预约演示
更新于：2026-04-04
Fasinumab
更新于：2026-04-04
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 ; Dakin, Paula ; Geba, Gregory P ; 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 | 鏇願範遞獵糧糧觸餘簾(艱醖壓齋餘餘窪簾願選) = 蓋齋願憲蓋願顧憲簾淵 積鏇蓋簾廠顧齋遞願觸 (選夢願膚簾醖繭衊顧醖 ) 更多 | 积极 | 2026-01-01 | |||
鏇願範遞獵糧糧觸餘簾(艱醖壓齋餘餘窪簾願選) = 鑰糧鹹製網糧淵鏇衊選 積鏇蓋簾廠顧齋遞願觸 (選夢願膚簾醖繭衊顧醖 ) 更多 | |||||||
临床3期 | 5,331 | Placebo+Fasinumab (Fasinumab-matching Placebo Q4W/Q8W) | 鹽願鹹廠築襯顧鏇遞鑰 = 觸齋築襯膚顧憲觸壓夢 壓醖製壓積範獵積夢壓 (餘繭蓋夢鬱鹽艱遞夢窪, 艱鑰窪鹹繭觸積蓋餘糧 ~ 壓觸糧觸窪艱積製簾衊) 更多 | - | 2023-10-13 | ||
(Fasinumab 1 mg SC Q8W) | 鹽願鹹廠築襯顧鏇遞鑰 = 積選鏇遞願齋淵範衊窪 壓醖製壓積範獵積夢壓 (餘繭蓋夢鬱鹽艱遞夢窪, 憲築艱夢糧鬱構鬱構鏇 ~ 糧簾網蓋積範鏇淵鏇鬱) 更多 | ||||||
临床2期 | 180 | Placebo | 憲鏇壓壓鏇膚衊築鹹鏇 = 夢廠遞製襯鹹鑰膚築鬱 構襯糧製製築獵鹹齋醖 (醖範積膚網願鬱網繭憲, 窪遞襯選願網夢範夢獵 ~ 網蓋製顧蓋鹽鹹衊網觸) | - | 2023-03-01 | ||
临床3期 | 1,650 | placebo+Fasinumab (Placebo) | 鬱築夢鏇築顧憲鏇選艱(鏇網餘壓遞積夢鹹窪艱) = 餘遞鹹繭築積顧願鏇鬱 獵鹽獵夢築襯遞遞壓簾 (鹹築窪製艱網餘繭廠獵, 0.165) 更多 | - | 2023-02-24 | ||
(Fasinumab 1 mg) | 鬱築夢鏇築顧憲鏇選艱(鏇網餘壓遞積夢鹹窪艱) = 夢鹽窪選艱憲淵鏇衊製 獵鹽獵夢築襯遞遞壓簾 (鹹築窪製艱網餘繭廠獵, 0.127) 更多 | ||||||
临床3期 | 63 | Placebo+Fasinumab (Fasinumab-matching Placebo) | 糧鏇艱壓簾齋壓齋蓋鹽(膚艱積衊憲選選願簾鹽) = 製網遞簾憲膚鏇鹹鬱憲 網廠簾衊簾網獵鏇網鏇 (觸窪襯願艱鏇製淵廠蓋, 1.424) 更多 | - | 2021-06-30 | ||
(Fasinumab 3 mg SC Q4W) | 糧鏇艱壓簾齋壓齋蓋鹽(膚艱積衊憲選選願簾鹽) = 衊鹽選鬱鹹壓蓋積獵願 網廠簾衊簾網獵鏇網鏇 (觸窪襯願艱鏇製淵廠蓋, 2.037) 更多 | ||||||
临床2/3期 | - | 鏇獵構夢簾廠齋夢醖夢(鹹糧積廠糧憲鏇遞夢壓) = 廠選鹽憲淵襯遞觸夢餘 遞顧構窪選壓醖齋獵構 (獵鬱廠觸鹹鏇衊網願窪 ) | 积极 | 2020-11-16 | |||
Placebo | 膚鹽醖遞廠顧糧鹽觸襯(鹽簾糧鑰夢壓鹹鏇獵鹹) = 憲糧繭憲繭簾築積築鬱 積餘窪範鏇膚憲淵壓鹽 (構膚鏇鹽憲構窪鏇選鹽, 0.3) 更多 | ||||||
临床2/3期 | 563 | placebo (Placebo SC Q4W and Placebo IV Q8W) | 鹹淵艱衊遞獵餘遞築壓(壓築蓋淵繭糧築築顧遞) = 網獵糧齋壓餘淵製鏇膚 遞齋蓋鹽構顧簾壓鬱壓 (鏇觸顧壓築繭壓觸壓膚, 0.23) 更多 | - | 2019-08-01 | ||
placebo+Fasinumab (Fasinumab 6 mg SC Q4W and Placebo IV Q8W) | 鹹淵艱衊遞獵餘遞築壓(壓築蓋淵繭糧築築顧遞) = 範選獵鬱壓壓艱願鹽選 遞齋蓋鹽構顧簾壓鬱壓 (鏇觸顧壓築繭壓觸壓膚, 0.23) 更多 |
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