An Open-label, Phase 1, Randomized, Parallel Design Study to Determine the Bioequivalence and Investigate the Safety and Tolerability of Subcutaneous Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants

This is a single-center, open-label, randomized, single-dose, parallel, Phase 1, 4-arm study designed to determine the bioequivalence and investigate the safety and tolerability profiles of subcutaneous amlitelimab delivered by 2 different devices at 2 different total doses in healthy adult participants.

开始日期2025-08-25

申办/合作机构

Sanofi

CTR20242734

/ 主动终止临床2期

CONQUEST 治疗硬化症平台临床研究：一项评价试验药物在系统性硬化症相关间质性肺疾病受试者中的安全性和有效性的多中心、双盲、随机、安慰剂对照、IIb 期平台临床研究

本研究的主要目的是根据第 52 周治疗期结束时 FVC（mL；在 SSc-ILD 研究受试者中测量）较基线的变化来评价 IP 相比安慰剂的有效性。本研究的次要目的是评价如下内容：？根据第 52 周如下指标较基线的变化来评价 IP 相比安慰剂的有效性： o 通过高分辨率计算机断层扫描（HRCT）定量 ILD（QILD）-全肺（WL）[QILD-WL]测量的肺部受累；以及 o 通过慢性疾病治疗功能评估（FACIT）-呼吸困难评分测量的呼吸困难（严重程度和功能限制）。？第 52 周时在弥漫性皮肤型 SSc 研究受试者中通过修订版弥漫性 SSc 综合反应指数（CRISS）评分测量的总体治疗反应；以及？ IP 的安全性和耐受性。

开始日期2025-06-27

申办/合作机构

北京MEDPACE医药科技有限公司

[+2]

NCT06686628

/ Active, not recruiting临床1期

An Open-label, Drug-drug Interaction Study to Investigate the Effects of Amlitelimab on the Pharmacokinetics of Selected Cytochrome P450 Substrates in Adult Participants With Moderate-to-severe Atopic Dermatitis

This is an open-label, single group, 2-period, Phase 1, single-sequence study. The study duration will be up to 342 days. The treatment period will be up to Week 29, where Week 29 is defined as End of Treatment (last amlitelimab administration at Week 25).
The number of visits will be 23 or 21 visits for participants who decide to continue amlitelimab therapy in the long-term extension study LTS17367 (RIVER-AD) study.

开始日期2024-11-20

申办/合作机构

Sanofi

100 项与 Amlitelimab 相关的临床结果

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100 项与 Amlitelimab 相关的转化医学

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100 项与 Amlitelimab 相关的专利（医药）

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项与 Amlitelimab 相关的文献（医药）

2025-12-01·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Improvement and maintenance of clinical outcome assessments in atopic dermatitis with amlitelimab

Article

作者: Gray, Cori ; Weber, Christine ; Brookes, Ella ; Merola, Joseph F. ; Weidinger, Stephan ; Igawa, Ken ; Blauvelt, Andrew ; Wang, Jennifer ; Chovatiya, Raj

Abstract:

Background:

Amlitelimab, a fully human, nondepleting, anti‐OX40 ligand monoclonal antibody, demonstrated reductions in lesional and pruritic endpoints in adults with moderate‐to‐severe atopic dermatitis (AD) in phase 2a and 2b trials.

Objectives:

Here, we examined the effect and durability of amlitelimab on clinical outcome assessments (COAs) in the randomized STREAM‐AD phase 2b trial.

Methods:

Adults with moderate‐to‐severe AD with prior inadequate response to or inadvisability of topical medications received subcutaneous amlitelimab (250 mg with 500‐mg loading dose, 250 mg, 125 mg or 62.5 mg) or placebo every 4 weeks in Part 1 (Weeks 0–24; 1:1:1:1:1 randomization). In Part 2, Week 24 clinical responders (defined as patients achieving Investigator Global Assessment [IGA] 0/1 and/or ≥ 75% reduction in the Eczema Area and Severity Index [EASI‐75]) were rerandomized 3:1 to withdraw or continue amlitelimab pre–Week 24 dose through Week 52. COAs, including SCORing Atopic Dermatitis, affected body surface area, Patient‐Oriented Eczema Measure, Dermatology Life Quality Index and Atopic Dermatitis Control Tool, were evaluated.

