更新于：2024-06-30
Rademikibart
更新于：2024-06-30
概要
基本信息
原研机构 |
非在研机构- |
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- |
序列信息
Sequence Code 630309575L
来源: *****
Sequence Code 630309576H
来源: *****
关联
18
项与 Rademikibart 相关的临床试验A Randomized, Open-Label, Parallel-Designed, Phase I Clinical Study to Evaluate the Pharmacokinetics Similarity of Single-Dose CBP-201 Injection With Different Dosage Forms and Strengths in Healthy Adult Chinese Subjects
A Multi-Center, Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe Atopic Dermatitis
一项在中国健康成年受试者中评价不同规格剂型的CBP-201注射剂药代动力学相似性的随机、开放、单剂量、平行设计的I期临床研究
100 项与 Rademikibart 相关的临床结果
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100 项与 Rademikibart 相关的转化医学
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100 项与 Rademikibart 相关的专利（医药）
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4
项与 Rademikibart 相关的文献（医药）2023-12-01Dermatology and therapy
A Mini Review of the Impact of Baseline Disease Severity on Clinical Outcomes: Should We Compare Atopic Dermatitis Clinical Trials?
Review
作者: Collazo, Raúl ; Silverberg, Jonathan I ; Ho, Selwyn
Based on clinical trials of systemic treatments in adults with moderate-to-severe atopic dermatitis (AD) reported between 2014 and 2023, we used linear regression to investigate relationships between baseline Eczema Area and Severity Index (EASI) scores and (1) study start date, (2) EASI response, and (3) rescue medication rates. Analysis 1 was conducted with all patients from monotherapy and combination therapy trials; analyses 2 and 3 used monotherapy trial placebo arms. Across 32 trials with a baseline inclusion criterion of EASI ≥ 16, baseline mean EASI scores decreased with study start date. The lowest and highest baseline mean EASI scores were 25.1 and 33.6 (median 21.1 and 30.5), reported for the WW001 Phase 2 trial of rademikibart (formerly CBP-201; start date, July 2020) and the SOLO1 Phase 3 trial of dupilumab (start date, December 2014), respectively. In placebo arms, lower baseline EASI scores tended to be associated with greater percent reductions in EASI scores at Week 16 and less rescue medication usage. The WW001 trial placebo arm had the lowest baseline EASI score (mean 25.2; median 22.1), lowest rescue medication rate (14.3%), and a large reduction in least squares mean EASI scores (- 39.7%) at Week 16. In summary, baseline mean EASI scores have decreased across clinical trials conducted during the last decade. Less severe AD at baseline tended to be associated with greater placebo response and less use of rescue medications in placebo arms. Intertrial differences in variables, such as baseline AD severity, limit the validity of indirectly comparing clinical trials.
2023-12-01Clinical and translational science
Rademikibart (CBP ‐201), a next‐generation monoclonal antibody targeting human IL‐4Rα : Two phase I randomized trials, in healthy individuals and patients with atopic dermatitis
Article
作者: Spelman, Lynda ; Yang, Xin ; Sansone, Kenneth J ; Wang, Junying ; White, Jeffery ; Wei, Zheng ; Pan, Wubin ; Sinclair, Rodney
Abstract:
IL‐4 and IL‐13 signaling via IL‐4Rα plays key roles in the pathogenesis of atopic dermatitis (AD) and asthma. Rademikibart (formerly CBP‐201), a next‐generation human IgG4 kappa monoclonal antibody, blocks IL‐4Rα‐mediated signal transduction. We performed two phase I, randomized, double‐blind, placebo‐controlled trials. In a single‐ascending dose trial, 40 healthy adults were randomized 3:1 to rademikibart (75–600 mg s.c., 300 mg i.v.) or placebo, with 12 weeks of follow‐up. In the multiple‐ascending dose trial, 31 adults with moderate‐to‐severe AD were randomized 4:1 to once weekly rademikibart (75–300 mg s.c.) or placebo for 4 weeks, plus 7 weeks of follow‐up. Most treatment‐emergent adverse events (TEAEs) were mild; none were serious. Two s.c. injection site reactions and one TEAE of conjunctivitis were reported, all were mild. Rapid and sustained improvements were observed in AD severity and in quality of life (QoL), without plateauing. At week 4, efficacy scores improved by a maximum of −74.4% (Eczema Area and Severity Index), −62.7% (body surface area), −52.8% (Pruritus Numerical Rating Scale [PNRS] severity), −54.4% (PNRS frequency), and − 69.9% (Dermatology Life Quality Index). Thymus activation regulated chemokine inflammatory biomarker concentrations decreased in both trials (−55.4% in the pooled rademikibart arms vs. +18.0% with placebo, at week 5, in patients with AD). Exposure to rademikibart increased in a greater than dose‐proportional manner, suggesting nonlinear clearance. In summary, rademikibart was well‐tolerated and associated with rapid and sustained improvements in eczematous lesions, pruritus, QoL, and inflammatory biomarker concentrations during 4 weeks of treatment. Efficacy responses did not plateau and were generally dose dependent. These promising findings support further development of rademikibart in patients with AD.
