更新于：2024-06-29
Iscalimab
更新于：2024-06-29
概要
基本信息
非在研机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)临床2期 |
特殊审评- |
序列信息
Sequence Code 197881L
来源: *****
Sequence Code 1191632838H
来源: *****
关联
18
项与 Iscalimab 相关的临床试验A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome
This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201(NCT03905525). Additionally, this Extension study will further explore the pharmacokinetics (PK) and efficacy of iscalimab at two dose level.
开始日期2021-01-05 |
在SLE患者中评估VAY736 和CFZ533药效学、药代动力学、安全及耐受性和临床疗效的安慰剂对照、随机双盲、平行队列研究。
在SLE患者中，评估VAY736 和CFZ533 的药效学、药代动力学、安全性、耐受性和初步临床疗效
开始日期2020-11-13 |
申办/合作机构 诺华（中国）生物医学研究有限公司 [+2] |
Investigator- and Subject-blinded, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy Trial of CFZ533 in Pediatric and Young Adult Subjects With New Onset Type 1 Diabetes (T1DM)
The study is a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on preservation of residual pancreatic β-cell function in new onset T1DM in pediatric and young adult subjects.
开始日期2019-11-08 |
100 项与 Iscalimab 相关的临床结果
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100 项与 Iscalimab 相关的转化医学
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100 项与 Iscalimab 相关的专利（医药）
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25
项与 Iscalimab 相关的文献（医药）2024-02-01·CNS drugs
The Efficacy and Safety of Different Targeted Drugs for the Treatment of Generalized Myasthenia Gravis: A Systematic Review and Bayesian Network Meta-analysis
Review
作者: Nie, Xiangtao ; Ma, Yongbo ; Zhu, Geke ; Guo, Xiuming ; Hao, Lei ; Qi, Wenjing
BACKGROUND:
The treatment of generalized myasthenia gravis (gMG) has been transformed by the development and approval of new targeted therapies. This analysis aimed to rank and compare the new therapies for gMG using efficacy and safety data from randomized controlled trials (RCTs).
METHODS:
We searched PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov (up to November 2022) for RCTs of targeted drugs for gMG. We used a Bayesian random-effects network meta-analysis (NMA) model and a Markov chain Monte Carlo (MCMC) model for statistical analysis. The primary outcome was the change in quantitative myasthenia gravis score (QMGS) from baseline, while the secondary outcome was the risk ratio (RR) of adverse events (AEs) during treatment. The surface under the cumulative ranking curve (SUCRA) was used to rank these targeted drugs, with higher SUCRA values indicating better efficacy or lower likelihood of AEs.
RESULTS:
In total, 13 studies (872 subjects) were included in this analysis evaluating 10 targeted drugs (batoclimab, belimumab, CFZ533, eculizumab, efgartigimod, nipocalimab, rituximab, ravulizumab, rozanolixizumab, and zilucoplan). With regards to the primary outcome, batoclimab [standardized mean difference (SMD), - 1.61; 95% credible interval (CrI), - 2.78, - 0.43] significantly reduced QMGS in patients with gMG when compared with placebo and was ranked as the most efficacious drug. Ranked second and third were eculizumab (SMD, - 0.67; 95% CrI, 1.43, 0.01) and zilucoplan (SMD, - 0.54; 95% CrI, - 1.56, 0.46), respectively. Nipoclimab (SMD, - 0.02; 95% CrI, - 1.04, 1.00) had the worst efficacy and ranked last among all targeted drugs. In our study, except for batoclimab, there was no statistically significant difference in the reduction of patient QMGS for the remaining targeted agents compared with placebo. With regards to the secondary outcomes, only batoclimab (RR, 0.19; 95% CrI, 0, 0.97) led to a significant reduction in the incidence of AEs when compared with the placebo. Belimumab (RR, 0.85; 95% CrI, 0.57, 1.19), CFZ533 (RR, 0.95; 95% CrI, 0.72, 1.25), eculizumab (RR, 0.99; 95% CrI, 0.85, 1.21), and efgartigimod (RR, 0.93; 95% CrI, 0.76, 1.15) also led to a lower incidence of AEs, although these effects were not significantly different from the placebo.
