A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study

The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.

开始日期2021-08-03

申办/合作机构

Institut de Recherches Intern Servier

[+1]

NCT04882007 / Unknown status临床2期

Randomized, Double-blind, Phase 2 Study to Evaluate the Efficacy and the Safety of OSE-127 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Previous Treatment(s)

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.

开始日期2020-10-02

申办/合作机构

OSE Immunotherapeutics SA

NCT03980080 / Completed临床1期

Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of OSE-127 in Healthy Subjects

This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only) Ascending Doses of OSE-127 in Healthy Subjects.

开始日期2018-12-19

申办/合作机构

OSE Immunotherapeutics SA

[+1]

100 项与 Lusvertikimab 相关的临床结果

登录后查看更多信息

100 项与 Lusvertikimab 相关的转化医学

登录后查看更多信息

100 项与 Lusvertikimab 相关的专利（医药）

登录后查看更多信息

项与 Lusvertikimab 相关的文献（医药）

2024-06-27·Blood

The IL-7R antagonist lusvertikimab reduces leukemic burden in xenograft ALL via antibody-dependent cellular phagocytosis

Article

作者: Pengam, Sabrina ; Winterberg, Dorothee ; Bergmann, Anke K. ; Poirier, Nicolas ; Dietterle, Anna ; Alten, Julia ; Cario, Gunnar ; Narbeburu, Emma ; Neyton, Stéphanie ; Dovhan, Vladyslava ; Antić, Željko ; Lenk, Lennart ; Corallo, Frédérique ; Heymann, Julia ; Wessels, Wiebke ; Brüggemann, Monika ; den Boer, Monique L. ; Baccelli, Irène ; Raffel, Simon ; Taurelle, Julien ; Escherich, Gabriele ; Déramé, Mylène ; Bourquin, Jean-Pierre ; Laqua, Anna ; Bornhauser, Beat ; Schrappe, Martin ; Schewe, Denis M. ; Reimer, Claas ; Vogiatzi, Fotini ; Mary, Caroline ; Peipp, Matthias ; Boer, Judith M. ; Schüler, Thomas

Abstract:

Acute lymphoblastic leukemia (ALL) arises from the uncontrolled proliferation of B-cell precursors (BCP-ALL) or T cells (T-ALL). Current treatment protocols obtain high cure rates in children but are based on toxic polychemotherapy. Novel therapies are urgently needed, especially in relapsed/refractory (R/R) disease, high-risk (HR) leukemias and T-ALL, in which immunotherapy approaches remain scarce. Although the interleukin-7 receptor (IL-7R) plays a pivotal role in ALL development, no IL-7R–targeting immunotherapy has yet reached clinical application in ALL. The IL-7Rα chain (CD127)–targeting IgG4 antibody lusvertikimab (LUSV; formerly OSE-127) is a full antagonist of the IL-7R pathway, showing a good safety profile in healthy volunteers. Here, we show that ∼85% of ALL cases express surface CD127. We demonstrate significant in vivo efficacy of LUSV immunotherapy in a heterogeneous cohort of BCP- and T-ALL patient-derived xenografts (PDX) in minimal residual disease (MRD) and overt leukemia models, including R/R and HR leukemias. Importantly, LUSV was particularly effective when combined with polychemotherapy in a phase 2-like PDX study with CD127high samples leading to MRD-negativity in >50% of mice treated with combination therapy. Mechanistically, LUSV targeted ALL cells via a dual mode of action comprising direct IL-7R antagonistic activity and induction of macrophage-mediated antibody-dependent cellular phagocytosis (ADCP). LUSV–mediated in vitro ADCP levels significantly correlated with CD127 expression levels and the reduction of leukemia burden upon treatment of PDX animals in vivo. Altogether, through its dual mode of action and good safety profile, LUSV may represent a novel immunotherapy option for any CD127+ ALL, particularly in combination with standard-of-care polychemotherapy.

