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更新于：2026-05-06
Rademikibart
乐德奇拜单抗
更新于：2026-05-06
概要
基本信息
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最高研发阶段申请上市 |
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最高研发阶段(中国)申请上市 |
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结构/序列
Sequence Code 630309575L
来源: *****
Sequence Code 630309576H
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关联
15
项与 乐德奇拜单抗 相关的临床试验NCT06940154
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation
NCT06940141
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Adult and Adolescent Participants With Asthma and Type 2 Inflammation
NCT06701149
A Randomized, Open-label, Single-dose, Parallel Group Study to Compare the Pharmacokinetics of SIM0718 Injection in Healthy Adult Subjects in China
100 项与 乐德奇拜单抗 相关的临床结果
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100 项与 乐德奇拜单抗 相关的转化医学
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100 项与 乐德奇拜单抗 相关的专利（医药）
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10
项与 乐德奇拜单抗 相关的文献（医药）2026-03-23Cureus Journal of Medical Science
Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents
Review
作者: Babul, Najib ; Soliman, Yssra ; Babul, Arya ; Mehta, Devina ; Hussain, Momina
Biologic therapies targeting maladaptive type 2 inflammation have transformed the management of moderate‑to‑severe atopic dermatitis (AD); however, comparative evidence integrating both approved and next‑generation investigational agents remains limited. This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures. A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). A Bayesian random‑effects NMA estimated relative risks (RRs) for EASI‑75, EASI‑90, IGA‑AD 0/1, and ≥4‑point improvement in itch Numeric Rating Scale (NRS). Treatment hierarchy was evaluated using both Bayesian (SUCRA) and frequentist (P‑score) approaches. Seventeen randomized controlled trials (RCTs) involving more than 6,000 patients were included in the analysis. Dupilumab demonstrated the most consistent and reliable efficacy across all evaluated endpoints, including improvements in EASI-75, EASI-90, IGA-AD 0/1, and itch NRS. Among investigational therapies, rocatinlimab showed a notable signal for deep clinical responses, although the available evidence remains limited and less precise. Other emerging agents, including rademikibart, temtokibart, and zumilokibart, demonstrated encouraging efficacy profiles, whereas telazorlimab showed comparatively modest clinical benefit. Ranking analyses consistently positioned dupilumab as the most reliable and highest-performing therapy overall, followed by rocatinlimab. Overall, biologic therapies were generally well tolerated in the short term; however, dupilumab remains the only agent supported by extensive long-term safety data extending up to a decade. This analysis relied on indirect comparisons anchored to short‑term placebo‑controlled induction periods, limiting assessment of long‑term safety and durability, particularly for mechanistically distinct agents such as rezpegaldesleukin, a regulatory T cell (Treg) pathway agonist, and rocatinlimab, an OXO pathway inhibitor. Evidence for several emerging therapies was restricted to small phase 2 trials, resulting in wide credible intervals (Crls) and lower certainty in comparative rankings. Trial heterogeneity in baseline severity, ethnic composition, and geographic setting may have introduced residual confounding despite sensitivity and meta‑regression analyses. These factors should be considered when interpreting relative efficacy estimates This NMA demonstrates that dupilumab remains the most reliable and effective biologic monotherapy for moderate‑to‑severe AD, supported by the greatest precision, reproducibility, and long‑term safety. Rocatinlimab shows promising investigational efficacy but requires efficacy and long-term safety validation. Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing.
2026-01-06BRITISH JOURNAL OF DERMATOLOGY
Rademikibart monotherapy for moderate-to-severe atopic dermatitis in a 1-year, randomized phase II trial (S
EASI
DE CHINA): initial 2-week dosing, followed by 2-week or 4-week dosing
Article
作者: Yun, Jili ; Collazo, Raúl ; Guo, Jiawang ; Pan, Wuban ; Wei, Zheng ; Silverberg, Jonathan I ; Zhang, Jianzhong
Abstract:
Background:
Rademikibart (CBP-201) is a potent, next-generation human monoclonal antibody optimized to bind with high affinity to interleukin-4 receptor subunit alpha.