Results:

Of the 390 randomized patients in Part 1, 190 were rerandomized in Part 2. Significant improvements in COAs were observed with all amlitelimab doses versus placebo at Week 24 ( p < 0.05 for all COAs). At Week 24, the majority of clinical responders achieved meaningful changes in COAs. At Week 52, these improvements were maintained in the majority of patients who achieved COA improvements at Week 24, regardless of treatment continuation or withdrawal during the 28‐week Part 2 period.

Conclusions:

Amlitelimab treatment led to clinically meaningful improvements in COAs by Week 24 versus placebo. COA improvements were maintained at Week 52 in patients continuing amlitelimab, as well as in patients who withdrew from amlitelimab, supporting the durable response of amlitelimab and the viability of extended drug dosing, which may ease treatment burden.

Clinical Trial Registration:

ClinicalTrials.gov Identifier: NCT05131477.

2025-12-01·CPT-Pharmacometrics & Systems Pharmacology

Population Pharmacokinetic and Pharmacodynamic Modeling for the Prediction of the Extended Amlitelimab Phase 3 Dosing Regimen in Atopic Dermatitis

Article

作者: O'Malley, John T. ; Papp, Kim ; Weidinger, Stephan ; Fabre, David ; Yen, Karl ; Tiraboschi, Gilles ; Lee, Chih‐Hung ; Beck, Lisa ; Bernigaud, Charlotte ; Bieber, Thomas ; Hurbin, Fabrice

ABSTRACT:

Amlitelimab is a fully human, nondepleting, anti‐OX40 ligand monoclonal antibody being investigated for the treatment of moderate‐to‐severe atopic dermatitis (AD) in adults and adolescents. Population pharmacokinetic (PopPK) and pharmacokinetic/pharmacodynamic‐Eczema Area and Severity Index (PopPK/PD‐EASI) models were used to inform dosing regimen selection for amlitelimab phase 3 trials. The PopPK model was developed using phase 1 (healthy volunteers) and phase 2 (participants with AD) trial data, including individual exposure variables from the STREAM‐AD phase 2b trial following subcutaneous amlitelimab doses ranging from 62.5 to 250 mg given every 4 weeks (Q4W). The PopPK model was used to compute exposures for an extended dosing regimen of 250 mg Q12W (with 500 mg loading dose [+LD]). The PopPK/PD‐EASI model was developed from phase 2 trials to predict treatment responses (EASI values) with selected dosing scenarios. Finally, the dose for individuals with lower body weight (i.e., < 40 kg) was determined. Utilizing the PopPK model, the amlitelimab 250 mg Q12W + LD computed exposures were between the exposures of 62.5 mg Q4W and 250 mg Q4W + LD efficacious doses in the STREAM‐AD trial. Using the PopPK/PD‐EASI model, the simulated efficacy for dosing scenarios of 250 mg Q12W + LD regimen from initiation or 250 mg Q4W + LD for 24 weeks followed by Q12W to Week 60 was similar to continuous 250 mg Q4W. Simulations identified that a twofold dose reduction would allow participants < 40 kg to achieve amlitelimab exposures within the range observed in participants ≥ 40 kg on 250 mg Q4W or Q12W. These results support evaluation of a Q12W dosing regimen for adults and adolescents in phase 3 trials.

2025-12-01·PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Efficacy and Safety of All Monoclonal Antibodies in Moderate‐to‐Severe Atopic Dermatitis: A Systematic Review and Network Meta‐Analysis

Review

作者: Fu, Linlin ; Yao, Yao ; Cai, Wenting ; Zhang, Jinping ; Wu, Yan

ABSTRACT:

Objective:

The aim of this study was to compare the efficacy and safety of monoclonal antibodies (mAb) for moderate‐to‐severe atopic dermatitis (AD).