2024-01-01·Journal of Otolaryngology-Head & Neck Surgery

Canadian Real-World Study Long-Term Clinical Results Using Dupilumab for Chronic Rhinosinusitis With Polyps

Article

作者: Kilty, Shaun J. ; Lasso, Andrea

Background:

Dupilumab, an anti-IL4 receptor-α monoclonal antibody, was the first biologic to be approved in Canada for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). In phase III clinical trials, it has demonstrated to be effective in reducing nasal polyp size and the severity of symptoms, improve disease-specific quality of life, and to have an acceptable safety profile. This study aims to present long-term follow-up data on disease-specific sinonasal outcomes of patients with CRSwNP who have been treated with dupilumab for up to 3 years in a real-world setting.

Methods:

Retrospective review of electronic medical records of a single Canadian rhinology center evaluating disease-specific sinonasal outcomes that are routinely collected for clinical care. This study included all patients who received dupilumab for the treatment of CRSwNP and who had completed at least one follow-up visit. The Sino-Nasal Outcome Test (SNOT)-22 was used to evaluate treatment symptom improvement.

Results:

Ninety-nine patients started dupilumab therapy during the study period. The mean SNOT-22 at the start of therapy was 61.1 (±22.91) At the time of the review, 65 patients had completed 1 year of therapy, 40 had completed 2 years of therapy, and 18 had completed 3 years of therapy. The mean SNOT-22 score at these timepoints was 16.75 (±13.86), 15.02 (±14.40), and 10.22 (±11.56), respectively.

Conclusion:

This real-world study shows that in patients with CRSwNP treated with dupilumab, improvement in disease-specific quality of life seen after 1 year continues and can be maintained at 3 years of treatment.

2023-03-15·Journal of immunology (Baltimore, Md. : 1950)

First-in-Human Study in Healthy Subjects with the Noncytotoxic Monoclonal Antibody OSE-127, a Strict Antagonist of IL-7Rα

Article

作者: Costantini, Dominique ; Conduzorgues, Jean-Pascal ; Poirier, Nicolas ; Abès, Riad ; Volckaert, Bram ; Teppaz, Géraldine ; De Sa, Fanny ; Girault, Isabelle ; Corallo, Frédérique ; Belarif, Lyssia ; Poli, Sonia ; Mary, Caroline ; Braudeau, Cécile ; Pengam, Sabrina ; Josien, Regis ; Soma, Emilienne ; Baccelli, Irène ; Fromond, Claudia

Abstract:

OSE-127 is a humanized mAb targeting the IL-7Rα-chain (CD127), under development for inflammatory and autoimmune disease treatment. It is a strict antagonist of the IL-7R pathway, is not internalized by target cells, and is noncytotoxic. In this work, a first-in-human, phase I, randomized, double-blind, placebo-controlled, single-center study was carried out to determine the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of OSE-127 administration. Sixty-three healthy subjects were randomly assigned to nine groups: six single ascending dose groups with i.v. administration (0.002–10 mg/kg), a single s.c. treatment group (1 mg/kg), and two double i.v. injection groups (6 or 10 mg/kg). Subjects were followed during <146 d. OSE-127’s pharmacokinetic half-life after a single dose increased from 4.6 (1 mg/kg) to 11.7 d (10 mg/kg) and, after a second dose, from 12.5 (6 mg/kg) to 16.25 d (10 mg/kg). Receptor occupancy was ≥95% at doses ≥0.02 mg/kg, and this saturation level was maintained >100 d after two i.v. infusions at 10 mg/kg. IL-7 consumption was inhibited by OSE-127 administration, as demonstrated by a decreased IL-7 pathway gene signature in peripheral blood cells and by ex vivo T lymphocyte restimulation experiments. OSE-127 was well tolerated, with no evidence of cytokine-release syndrome and no significant alteration of blood lymphocyte counts or subset populations. Altogether, the observed lack of significant lymphopenia or serious adverse events, concomitant with the dose-dependent inhibition of IL-7 consumption by target cells, highlights that OSE-127 may show clinical activity in IL-7R pathway–involved diseases.