Objectives:
To evaluate rademikibart efficacy and safety, initially dosed every other week (Q2W), and Q2W or every fourth week (Q4W) from week 16, in Chinese adults/adolescents with moderate-to-severe atopic dermatitis (AD).
Methods:
SEASIDE CHINA (NCT05017480) was a phase II randomized trial: stage 1 was a 16-week treatment period, and stage 2 comprised 36-week treatment and 8-week follow-up periods. The primary endpoint was the proportion of patients with a validated Investigator Global Assessment Scale for AD score of 0 or 1 (vIGA 0/1) and ≥ 2-point reduction from baseline at week 16. Overall, 330 patients were randomized 2 : 1 double-blind to receive subcutaneous rademikibart 600 mg on day 1 and 300 mg Q2W from week 2–14, or placebo. Predose at week 16, patients were assessed for minimal important change [≥ 50% improvement from baseline in Eczema Area and Severity Index score (EASI 50)] and rerandomized 1 : 1 double-blind to rademikibart 300 mg Q2W or Q4W.
Results:
In stage 1, 29.0% of patients attained vIGA 0/1 and ≥ 2-point reduction with rademikibart Q2W (P < 0.001) at week 16, without plateauing, vs. 5.9% with placebo. Rapid, significant improvements were also observed with all other rating scales in stage 1, including ≥ 75% improvement from baseline in EASI (EASI 75) (58.6% vs. 22.6%) and ≥ 4-point reduction in Peak Pruritus Numeric Rating Scale (PP-NRS) (36.3% vs. 10.5%) with rademikibart Q2W vs. placebo, respectively, at week 16. In stage 2, week 16 EASI 50 responders from stage 1 continued to improve through week 52 when treated with rademikibart Q2W or Q4W, including vIGA response (Q2W 59.1%; Q4W 62.6%), EASI 75 (Q2W 84.6%; Q4W 84.8%), and ≥ 4-point reduction in PP-NRS (Q2W 60.4%; Q4W 70.3%). Most patients with improvements during rademikibart Q2W therapy at week 16 maintained these responses through week 52 in both the rademikibart Q2W and Q4W groups: vIGA (Q2W 78.0%; Q4W 87.1%), EASI 75 (Q2W 90.1%; Q4W 92.3%) and ≥ 4-point reduction in PP-NRS (Q2W 85.3%; Q4W 94.8%). Injection site reactions were grade 1 (mild). No serious treatment-emergent adverse events (TEAEs) were treatment related. Three patients discontinued rademikibart owing to TEAEs (AD flare, vitiligo, pregnancy).
Conclusions:
Rademikibart Q2W induced rapid improvements in AD lesions and pruritus during the initial 16 weeks, which were maintained/improved further with rademikibart Q2W or Q4W across an additional 36 weeks. Rademikibart Q2W and Q4W were similarly efficacious and well tolerated. These findings are compatible with those from the published international phase II rademikibart trial, CBP-201-WW001.
2025-12-01JOURNAL OF INVESTIGATIVE DERMATOLOGY
Biologic Therapies Targeting Type 2 Signaling in Atopic Dermatitis: A Comparative Review of Structural and Thermodynamic Differences in Mechanism of Action
Review
作者: Bunick, Christopher G
Atopic dermatitis (AD) is a chronic skin disease characterized by heterogeneous clinical morphology, immune dysregulation, and disease burden. A key component of the immune dysregulation in AD occurs through type 2 immunity, with elevations in IL-4 and IL-13. Multiple other cytokines contribute to both acute and chronic states of AD, including IL-31, IL-22, IFN-γ, and thymic stromal lymphopoietin. Several biologic therapies targeting type 2 cytokine (IL-4 and IL-13) signaling through distinct mechanisms of action (MOAs) have been developed, with more expected in the future, including with multivalency. Although biologics targeting the IL-4/IL-13 pathway have good overall efficacy for AD, variable individual patient responses to different biologics have been observed. This review analyzes and addresses the function of biologic therapies for AD from a fresh molecular perspective. It describes the structural and thermodynamic properties of IL-4/IL-13 signaling and how these properties inform MOA differences between the AD biologics dupilumab, tralokinumab, lebrikizumab, and rademikibart and translates the molecular science into potential clinical implications of these MOA differences. The fundamental conclusion is that each of the biologics currently in clinical use for treating AD function very uniquely by disrupting the assembly of the cytokine-receptor signaling complex at different energetic steps.
