预约演示
更新于：2026-02-27
Fasinumab
更新于：2026-02-27
概要
基本信息
在研机构- |
最高研发阶段终止临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评快速通道 (美国)、儿科研究计划 (欧盟) |
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结构/序列
Sequence Code 13007045H
来源: *****
Sequence Code 13007544L
来源: *****
关联
19
项与 Fasinumab 相关的临床试验NCT03949673
Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
NCT03491904
A Phase 1, Multicenter, Randomized, Open-Label, Parallel-Group, Multi-Dose Study in Patients With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee or Hip to Assess the Patients' Ability to Self-Administer Fasinumab Using an Auto-Injector and to Characterize the Pharmacokinetics of Fasinumab Using Two Different Presentations
EUCTR2018-001411-71-GB
Study to Evaluate Synovial Fluid in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip
100 项与 Fasinumab 相关的临床结果
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100 项与 Fasinumab 相关的转化医学
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100 项与 Fasinumab 相关的专利（医药）
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25
项与 Fasinumab 相关的文献（医药）2026-03-01Osteoarthritis and cartilage open
Identification of alkaline phosphatase as a putative biomarker of anti-NGF treatment-associated arthropathies: Machine learning-assisted analyses of clinical trial data
Article
作者: Hamon, Sara C ; Musser, Bret J ; Patel, Yamini ; Wipperman, Matthew F ; Manvelian, Garen ; Eng, Simon ; Gao, Haitao ; Ho, Tina ; Hamilton, Jennifer D ; McIntyre, Debra A G ; Li, Dateng ; Hectors, Stefanie ; Geba, Gregory P ; Banerjee, Poulabi ; Ushirogawa, Yoshiteru ; DiMartino, Stephen J ; Ota, Kristie T ; Chio, Erica ; Wei, Henry G ; Ogawa, Kei ; Wang, Chen Guang ; Ehmann, Peter J
Objective:
Nerve growth factor (NGF) inhibitors have been shown to provide pain relief in patients with osteoarthritis but are associated with adjudicated arthropathies (AAs). Exploratory analyses were performed to identify whether peripheral biomarkers routinely collected in trials can predict AAs, independent of known clinical covariates.
Methods:
Clinical and biomarker data from seven phase 2/3 fasinumab trials were pooled, and 33 laboratory baseline and week 16 change variables were assessed. Individuals with AA were identified and propensity score matched 1:1 to non-AA controls, creating four unique sets of non-AA individuals. Random forest machine learning models were used. Variables with >30 % missing data were excluded. The training/validation set included 75 % of the available dataset; 10 % formed the working validation test set, and 15 % a held-back test set. Area under the curve of the receiving operating characteristic (AUROC) and ranked feature importance were assessed across models using peripheral biomarkers to predict AA vs non-AA individuals.
Results:
Of the final dataset (n = 11,490), 911 AA individuals were compared with four unique sets of non-AA individuals (n = 878-908). The AUROC was 0.51-0.57 for biomarkers at baseline and 0.54-0.62 for biomarker changes at week 16. Change in alkaline phosphatase (ALP) from baseline to week 16 was the only important variable identified consistently across models. ALP was also elevated by several points on average in individuals receiving fasinumab.
Conclusion:
Change in ALP (baseline to week 16) was associated with AA events after treatment with fasinumab. Other measured peripheral biomarkers were not linked with AA events.
2026-01-01RMD Open
A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip
Article
作者: Eng, Simon ; Manvelian, Garen ; Magyar, Andrew ; Patel, Yamini ; Trinh, Ngan ; Ho, Tina ; Geba, Gregory P ; Pervin, Kauser ; Braunstein, Ned ; Cicirello, Helen ; Dakin, Paula ; Fetell, Michael ; DiMartino, Stephen J
Background:
Chronic pain due to osteoarthritis (OA) causes considerable burden, and current treatment options are limited. This phase III study aimed to compare the efficacy and safety of fasinumab, an investigational, anti-nerve growth factor monoclonal antibody, with placebo and naproxen in patients with moderate-to-severe pain due to OA of the knee or hip.
Methods:
Patients with difficult-to-treat OA were randomised 3:3:3:1 to fasinumab 1 mg subcutaneous (SC) every 4 weeks (Q4W), fasinumab 1 mg SC every 8 weeks (Q8W), naproxen 500 mg orally two times a day or placebo. The co-primary endpoints were changes in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain and physical function subscale scores (0–10) from baseline to week 16 for fasinumab versus placebo; comparison with naproxen was a secondary endpoint. Safety was also assessed.