CONCLUSIONS:
Batoclimab had the best efficacy and safety for the treatment of gMG and was ranked first out of the 10 targeted drugs included in this study. Eculizumab was ranked second, and nipocalimab had the worst efficacy. With the exception of batoclimab, the incidence of AEs for the remaining drugs was not statistically significantly different from placebo. We note, however, that wide CrIs reflect the uncertainty in this analysis owing to the small number of available studies and low numbers of study participants; moreover, batoclimab had the widest CrI of all drugs in this analysis. More well-designed studies with long-term follow-up are needed to further evaluate and compare the efficacy and safety of these drugs in the future.
2024-01-01·Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia
Efficacy and safety of iscalimab, a novel anti-CD40 monoclonal antibody, in moderate-to-severe myasthenia gravis: A phase 2 randomized study
Article
作者: Poverennova, Irina ; Roubenoff, Ronenn ; Rush, James S ; Dupuy, Cyrielle ; Tichy, Mia ; Vissing, John ; Genge, Angela ; Jordan, Berit ; Devlikamova, Farida ; Kinhikar, Arvind ; GomezMancilla, Baltazar ; Pezous, Nicole ; Espié, Pascal ; Gergely, Peter ; Meriggioli, Matthew N ; Meisel, Andreas ; Lin, Thy-Sheng ; Dionne, Annie ; Hartmann, Nicole ; Stuchevskaya, Fatima ; Andersen, Henning ; Schoser, Benedikt
BACKGROUND:
Increased morbidity in many patients with myasthenia gravis (MG) on long-term immunosuppression highlights the need for improved treatments. The aim of this study is to investigate the safety and efficacy of iscalimab (CFZ533), a fully human anti-CD40 monoclonal antibody, in patients with moderate-to-severe MG receiving standard-of-care (SoC) therapies.
METHODS:
In this double-blind, placebo-controlled phase 2 study, symptomatic patients (n = 44) despite SoC were randomized 1:1 to receive intravenous iscalimab (10 mg/kg; n = 22) or placebo (n = 22) every 4 weeks for 6 doses in total. Patients were followed up for 6 months after the last dose. The total duration of the study was 52 weeks.
RESULTS:
In total, 34 of 44 patients (77.3 %) completed the study. The primary endpoint, Quantitative MG score, did not change significantly between baseline and week 25 for iscalimab (median [90 % CI], -4.07 [-5.67, -2.47]) versus placebo (-2.93 [-4.53, -1.33]); however, non-thymectomized patients (n = 29) showed more favorable results (iscalimab, -4.35 [-6.07, -2.64] vs placebo, -2.26 [-4.16, -0.36]). A statistically significant difference between iscalimab and placebo groups was observed in MG Composite score (adjusted mean change: -4.19 [-6.67, -1.72]; p = 0.007) at week 13, and MG-Activities of Daily Living score (-1.93 [-3.24, -0.62]; p = 0.018) at week 21. Adverse events were comparable between the iscalimab (91 %) and placebo (96 %) groups.
CONCLUSION:
Iscalimab showed favorable safety and improvements compared with placebo in non-thymectomized patients with moderate-to-severe MG. It did not show any protective effect in patients with moderate-to-severe MG.
2023-07-17·The Journal of clinical investigation
Single-cell transcriptomic analysis of renal allograft rejection reveals insights into intragraft TCR clonality.