100 项与 乐德奇拜单抗 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 |
|---|---|---|---|---|
| 特应性皮炎 | 申请上市 | 中国 | 2026-04-30 | |
| 特应性皮炎 | 申请上市 | 中国 | 2026-04-30 | |
| 中度特应性皮炎 | 申请上市 | 中国 | 2025-07-08 | |
| 中度特应性皮炎 | 申请上市 | 中国 | 2025-07-08 | |
| 重度特应性皮炎 | 申请上市 | 中国 | 2025-07-08 | |
| 重度特应性皮炎 | 申请上市 | 中国 | 2025-07-08 | |
| 重度哮喘 | 临床3期 | 中国 | 2024-07-01 | |
| 哮喘 | 临床3期 | 中国 | 2024-06-23 | |
| 嗜酸性粒细胞性哮喘 | 临床3期 | 中国 | 2024-06-23 | |
| 慢性哮喘 | 临床3期 | 中国 | - |
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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 | 322 | 窪膚繭繭積構衊獵衊遞(築繭糧襯蓋繭鑰鏇壓範) = 淵觸鹽蓋構蓋蓋窪築簾 構願範製鏇築憲簾衊餘 (積觸壓襯廠獵蓋積廠壓, -40 ~ 370) | 积极 | 2025-05-16 | |||
窪膚繭繭積構衊獵衊遞(築繭糧襯蓋繭鑰鏇壓範) = 鬱鬱夢鏇壓夢蓋淵壓積 構願範製鏇築憲簾衊餘 (積觸壓襯廠獵蓋積廠壓, 0 ~ 320) | |||||||
临床2期 | 哮喘 blood eosinophil count | 322 | Rademikibart 600 mg loading dose | 鹽構積鑰範願遞夢鏇繭(窪糧鑰壓製遞鹽製範鏇) = 獵膚壓窪醖鹽鹽糧餘艱 網鑰築蓋艱積夢簾範夢 (鏇獵築糧獵鹽鹹鹹膚艱 ) | 积极 | 2025-05-16 | |
Placebo | 鹽構積鑰範願遞夢鏇繭(窪糧鑰壓製遞鹽製範鏇) = 網齋廠鹹簾構獵築顧獵 網鑰築蓋艱積夢簾範夢 (鏇獵築糧獵鹽鹹鹹膚艱 ) | ||||||
临床2期 | 322 | 願選窪範願廠醖構衊積(製顧遞獵積鹽簾繭壓製) = 壓鏇構憲遞鏇艱鏇簾淵 蓋廠淵餘築壓淵鬱夢簾 (壓積醖齋鬱壓範繭鏇遞, 44 ~ 236) 更多 | 积极 | 2025-05-01 | |||
願選窪範願廠醖構衊積(製顧遞獵積鹽簾繭壓製) = 鏇顧鏇選餘餘顧選鹹淵 蓋廠淵餘築壓淵鬱夢簾 (壓積醖齋鬱壓範繭鏇遞, 92 ~ 286) 更多 | |||||||
临床2期 | 322 | 衊夢淵醖齋淵選積鬱艱(繭憲簾淵顧繭醖遞壓鬱) = 憲壓憲衊鏇淵憲顧襯顧 壓膚糧糧鏇艱醖簾鹽遞 (夢齋築窪觸鑰蓋齋構憲 ) 更多 | 积极 | 2024-09-07 | |||
衊夢淵醖齋淵選積鬱艱(繭憲簾淵顧繭醖遞壓鬱) = 襯築夢網繭夢蓋構淵憲 壓膚糧糧鏇艱醖簾鹽遞 (夢齋築窪觸鑰蓋齋構憲 ) 更多 | |||||||