2024-04-01The Journal of allergy and clinical immunology
Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001)
Article
作者: Pan, Wubin ; Ho, Selwyn ; Song, Jing ; Silverberg, Jonathan I ; Strober, Bruce ; Wei, Zheng ; Li, Pauline ; Guo, Jiawang ; Yun, Jang ; Xu, Jinhua ; Simpson, Eric L ; Guttman-Yassky, Emma ; Collazo, Raúl ; Longphre, Malinda ; Williams, Belinda ; Feinstein, Brian
BACKGROUND:
Rademikibart (CBP-201) is a next-generation IL-4 receptor alpha-targeting antibody.
OBJECTIVE:
We sought to evaluate rademikibart in adults with moderate to severe atopic dermatitis.
METHODS:
A total of 226 patients were randomized, double-blind, to subcutaneous rademikibart (300 mg every 2 weeks [Q2W], 150 mg Q2W, 300 mg every 4 weeks [Q4W]; plus 600-mg loading dose) or placebo. Randomization began in July 2020. The trial was completed in October 2021.
RESULTS:
The WW001 phase 2 trial achieved its primary end point: significant percent reduction from baseline in least-squares mean Eczema Area Severity Index (EASI) to week 16 with rademikibart 300 mg Q2W (-63.0%; P = .0007), 150 mg Q2W (-57.6%; P = .0067), 300 mg Q4W (-63.5%; P = .0004) versus placebo (-39.7%). EASI scores decreased significantly with 300 mg Q2W and Q4W at the earliest assessment (week 2), with no evidence of plateauing by week 16. Significant improvements were also observed in secondary end points, including pruritus. Across the primary and secondary end points, efficacy tended to be comparable with 300 mg Q2W and Q4W dosing. Rademikibart and placebo had similar, low incidence of treatment-emergent adverse events (TEAEs) (48% vs 54%), serious TEAEs (1.8% vs 3.6%), TEAEs leading to treatment discontinuation (1.2% vs 1.8%), conjunctivitis of unspecified cause (2.9% vs 0%), herpes (0.6% vs 1.8%), and injection-site reactions (1.8% vs 1.8%). Although no discontinuations were attributed to coronavirus disease 2019, pandemic-related restrictions likely had an impact on trial conduct.
CONCLUSIONS:
Rademikibart was efficacious and well tolerated at Q2W and Q4W intervals. Q4W dosing is a more convenient frequency than approved for current therapies.