Methods:

The randomized controlled trials (RCTs) of monoclonal antibodies in the treatment of moderate‐to‐severe AD were searched in the database of PubMed, Embase, Web of Science and Cochrane Library, up to November 2024. The control group included placebo. The efficacy indicators were the percentage of patients achieving 50%, 75%, 90% improvement in Eczema Area and Severity Index score (EASI‐50, EASI‐75, EASI‐90) and the percentage of patients with an Investigator Global Assessment (IGA) Score of 0 or 1 from baseline until the time of efficacy observation, and the percent change in Pruritus Numerical Rating Scale (NRS), EASI score, SCORing Atopic Dermatitis (SCORAD), and change in Percent Body Surface Area (BSA), Dermatology Life Quality Index (DLQI). The statistical analysis was performed by Stata14 and RevMan5.4. Data processing, network evidence plots, surface under the cumulative ranking curve (SUCRA) ranking, league plots and funnel plots were generated. Risk ratio (RR) and 95% confidence interval (95% CI) were used as effect sizes to analyze binary categorical variables.

Results:

This study included 32 RCTs with 7588 patients. Spesolimab, Rademikibart, Dupilumab, Amlitelimab were more effective than placebo in EASI‐50 (RRs ranging between 1.31 and 22.65), EASI‐75(RRs ranging between 1.51 and 36.58), EASI‐90(RRs ranging between 3.72 and 5.49), and the percentage of patients in IGA score of 0 or 1 (RRs ranging between 1.78 and 13.36). Dupilumab showed relatively good efficacy according to SUCRA ranking on percent change in NRS, EASI, SCORAD. Dupilumab exhibited a lower incidence of serious adverse events than placebo, and the difference was statistically significant (RR = 0.43, 95% CI 0.30–0.63). Other safety analysis results showed no statistical difference.

Conclusions:

Through the analysis of the primary efficacy indicators, this network meta‐analysis (NMA) study indicated that all monoclonal antibodies performed better than placebo. Based on the results of this study, Spesolimab, Rademikibart, Dupilumab, Amlitelimab were recommended treatment options with relatively good efficacy and safety.