Article
作者: Caldwell, J Timothy ; Hildeman, David A ; Regnier, Catherine H ; Alloway, Rita R ; Rush, James S ; Burg, Ashley R ; Shields, Adele R ; Gray, George I ; Wieczorek, Grazyna ; Shi, Tiffany ; Cuda, Carla M ; Woodle, E Steve ; Roskin, Krishna M ; Foote, Sara G ; Baker, Brian M ; Castro-Rojas, Cyd M ; Allman, David A ; Chukwuma, P Chukwunalu ; Alonso, Jesus A
Bulk analysis of renal allograft biopsies (rBx) identified RNA transcripts associated with acute cellular rejection (ACR); however, these lacked cellular context critical to mechanistic understanding of how rejection occurs despite immunosuppression (IS). We performed combined single-cell RNA transcriptomic and TCR-α/β sequencing on rBx from patients with ACR under differing IS drugs: tacrolimus, iscalimab, and belatacept. We found distinct CD8+ T cell phenotypes (e.g., effector, memory, exhausted) depending upon IS type, particularly within expanded CD8+ T cell clonotypes (CD8EXP). Gene expression of CD8EXP identified therapeutic targets that were influenced by IS type. TCR analysis revealed a highly restricted number of CD8EXP, independent of HLA mismatch or IS type. Subcloning of TCR-α/β cDNAs from CD8EXP into Jurkat 76 cells (TCR-/-) conferred alloreactivity by mixed lymphocyte reaction. Analysis of sequential rBx samples revealed persistence of CD8EXP that decreased, but were not eliminated, after successful antirejection therapy. In contrast, CD8EXP were maintained in treatment-refractory rejection. Finally, most rBx-derived CD8EXP were also observed in matching urine samples, providing precedent for using urine-derived CD8EXP as a surrogate for those found in the rejecting allograft. Overall, our data define the clonal CD8+ T cell response to ACR, paving the next steps for improving detection, assessment, and treatment of rejection.
16
项与 Iscalimab 相关的新闻（医药）2023-07-11
Sanofi/formerly Provention's Tzield (teplizumab), a CD3 mAb, is the only FDA-approved disease-modifying therapy that delays progression of Stage 2 T1D in patients 8 years and older. However, less than half of U.S. clinicians are impressed with the drug's ability to delay T1D onset, according to findings from
REACH Market Research.
NEWTON, Mass., July 11, 2023 /PRNewswire/ -- Type 1 Diabetes (T1D) is a life-long autoimmune disease where the immune system destroys the insulin-producing islet cells in the pancreas until they no longer produce insulin. To date, insulin replacement therapy has been the backbone of T1D treatment but has a significant treatment burden on patients. Recently, clinical development appears to be shifting towards therapies that could delay the need for insulin and preserve beta cell function.
To access REACH's MarketVue® Report on Type 1 Diabetes, visit or contact us at [email protected].
The launch of Tzield is an important milestone in T1D disease management in that patients in the pre-diabetic stage now have an option to delay T1D onset by ~2 years, thereby delaying insulin use. Further, the approval has increased interest and awareness around screening patients who may be at risk for the disease.
While the approval of Tzield has created excitement amongst clinicians, the response to its efficacy and dosing is underwhelming; less than 30% of interviewed doctors reported that they found the dosing impressive, according to
REACH Market Research
's MarketVue® assessment.
Endocrinologist, U.S.: "What are the potential benefits of a drug like teplizumab in a person who has stage 2 diabetes? It is not a magical bullet, but it's a good start."
The current T1D pipeline consists largely of insulin-based treatments with few therapies in development to delay T1D and insulin use in recent-onset patients, including:
Sanofi's teplizumab label extension for patients 0-7 yrs and recent-onset T1D
NIDDK's anti-thymocyte globulin and granulocyte colony-stimulating factor
Diamyd Medical AB's Diamyd, an anti-IL5 mAb
Dompe Farmaceutici S.p.A's ladarixin, an anti-IL-8, CXCR1 and CXCR2 inhibitor
Novartis' iscalimab, an anti-CD40 mAb
Endocrinologists interviewed by REACH are eager for preventative treatments that offer a longer time to T1D progression and more convenient dosing than Tzield.
Meghana Pandit, REACH Analyst: "Tzield as a concept is viewed favorably by physicians, however, there are concerns around its dosing, and efficacy profile which is reported as marginal."
About MarketVue®
MarketVue® reports are a rare disease focused, fresh alternative to traditionally long and outdated market research reports. MarketVue® reports cover rare disease epidemiology and key market dynamics based on research from key opinion leader interviews, physician surveys, and secondary data.
About REACH Market Research
REACH is an independent pharmaceutical market research company focused on rare and niche diseases. With decades of experience in pharmaceutical market research and life sciences consulting, REACH fills an important gap in the market – accessible market research solutions for rare and niche diseases.
