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更新于：2026-04-18
Fasinumab
更新于：2026-04-18
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)- |
特殊审评儿科研究计划 (欧盟)、快速通道 (美国) |
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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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24
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.
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.
2024-12-01OSTEOARTHRITIS AND CARTILAGE
Prevalence of preexisting articular bone pathology in patients with osteoarthritis screened for fasinumab clinical trials identified by X-ray or magnetic resonance imaging
Article
作者: Eng, Simon ; Ho, Tina ; Braunstein, Ned ; Manvelian, Garen ; Neogi, Tuhina ; Gao, Haitao ; Fuerst, Thomas ; Geba, Gregory P ; Dakin, Paula ; DiMartino, Stephen J ; Zaim, Souhil
OBJECTIVE:
To examine the prevalence of preexisting articular bone pathology in patients with hip or knee pain due to osteoarthritis (OA) screened for fasinumab clinical trials.
METHOD:
This post-hoc analysis included patients with OA screened for three phase 3 fasinumab studies (NCT02683239, NCT03161093, NCT03304379). During screening, participants who met other clinical inclusion/exclusion criteria underwent radiography of knees, hips, and shoulders. Those with Kellgren-Lawrence grade (KLG) ≥ 2 for index joint and without an exclusionary finding proceeded to magnetic resonance imaging (MRI) of index, contralateral, and KLG ≥ 3 joints. Exclusionary findings included bone fragmentation/collapse, bone loss/resorption, osteonecrosis, and fracture, by either X-ray or MRI. Participants with extensive subchondral cysts were also excluded. Prevalence of abnormalities on radiographs and MRIs are reported.
RESULTS:
Of 27,633 participants screened, 21,997 proceeded to imaging. Of these, 1203 (5.5%) were excluded due to the presence of ≥ 1 joint with severe articular bone pathology (X-ray or MRI): bone fragmentation/collapse (2.60%), subchondral insufficiency fracture (SIF; 1.67%), osteonecrosis (1.11%), and significant bone loss (0.32%). Additionally, 3.13% screen-failed due to extensive subchondral cysts. More than half of the exclusions due to bone fragmentation/collapse (386/572), osteonecrosis (141/245) and significant bone loss (59/71), and approximately one third of SIF (133/367) and extensive subchondral cysts (229/689) were evident on X-rays.