项与 Lusvertikimab 相关的新闻（医药）

2024-12-18

·GlobeNewswire-Health Care

OSE Immunotherapeutics to Present Anti-IL-7R Lusvertikimab Phase 2 Induction Results in Ulcerative Colitis at 20th Congress of ECCO

A clinical abstract on the induction results from the CoTikiS Phase 2 trial of anti-IL-7 Receptor Lusvertikimab in Ulcerative Colitis accepted for Oral Presentation and selected amongst the Top 10 oral abstracts for 20th Congress of European Crohn’s and Colitis Organization (ECCO) Highlights. Research highlights OSE Immunotherapeutics’ continued commitment to advancing the treatment and management of IBD. NANTES, France, December 18, 2024 – 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced that an abstract related to its first in class anti-IL-7 Receptor (IL-7R) Lusvertikimab, has been accepted for Oral Presentation at the 20th congress of the European Crohn’s and Colitis Organization (ECCO) being held February 19-22, 2025, in Berlin (Germany). Details of the presentation: EC25-1892 - "Lusvertikimab, a first-in-class IL7 receptor antagonist, in moderate to severe Ulcerative Colitis: results of a multicenter, randomized, placebo-controlled phase II study" has been accepted as an Oral Presentation in the Scientific Program and selected amongst the Top 10 oral abstracts for the Congress Highlights of ECCO’25 video. Presentation number: OP36Session name: Sustainability in IBD and beyond - Session 10: Hot topics in IBDSession date: 22/02/25; Session time: 08:30 - 10:50; Presentation time: 10:10 - 10:20Session hall: Plenary Hall / Hall B Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are excited to present for the first time at a congress the clinical efficacy and safety data from the induction study in ulcerative colitis. This prestigious scientific meeting gathers the world’s leading specialists in Inflammatory Bowel Diseases (IBD). Lusvertikimab, a pure interleukin-7 receptor antagonist mAb that exclusively blocks IL-7 boasts a differentiated mechanism of action and a favorable tolerance profile. We believe Lusvertikimab is uniquely positioned in IBD, with potential also for a broader spectrum of chronic inflammatory and autoimmune diseases.” Interleukin-7 (IL-7) produced locally by epithelial cells is a crucial survival factor for pathogenic T lymphocytes residing in tissues, such as colitogenic memory T cells1. Lusvertikimab is a unique antagonist of IL-7R targeting the CD127 receptor, the alpha chain of the IL-7R, with a differentiated mechanism of action allowing a selective inhibition of the IL-7 biology while sparing TSLP (Thymic Stromal LymphoPoietin) cytokine and growth factor. This allows potent inhibition of pathogenic memory and effector T lymphocytes expressing high level of CD127, while promoting regulatory T cells (Tregs) biology expressing low level of CD127. The protective role of TSLP in intestinal immunity has been reproducibly described, in particular to instruct Treg generation against commensal bacteria2 and TSLP inhibition has been reported to exacerbate mucosal inflammation and colitis3. This biology together with the results of the CoTikiS study supports the continued clinical development of a pure IL-7 antagonist in IBD, and other diseases where Tregs and microbiota cross-talks are implicated in tissular healing. Interleukin-7 Receptor (IL-7R) overexpression has been associated with numerous diseases4 and therapeutic areas, with preclinical efficacy already demonstrated in IBD5, rheumatoid arthritis6, neuroinflammation7, airways inflammation8, dermatology9, type 1 diabetes10 and lupus11. ABOUT ULCERATIVE COLITIS (UC)Ulcerative colitis is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers. This condition is the result of the immune system’s overactive response. UC affects 3.3 million patients in the US, Europe and Japan (1). Despite broad therapeutic options, remission rates remain only 25-30% (2) leaving most patients without satisfactory treatments. 