272

项与 Amlitelimab 相关的新闻（医药）

2026-02-02

·Firstwordpharma

Sanofi posts a win for venglustat in Gaucher study, but a miss in Fabry disease

Sanofi announced Monday mixed results from a pair of pivotal studies of venglustat in two rare lysosomal storage disorders, with the oral glucosylceramide synthase inhibitor (GCSi) recording a hit in type 3 Gaucher disease (GD3) and a miss in Fabry disease. The contrasting outcomes are the latest to emerge from the company's late-stage pipeline, following differing results earlier this year from the investigational OX40-ligand-blocking monoclonal antibody amlitelimab in two atopic dermatitis trials.The Phase III LEAP2MONO study randomised 43 adult and paediatric patients with neurological manifestations of GD3 to receive venglustat once-daily or enzyme replacement therapy (ERT). The trial's primary endpoints were change in Scale for Assessment and Rating of Ataxia (SARA) modified total score and change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score, with key secondary goals including percent change in spleen volume, liver volume and platelet count, as well as change in haemoglobin levels.Results showed that venglustat demonstrated statistically significant improvements in neurological symptoms as measured by both SARA and RBANS at week 52 compared to ERT. Sanofi added that the therapy also achieved three out of the four key secondary endpoints, performing as well as ERT on non-neurological outcomes, including changes in spleen volume, liver volume and haemoglobin levels.Regulatory filings in GD3"What excites us most is the potential to address critical unmet medical needs. A daily pill could make a serious difference for Gaucher patients facing neurological challenges," said Houman Ashrafian, head of R&D at Sanofi. The company indicated that based on the results, it will pursue global regulatory filings for venglustat in GD3.Sanofi currently markets the injectable therapy Cerezyme (imiglucerase) for Gaucher disease, as well as the oral drug Cerdelga (eliglustat) for those with type 1 disease. The drugmaker's portfolio also includes the injectable therapy Fabrazyme (agalsidase beta) for Fabry disease. However, the latest results dent its hopes of adding an oral Fabry disease therapy to its arsenal.Fabry setbackThe Phase III PERIDOT study randomised 122 patients aged 16 years and older with Fabry disease to receive venglustat or placebo. Sanofi noted that the trial failed to hit its primary endpoint of percent change from baseline on patient-defined most bothersome symptoms, as assessed by the Fabry Disease Patient-Reported Outcome (FD-PRO) instrument.According to the company, reductions in neuropathic and abdominal pain were observed in both study arms. Additional analyses of the data are ongoing, while the late-stage CARAT trial evaluating the effect of venglustat on left cardiac ventricular mass index in men and women with Fabry disease is ongoing.Findings from both LEAP2MONO and PERIDOT are scheduled to be presented this week at the annual WORLDSymposium.Aside from the positive results in GD3, Venglustat, which works by reducing the abnormal accumulation of sugar-and-fat molecules in cells and organs, has racked up a number of study failures. In 2024, Sanofi disclosed that the Phase III AMETHIST trial for GM2 gangliosidosis was discontinued based on “the absence of positive trends” for clinical endpoints, adding to a pivotal Phase II/III study setback in autosomal dominant polycystic kidney disease and another in Parkinson's disease with GBA mutations.

临床3期临床结果

2026-02-02

·Pharmaceutical Technology

Amgen hands back eczema drug to Kyowa Kirin despite positive late-stage data

