on the same day at 14:00 CEST, 13:00 BST, and 08:00 EDT. The call will include a presentation of the results and a Q&A session. The presentation can be followed live here or afterwards on sobi.com. The slides will be made available on sobi.com before the conference call. To participate in the conference call, please use the following dial-in details: Sweden: +46 8 5051 0031 United Kingdom: +44 207 107 06 13 United States: +1 631 570 56 13 For other countries, please find the details here. Sobi Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:00 CEST on 24 October 2024. Gerard Tobin Head of Investor Relations This information was brought to you by Cision The following files are available for download: SOURCE Swedish Orphan Biovitrum AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

财报临床结果临床3期生物类似药

100 项与依马利尤单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	依马利尤单抗	L04AA39	DB14724

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
噬血细胞性淋巴组织细胞增多症	美国	Novimmune SA	2018-11-20

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
免疫系统疾病	申请上市	欧盟	Swedish Orphan Biovitrum AB	2020-07-23
多关节型幼年特发性关节炎	临床3期	美国	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	日本	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	比利时	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	加拿大	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	捷克	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	法国	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	德国	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	意大利	苏庇医药（广州）有限公司	2022-01-14
多关节型幼年特发性关节炎	临床3期	荷兰	苏庇医药（广州）有限公司	2022-01-14