Results:
Of 3307 patients randomised, 1801 were included in the analysis for efficacy, and 3014 were included in the safety analysis. Statistically significantly greater reductions in the WOMAC pain and physical function scores, respectively, at week 16 were seen for fasinumab 1 mg Q4W (–2.90 and –2.78) compared with placebo (–2.32 and –2.10) and naproxen (−2.61 and –2.41); all p<0.005. Adjudicated arthropathies (AAs) and joint replacements occurred in all treatment groups, but were higher in the fasinumab 1 mg Q8W and 1 mg Q4W groups than in the placebo and naproxen groups. Patients with AAs: 7.2%, 9.7%, 1.1% and 2.6%, respectively; patients with joint replacements: 5.6%, 6.4%, 3.4% and 3.1%, respectively. Of the AAs in the fasinumab arms, 95.0% and 75.5% were rapid-progressive OA type 1 in the 1 mg Q8W and 1 mg Q4W arms, respectively. No new safety concerns were identified.
Conclusion:
In a difficult-to-treat population with OA, fasinumab 1 mg Q4W achieved clinically meaningful improvements by week 16 versus placebo and naproxen. The safety profile was similar to that previously observed for fasinumab.
Trial registration number:
NCT03161093
.
2025-01-01CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL
The Effects of Fasinumab on Peripheral Nerve Function and Ganglion Anatomy: Results From a Randomized, Double-Blind, Placebo-Controlled Study in Patients With Pain Due to Osteoarthritis of the Knee or Hip, and a Series of Nonclinical Studies
Article
作者: Krueger, Pamela ; Manvelian, Garen ; Macdonald, Lynn E ; Patel, Yamini ; Gao, Haitao ; Turner, Kenneth C ; Trinh, Ngan ; Braunstein, Ned ; Fetell, Michael ; Hassan, Hazem E ; Ho, Tina ; Geba, Gregory P ; Mei, Jingning ; Croll, Susan D ; Soltys, Randy ; Cortes-Burgos, Luz ; Eng, Simon ; Trejos, Jesus ; Dakin, Paula ; DiMartino, Stephen
Purpose:
Osteoarthritis (OA) is a chronic disease where breakdown and loss of cartilage leads to pain, primarily in the joints. Nerve growth factor inhibitors (eg, fasinumab) can reduce pain, but have been associated with nervous system adverse events (AEs). Here we describe the results of a Phase 2, randomized, double-blind, placebo-controlled study and a series of nonclinical analyses investigating the effects of fasinumab on peripheral nerve function and ganglion anatomy.
Methods:
In the Phase 2 study, 180 adults with knee or hip OA and moderate-to-severe pain inadequately controlled with analgesics, who could not tolerate/were unwilling to take opioids, received subcutaneous fasinumab 1 mg every 4 weeks or placebo for 12 weeks. The primary endpoint was change from baseline to Week 16 in conduction velocity and amplitude for the peroneal, sural, and ulnar nerves. Secondary endpoints included peripheral sensory events. The nonclinical analyses involved adult and developing Sprague-Dawley rats and developing cynomolgus monkeys; endpoints included baseline and isoproterenol‑induced hemodynamic parameters, dorsal root ganglia (DRG) and superior cervical ganglia (SCG) volumes, neuron volumes and counts, and volumes and counts of specific neural subsets.
Findings:
In the Phase 2 study, nerve conduction velocities and action potential amplitudes between baseline and Week 16 were generally within normal ranges. There were no compelling differences in nerve conduction tests between fasinumab- and placebo-treated patients. Incidences of AEs, including peripheral sensory AEs, were similar between fasinumab and placebo. In the nonclinical analyses, neither hemodynamic parameters nor DRG and SCG stereological parameters were statistically significantly different between fasinumab-treated and isotype control antibody-treated rats.
Implications:
No clinically meaningful differences were observed between fasinumab- and placebo-treated patients for nerve conduction velocities and action potential amplitudes. In the nonclinical studies, no significant changes could be detected in adult rat ganglion anatomical parameters or hemodynamic parameters at a variety of fasinumab doses. Results from these studies demonstrated that fasinumab did not affect the tested nervous system parameters in adult humans or rats.Trial registration number: NCT02447276; https://clinicaltrials.gov/study/NCT02447276.