Kyowa Kirin will regain control of the global programme for rocatinlimab in AD as Amgen terminates development and commercialisation agreement. Image credit: Antonina Vlasova via ShutterStock.com. Amgen is handing back the rights of its successful in-licensed atopic dermatitis (AD) asset, rocatinlimab, to Kyowa Kirin. In a statement to Pharmaceutical Technology , an Amgen spokesperson noted that this move was part of its “ongoing portfolio prioritisation process”, which will see the company transfer responsibility for the rocatinlimab programme back to its original developer. As Amgen relinquishes its stake in the anti-OX40 monoclonal antibody (mAb), Kyowa will now take full responsibility for the drug’s further development, as well as future regulatory submissions and commercialisation efforts involving the OX40 receptor agonist. The Tokyo-based pharma plans to submit rocatinlimab to regulators for AD in H1 2026. If rocatinlimab gets the regulatory go-ahead, Kyowa plans to “commercialise the drug through a flexible, market-by-market approach, starting in the US”, the company’s president and COO, Abdul Mullick tells Pharmaceutical Technology . Mullick said: “Kyowa Kirin is confident in the potential of rocatinlimab to address critical unmet needs for patients with moderate-to-severe AD, who are looking for new long-lasting options that may address the chronic nature of unpredictable flares. Rocatinlimab’s science and its highly differentiated mechanism of action targeting the OX40 receptor make it a potentially unique treatment option.” A patient-based forecast from GlobalData estimates that rocatinlimab will generate 2033 global sales of $1.7bn in AD. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The OX40 ligand’s role in AD Once touted as one of the most promising new targets in AD , analyst excitement around the OX40 drug class has taken a hit as trial data have failed to meet expectations. This comes as recent late-stage efficacy and safety readouts for both rocatinlimab and Sanofi’s rival OX40 candidate, amlitelimab, garnered lukewarm responses. During the Phase III ROCKET-IGNITE , ROCKET-HORIZON and ASCEND trials of rocatinlimab, the drug met all its co-primary and secondary endpoints, but efficacy results generally fell short of analyst expectations. It was a similar outcome for amlitelimab, which did not live up to the legacy of Sanofi and Regeneron’s best-selling AD drug, Dupixent (dupilumab), leading GlobalData analysts to theorise that the drug will see most uptake in the second- or third-line setting . In the Phase II ATLANTIS trial (NCT05769777) in AD, treatment with amlitelimab also triggered a cutaneous case of Kaposi’s sarcoma – a rare vascular cancer linked to OX40 deficiency – in a patient with known risk factors. In a research note, William Blair analyst Matt Phipps noted that this finding “could be a real safety risk for the OX40 class”. However, Mullick believes that the mechanistic differences between OX40 ligand (amlitelimab) and OX40 receptors’ (rocatinlimab)-targeting approaches mean that “findings for one should not predict outcomes for the other”. Unmet needs in AD In recent years, biologics have triggered a fundamental shift in the AD treatment landscape, with therapies like Dupixent offering patients significant symptomatic relief while showing some disease-modifying potential. Despite these advancements, Mullick cautions that a large number of patients do not achieve optimal treatment targets. “More than 50% of patients receiving systemics discontinue within the first year, highlighting the remaining need for options that provide more long-term control of the disease,” he said. According to Mullick, rocatinlimab’s differentiated mechanism of action makes it “unique”, with its potential as a treatment option expanding across a range of clinical scenarios. A recent report from GlobalData , parent company of Pharmaceutical Technology , forecasts that the AD market will be worth $22.4bn across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) by 2033.