SOURCE REACH Market Research
上市批准
2023-05-31
Pictured: Sanofi sign in front of building/iStock, JHVEPhoto
Wednesday, Sanofi released data from a Phase II study showing its investigational anti-CD40L antibody frexalimab met the trial's primary endpoint and significantly lowered disease activity in patients with relapsing multiple sclerosis.
After 12 weeks, patients treated with high and low doses of frexalimab saw an 89% and 79% reduction in the number of new gadolinium-enhancing (GdE) T1-lesions, respectively, compared with the placebo. At the 24-week follow-up, 96% of patients in the higher dose group did not show signs of new GdE T1-lesions.
Both frexalimab doses also decreased total GdE T1-lesions and new or enlarging T2-lesions.
As for safety, Sanofi found frexalimab to be generally well-tolerated.
Sanofi will present these findings during a late-breaking session at the 2023 Consortium of Multiple Sclerosis Centers annual meeting. The company will also push frexalimab into a pivotal trial in MS, which is expected to begin in 2024.
Frexalimab is an investigational monoclonal antibody that works by blocking the costimulatory CD40/CD40L pathway, which under healthy circumstances, is crucial for the activation and function of the adaptive and innate immune response. By inhibiting this pathway, frexalimab could address the underlying hyperactive autoimmune pathology of MS.
Sanofi’s candidate belongs to a class of medications that is promising in theory but has historically been held back by safety concerns. In the late 1990s, Biogen kicked off several clinical trials of its anti-CD40L antibody ruplizumab and a competing antibody, toralizumab, developed by Idec Pharmaceuticals.
Both were eventually discontinued due to thromboembolic side effects.
More recently, Novartis has also encountered difficulties with its CD40L blocker iscalimab. In September 2021, the investigational antibody failed to prove its superiority to tacrolimus at preventing organ rejection in kidney transplant recipients. The company was forced to terminate this trial.