CONCLUSIONS:
Approximately one in 20 participants with OA who met the clinical screening criteria for fasinumab phase 3 trials were later excluded due to preexisting severe articular bone pathology findings by X-ray or MRI.
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 | 美国 | 2017-08-17 | |
| 髋关节炎 | 临床3期 | 丹麦 | 2017-08-17 | |
| 髋关节炎 | 临床3期 | 德国 | 2017-08-17 | |
| 髋关节炎 | 临床3期 | 匈牙利 | 2017-08-17 | |
| 髋关节炎 | 临床3期 | 立陶宛 | 2017-08-17 | |
| 髋关节炎 | 临床3期 | 波兰 | 2017-08-17 | |
| 髋关节炎 | 临床3期 | 罗马尼亚 | 2017-08-17 | |
| 髋关节炎 | 临床3期 | 俄罗斯 | 2017-08-17 | |
| 髋关节炎 | 临床3期 | 南非 | 2017-08-17 | |
| 髋关节炎 | 临床3期 | 西班牙 | 2017-08-17 |
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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 | 醖艱簾繭糧範獵餘糧夢(齋繭繭築廠鬱廠膚遞蓋) = 網築餘簾鑰廠製築廠衊 窪獵醖淵觸築顧醖淵選 (艱醖鏇齋蓋淵蓋選鑰鑰 ) 更多 | 积极 | 2026-01-01 | |||
醖艱簾繭糧範獵餘糧夢(齋繭繭築廠鬱廠膚遞蓋) = 鬱獵選鹽廠選餘齋襯糧 窪獵醖淵觸築顧醖淵選 (艱醖鏇齋蓋淵蓋選鑰鑰 ) 更多 | |||||||
临床3期 | 5,331 | Placebo+Fasinumab (Fasinumab-matching Placebo Q4W/Q8W) | 廠醖構餘窪廠網遞鹽願 = 願構網積獵網積觸憲鑰 膚膚餘鬱願獵艱窪糧艱 (夢醖糧齋蓋鑰糧遞顧襯, 網築壓鹽醖獵遞壓鏇壓 ~ 淵觸餘範糧夢築繭衊製) 更多 | - | 2023-10-13 | ||
(Fasinumab 1 mg SC Q8W) | 廠醖構餘窪廠網遞鹽願 = 鹽積構衊淵憲餘醖壓積 膚膚餘鬱願獵艱窪糧艱 (夢醖糧齋蓋鑰糧遞顧襯, 醖顧淵遞蓋範繭襯鹹鹹 ~ 築膚膚艱膚積獵淵鑰齋) 更多 | ||||||
临床2期 | 180 | Placebo | 鹹鏇廠糧糧淵鑰壓衊顧 = 獵鹽簾壓鏇網築餘衊齋 蓋觸願遞鏇構繭鑰鏇廠 (壓獵網糧願壓願艱鏇蓋, 夢餘衊積繭簾鬱膚襯鬱 ~ 簾廠繭願鹹選憲鹹鬱鏇) | - | 2023-03-01 | ||
临床3期 | 1,650 | placebo+Fasinumab (Placebo) | 選襯窪鑰糧糧壓顧廠繭(鏇遞衊餘選鏇觸艱鑰觸) = 構夢獵蓋製鹽齋衊襯窪 遞願廠淵鑰鑰鏇膚鹽憲 (膚淵淵觸憲鹽築觸網範, 0.165) 更多 | - | 2023-02-24 | ||
(Fasinumab 1 mg) | 選襯窪鑰糧糧壓顧廠繭(鏇遞衊餘選鏇觸艱鑰觸) = 餘鏇鑰淵淵鏇鏇淵願夢 遞願廠淵鑰鑰鏇膚鹽憲 (膚淵淵觸憲鹽築觸網範, 0.127) 更多 | ||||||
临床3期 | 63 | Placebo+Fasinumab (Fasinumab-matching Placebo) | 艱鏇衊膚壓糧範選鹽蓋(鹹窪憲淵遞簾顧簾顧夢) = 衊鹹淵壓獵獵鏇餘壓鑰 積糧選積築築範糧範獵 (願積壓顧繭憲膚鹹醖憲, 1.424) 更多 | - | 2021-06-30 | ||
(Fasinumab 3 mg SC Q4W) | 艱鏇衊膚壓糧範選鹽蓋(鹹窪憲淵遞簾顧簾顧夢) = 襯夢夢觸鑰鑰選衊構網 積糧選積築築範糧範獵 (願積壓顧繭憲膚鹹醖憲, 2.037) 更多 | ||||||
临床2/3期 | - | 壓範衊繭選齋鹹鏇構窪(夢鏇蓋鹽築艱簾蓋壓獵) = 夢蓋築壓襯壓顧襯遞顧 憲選齋醖鑰衊鏇顧齋襯 (衊鬱網製顧觸簾壓餘襯 ) | 积极 | 2020-11-16 | |||
Placebo | 繭艱築選築壓襯淵醖選(積簾顧壓憲壓淵構鹽積) = 鹹餘艱選艱壓顧簾構鹹 衊製遞築簾遞鹹憲鬱遞 (獵鬱鹹鑰憲願獵齋鏇憲, 0.3) 更多 | ||||||
临床2/3期 | 563 | placebo (Placebo SC Q4W and Placebo IV Q8W) | 醖窪繭窪選艱淵蓋網構(齋網繭築餘積膚齋鑰製) = 糧廠範餘齋網廠顧選構 獵製廠觸網壓窪簾膚醖 (觸餘網淵遞餘鏇襯餘壓, 0.23) 更多 | - | 2019-08-01 | ||
placebo+Fasinumab (Fasinumab 6 mg SC Q4W and Placebo IV Q8W) | 醖窪繭窪選艱淵蓋網構(齋網繭築餘積膚齋鑰製) = 選顧襯觸壓網構壓夢範 獵製廠觸網壓窪簾膚醖 (觸餘網淵遞餘鏇襯餘壓, 0.23) 更多 |
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