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更新于：2025-09-27
Tulisokibart
更新于：2025-09-27
概要
基本信息
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- |
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结构/序列
Sequence Code 719540590H
来源: *****
Sequence Code 719540597L
来源: *****
关联
14
项与 Tulisokibart 相关的临床试验NCT07176390
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
NCT07133633
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
CTR20252479
一项在中度至重度化脓性汗腺炎受试者中评价Tulisokibart的有效性和安全性的IIb期、随机、双盲、安慰剂对照研究
100 项与 Tulisokibart 相关的临床结果
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100 项与 Tulisokibart 相关的转化医学
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100 项与 Tulisokibart 相关的专利（医药）
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6
项与 Tulisokibart 相关的文献（医药）2025-08-01Lancet Gastroenterology & Hepatology
Tulisokibart shows promise for Crohn's disease
Article
作者: Lindsay, James
2025-08-01Lancet Gastroenterology & Hepatology
Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial
Article
作者: Llewellyn, Heather ; Al Kharrat, Houssam ; Longman, Randy S ; Jang, InSock ; Luo, Allison ; Sands, Bruce E ; Marchelletta, Ron ; Targan, Stephan R ; DuVall, Aaron ; McGovern, Dermot P B ; Siegel, Corey A ; Yen, Mark ; Wang, Yong ; Woynarowski, Marek ; Feagan, Brian G ; Bilsborough, Janine ; Anderson, Jaclyn K ; Towfic, Fadi ; Nguyen, Deanna D ; Sabino, João ; Lu, Jiandong ; Kierkus, Jaroslaw ; Laurent, Olivier ; Muñoz-Elias, Ernesto J ; Dubinsky, Marla C
BACKGROUND:
TNF-like cytokine 1A (TL1A) is a key mediator of inflammation and fibrosis. The efficacy and safety of the anti-TL1A monoclonal antibody tulisokibart as induction treatment was assessed in adults with moderately to severely active Crohn's disease with a history of insufficient response, loss of response, or intolerance to conventional or approved biological therapies.
METHODS:
In the phase 2a, multicentre, open-label APOLLO-CD study, participants aged 18 years or older with moderately to severely active Crohn's disease, as defined by a Crohn's Disease Activity Index (CDAI) of 220-450 and a Simple Endoscopy Score for Crohn's Disease (SES-CD) of at least 6 for ileocolonic or colonic disease or at least 4 for isolated ileal disease, received intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10). This Article reports the results of the primary analysis of the induction period. The primary endpoints were safety and the proportion of participants with endoscopic response at week 12, defined as a decrease in SES-CD of at least 50% from baseline. Safety was analysed in all participants treated with tulisokibart, and endoscopic response was analysed in the per-protocol analysis set, which included all participants treated with tulisokibart with baseline CDAI and SES-CD scores, except those with prespecified important protocol deviations. This trial is registered with ClinicalTrials.gov (NCT05013905) and is closed for recruitment; an open-label extension is ongoing.
FINDINGS:
Of 101 participants screened for eligibility, 55 eligible participants were enrolled and received tulisokibart. The mean age of participants was 39·1 years (SD 15·7), 34 (62%) were male, 21 (38%) were female, and 39 (71%) had received previous biological therapy. At week 12, endoscopic response was observed in 13 (26·0% [95% CI 15·9-39·6]) of 50 participants receiving tulisokibart in the per-protocol analysis set. Adverse events occurred in 43 (78%) of 55 participants, with most adverse events being mild to moderate in severity. The most frequently occurring adverse events (≥5% of participants) were COVID-19 (six [11%] participants), urinary tract infection (five [9%]), Crohn's disease (five [9%]), anaemia (four [7%]), nasopharyngitis (three [5%]), and fatigue (three [5%]). Eight (15%) participants had serious adverse events, none of which were considered related to the study drug by the investigator. There were no deaths.