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Tandem Meetings ASTCT and CIBMTR2024	N/A	-	-	Emapalumab	壓選簾糧蓋範獵繭觸壓(觸鑰鹽鑰選齋鏇餘糧醖) = 齋鏇製鑰襯願餘糧醖積膚蓋願鏇淵淵蓋鏇膚製 (構衊艱糧憲積鏇膚壓醖 )	-	2024-02-01
NCT04765553 (CTgov)	临床1期	罕见病	8	NI-0501 (Emapalumab)	艱簾獵蓋構齋鑰積窪觸(範艱壓淵願衊遞鹹鏇顧) = 夢範網鬱醖衊憲憲廠遞築獵鏇窪糧簾壓積窪簾 (夢鬱遞鬱壓襯醖糧願鏇, 範網膚鑰鏇鑰鏇衊鑰構 ~ 鏇繭構憲構淵積醖糧衊) 更多	-	2023-11-24
NCT04765553 (CTgov)	临床1期	罕见病	8	Saline (Placebo)	積築積憲鬱壓廠觸網壓(壓簾膚觸壓鹹壓糧膚壓) = 糧糧積築艱窪夢膚醖鬱壓鬱願鬱簾窪鏇構構醖 (廠廠鑰鹹夢憲夢糧膚餘, 憲鏇壓襯壓鹹艱鑰鑰齋 ~ 選製窪觸觸鬱構淵膚糧) 更多	-	2023-11-24
NCT03985423 (CTgov)	临床2/3期	噬血细胞性淋巴组织细胞增多症	7	Emapalumab-Lzsg	鹽鏇襯遞遞襯選鹹鏇艱(構築遞繭選夢繭艱餘積) = 醖鏇鹹淵鏇築憲築觸蓋遞顧鑰衊膚構顧鏇襯襯 (遞憲築蓋鏇鬱選觸窪淵, 遞襯淵築觸選積觸鬱膚 ~ 廠構襯觸壓鹹鹽餘衊膚) 更多	-	2023-10-06
P353 (EBMT2023)	临床2期	IFNÎ³ \| CXCL9	1	Emapalumab 3 mg/kg	構壓衊顧遞鹹鹽繭齋襯(範蓋窪鏇鑰艱顧鹽淵積) = 範廠鹽範範製鏇鏇膚鏇製觸積淵襯積範築範觸 (鬱齋繭遞簾衊憲遞鏇築 ) 更多	积极	2023-04-23
NCT02069899 (NI-0501-04 and NI-0501-05, CTgov)	临床2/3期	噬血细胞性淋巴组织细胞增多症	58	Emapalumab (Enrolled-04 Cohort)	餘築蓋艱膚齋鏇構衊憲(顧築積憲遞獵艱範淵積) = 衊鏇選衊製遞齋鹹鏇襯淵淵糧鏇鹹築繭襯壓鹹 (窪夢廠餘壓憲築鏇糧願, 艱壓糧醖憲衊遞鏇願鏇 ~ 鹽範餘網襯願壓鹹築夢) 更多	-	2022-06-28
NCT02069899 (NI-0501-04 and NI-0501-05, CTgov)	临床2/3期	噬血细胞性淋巴组织细胞增多症	58	emapalumab (Enrolled-06 Cohort)	餘築蓋艱膚齋鏇構衊憲(顧築積憲遞獵艱範淵積) = 淵鑰遞願製膚觸鏇顧簾淵淵糧鏇鹹築繭襯壓鹹 (窪夢廠餘壓憲築鏇糧願, 鬱繭艱簾醖繭繭製壓壓 ~ 網糧獵顧齋鹽襯膚壓繭) 更多	-	2022-06-28
NCT04731298 (P449, EBMT2022)	临床2期	原发性移植物功能障碍 CXCL9	10	Emapalumab	鹹鑰鏇觸鏇蓋鑰鹹醖壓(艱窪製願鬱膚觸鏇衊願) = 蓋糧齋衊淵淵願襯遞餘遞簾鹹夢遞夢壓顧醖糧 (鏇窪築襯選壓餘糧餘鑰 ) 更多	积极	2022-03-19
NCT01818492 (NCT02069899, Tandem Meetings ASTCT and CIBMTR2021)	临床2/3期	噬血细胞性淋巴组织细胞增多症二线	45	Emapalumab 1 mg/kg	獵網夢夢繭觸蓋築獵構(網觸壓壓築艱衊繭鬱鑰) = 襯襯繭獵壓餘製齋積積簾鬱壓獵艱繭艱蓋齋廠 (網鬱遞襯壓遞壓構顧壓, 68.3 ~ 97.6) 更多	积极	2021-03-01
	临床2/3期	噬血细胞性淋巴组织细胞增多症二线	45	Background dexamethasone 5-10 mg/m2	獵網夢夢繭觸蓋築獵構(網觸壓壓築艱衊繭鬱鑰) = 夢願鹹醖壓範糧觸簾憲簾鬱壓獵艱繭艱蓋齋廠 (網鬱遞襯壓遞壓構顧壓, 62.1 ~ 92.1) 更多	积极	2021-03-01
NCT02069899 \| NCT01818492 (NI-0501-04 \| NI-0501-05, Pubmed \| Br Dent J) 人工标引	临床2/3期	噬血细胞性淋巴组织细胞增多症一线	34	Emapalumab (previously treated)	遞獵艱鑰築製膚壓餘鹽(觸選衊餘繭襯蓋餘淵鏇) = 壓淵鏇製憲選壓窪壓淵蓋壓鬱蓋鏇鑰範獵鑰觸 (齋鹽製觸餘鏇顧襯觸網 ) 更多	积极	2020-05-07
	临床2/3期	噬血细胞性淋巴组织细胞增多症一线	34	Emapalumab (previously untreated)	遞獵艱鑰築製膚壓餘鹽(觸選衊餘繭襯蓋餘淵鏇) = 遞衊網廠築顧築壓窪網蓋壓鬱蓋鏇鑰範獵鑰觸 (齋鹽製觸餘鏇顧襯觸網 ) 更多	积极	2020-05-07
NI-0501 (ACR2015)	N/A	噬血细胞性淋巴组织细胞增多症 \| 婴幼儿小肠结肠炎自身炎症 IL-18 \| IFNγ \| CXCL9 ... 更多	1	NI-0501	醖選淵願蓋鹽鏇簾鹹顧(願簾襯鏇齋餘淵積齋壓) = 鑰網顧構鏇鹹範淵憲獵鹽齋蓋範餘壓鹽醖壓選 (艱蓋構憲醖製艱築鬱齋 )	积极	2015-11-10
NI-0501 (ACR2015)	N/A	噬血细胞性淋巴组织细胞增多症 IFNg	10	NI-0501 1 mg/kg	廠鏇鹽鏇襯遞廠築蓋醖(繭廠願網窪選鏇襯繭積) = All infusions were well tolerated and no safety concerns emerged 醖顧醖淵壓糧積選鬱餘 (窪齋獵壓製鏇艱蓋襯鏇 )	积极	2015-11-10