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更新于：2026-03-16
Afimkibart
更新于：2026-03-16
概要
基本信息
原研机构 |
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 1696250L
来源: *****
Sequence Code 9885619H
来源: *****
关联
22
项与 Afimkibart 相关的临床试验NCT07298421
A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2-17 Years With Moderately to Severely Active Crohn's Disease
NCT07158242
A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis
NCT07223697
An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials
100 项与 Afimkibart 相关的临床结果
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100 项与 Afimkibart 相关的转化医学
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100 项与 Afimkibart 相关的专利（医药）
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4
项与 Afimkibart 相关的文献（医药）2025-10-01The Lancet Gastroenterology & Hepatology
Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): a multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, phase 2b trial
Article
作者: Bojic, Daniela ; Chandra, Deepa E ; Jairath, Vipul ; D'Haens, Geert ; Hung, Kenneth E ; McBride, Jacqueline M ; Neelakantan, Srividya ; Schiffman, Courtney ; Banerjee, Anindita ; Leong, Rupert W ; Feagan, Brian G ; Peyrin-Biroulet, Laurent ; Allegretti, Jessica R ; Lasch, Karen ; Peeva, Elena ; Vincent, Michael S ; Schreiber, Stefan ; Yarur, Andres J ; Danese, Silvio ; Kierkuś, Jarosław
BACKGROUND:
TNF-like ligand 1A (TL1A) is an emerging therapeutic target for inflammatory bowel disease. We evaluated the safety and efficacy of multiple doses of afimkibart, a TL1A-directed antibody, in patients with moderately-to-severely active ulcerative colitis.
METHODS:
The multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, phase 2b, TUSCANY-2 trial was conducted at 114 centres in 23 countries across North America, Europe, Asia, Africa, Australia, and South America. Adults (aged 18-75 years) with moderately-to-severely active ulcerative colitis (total Mayo score [tMS] 6-12, endoscopic subscore ≥2) were randomly assigned (2:2:2:2:2:3:1:1:1) to one of nine treatment sequences to receive subcutaneous afimkibart 50 mg, 150 mg, 450 mg, or matched placebo every 4 weeks during the 12-week induction period, and subcutaneous afimkibart 50 mg, 150 mg, or 450 mg during the treat-through 40-week maintenance period. Investigators and patients were masked to treatment. Study drugs were administered by masked site personnel following preparation by an unmasked pharmacist at the investigational site. Efficacy was assessed at weeks 14 and 56 in the intent-to-treat populations. The primary efficacy endpoint of clinical remission at week 14 by tMS (defined as tMS ≤2, with no individual subscore >1) was assessed in those who received at least one dose of drug or placebo during induction, excluding patients who had missing data due to complications resulting from COVID-19. Safety endpoints were also analysed in those who were randomly assigned and received at least one dose of assigned treatment. This study is registered with ClinicalTrials.gov, NCT04090411.
FINDINGS:
Between Dec 19, 2019, and Oct 25, 2022, 246 patients were randomly assigned treatment, of whom 245 were treated, 228 completed induction, and 178 completed maintenance. Median age was 39 years (IQR 30·0-51·0), 99 (40%) patients were female and 146 (60%) were male; median disease duration was 4·7 years (IQR 2·5-10·2). At week 14, the primary endpoint of clinical remission by tMS was reported in 12 (26%) of 47 patients in the afimkibart 50 mg group (risk difference vs placebo [RD] 13·9% [90% CI -0·2 to 27·7]; p=0·0545), 14 (23%) of 60 patients in the afimkibart 150 mg group (RD 11·7% [-1·7 to 24·1]; p=0·0823), and 21 (24%) of 88 patients in the in the afimkibart 450 mg group (RD 12·2% [-0·6 to 22·9]; p=0·0642) versus five (12%) of 43 patients in the placebo group. In alignment with updated US Food and Drug Administration guidance, clinical remission using the modified Mayo score at week 14 was reported in 14 (30%) of 47 patients in the afimkibart 50 mg group (RD 18·2% [90% CI 3·3 to 32·2]), 21 (35%) of 60 patients in the in the afimkibart 150 mg group (RD 23·4% [6·2 to 36·3]), and 28 (32%) of 88 patients in the in the afimkibart 450 mg group (RD 20·2% [3·2 to 31·3]) versus five (12%) of 43 patients in the placebo group. Overall, 117 (48%) of 245 patients in the induction phase and 132 (59%) of 224 patients in the maintenance phase reported at least one treatment-emergent adverse event; incidences of treatment-emergent adverse events during induction were similar with placebo and afimkibart. The most common treatment-emergent adverse events (occurring in ≥5% of patients) during induction were nausea, urinary tract infection, ulcerative colitis, anaemia, fatigue, headache, and pyrexia. Six serious adverse events were reported during induction in the active treatment groups and four in the placebo group. Two patients who completed induction and did not receive the study drug during maintenance had serious adverse events during safety follow-up. During the maintenance period, 12 (5%) of 224 patients had 13 serious adverse events. No deaths occurred.