INTERPRETATION:
This proof-of-concept study showed that tulisokibart is potentially efficacious in moderately to severely active Crohn's disease and is well tolerated. Randomised controlled trials with longer duration are needed to confirm these results; a double-blind, placebo-controlled, phase 3 trial is currently underway.
FUNDING:
Prometheus Biosciences, a subsidiary of Merck & Co, Rahway, NJ, USA.
2025-06-01Pharmacology Research & Perspectives
Comparative Efficacy of Different Targeted Therapies in Patients With Moderate‐to‐Severe Ulcerative Colitis: Systematic Review/Network Meta‐Analysis and Mechanistic Overview
Review
作者: Xu, Li ; Sun, Yingzhe ; Hu, Suying ; Hu, Fang ; Pan, Pingting ; Dai, Youran ; Yang, Wenhui ; Li, Qiushuang ; Liu, Shan
ABSTRACT:
Ongoing evaluations of targeted therapies for moderate‐to‐severe ulcerative colitis (UC) continue to unfold, with the emergence of novel drugs. However, head‐to‐head trials comparing these therapies are still lacking. The aim of this study is to investigate the therapeutic effects of targeted therapies in moderate‐to‐severe UC. The Cochrane Library, Web of Science, PubMed, and Embase were searched from the inception to November 12, 2024. Statistical analyses included multivariate random effects models and Bayesian modeling. Stratified and sensitivity analyses were also performed. Publication bias was assessed using funnel plots. Outcomes such as clinical response/remission, endoscopic remission, mucosal healing, quality of life, adverse events (AEs), and serious adverse events (SAEs) were used to quantify the relative therapeutic effects. Thirty‐three studies (33 reported on the induction phase; 13 reported on the maintenance phase) were identified. In the induction phase, Upadacitinib 45 mg demonstrated the highest efficacy in achieving clinical remission (OR 10.03; 95% CI, 4.83–20.80), clinical response (OR 7.96; 95% CI, 3.89–16.28), and mucosal healing rate (OR 8.91; 95% CI, 3.36–23.62). Cobitolimod 250 mg was the first‐ranked treatment (SUCRA, 92.67%) in Endoscopic remission. Vedolizumab 108 mg was the best dosage in reducing Adverse Events (AEs). The optimal dosage for reducing Serious Adverse Events (SAEs) was found to be Tulisokibart 1000/500 mg. During the maintenance phase, Etrasimod 2 mg/kg ranked first in clinical remission (OR 9.58; 95% CI, 2.82–32.59), and Upadacitinib 45 mg was superior in endoscopic remission. Additionally, the most effective medication for raising quality of life was Guselkumab 200 mg (OR 3.04; 95% CI, 1.70–5.40). Consequently, there is a need for further high‐quality research to conclusively determine the best therapeutic option.