15% of patients (3) fail to respond to all therapies and undergo surgery as a last option.(1) EvaluatePharma (2) Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.212572(3) Scientific Reports volume 10, Article number: 12546 (2020)ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn Contacts Fiona Olivierfiona.olivier@ose-immuno.comSylvie Détrysylvie.detry@ose-immuno.comFrench Media Contact FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@rooneypartners.com+1 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 Markus F. Neurath, Strategies for targeting cytokines in inflammatory bowel disease, Nat Rev Immunol 20242 I Spadoni et al., Dendritic cells produce TSLP that limits the differentiation of Th17 cells, fosters Treg development, and protects against colitis, Mucosal Immunol, 2012 3 Jonathan L Messerschmidt et al., TSLP/dendritic cell axis promotes CD4+ T cell tolerance to the gut microbiome, JCI Insight, 2023 Betsy C Taylor et al., TSLP regulates intestinal immunity and inflammation in mouse models of helminth infection and colitis, J Exp Med, 20094 Barata, J. T., S. K. Durum, and B. Seddon. 2019. Flip the coin: IL-7 and IL-7R in health and disease. Nat. Immunol. 20: 1584_1593.5 Belarif, L., R. Danger, L. Kermarrec, V. Nerri`ere-Daguin, S. Pengam, T. Durand, C. Mary, E. Kerdreux, V. Gauttier, A. Kucik, et al. 2019. IL-7 receptor influences anti-TNF responsiveness and T cell gut homing in inflammatory bowel disease. J. Clin. Invest., 2019.Willis, C. R. et al., Interleukin-7 receptor blockade suppresses adaptive and innate inflammatory responses in experimental colitis. J. Inflamm., 2012.6 Sarita A Y Hartgring, Blockade of the interleukin-7 receptor inhibits collagen-induced arthritis and is associated with reduction of T cell activity and proinflammatory mediators, Arthritis Rheum, 2010Zhenlong Chen, The novel role of IL-7 ligation to IL-7 receptor in myeloid cells of rheumatoid arthritis and collagen-induced arthritis, J Immunol, 2013 7 Li-Fen Lee et al., IL-7 promotes T(H)1 development and serum IL-7 predicts clinical response to interferon-β in multiple sclerosis 8 Hoa Le Mai et al., Targeting the interleukin-7 receptor alpha by an anti-CD127 monoclonal antibody improves allergic airway inflammation in mice, Clin Exp Allergy, 2020 9 Lyssia Belarif et al., IL-7 receptor blockade blunts antigen-specific memory T cell responses and chronic inflammation in primates, Nat Commun, 2018Zhenpeng Dai et al., Blockade of IL-7 signaling suppresses inflammatory responses and reverses alopecia areata in C3H/HeJ mice, Sci Adv, 2021 10 Li-Fen Lee et al., Anti-IL-7 receptor-α reverses established type 1 diabetes in nonobese diabetic mice by modulating effector T-cell function, Proc Natl Acad Sci U S A, 2012 Cristina Penaranda, IL-7 receptor blockade reverses autoimmune diabetes by promoting inhibition of effector/memory T cells, Proc Natl Acad Sci U S A, 201211 Rosana Gonzalez-Quintial et al., Systemic autoimmunity and lymphoproliferation are associated with excess IL-7 and inhibited by IL-7Rα blockade PLoS One, 2011 Attachment EN_241218_ECCO Lusvertikimab

