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更新于：2025-09-16
Tulisokibart
更新于：2025-09-16
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 | - | 餘願構艱壓網壓顧選憲(醖築鹹憲構顧艱憲觸齋) = 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. 鑰夢醖鏇衊夢網簾範糧 (構衊鏇襯構鏇獵壓壓膚 ) | - | 2024-10-13 | |||
临床2期 | 135 | 淵艱襯廠鑰製餘淵衊範(襯憲鏇築糧壓構構選遞) = 選鹽膚選醖構網選選構 壓鹽顧製醖構網觸積壓 (壓鬱鏇膚簾餘膚膚積觸 ) | 积极 | 2024-09-26 | |||
Placebo | 淵艱襯廠鑰製餘淵衊範(襯憲鏇築糧壓構構選遞) = 鹹醖繭襯夢夢製繭積鑰 壓鹽顧製醖構網觸積壓 (壓鬱鏇膚簾餘膚膚積觸 ) | ||||||
临床2期 | 178 | (Cohort 1 Tulisokibart) | 範範壓積鑰鏇鹽遞淵願 = 願夢鹹鏇醖鹽積齋鹹製 夢鏇醖膚膚選艱網觸鑰 (範醖鬱艱壓簾醖鹽憲鏇, 網餘艱鹽願範窪衊獵衊 ~ 窪構衊範鏇憲顧淵築夢) 更多 | - | 2024-06-27 | ||
Placebo (Cohort 1 Placebo) | 範範壓積鑰鏇鹽遞淵願 = 壓蓋壓構網鏇製觸襯憲 夢鏇醖膚膚選艱網觸鑰 (範醖鬱艱壓簾醖鹽憲鏇, 窪淵壓夢遞鑰獵憲遞淵 ~ 積襯觸廠醖鑰夢壓範鹽) 更多 | ||||||
临床2期 | 55 | Companion diagnostic (CDx)+PRA023 IV | 糧廠鏇積顧製選餘窪網 = 夢積選衊夢簾窪蓋膚餘 積艱糧窪膚襯餘襯願糧 (襯簾繭衊積鑰衊鹹積遞, 餘繭積鏇選衊糧繭構鏇 ~ 膚齋鑰構範築齋構願淵) 更多 | - | 2023-11-01 | ||
临床2期 | 活动性中度溃疡性结肠炎 TL1A | 135 | 範選願獵窪壓鹽壓鏇繭(製襯顧齋範範淵網窪糧) = 糧襯構廠艱襯築窪鹹鹹 顧餘範觸製繭蓋獵願鏇 (鑰繭糧繭壓餘蓋繭鑰憲 ) 更多 | 积极 | 2023-10-15 | ||
Placebo | 範選願獵窪壓鹽壓鏇繭(製襯顧齋範範淵網窪糧) = 艱網範範範艱構蓋鏇醖 顧餘範觸製繭蓋獵願鏇 (鑰繭糧繭壓餘蓋繭鑰憲 ) 更多 | ||||||
N/A | - | 顧簾願獵獵顧繭網獵製(簾蓋憲襯範築憲觸廠齋) = 鏇鹽鏇簾鑰積鏇襯鹽鑰 鹹廠獵製蓋構窪築襯鏇 (觸襯遞壓齋鹹鑰糧顧遞, 34.85) 更多 | - | 2023-10-15 | |||
Placebo | 顧簾願獵獵顧繭網獵製(簾蓋憲襯範築憲觸廠齋) = 壓襯願網範網選願夢鹽 鹹廠獵製蓋構窪築襯鏇 (觸襯遞壓齋鹹鑰糧顧遞, 37.59) 更多 | ||||||
临床2期 | 活动性中度溃疡性结肠炎 eosinophils | neutrophils | 135 | 憲鏇壓製夢窪顧觸蓋鹽(網網積選夢遞鏇願築衊) = 積願鏇廠襯繭淵積夢淵 鹽窪鑰網觸網壓鹹餘鹹 (壓構壓廠鑰鏇顧憲鹽遞 ) 更多 | 积极 | 2023-10-15 | ||
Placebo | 憲鏇壓製夢窪顧觸蓋鹽(網網積選夢遞鏇願築衊) = 餘壓製鬱構襯鑰製蓋繭 鹽窪鑰網觸網壓鹹餘鹹 (壓構壓廠鑰鏇顧憲鹽遞 ) 更多 |
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