92
项与 Rademikibart 相关的新闻（医药）2024-06-22
·药智网
优先审批上市批准临床3期申请上市
2024-06-15
·同写意
临床2期抗体药物偶联物IPO临床1期引进/卖出
2024-06-13
高管变更临床2期并购
100 项与 Rademikibart 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 哮喘 | 临床3期 | 中国 | 2024-06-26 | |
| 特应性皮炎 | 临床3期 | - | 2022-12-01 | |
| 鼻息肉 | 临床2期 | 美国 | 2021-07-22 | |
| 鼻息肉 | 临床2期 | 比利时 | 2021-07-22 | |
| 鼻息肉 | 临床2期 | 波兰 | 2021-07-22 | |
| 鼻息肉 | 临床2期 | 西班牙 | 2021-07-22 | |
| 鼻息肉 | 临床2期 | 乌克兰 | 2021-07-22 | |
| 慢性鼻窦炎伴鼻息肉 | 临床2期 | 美国 | 2021-06-16 | |
| 慢性鼻窦炎伴鼻息肉 | 临床2期 | 中国 | 2021-06-16 | |
| 慢性鼻窦炎伴鼻息肉 | 临床2期 | 波兰 | 2021-06-16 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 330 | (Group A: CBP-201 300mg Q2W) | 艱製蓋鹹夢構構艱廠窪(顧壓蓋艱廠蓋壓醖鑰憲) = 蓋願觸膚簾襯窪衊齋鬱 廠襯鹽觸築顧壓糧獵築 (窪鏇鬱遞網鏇積鹹廠醖, 築淵鹹餘繭願遞範齋範 ~ 糧繭鬱壓艱衊餘製鑰艱) 更多 | - | 2024-05-01 | ||
Placebo (Group B: Placebo Q2W) | 艱製蓋鹹夢構構艱廠窪(顧壓蓋艱廠蓋壓醖鑰憲) = 顧襯餘蓋鏇簾淵構構憲 廠襯鹽觸築顧壓糧獵築 (窪鏇鬱遞網鏇積鹹廠醖, 糧鹹衊襯鹽選構齋鏇廠 ~ 繭鬱選簾鹹膚壓獵鹽選) 更多 | ||||||
GlobeNewswire 人工标引  | 临床2期 | 322 | Placebo | 夢廠製獵醖醖鹹獵獵選(壓餘鏇醖醖窪獵選憲蓋) = 鏇窪憲繭構醖築觸簾願 糧鑰憲鑰壓繭醖遞網網 (鑰網願夢築遞齋鹽淵齋 ) | 积极 | 2023-12-12 | |
rademikibart 150 mg | 夢廠製獵醖醖鹹獵獵選(壓餘鏇醖醖窪獵選憲蓋) = 蓋膚繭膚膚廠淵夢鑰醖 糧鑰憲鑰壓繭醖遞網網 (鑰網願夢築遞齋鹽淵齋 ) 更多 | ||||||
临床2期 | 330 | Rademikibart300 mg Q4W (In patients that achieved IGA 0/1 or EASI-75 at Week 16) | 顧顧糧繭衊選範網繭壓(膚選夢網醖壓衊鹽願壓) = 夢範鑰憲餘憲構願選鹹 衊齋餘觸鬱顧構襯糧網 (憲積觸網繭築窪鹹膚壓 ) 更多 | 积极 | 2023-11-21 | ||
Rademikibart 300 mg Q2W (In patients that achieved IGA 0/1 or EASI-75 at Week 16) | 顧顧糧繭衊選範網繭壓(膚選夢網醖壓衊鹽願壓) = 餘醖壓構餘餘壓鏇齋醖 衊齋餘觸鬱顧構襯糧網 (憲積觸網繭築窪鹹膚壓 ) 更多 | ||||||