临床2期临床结果免疫疗法

2024-11-05

·PipelineReview

OSE Immunotherapeutics Announces Statistically Significant and Clinically Meaningful Results from the Phase 2 Study of Anti-IL7R mAb Lusvertikimab for the Treatment of Ulcerative Colitis

NANTES, France I November 4, 2024 I OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today reported positive results from the induction period of the CoTikiS randomized, double-blind, placebo-controlled, Phase 2 study of Lusvertikimab (OSE-127) demonstrating a strong efficacy and favorable safety profile in moderate to severe active ulcerative colitis (UC). Topline results from the CoTikiS Phase 2 Study The randomized, double-blind Phase 2 clinical trial CoTikiS has evaluated the efficacy and the safety of Lusvertikimab versus placebo in 136 patients with moderate to severe active UC who failed or lost response to previous treatment(s)*. CoTikiS is a 50-week study, with a 10-week induction period evaluating two doses (450mg or 850mg) of Lusvertikimab against placebo, a 24-week additional open label treatment extension period (OLE) during which all subjects received Lusvertikimab 850mg infusions every 4 weeks and a 16-week safety follow-up period free of treatment. Lusvertikimab (Lusv) met the primary efficacy endpoint defined by the improvement of the Modified Mayo Score (MMS)** at week 10 (W10) at the two doses tested and demonstrated statistically significant and clinically meaningful results on key secondary endpoints. A favorable safety profile was observed during both the induction period and during the 6 months of open-label extension period trial. 134 patients were analyzed in the W0-W10 period [group 850mg (50 patients); group 450mg (35 patients); drug group pooled 850mg + 450mg (85 patients); group placebo (49 patients)]. A total of 120 patients treated with Lusvertikimab participated to the additional 24-week OLE treatment period. Final analysis of the primary endpoint at W10*** Improvement of the global Disease Activity Index of UC (MMS) Key secondary endpoint results at W10 Clinical remission**** Endoscopic remission (endoscopic score at 0) Endoscopic improvement (endoscopic score ≤ 1 point) Ulcerative Colitis Endoscopic index of Severity***** (UCEIS score decreases at week 10) Safety Profile Lusvertikimab displayed a good safety profile and was well tolerated, with no difference between both dose groups and placebo in the incidence of drug related serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, severe drug-related AEs, opportunistic infections or infusion reactions during the induction period. In addition, no safety signal was observed in the patient population who received 850mg of Lusvertikimab for an additional 24-week period in the OLE, regardless of the initial randomization groups. Pr. Arnaud Bourreille, Associate professor in Gastroenterology, Institut des Maladies de l’Appareil Digestif, Nantes University Hospital, Principal/ Scientific coordination of the CoTikiS study , said: “We are very excited to share these positive topline efficacy results which could establish Lusvertikimab as a potential new breakthrough therapeutic option for UC patients. We are beyond enthusiastic with the very high endoscopy efficacy and what it could mean for patients suffering from chronic ulcerative colitis. This promising drug-candidate with a differentiated mode of action and very good safety profile needs to be further actively explored in ulcerative colitis and in other indications. We are grateful to all the investigators and patients for their participation in this study and we are eager to present a more complete clinical and biomarkers data set in future medical congresses.” Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics , adds: “These impressive efficacy and safety results represent a major milestone in the clinical development of Lusvertikimab and a strong catalyst for the subsequent steps. Lusvertikimab has clearly demonstrated meaningful clinical proof-of-efficacy in UC and we are now looking forward to further evaluating it in additional studies with the ultimate goal of making this innovative therapy accessible to millions of patients in need of more efficacious and safe treatments. Lusvertikimab is a pure interleukin-7 receptor antagonist mAb and we believe it has a broad first-in-class potential in various chronic inflammatory and autoimmune diseases. We look forward to making progress on this strategy and to go ahead with the most relevant partners.” * Previous corticosteroids, immunosuppressive agents or previous biological treatments. ** Ulcerative Colitis is a chronic inflammatory disease of the rectum and colon characterized by mucosal inflammation, abdominal pain associated with symptoms and frequency of diarrhea and rectal bleeding. The moderate to severe UC is measured by a Modified Mayo Score (MMS) between 4 and 9, inclusive. The primary endpoint is the mean change at Week 10 from baseline in the Modified Mayo Score, a Disease Activity Index for UC defined by the addition of the stool frequency and the rectal bleeding sub-scores (two patient’s clinical elements as Patient Reported Outcomes) and the endoscopic sub-score (mucosal endoscopy activity), assessed by an endoscopist through a central reading platform. *** An interim Futility analysis performed early (about 30% of patients) by the IDMC proposed interruption of the 450 mg group for risk of futility. The 850 mg group was initially considered as primary analysis, in the final analysis the futility of the 450mg was not confirmed. SAP (Statistical Analysis Plan) Addendum: Results of 450mg group reconsidered with all patients already included in this group. In addition, the two groups have been pooled for the drugs cohort to a global treatment effect. **** Clinical remission at Week 10, a modified Mayo score of ≤ 2 points with no individual sub-score of > 1 point and a rectal bleeding at 0, therefore a stool frequency score of 0 or 1 and an endoscopic score of 0 or 1. ***** Ulcerative Colitis Endoscopic Index of Severity, UCEIS, is a validated endoscopic scoring tool with lower interobserver variability, score change at Week 10 from baseline measuring specific subscores: vascular pattern/ presence of bleeding/ erosions and ulcerations (Pabla B S et al Gastroenterol Clin North Am. 2020). About OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I). The Company’s current well-balanced first-in-class clinical pipeline includes: OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com . Follow us on X and LinkedIn SOURCE: OSE Immunotherapeutics