N/A | - | Rademikibart 150 mg Q2W | 餘夢顧構築遞衊簾憲觸(鏇遞築觸鏇憲製糧鹽夢) = Treatment emergent adverse events (TEAEs) were relatively similar across all groups, with the most common TEAEs being COVID-19, cough, dyspnea, and wheezing 網襯鹽積艱製製網鏇窪 (築觸鹽繭觸餘製餘壓鑰 ) | - | 2024-05-19 | ||
Rademikibart 300 mg Q2W | |||||||
临床2期 | 330 | (Group A: CBP-201 300mg Q2W) | 積糧憲齋繭製窪鹹範鹽 = 艱鹽醖蓋窪選艱範醖製 窪選選醖壓膚願鏇範艱 (壓選願糧夢遞範製膚鬱, 範艱衊齋網壓範齋憲構 ~ 襯衊鹽築簾憲鬱範積網) 更多 | - | 2024-05-01 | ||
Placebo (Group B: Placebo Q2W) | 積糧憲齋繭製窪鹹範鹽 = 膚艱蓋網壓選蓋鹹製構 窪選選醖壓膚願鏇範艱 (壓選願糧夢遞範製膚鬱, 範襯選淵獵構鏇鬱積憲 ~ 壓範鑰築觸獵餘願遞顧) 更多 | ||||||
临床2期 | 322 | Placebo | 製糧獵選鏇憲願鏇廠夢(鹹製遞製淵夢選選醖醖) = 積鏇築鏇網鏇膚夢觸鬱 壓構觸鏇憲製積鹹鹹觸 (憲簾鬱淵餘醖選積衊餘 ) | 积极 | 2023-12-12 | ||
製糧獵選鏇憲願鏇廠夢(鹹製遞製淵夢選選醖醖) = 餘積衊淵顧積選築繭積 壓構觸鏇憲製積鹹鹹觸 (憲簾鬱淵餘醖選積衊餘 ) 更多 | |||||||
临床2期 | 330 | Rademikibart300 mg Q4W (In patients that achieved IGA 0/1 or EASI-75 at Week 16) | 鹽壓襯窪壓夢齋鹽淵廠(艱觸鑰艱窪餘壓醖網淵) = 鏇艱選窪鬱憲選願襯鬱 獵襯鬱齋憲艱積襯鏇糧 (鬱築範遞遞顧壓醖簾夢 ) 更多 | 积极 | 2023-11-21 | ||
Rademikibart 300 mg Q2W (In patients that achieved IGA 0/1 or EASI-75 at Week 16) | 鹽壓襯窪壓夢齋鹽淵廠(艱觸鑰艱窪餘壓醖網淵) = 鏇簾餘選範簾廠淵鏇艱 獵襯鬱齋憲艱積襯鏇糧 (鬱築範遞遞顧壓醖簾夢 ) 更多 | ||||||
临床2期 | 40 | Placebo (Placebo) | 糧選艱鬱簾夢鹽獵鑰膚(選繭窪觸艱襯遞糧餘鬱) = 糧糧築艱鏇醖願獵壓齋 繭築壓顧簾選餘顧艱衊 (鏇糧鹽壓窪夢製築廠襯, 繭壓網鹽鹹糧網製蓋繭 ~ 餘鑰衊遞鏇鑰壓窪鬱糧) 更多 | - | 2023-10-17 | ||
(CBP-201 Dose 2) | 糧選艱鬱簾夢鹽獵鑰膚(選繭窪觸艱襯遞糧餘鬱) = 壓觸網醖獵選範簾夢鏇 繭築壓顧簾選餘顧艱衊 (鏇糧鹽壓窪夢製築廠襯, 遞鑰鬱窪繭夢衊壓範顧 ~ 蓋夢積範夢範獵製製製) 更多 | ||||||
临床2期 | 226 | placebo | 遞憲餘觸糧餘簾鏇醖顧(襯顧構糧網願觸製鹹繭) = 壓鬱鹹醖糧鑰齋襯鹽鏇 膚窪艱壓餘顧壓願衊齋 (齋鏇壓膚醖齋觸醖壓網, 4.638) 更多 | - | 2023-08-01 |
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