A year later, in October 2022, Novartis axed another iscalimab trial in liver transplantation after the antibody had a worse benefit/risk pro tacrolimus in these patients.
Sanofi Rallies in MS
Wednesday’s data drop comes nearly a year after the FDA put Sanofi’s other lead MS candidate, tolebrutinib, under partial clinical hold.
The regulatory order was triggered by documented cases of drug-induced liver injury in trial participants who had been treated with the candidate. According to Sanofi, patients who developed these liver injuries had underlying conditions that predisposed them to the complication, and discontinuing treatment would normalize liver injury biomarker levels.
Tolebrutinib is in a class of drugs that inhibit the BTK enzyme, an essential component in the B-cell development pathway. Targeting BTK could dampen the excessive activation of B-cells, which play a role in autoimmune diseases such as MS and myasthenia gravis.
In February 2023, after having its development suspended for months, Sanofi discontinued the development of tolebrutinib for myasthenia gravis. The drug remains under the FDA’s pause for MS.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com
临床结果临床2期临床失败
2023-04-27
最近，诺华公司决定将心血管、血液学、实体瘤、免疫学和神经科学五个治疗领域以及一小部分技术平台作为其研发活动的重点。为了增强对这五个核心治疗领域的关注，诺华公司（Novartis）对其管线进行了大规模削减，放弃了10%的研发项目。诺华首席执行官、医学博士Vas Narasimhan在凌晨与媒体的电话会议上表示：“我们将管线规模减少了约10%。这主要是因为我们削减了这五个核心治疗领域之外的资产，如果不符合该框架，我们要么停止这些项目，要么撤资。”Narasimhan在随后与分析师的通话中进一步阐述了这一决定，他解释说，“管道“清理”是将诺华公司的研发与其他大型制药公司进行比较的结果，我们的项目比同行多，这导致我们每个项目的投资比同行少。”诺华公司正在筹备的项目数量从150个下降到134个。实体瘤是一个持续关注的领域，受到的削减程度最大，在两次更新之间，活跃项目的数量从42个下降到32个。诺华放弃的研发管线们下面概述了诺华公司在季度管线更新中删除的项目。1、司他利珠单抗spartalizumab（临床Ⅲ期）但在罗列项目之前，司他利珠单抗spartalizumab值得着重交代。在2022年第四季度，诺华公司列出了六项涉及司他利珠单抗spartalizumab的研究。司他利单抗是一种抗PD-1检查点抑制剂，在2020年的黑色素瘤3期试验中失败。如今，诺华停止了几乎所有PD-1单抗spartalizumab的研究，转而支持百济神州的tislelizumab。目前Spartalizumab在管线图中只有一条，作为与CD73拮抗剂NZV930联合的1期药物的一部分。 2、ADPT06(临床II期)ADPT06是诺华公司在自免疫药物的2期临床试验中测试的平台化认知障碍候选药物。在这项针对阿尔茨海默病引起的轻度认知障碍患者的试验中，据悉诺华公司测试了卡纳单抗canakinumab（Ilaris）。卡纳单抗是一种高选择性，全人源化，抗白介素-1β的单体。其在2009年6月被美国FDA批准用于治疗4岁以上儿童和成人的Cryopyrin蛋白相关性周期综合征患者4年后，即2013年，Canakinumab被欧盟批准用于急性痛风性关节炎。