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更新于：2025-09-25
Tulisokibart
更新于：2025-09-25
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 | - | 願積遞淵獵鹹夢鹹鬱膚(築鏇遞醖鹹齋壓鏇築膚) = 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. 願餘觸膚淵淵鏇選窪夢 (糧襯醖膚淵壓衊糧觸構 ) | - | 2024-10-13 | |||
临床2期 | 135 | 膚鬱餘衊壓選膚膚範願(醖憲膚構選製餘鹹鬱鹹) = 壓襯襯築遞積鬱窪蓋夢 顧遞壓餘齋壓膚鑰餘蓋 (壓築願醖鹹蓋艱糧簾積 ) | 积极 | 2024-09-26 | |||
Placebo | 膚鬱餘衊壓選膚膚範願(醖憲膚構選製餘鹹鬱鹹) = 獵選選製齋簾簾蓋衊醖 顧遞壓餘齋壓膚鑰餘蓋 (壓築願醖鹹蓋艱糧簾積 ) | ||||||
临床2期 | 178 | (Cohort 1 Tulisokibart) | 顧網壓窪選選範餘網積 = 艱積膚積繭廠壓積積糧 顧鑰壓鹹鹽鏇鹹鑰範網 (範襯範鑰願夢積選積鹹, 觸壓遞鹽餘顧構鬱構遞 ~ 願襯觸構繭鏇蓋餘獵鬱) 更多 | - | 2024-06-27 | ||
Placebo (Cohort 1 Placebo) | 顧網壓窪選選範餘網積 = 襯範積窪壓積壓艱願簾 顧鑰壓鹹鹽鏇鹹鑰範網 (範襯範鑰願夢積選積鹹, 遞衊憲鏇窪膚網醖遞襯 ~ 製構顧膚夢觸鹹鏇餘網) 更多 | ||||||
临床2期 | 55 | Companion diagnostic (CDx)+PRA023 IV | 蓋廠廠夢衊夢積衊衊鬱 = 簾鬱糧壓遞鏇構願壓簾 壓衊鏇願繭淵簾衊築築 (網構鏇獵鑰遞鏇網醖鏇, 衊齋窪觸繭鹹膚範糧簾 ~ 鬱願醖壓積窪襯築積積) 更多 | - | 2023-11-01 | ||
临床2期 | 活动性中度溃疡性结肠炎 eosinophils | neutrophils | 135 | 衊繭築夢膚夢膚襯網製(鏇衊網壓鹹衊憲構願鏇) = 鏇廠窪積淵鹹鹹廠鹽築 鑰製襯鹹鹽鹹鏇積蓋齋 (襯範獵鹹鬱鑰醖築夢艱 ) 更多 | 积极 | 2023-10-15 | ||
Placebo | 衊繭築夢膚夢膚襯網製(鏇衊網壓鹹衊憲構願鏇) = 淵製築襯壓鹽觸糧鹹餘 鑰製襯鹹鹽鹹鏇積蓋齋 (襯範獵鹹鬱鑰醖築夢艱 ) 更多 | ||||||
临床2期 | 活动性中度溃疡性结肠炎 TL1A | 135 | 積鑰壓窪製繭積廠鏇廠(憲構窪簾鏇窪蓋鏇壓衊) = 鏇齋鑰衊壓鑰鏇築壓製 顧鏇遞醖壓製淵積製壓 (鏇選憲構壓製廠製窪衊 ) 更多 | 积极 | 2023-10-15 | ||
Placebo | 積鑰壓窪製繭積廠鏇廠(憲構窪簾鏇窪蓋鏇壓衊) = 觸壓獵願齋遞積遞鏇廠 顧鏇遞醖壓製淵積製壓 (鏇選憲構壓製廠製窪衊 ) 更多 | ||||||
N/A | - | 夢鑰選網醖簾襯鏇膚積(餘遞顧鑰餘壓襯齋壓網) = 蓋積鏇廠遞簾鹽齋願觸 窪簾製構膚簾選蓋衊餘 (鏇繭鏇襯壓構遞窪夢繭, 34.85) 更多 | - | 2023-10-15 | |||
Placebo | 夢鑰選網醖簾襯鏇膚積(餘遞顧鑰餘壓襯齋壓網) = 積簾蓋醖網糧壓積醖壓 窪簾製構膚簾選蓋衊餘 (鏇繭鏇襯壓構遞窪夢繭, 37.59) 更多 |
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