187
项与 Tulisokibart 相关的新闻（医药）2025-09-15
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100 项与 Tulisokibart 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 克罗恩病 | 临床3期 | 美国 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 中国 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 日本 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 澳大利亚 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 奥地利 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 比利时 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 加拿大 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 智利 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 哥伦比亚 | 2024-06-05 | |
| 克罗恩病 | 临床3期 | 克罗地亚 | 2024-06-05 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | - | 鹽鏇顧構夢繭廠鏇窪餘(鏇網憲築衊觸範窪夢淵) = Through week 50, AEs occurred in 63% and 77% of patients receiving tulisokibart 250 mg and 100 mg, respectively; most were mild to moderate in severity. Serious AEs occurred in 1 patient (3%) and two patients (7%) in the tulisokibart 250 mg and 100 mg groups, respectively. 餘鹹艱鏇積選顧積壓窪 (窪範觸範繭築餘鹹築膚 ) | - | 2024-10-13 | |||
临床2期 | 135 | 餘繭衊壓醖鑰遞齋鑰餘(選鹽餘獵淵願鏇遞壓衊) = 醖顧築鹹築餘壓築積積 衊襯鏇顧繭觸構廠觸獵 (壓選鑰鏇鏇製齋範繭積 ) | 积极 | 2024-09-26 | |||
Placebo | 餘繭衊壓醖鑰遞齋鑰餘(選鹽餘獵淵願鏇遞壓衊) = 範醖醖壓艱廠願繭鬱襯 衊襯鏇顧繭觸構廠觸獵 (壓選鑰鏇鏇製齋範繭積 ) | ||||||
临床2期 | 178 | (Cohort 1 Tulisokibart) | 選鬱簾遞繭襯醖鬱膚構 = 觸觸壓網繭築餘獵壓齋 製廠製鏇齋鏇願製鏇構 (膚蓋憲願蓋願衊遞獵獵, 觸齋製鑰蓋鑰選壓蓋構 ~ 膚鬱鹽願艱餘網顧構艱) 更多 | - | 2024-06-27 | ||
Placebo (Cohort 1 Placebo) | 選鬱簾遞繭襯醖鬱膚構 = 艱餘繭獵築淵觸遞壓廠 製廠製鏇齋鏇願製鏇構 (膚蓋憲願蓋願衊遞獵獵, 網鹹壓願鹽鏇觸積窪艱 ~ 積醖衊遞鹽鑰淵壓選壓) 更多 | ||||||
临床2期 | 55 | Companion diagnostic (CDx)+PRA023 IV | 醖糧積觸淵憲窪觸膚糧 = 廠餘構簾廠製觸壓遞憲 築壓鑰餘製鏇獵憲網選 (醖鏇壓膚醖製衊顧襯淵, 顧範夢艱鏇願廠壓鑰壓 ~ 築製範壓膚獵餘願築艱) 更多 | - | 2023-11-01 | ||
N/A | - | 選觸鹹糧網糧壓夢廠簾(襯糧衊廠選範襯遞範淵) = 獵鏇築繭膚糧窪醖鹹積 遞憲範願憲鑰衊構夢網 (顧艱衊鬱憲願鬱鬱衊構, 34.85) 更多 | - | 2023-10-15 | |||
Placebo | 選觸鹹糧網糧壓夢廠簾(襯糧衊廠選範襯遞範淵) = 繭醖襯簾範餘構積鹹鹹 遞憲範願憲鑰衊構夢網 (顧艱衊鬱憲願鬱鬱衊構, 37.59) 更多 | ||||||
临床2期 | 活动性中度溃疡性结肠炎 eosinophils | neutrophils | 135 | 築繭鹹繭憲艱顧範衊遞(鑰蓋蓋餘鏇構願構淵夢) = 鏇蓋蓋膚觸壓憲廠構願 選廠顧襯廠襯襯顧膚窪 (構築夢糧範憲艱餘憲廠 ) 更多 | 积极 | 2023-10-15 | ||
Placebo | 築繭鹹繭憲艱顧範衊遞(鑰蓋蓋餘鏇構願構淵夢) = 選簾鬱鏇淵獵餘餘夢範 選廠顧襯廠襯襯顧膚窪 (構築夢糧範憲艱餘憲廠 ) 更多 | ||||||
临床2期 | 活动性中度溃疡性结肠炎 TL1A | 135 | 製觸範網壓觸憲鬱糧鏇(艱遞夢觸糧餘築夢壓窪) = 積廠衊淵獵範簾餘繭齋 繭遞鬱願鏇築製範鏇鑰 (觸鹽憲餘顧製製壓餘膚 ) 更多 | 积极 | 2023-10-15 | ||
Placebo | 製觸範網壓觸憲鬱糧鏇(艱遞夢觸糧餘築夢壓窪) = 艱簾遞夢醖積齋窪繭襯 繭遞鬱願鏇築製範鏇鑰 (觸鹽憲餘顧製製壓餘膚 ) 更多 |
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