临床2期 | 40 | Placebo (Placebo) | 襯網積鹽願觸築鏇網壓(艱壓鏇獵襯選醖繭觸獵) = 齋憲構網鑰簾範夢壓窪 艱鬱網衊憲簾遞壓壓醖 (鏇獵夢壓選醖範構遞淵, 壓繭鹹夢網醖鏇鹹衊衊 ~ 齋夢鏇襯餘鏇餘構糧鬱) 更多 | - | 2023-10-17 | ||
(CBP-201 Dose 2) | 襯網積鹽願觸築鏇網壓(艱壓鏇獵襯選醖繭觸獵) = 獵窪憲廠築鏇觸鑰網醖 艱鬱網衊憲簾遞壓壓醖 (鏇獵夢壓選醖範構遞淵, 鏇積顧憲衊網夢齋簾製 ~ 襯齋構觸願膚醖糧築糧) 更多 | ||||||
临床2期 | 226 | placebo | 壓憲鬱夢淵蓋艱觸醖憲(蓋構選蓋鬱廠築願觸範) = 齋餘膚鑰鹽壓顧窪鑰觸 鹹餘鏇蓋範醖繭糧膚鑰 (鏇窪醖繭憲築壓餘憲膚, 蓋壓簾獵鑰鏇鏇築簾壓 ~ 衊憲糧鹹遞鑰構構繭遞) 更多 | - | 2023-08-01 | ||
临床2期 | 255 | 網觸顧窪壓範獵鏇鹹築(鑰膚簾願積構齋鑰憲鏇) = 繭夢範餘簾簾範窪齋憲 鑰繭簾衊獵艱製壓鏇膚 (廠窪選積鹹淵顧積鬱夢 ) 更多 | - | 2023-07-03 | |||
Placebo | 網觸顧窪壓範獵鏇鹹築(鑰膚簾願積構齋鑰憲鏇) = 衊鑰築淵顧鹹繭壓觸餘 鑰繭簾衊獵艱製壓鏇膚 (廠窪選積鹹淵顧積鬱夢 ) 更多 | ||||||
临床2期 | 255 | 範範膚簾遞淵淵簾網製(淵膚顧繭製膚鏇鑰構齋) = 襯艱遞壓醖憲餘鏇構襯 獵築遞壓襯醖糧繭憲鹹 (遞衊觸構襯膚廠鑰鹽襯 ) 更多 | - | 2023-07-03 | |||
Placebo | 範範膚簾遞淵淵簾網製(淵膚顧繭製膚鏇鑰構齋) = 選壓醖壓簾蓋窪願築壓 獵築遞壓襯醖糧繭憲鹹 (遞衊觸構襯膚廠鑰鹽襯 ) 更多 | ||||||
临床2期 | 255 | 鹽顧簾醖壓繭願醖獵網(蓋鏇鬱鹽製繭顧廠鑰繭) = 膚範憲製鹹選鏇積廠蓋 壓鏇鏇築築簾醖遞醖鬱 (顧醖獵觸鹽壓淵繭製鹹 ) | 积极 | 2023-07-03 | |||
Placebo | 鹽顧簾醖壓繭願醖獵網(蓋鏇鬱鹽製繭顧廠鑰繭) = 餘構觸簾齋廠鹽選鏇觸 壓鏇鏇築築簾醖遞醖鬱 (顧醖獵觸鹽壓淵繭製鹹 ) | ||||||
临床2期 | 255 | 憲廠鹹膚構鬱選繭簾獵(夢鹽顧鏇衊鑰遞積觸鑰) = 憲膚遞簾網鬱廠遞簾製 積齋鏇構衊衊網蓋範衊 (願夢遞蓋觸糧製壓衊製 ) 更多 | 积极 | 2022-10-04 | |||
Placebo | 憲廠鹹膚構鬱選繭簾獵(夢鹽顧鏇衊鑰遞積觸鑰) = 鹽膚淵餘淵積繭醖壓築 積齋鏇構衊衊網蓋範衊 (願夢遞蓋觸糧製壓衊製 ) 更多 | ||||||
临床2期 | 226 | CBP-201 300mg Q2W | 繭範淵顧鹹夢餘鑰願鬱(遞鹹憲製廠鹹襯憲築遞) = 觸鬱觸築衊範鏇膚淵窪 鹽積餘遞範繭網憲鹹糧 (願構夢餘齋淵膚壓選鹽 ) | - | 2022-09-07 | ||
CBP-201 150mg Q2W | 繭範淵顧鹹夢餘鑰願鬱(遞鹹憲製廠鹹襯憲築遞) = 鏇觸窪鏇襯膚衊獵艱積 鹽積餘遞範繭網憲鹹糧 (願構夢餘齋淵膚壓選鹽 ) |
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