临床结果免疫疗法临床2期

2024-11-04

·药明康德

临床缓解率提高3倍以上！潜在“first-in-class”疗法2期临床结果积极

▎药明康德内容团队编辑 OSE Immunotherapeutics今日公布了在研抗体疗法lusvertikimab（OSE-127）在随机双盲、安慰剂对照的2期临床试验CoTikiS中的诱导治疗期积极结果，显示其在中度至重度活动性溃疡性结肠炎（UC）患者中具有显著疗效和良好的安全性。 CoTikiS试验涉及136名先前治疗失效或无应答的中度至重度活动性UC患者。它是一项为期50周的研究，包括为期10周的诱导治疗期，评估两种剂量（450 mg或850 mg）lusvertikimab对比安慰剂的效果。 Lusvertikimab在第10周达到了主要疗效终点，即UC疾病活动指数评分MMS的改善。数据显示，在850 mg剂量组，lusvertikimab与安慰剂相比，评分差异为-0.9分（p=0.036）；在450 mg组：lusvertikimab与安慰剂相比差异为-1.16分（p=0.019）。合并450 mg和850 mg组，lusvertikimab与安慰剂相比差异为-1.00分（p=0.010）。 Lusvertikimab在关键次要终点上显示出统计学显著性和具有临床意义的结果。在临床缓解率方面，850 mg组为13%，450 mg组为22%，安慰剂组为4%。在内镜缓解率方面，850 mg组为19.4%，450 mg组为34.7%，安慰剂组为12.6%。图片来源：123RF Lusvertikimab显示出良好的安全性和耐受性，在诱导治疗期内，两个剂量组与安慰剂组之间在药物相关严重不良事件（SAEs）、导致停药的不良事件（AEs）、机会性感染或输注反应的发生率上无差异。此外，在开放标签扩展研究中接受850 mg的lusvertikimab额外24周治疗的患者中，无论初始随机分组如何，均未观察到新的安全信号。 Lusvertikimab是一款潜在“first-in-class”，靶向IL7R的单克隆抗体。新闻稿表示这些数据为未来开发其成为治疗自身免疫性疾病和炎症性疾病的首款IL-7拮抗剂铺平了道路。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] OSE Immunotherapeutics Announces Statistically Significant and Clinically Meaningful Results from the Phase 2 Study of Anti-IL7R mAb Lusvertikimab for the Treatment of Ulcerative Colitis. Retrieved November 4, 2024, from https://www.globenewswire.com/news-release/2024/11/04/2973708/0/en/OSE-Immunotherapeutics-Announces-Statistically-Significant-and-Clinically-Meaningful-Results-from-the-Phase-2-Study-of-Anti-IL7R-mAb-Lusvertikimab-for-the-Treatment-of-Ulcerative-C.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床2期临床结果

