A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients with Pain due to Osteoarthritis of the Knee

开始日期2019-09-05

申办/合作机构

Regeneron Pharmaceuticals, Inc.

NCT03956550 / Terminated临床2期

A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy.
The secondary objectives of the study are:
To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations

开始日期2019-05-21

申办/合作机构

Regeneron Pharmaceuticals, Inc.

NCT03645746 / Completed临床1期

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN5069 in Healthy Volunteers

The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants.
The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069

开始日期2018-08-23

申办/合作机构

Regeneron Pharmaceuticals, Inc.

100 项与 Nadecnemab 相关的临床结果

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100 项与 Nadecnemab 相关的转化医学

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100 项与 Nadecnemab 相关的专利（医药）

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项与 Nadecnemab 相关的文献（医药）

2023-08-01·Neurobiology of Pain

Monoclonal antibodies against GFRα3 are efficacious against evoked hyperalgesic and allodynic responses in mouse join pain models but, one of these, REGN5069, was not effective against pain in a randomized, placebo-controlled clinical trial in patients with osteoarthritis pain

Article

作者: Macdonald, Lynn E ; Logovinsky, Veronika ; Torres, Richard ; Ganguly, Samit ; Turner, Kenneth C ; Miller, Jutta ; Murphy, Andrew J ; Fairhurst, Jeanette L ; Hunt, Charleen ; Babb, Robert ; Croll, Susan D ; Rottey, Sylvie ; Delfino, Frank J ; Cortes-Burgos, Luz ; Breazna, Aurora ; Bhore, Rafia ; Rafique, Ashique ; Gao, Min ; Somersan-Karakaya, Selin ; Patel, Yamini ; Badithe, Ashok ; Harari, Olivier ; Poueymirou, William T ; DeVeaux, Michelle ; Surowitz, Ronald ; LaCroix-Fralish, Michael

The artemin-GFRα3 signaling pathway has been implicated in various painful conditions including migraine, cold allodynia, hyperalgesia, inflammatory bone pain, and mouse knees contain GFRα3-immunoreactive nerve endings. We developed high affinity mouse (REGN1967) and human (REGN5069) GFRα3-blocking monoclonal antibodies and, following in vivo evaluations in mouse models of chronic joint pain (osteoarthritic-like and inflammatory), conducted a first-in-human phase 1 pharmacokinetics (PK) and safety trial of REGN5069 (NCT03645746) in healthy volunteers, and a phase 2 randomized placebo-controlled efficacy and safety trial of REGN5069 (NCT03956550) in patients with knee osteoarthritis (OA) pain. In three commonly used mouse models of chronic joint pain (destabilization of the medial meniscus, intra-articular monoiodoacetate, or Complete Freund's Adjuvant), REGN1967 and REGN5069 attenuated evoked behaviors including tactile allodynia and thermal hyperalgesia without discernably impacting joint pathology or inflammation, prompting us to further evaluate REGN5069 in humans. In the phase 1 study in healthy subjects, the safety profiles of single doses of REGN5069 up to 3000 mg (intravenous) or 600 mg (subcutaneous) were comparable to placebo; PK were consistent with a monoclonal antibody exhibiting target-mediated disposition. In the phase 2 study in patients with OA knee pain, two doses of REGN5069 (100 mg or 1000 mg intravenous every 4 weeks) for 8 weeks failed to achieve the 12-week primary and secondary efficacy endpoints relative to placebo. In addition to possible differences in GFRα3 biology between mice and humans, we highlight here differences in experimental parameters that could have contributed to a different profile of efficacy in mouse models versus human OA pain. Additional research is required to more fully evaluate any potential role of GFRα3 in human pain.

100 项与 Nadecnemab 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
膝关节炎	临床2期	摩尔多瓦	Regeneron Pharmaceuticals, Inc.	2019-05-21
膝关节炎	临床2期	格鲁吉亚	Regeneron Pharmaceuticals, Inc.	2019-05-21
膝关节炎	临床2期	乌克兰	Regeneron Pharmaceuticals, Inc.	2019-05-21
膝关节炎	临床2期	波兰	Regeneron Pharmaceuticals, Inc.	2019-05-21
膝关节炎	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2019-05-21
疼痛	临床2期	美国	Regeneron Pharmaceuticals, Inc.	2019-05-21
疼痛	临床2期	乌克兰	Regeneron Pharmaceuticals, Inc.	2019-05-21
疼痛	临床2期	波兰	Regeneron Pharmaceuticals, Inc.	2019-05-21
疼痛	临床2期	格鲁吉亚	Regeneron Pharmaceuticals, Inc.	2019-05-21
疼痛	临床2期	摩尔多瓦	Regeneron Pharmaceuticals, Inc.	2019-05-21

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03956550 (CTgov)	临床2期	疼痛 \| 膝关节炎	259	placebo (Placebo)	衊憲鹹網鬱艱網積積夢(憲淵簾築願範遞壓鏇艱) = 積製糧窪築膚積壓製顧艱夢蓋壓願獵鏇餘淵顧 (襯構鹽鹹壓齋膚鹽繭選, 鹹積構鏇糧積鏇簾壓蓋 ~ 積願壓膚廠積蓋夢網繭) 更多	-	2021-07-01
				REGN5069 (REGN5069 100 mg Q4W)	衊憲鹹網鬱艱網積積夢(憲淵簾築願範遞壓鏇艱) = 製觸範憲鹹鬱製壓廠廠艱夢蓋壓願獵鏇餘淵顧 (襯構鹽鹹壓齋膚鹽繭選, 選襯範窪醖蓋壓繭製觸 ~ 膚餘選鬱夢蓋衊廠選繭) 更多