INTERPRETATION:
Differences in the primary endpoint of clinical remission by tMS were not significantly different for any dose of afimkibart compared with placebo. However, secondary endpoints suggest that afimkibart was associated with a favourable benefit-risk profile, with clinically meaningful improvements in clinical remission with the modified Mayo score for patients with moderately-to-severely active ulcerative colitis. These results support the continued development of afimkibart.
FUNDING:
Pfizer, Roivant Sciences, and F Hoffmann-La Roche.
2022-03-02Inflammatory bowel diseases2区 · 医学
Antitumor Necrosis Factor-like Ligand 1A Therapy Targets Tissue Inflammation and Fibrosis Pathways and Reduces Gut Pathobionts in Ulcerative Colitis
2区 · 医学
Article
作者: Ye, Zhan ; Zhang, Jenny ; Danese, Silvio ; Li, Xingpeng ; Hassan-Zahraee, Mina ; Hung, Kenneth E ; Chandra, Deepa E ; Quan, Jie ; Neelakantan, Srividya ; Hyde, Craig L ; Klopocka, Maria ; Raha, Nancy ; Romatowski, Jacek ; Scherl, Ellen J ; Ziemek, Daniel ; Baniecki, Mary Lynn ; Longman, Randy ; Allegretti, Jessica R ; Xi, Li ; Karlsson, Fridrik ; Vincent, Michael S ; Lepsy, Christopher ; Schoenbeck, Uwe
Abstract:
Background:
The first-in-class treatment PF-06480605 targets the tumor necrosis factor-like ligand 1A (TL1A) molecule in humans. Results from the phase 2a TUSCANY trial highlighted the safety and efficacy of PF-06480605 in ulcerative colitis. Preclinical and in vitro models have identified a role for TL1A in both innate and adaptive immune responses, but the mechanisms underlying the efficacy of anti-TL1A treatment in inflammatory bowel disease (IBD) are not known.
Methods:
Here, we provide analysis of tissue transcriptomic, peripheral blood proteomic, and fecal metagenomic data from the recently completed phase 2a TUSCANY trial and demonstrate endoscopic improvement post-treatment with PF-06480605 in participants with ulcerative colitis.
Results:
Our results revealed robust TL1A target engagement in colonic tissue and a distinct colonic transcriptional response reflecting a reduction in inflammatory T helper 17 cell, macrophage, and fibrosis pathways in patients with endoscopic improvement. Proteomic analysis of peripheral blood revealed a corresponding decrease in inflammatory T-cell cytokines. Finally, microbiome analysis showed significant changes in IBD-associated pathobionts, Streptococcus salivarius, S. parasanguinis, and Haemophilus parainfluenzae post-therapy.
Conclusions:
The ability of PF-06480605 to engage and inhibit colonic TL1A, targeting inflammatory T cell and fibrosis pathways, provides the first-in-human mechanistic data to guide anti-TL1A therapy for the treatment of IBD.
2021-11-01Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association1区 · 医学
Anti-TL1A Antibody PF-06480605 Safety and Efficacy for Ulcerative Colitis: A Phase 2a Single-Arm Study
1区 · 医学
Article
作者: Schoenbeck, Uwe ; Scherl, Ellen J ; Banfield, Christopher ; Li, Gang ; Vincent, Michael S ; Neelakantan, Srividya ; Ye, Zhan ; Chandra, Deepa E ; Peeva, Elena ; Rath, Natalie ; Hung, Kenneth E ; Klopocka, Maria ; Romatowski, Jacek ; Hassan-Zahraee, Mina ; Allegretti, Jessica R ; Danese, Silvio ; Lepsy, Christopher
BACKGROUND & AIMS:
An immune component of inflammatory bowel disease is up-regulated tumor necrosis factor-like ligand 1A (TL1A). Anti-TL1A antibodies such as PF-06480605, a fully human immunoglobulin G1 monoclonal antibody, may have therapeutic potential.
METHODS:
This Phase 2a, multicenter, single-arm, open-label study (TUSCANY) evaluated safety, tolerability, efficacy, pharmacokinetics, and immunogenicity in PF-06480605-treated participants with moderate to severe ulcerative colitis (UC). Participants received 500 mg intravenous PF-06480605 every 2 weeks, 7 doses total, with a 3-month follow-up period. Primary safety and efficacy endpoints were the incidence of adverse events (AEs) and week 14 endoscopic improvement (EI) (Mayo endoscopic subscore = 0 or 1), respectively. Secondary endpoints included total soluble TL1A (free/drug-bound) (sTL1A), incidence of anti-drug and neutralizing antibodies, PF-06480605 concentrations, and changes in fecal calprotectin and high-sensitivity C-reactive protein. Histology was assessed at week 14.
RESULTS:
The study enrolled 50 participants; 42 completed. Of 109 treatment-emergent AEs, 18 were treatment-related. The most common AEs were UC disease exacerbation and arthralgia (6 participants each). Four serious AEs, no deaths, and no malignancies were reported. Week 14 EI was observed in a statistically significant proportion of participants (38.2% [uniformly minimum-variance unbiased estimator, per protocol population]). Minimal histologic disease was observed after treatment (Robarts Histopathology Index ≤5: 33.3%; Geboes Index ≤3.2: 47.6%). sTL1A increase over time from baseline indicated sustained target engagement. Forty-one participants (82%) tested positive for anti-drug antibodies and 5 (10%) for neutralizing antibodies.