100 项与 Lusvertikimab 相关的药物交易

登录后查看更多信息

研发状态

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
干燥综合征	临床2期	法国	OSE Immunotherapeutics SA	2022-01-30
干燥综合征	临床2期	法国	Servier Group	2022-01-30
原发性干燥综合征	临床2期	美国	Institut de Recherches Intern Servier	2021-08-03
原发性干燥综合征	临床2期	美国	Adir SRL	2021-08-03
原发性干燥综合征	临床2期	澳大利亚	Adir SRL	2021-08-03
原发性干燥综合征	临床2期	澳大利亚	Institut de Recherches Intern Servier	2021-08-03
原发性干燥综合征	临床2期	法国	Adir SRL	2021-08-03
原发性干燥综合征	临床2期	法国	Institut de Recherches Intern Servier	2021-08-03
原发性干燥综合征	临床2期	德国	Institut de Recherches Intern Servier	2021-08-03
原发性干燥综合征	临床2期	德国	Adir SRL	2021-08-03

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


NCT04882007 (CoTikiS, GlobeNewswire) 人工标引	临床2期	溃疡性结肠炎	136	Lusvertikimab	-	积极	2024-11-04
				Lusvertikimab (850mg)	齋夢積積襯顧構憲網糧(襯繭願積淵衊選顧糧鹽) = 淵範醖糧鏇構製築鏇淵鬱鏇鬱顧夢簾鹽齋餘選 (遞鑰製繭選鑰願簾膚遞 ) 达到更多
NCT04882007 (CoTikiS, PipelineReview) 人工标引	临床2期	活动性中度溃疡性结肠炎 \| 活动性重度溃疡性结肠炎	136	Lusvertikimab	膚鬱憲餘範製遞醖範構(醖鬱鹹顧鹽膚構製艱鹹) = no safety signal was reported by the Data Safety Monitoring Board during the trial. Both doses of lusvertikimab show favorable safety profile in comparison with placebo, with similar rates of adverse events across the 3 treatment groups. 鹹醖鹹鏇壓顧壓築醖顧 (艱膚憲鑰積鹹顧築餘廠 )	积极	2024-07-24
				Lusvertikimab (850 mg group)
NCT04605978 (EULAR2024) 人工标引	临床2期	原发性干燥综合征	48	S95011	衊築夢鹽壓餘艱淵蓋膚(襯製膚鏇觸膚選築積顧) = 網廠醖簾糧網構製淵鹹觸鹹膚選鬱餘觸遞醖蓋 (築繭淵衊繭衊鏇選鏇鬱, 6.5) 更多	不佳	2024-06-14
				Placebo	衊築夢鹽壓餘艱淵蓋膚(襯製膚鏇觸膚選築積顧) = 製壓選構壓獵鹹顧網觸觸鹹膚選鬱餘觸遞醖蓋 (築繭淵衊繭衊鏇選鏇鬱, 4.4) 更多
NCT04605978 (CTgov)	临床2期	原发性干燥综合征	48	S95011 concentrate for solution for infusion (S95011 Concentrate for Solution for Infusion)	膚艱鏇構鑰獵窪鬱艱鬱(積選蓋窪網壓餘鑰顧鹽) = 願範觸淵網膚憲繭廠醖願獵網衊艱壓繭繭鏇遞 (夢遞選構壓獵顧醖網積, 鑰夢鏇遞繭鏇顧膚餘顧 ~ 選醖壓鏇觸膚艱築醖壓) 更多	-	2024-04-23
				Placebo concentrate for solution for infusion (S95011 Placebo Concentrate for Solution for Infusion)	膚艱鏇構鑰獵窪鬱艱鬱(積選蓋窪網壓餘鑰顧鹽) = 獵積簾鬱網醖艱糧糧簾願獵網衊艱壓繭繭鏇遞 (夢遞選構壓獵顧醖網積, 廠鹹淵糧醖顧膚淵顧夢 ~ 糧窪糧襯鑰鬱鹽築壓艱) 更多