2016年，Canakinumab在美同天斩获3种罕见病适应症：肿瘤坏死因子受体相关周期热综合征(TRAPS)、高免疫球蛋白D综合征(HIDS)/甲羟戊酸激酶缺乏(MKD)、家族性地中海热(FMF)。2020年，Canakinumab在美被批准用于治疗活动性斯蒂尔氏病。现在它作为阿兹海默症候选药物之路已经正式停止。 3、HSY244 (临床II期)HSY244是诺华公司于2020年进入二期临床的一种心房颤动候选药物。根据欧洲数据库，诺华“提前结束”了这项研究，但ClinicalTrials.gov仍将其列为招募患者中。诺华的 CRM（心血管、肾科和代谢）领域针对临床上高度未满足需求，拥有强大的中后期管线。同公司的兄弟竞品PCSK9 siRNA 药物 Inclisiran（Leqvio®）是其中最受瞩目的产品，针对高血脂适应症的 BLA 已经在多个国家和地区获批，另有 3 个适应症也已经进展至 3 期临床。其他将要进展至临床 3 期的还包括沙库巴曲缬沙坦（Entresto®）的慢性心衰适应症、反义核苷酸（ASO）药物 Pelacarsen、HSY244，以及 Iptacopan。其中HSY244药物在此次管线缩减中被砍。4、Ensovibep (临床II期)Ensovibep是诺华去年年初以1.5亿瑞士法郎（1.68亿美元）购买的新冠肺炎抗病毒药物。几个月内，由于美国食品药品监督管理局没有批准该药物的紧急使用授权（EUA），要求提供第三阶段临床的数据，诺华公司将该分子短期内推向市场的计划宣告失败，因此管线被裁撤。Ensovibep是设计的锚蛋白重复序列（DARPins）形式的蛋白药物，是一种拟抗体，串联多种功能抗体片段，具备多种抗体特性。2022年1月10日，诺华与合作伙伴Molecular Partners共同宣布，DARPins（设计的锚蛋白重复序列）形式的蛋白药物Ensovibep（开发代码：MP0420）临床2期试验（EMPATHY研究的A部分）顶线结果积极，达到主要终点及2个次要终点。诺华将行使项目选择权，向Molecular Partners支付1.5亿瑞郎（约1.65亿美元）里程碑付款以获得Ensovibep相关权益，加速建设Ensovibep产能，并计划寻求全球药监机构的紧急授权，首要目标为获得FDA的紧急使用授权（EUA），如Ensovibep获批上市，Molecular Partners将有资格获得22%的销售分成。而如今，这个项目也被砍掉了。 5、LKA651 (临床II期)LKA651是诺华公司在糖尿病视网膜病变研究与MorphoSys合作的EPO抑制剂。去年夏天，诺华公司完成了该候选药物的2期临床试验。被裁撤的原因可能是同类产品的竞争。6、FIA586（临床I期）诺华的研发管线中有6款肝病候选药物：ADTP02：非酒精性脂肪性肝炎（NASH），临床二期；iscalimab：肝移植（新适应症），临床二期；FIA586：非酒精性脂肪性肝炎（NASH），临床一期；tropifexor,cenicriviroc（定剂量组合）：非酒精性脂肪性肝炎（NASH），临床二期；tropifexor：非酒精性脂肪性肝炎（NASH），临床二期；lanalumab：自身免疫性肝炎（AIH）（新适应症），临床二期。其中FIA586将从管线中退出，诺华推倒了非酒精性脂肪性肝炎的多米诺骨牌。7、MHS552（临床I期）MHS552是诺华公司在一项狼疮1期试验中研究的一种自身免疫性疾病候选药物。该公司申请在1型糖尿病中测试该分子，但在招募任何患者之前撤回了这项研究。8、ADPT03（临床I期）ADPT03是针对镰状细胞病的BCL11A项目。Intellia透露，诺华公司已于今年早些时候停止了体外CRISPR编辑的细胞疗法的工作，该疗法旨在降低BCL11A的活性。基础研究表明，高水平的由α-和γ-珠蛋白组成的红细胞-胎儿血红蛋白（HbF）可通过减轻镰状血红蛋白聚合和红细胞镰状化来改善这些症状。BCL11A是成人红细胞中γ珠蛋白表达和HbF产生的抑制因子，它的下调是诱导HbF的有潜力的治疗策略。9、JEZ567（临床I期）JEZ567（CD123 CART）是一种CART细胞疗法，对患者T细胞进行工程化以识别和消除表达CD123的肿瘤细胞，适应症为急性髓系白血病。CD123广泛表达于骨髓增生异常综合征以及血液恶性肿瘤患者的骨髓细胞，包括急性髓性白血病（AML）、B细胞急性淋巴细胞白血病（B-ALL）、毛细胞白血病（HCL）、BPDCN、慢性髓细胞白血病（CML）和霍奇金淋巴瘤（HL）。CD123表达于75%-89%的AML、超过90%的BPDCN患者中，因此是T细胞过继免疫治疗的一个非常有吸引力的靶点。现在，项目已经被停掉。 10、MAK683（临床I期）MAK683 是一种高效的PRC2抑制剂，可阻断癌细胞增殖，诺华公司自2016年以来在弥漫性大B细胞淋巴瘤患者中进行了研究。抑制正常或过度活跃的PRC2可以在几种类型的癌症中降低癌细胞存活率并抑制肿瘤生长。现在该项目已经停止。但是诺华公司在靶向EZH2的小分子抑制剂中已有药物经过FDA批准上市，Tazemetostat于2020年被美国FDA批准用于治疗晚期上皮样肉瘤和滤泡性淋巴瘤，标志着用于治疗人类癌症的EZH2抑制剂开发的一个重要里程碑。 11、WVT078（临床I期）WVT078是诺华公司在多发性骨髓瘤中研究的一种BCMAxCD3双特异性抗体。I期研究的初步临床数据表明，WVT078在人体中表现出强大的抗MM活性和良好的耐受性，且安全性和有效性良好。但许多其他BCMA候选药物在其他公司的存在，使WVT078不适合诺华公司专注于“对患者具有变革潜力的高价值药物”。参考出处&原作者：见下图