100 项与 Fasinumab 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 |
|---|---|---|---|---|
| 髋关节炎 | 临床3期 | 意大利 | 2016-04-15 | |
| 膝关节炎 | 临床3期 | 意大利 | 2016-04-15 | |
| 骨关节炎 | 临床3期 | 保加利亚 | 2016-02-17 | |
| 骨关节炎 | 临床3期 | 智利 | 2016-02-17 | |
| 骨关节炎 | 临床3期 | 哥伦比亚 | 2016-02-17 | |
| 骨关节炎 | 临床3期 | 爱沙尼亚 | 2016-02-17 | |
| 骨关节炎 | 临床3期 | 中国香港 | 2016-02-17 | |
| 骨关节炎 | 临床3期 | 墨西哥 | 2016-02-17 | |
| 骨关节炎 | 临床3期 | 秘鲁 | 2016-02-17 | |
| 疼痛 | 临床3期 | 保加利亚 | 2016-02-17 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 1,801 | 壓觸製衊觸憲遞襯艱壓(築膚憲觸築網鑰鹽構壓) = 齋築選餘廠蓋艱膚衊艱 廠醖齋鏇餘觸齋製網獵 (夢窪選糧襯糧壓鑰蓋顧 ) 更多 | 积极 | 2026-01-01 | |||
壓觸製衊觸憲遞襯艱壓(築膚憲觸築網鑰鹽構壓) = 鏇願獵積選膚積膚糧衊 廠醖齋鏇餘觸齋製網獵 (夢窪選糧襯糧壓鑰蓋顧 ) 更多 | |||||||
临床3期 | 5,331 | Placebo+Fasinumab (Fasinumab-matching Placebo Q4W/Q8W) | 鏇選壓醖鑰夢鬱鏇襯積 = 範獵鏇製範餘網繭顧積 醖觸選鬱鏇網鏇願膚鑰 (憲襯餘夢壓夢蓋遞糧繭, 鹽憲襯鏇顧鬱衊衊鏇窪 ~ 壓範醖餘窪夢夢鹽築觸) 更多 | - | 2023-10-13 | ||
(Fasinumab 1 mg SC Q8W) | 鏇選壓醖鑰夢鬱鏇襯積 = 遞廠壓憲膚遞襯鬱觸膚 醖觸選鬱鏇網鏇願膚鑰 (憲襯餘夢壓夢蓋遞糧繭, 艱憲憲廠窪醖襯鹽築壓 ~ 鹽壓築網襯觸選襯選網) 更多 | ||||||
临床2期 | 180 | Placebo | 憲積艱淵製製網淵網願 = 蓋鹹鹽齋齋積鏇鏇衊窪 觸鑰鏇齋鹹製膚遞顧壓 (積鬱蓋網衊壓憲鹽淵艱, 鬱獵觸願製遞簾鹽廠簾 ~ 選觸遞鑰膚齋顧簾鑰襯) | - | 2023-03-01 | ||
临床3期 | 1,650 | placebo+Fasinumab (Placebo) | 膚壓積餘膚簾糧繭簾蓋(艱鏇觸觸範窪齋願膚壓) = 鹹憲膚鹹齋衊糧鹽壓鬱 築簾製齋獵衊鏇鹹糧積 (製製糧網鬱襯餘衊製積, 0.165) 更多 | - | 2023-02-24 | ||
(Fasinumab 1 mg) | 膚壓積餘膚簾糧繭簾蓋(艱鏇觸觸範窪齋願膚壓) = 觸選壓構觸選淵蓋醖鬱 築簾製齋獵衊鏇鹹糧積 (製製糧網鬱襯餘衊製積, 0.127) 更多 | ||||||
临床3期 | 63 | Placebo+Fasinumab (Fasinumab-matching Placebo) | 膚鑰獵築願鬱積構鏇網(艱醖糧齋遞鹹醖構鑰築) = 構製選廠獵襯糧衊壓範 鬱積網淵構淵衊蓋夢廠 (夢窪憲繭簾繭憲遞繭獵, 1.424) 更多 | - | 2021-06-30 | ||
(Fasinumab 3 mg SC Q4W) | 膚鑰獵築願鬱積構鏇網(艱醖糧齋遞鹹醖構鑰築) = 壓觸窪範襯齋繭窪蓋醖 鬱積網淵構淵衊蓋夢廠 (夢窪憲繭簾繭憲遞繭獵, 2.037) 更多 | ||||||
临床2/3期 | - | 築鬱襯鬱淵顧窪顧壓憲(夢廠觸築網鏇積夢衊壓) = 鬱膚觸遞廠簾淵襯獵繭 襯獵範窪鹹醖憲製淵襯 (蓋遞蓋選遞餘壓鏇壓齋 ) | 积极 | 2020-11-16 | |||
Placebo | 網襯蓋築範鬱製憲鹽夢(鑰壓繭淵製餘鑰築壓艱) = 遞觸衊齋糧衊廠鹹製襯 觸憲襯簾夢糧獵網繭網 (範願襯壓壓壓窪鑰製鏇, 0.3) 更多 | ||||||
临床2/3期 | 563 | placebo (Placebo SC Q4W and Placebo IV Q8W) | 選淵簾齋艱廠遞範糧窪(夢積範簾廠淵齋餘顧願) = 鏇壓壓廠窪夢餘廠淵簾 壓網鏇鹹壓獵淵積鹽顧 (構鏇餘鬱襯窪膚糧獵壓, 0.23) 更多 | - | 2019-08-01 | ||
placebo+Fasinumab (Fasinumab 6 mg SC Q4W and Placebo IV Q8W) | 選淵簾齋艱廠遞範糧窪(夢積範簾廠淵齋餘顧願) = 獵憲選範鑰艱鬱顧淵願 壓網鏇鹹壓獵淵積鹽顧 (構鏇餘鬱襯窪膚糧獵壓, 0.23) 更多 |
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