CONCLUSIONS:
PF-06480605 demonstrated an acceptable safety profile and statistically significant EI in participants with moderate to severe UC, warranting further study in a larger participant cohort. Tissue histopathology analyses support this conclusion.
TRIAL REGISTRATION NUMBER:
https://clinicaltrials.gov/NCT02840721.
100 项与 Afimkibart 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 |
|---|---|---|---|---|
| 小儿克罗恩病 | 临床3期 | - | 2026-05-29 | |
| 活动性中度克罗恩病 | 临床3期 | 加拿大 | 2025-03-26 | |
| 活动性中度克罗恩病 | 临床3期 | 塞尔维亚 | 2025-03-26 | |
| 活动性重度克罗恩病 | 临床3期 | 加拿大 | 2025-03-26 | |
| 活动性重度克罗恩病 | 临床3期 | 塞尔维亚 | 2025-03-26 | |
| 克罗恩病 | 临床3期 | 日本 | 2025-03-17 | |
| 克罗恩病 | 临床3期 | 丹麦 | 2025-03-17 | |
| 克罗恩病 | 临床3期 | 多米尼加共和国 | 2025-03-17 | |
| 克罗恩病 | 临床3期 | 危地马拉 | 2025-03-17 | |
| 克罗恩病 | 临床3期 | 墨西哥 | 2025-03-17 |
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临床结果
临床结果
适应症
分期
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临床2期 | 溃疡性结肠炎 诱导 | 维持 | 246 | 膚膚憲繭構範遞憲齋遞(積鬱衊積鬱憲築網膚壓) = 壓鏇鹹觸顧蓋鏇選觸鹹 襯範窪製夢簾淵願鏇鹽 (積鹽製餘衊艱觸獵淵顧 ) 更多 | 不佳 | 2025-10-01 | ||
膚膚憲繭構範遞憲齋遞(積鬱衊積鬱憲築網膚壓) = 憲衊範鏇選壓鏇簾顧鬱 襯範窪製夢簾淵願鏇鹽 (積鹽製餘衊艱觸獵淵顧 ) 更多 | |||||||
临床2期 | 245 | RO7790121 50mg | 糧壓製襯糧願艱選鏇製(糧願顧淵繭餘鏇構齋夢) = 繭蓋願齋鑰鹹衊鑰窪鹽 窪製遞鏇簾憲襯淵鹹窪 (鹹鏇衊遞淵醖齋簾鏇製, 28.3–53.5) 更多 | 积极 | 2024-10-13 | ||
RO7790121 150mg | 糧壓製襯糧願艱選鏇製(糧願顧淵繭餘鏇構齋夢) = 繭遞廠願鏇餘鹹積壓醖 窪製遞鏇簾憲襯淵鹹窪 (鹹鏇衊遞淵醖齋簾鏇製, 27.8–48.6) 更多 | ||||||
临床1期 | 12 | (PF-06480605 450mg) | 獵膚餘襯觸淵廠壓膚簾(鏇鏇鬱廠夢壓鏇艱膚壓) = 齋願醖醖積淵夢鏇醖鹹 夢構窪鏇構廠獵積鑰觸 (願構艱鏇繭鹹淵構築顧, 26) 更多 | - | 2024-03-21 | ||
placebo (Placebo) | 窪夢夢築糧膚襯顧膚蓋 = 鹽遞憲壓憲淵網壓繭醖 鬱鬱衊糧廠壓憲範築鹹 (構繭築鏇壓壓築衊鏇築, 窪製艱鬱顧壓網衊積獵 ~ 獵網觸簾窪廠繭膚築齋) 更多 | ||||||
临床2期 | - | 製顧鏇遞積製夢範願齋(淵憲遞膚餘觸鬱顧遞膚) = 網獵範範襯鹽壓廠鑰鏇 夢鑰願壓繭餘鏇壓膚遞 (醖襯範夢顧鬱觸蓋鑰醖 ) 更多 | 积极 | 2023-06-22 | |||
临床2期 | 45 | 鏇簾憲積夢繭餘鹹網淵(鏇壓膚顧獵餘夢醖廠鹽) = 簾選壓繭顧願製製簾築 願壓淵襯蓋糧憲鏇窪顧 (壓觸蓋糧願衊簾繭鹹鏇 ) | 积极 | 2020-10-28 | |||
临床2期 | 50 | 鹹鑰繭襯構鹹壓餘製顧 = 廠憲繭襯齋窪鬱鑰壓觸 蓋遞夢淵構鬱蓋鏇餘構 (蓋壓繭醖襯襯衊鏇願淵, 餘艱鏇夢鬱淵簾簾築淵 ~ 艱觸醖鏇廠獵艱齋艱醖) 更多 | - | 2019-06-19 |
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