临床3期临床2期临床失败
100 项与 Iscalimab 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 1型糖尿病 | 临床2期 | 比利时 | 2019-11-08 | |
| 1型糖尿病 | 临床2期 | 德国 | 2019-11-08 | |
| 1型糖尿病 | 临床2期 | 意大利 | 2019-11-08 | |
| 1型糖尿病 | 临床2期 | 斯洛文尼亚 | 2019-11-08 | |
| 1型糖尿病 | 临床2期 | 西班牙 | 2019-11-08 | |
| 1型糖尿病 | 临床2期 | 英国 | 2019-11-08 | |
| 肝移植排斥反应 | 临床2期 | 美国 | 2019-10-07 | |
| 肝移植排斥反应 | 临床2期 | 阿根廷 | 2019-10-07 | |
| 肝移植排斥反应 | 临床2期 | 比利时 | 2019-10-07 | |
| 肝移植排斥反应 | 临床2期 | 捷克 | 2019-10-07 |
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临床结果
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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 |
|---|
临床2期 | 15 | 獵鏇淵鏇鑰襯齋鹽夢憲(積襯鏇鹽醖遞糧醖醖獵) = 鹽遞繭淵蓋糧築鏇夢窪 遞夢襯獵廠廠襯襯遞餘 (餘範願選壓鏇夢獵鏇醖 ) 更多 | 积极 | 2020-03-01 | |||
临床2期 | 69 | (Cohort 1 CFZ533) | 構網窪壓遞獵鏇繭遞醖(鬱簾廠觸淵願齋襯網膚) = 鹹鹹衊築鹹齋醖願範襯 夢窪淵選積廠積壓網鏇 (廠鹹觸窪選蓋遞鬱鑰願, 衊蓋齋選遞顧願鹽糧範 ~ 構醖鏇齋鏇鹹糧膚鏇鹽) 更多 | - | 2019-08-14 | ||
Placebo+CFZ533 (Cohort 1 Placebo) | 構網窪壓遞獵鏇繭遞醖(鬱簾廠觸淵願齋襯網膚) = 窪獵衊簾壓鏇網淵醖積 夢窪淵選積廠積壓網鏇 (廠鹹觸窪選蓋遞鬱鑰願, 鑰衊製膚憲遞鹹製糧簾 ~ 廠觸選鬱選願簾襯鹽築) 更多 | ||||||
临床2期 | 44 | Placebo+CFZ533 (CFZ533) | 糧夢壓鹽餘齋艱蓋遞夢(廠餘夢獵窪衊鹹網範觸) = 獵窪鬱壓艱醖夢衊窪觸 獵築餘餘鹹顧淵壓襯鏇 (艱顧壓齋顧廠膚築築齋, 築觸壓醖蓋顧蓋齋鬱襯 ~ 構鏇網範積鬱衊積範觸) 更多 | - | 2019-07-25 | ||
Placebo (Placebo) | 糧夢壓鹽餘齋艱蓋遞夢(廠餘夢獵窪衊鹹網範觸) = 簾遞夢齋衊艱鹽積壓齋 獵築餘餘鹹顧淵壓襯鏇 (艱顧壓齋顧廠膚築築齋, 遞壓鹹鹹糧獵觸選鹹築 ~ 齋鏇襯鹹鬱鏇顧壓範觸) 更多 | ||||||
临床1/2期 | - | 窪鹹顧淵鹽廠獵繭選蓋(鹽築鏇膚膚遞構觸齋構) = lower CADI scores compared with tacrolimus 願鑰憲鑰夢夢窪艱顧築 (遞膚窪衊壓廠膚繭齋選 ) | 非劣 | 2019-06-06 | |||
临床1/2期 | - | 59 | 選夢觸鹹鏇憲糧廠蓋網(窪願壓艱憲醖選鹽製鏇) = 願積鹹範繭憲壓願繭夢 蓋鏇鑰觸構範築範淵顧 (醖顧築鹹艱齋積製廠鏇, 蓋壓積衊積窪憲憲繭窪 ~ 憲壓鏇鹹鬱鑰鹽餘築糧) 更多 | - | 2018-12-21 | ||
遞醖顧醖壓襯遞淵繭遞(獵觸網簾鹽製廠構窪網) = 鬱構醖壓壓獵鹽鬱淵壓 廠齋糧遞網襯獵簾壓蓋 (繭遞網憲齋顧蓋製憲鏇, 膚憲築願網觸選鬱鹹醖 ~ 鹽願鏇築顧構醖鬱夢遞) 更多 | |||||||
临床2期 | 15 | 鑰願範餘積簾遞糧遞淵(齋壓製艱獵鑰鬱繭積糧) = 淵獵夢廠觸簾鏇壓積顧 鹹製製壓窪衊觸製範艱 (簾範餘醖淵糧膚顧淵積, 顧膚衊繭積鹽網廠獵鹹 ~ 糧觸觸構鹹積鏇膚壓襯) 更多 | - | 2018-05-21 |
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