临床结果引进/卖出临床3期临床2期

2026-02-01

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遗传对寿命影响高估? 新模型称占50%以上

遗传对寿命影响高估?新模型称占50%以上一句话结论:新研究剔除环境乱因后发现遗传对人类寿命贡献可能高达55%，远高于此前20%左右的估计。为什么重要:这一结果颠覆旧认知，强化了长寿基因筛选和抗衰老药物开发的意义；同时提醒健康长寿不只靠生活方式，遗传学作用被严重低估。关键要点:• 新方法: 以色列魏茨曼研究所团队在 Science 发表数学模型分析，剔除感染、事故等“外因死亡”，利用双胞胎及兄弟姐妹数据重新估算寿命遗传率。• 核心发现: 若扣除外部致死因素，遗传因素对寿命变异的贡献升至约55%（原估值仅20%），几乎翻倍。此前研究因未区分年代差异，环境噪声掩盖了遗传效应。• 学界反响: 丹麦专家在同期述评称，该结果为大规模鉴定长寿相关基因变异提供了更充分的理由，以研发生物干预模拟这些“长寿基因”机制。适用与避坑:• 个体指导: 尽管基因影响被上调，但约50%寿命仍取决于生活方式和医疗条件，戒烟、运动等外因依然举足轻重。基因检测或可用于预测大致寿命范围，但过度解读可能引发不必要焦虑。• 行动建议: 有长寿家族史者可关注相关基因研究进展，但无论遗传如何，培养健康习惯始终是增进寿命上限的基础。标签: 长寿 / 基因 / 研究来源: STAT News (驻欧健康记者 Andrew Joseph)时间: 2026-01-29 ~14:00 PT引用: 新模型剔除历史高死亡因素后估算，遗传对寿命遗传率约55%，较旧估计提升逾一倍。研究者指出以往未扣除传染病等外因，低估了基因作用。长寿遗传率显著提高，支持寻找抗衰老基因药物靶点。相关: 《科学》述评强调遗传贡献增大，力挺大规模“长寿基因”挖掘和多基因寿命评分，以连接基因差异与具体衰老通路。‘【实验数据】【科研转述】【医疗问题请咨询医生】新品湿疹药Amlitelimab三期有喜有忧一句话结论:赛诺菲新型湿疹生物制剂amlitelimab在两项III期试验中一种达到主要终点，约1/3中重度异位性皮炎患者皮损几乎全清；另一试验因统计口径差异未达欧盟预设阈值，且出现1例罕见皮肤癌不良事件。为什么重要:Dupixent（度普利尤单抗）即将专利到期，此备受期待的后继药物表现不一，引发业界对其全球审批前景的关注。结果显示amlitelimab有望在美获批（满足FDA要求），但在欧盟或受挫，需要更多数据证明疗效稳健和安全性。关键要点:• 药物概况: Amlitelimab是抗OX40配体的人源化单抗，可调节T细胞过度活化。赛诺菲2021年$11亿收购Kymab获得该药，定位为Dupixent升级版，特点是作用机制不同且给药频度可减至每季一次。• 试验数据: 两项多中心III期试验（代号SHORE和COAST-2）入组中重度湿疹患者，对比amlitelimab不同给药方案与安慰剂。SHORE试验达主要终点：12周或4周给药组约28%-33%患者达临床皮损清除或近清除，与安慰剂组相比差异显著。COAST-2试验中，每12周给药组达清除比例28%，对比安慰剂19%，按欧洲EMA统计法未达显著性（美FDA统计则可以）。• 安全信号: 为评估长效安全性，赛诺菲同步进行了ATLANTIS 2期安全研究，结果提示疗效随治疗持续有进一步提升且1年未见效 plateau。但其中1例amlitelimab组患者出现Kaposi肉瘤（一种与皮损相关的皮肤癌），引发潜在免疫抑制顾虑，FDA可能要求标注黑框警告。总体停药不良率低，注射部位反应等与同类药相当。适用与避坑:• 适用人群: 针对现有Dupixent效果不佳或需更长给药间隔的中重度特应性皮炎（湿疹）成人患者。amlitelimab若获批，可能成为需季注射的新选择。由于其作用免疫通路不同，可作为Dupixent替代或序贯治疗选项。但安全性监测仍很重要，特别关注长期肿瘤发生风险。• 临床建议: 在amlitelimab上市前，患者应继续标准疗法（Dupixent等或JAK抑制剂）控制病情。切勿自行停药等待新药，以免湿疹恶化。未来若使用amlitelimab，需定期皮肤检查排查肿瘤迹象。如有不明皮损应及时报告医生。标签: 湿疹 / 生物制剂 / 临床试验 / 皮肤病来源: BioPharma Dive 深度报道 (记者 Jonathan Gardner)时间: 2026-01-23 ~08:30 PT引用: 赛诺菲公布III期数据显示：amlitelimab联合外用激素让约四分之一到三分之一湿疹患者皮损近乎全清（IGA评分0/1），满足FDA疗效要求；但按欧盟算法仅28%对19%（药物 vs 安慰剂），未达显著性。安全研究中观察到1例Kaposi肉瘤病例，料将触发FDA黑框警示。相关: Amgen同靶点抗OX40L药物因2024年数据不佳一度令市场预期降温。赛诺菲此次结果喜忧参半，其股票在消息发布后波动。分析师认为amlitelimab凭剂型和剂量优势有望在美获批，但欧盟审评恐更严格，需等待年内更多III期结果。【实验数据】【科研转述】【非医疗建议】【非上市药物】【医疗问题请咨询医生】【小改变大作用:多睡5分钟可延寿一年一句话结论:英澳合作研究表明，对于生活方式较差者，每天增加5分钟睡眠、2分钟运动并每周多吃一份蔬菜，可使预期寿命理论上延长约一年，同时健康寿命（无重大疾病年限）延长四年。为什么重要:研究挑战了“必须大幅改变才能变健康”的观念，证明即使微小调整也能带来实质健康收益。这为大众尤其是忙碌人群提供了更易坚持的改善策略，有望提高全民执行健康生活方式的积极性。关键要点:• 研究设计: 发表在 eClinicalMedicine 的这项队列研究跟踪了近6万名英国成年受试者约8年。利用可穿戴设备记录睡眠和活动，结合饮食问卷，估算生活方式细微变化对寿命及“健康寿命”（无心脏病、糖尿病、痴呆等）影响。• 主要发现: 与基础习惯较差者相比，每日额外5分钟睡眠、2分钟中等运动、每周多1份蔬菜（或少吃1份加工肉），预期寿命增加约1年。若每日增睡24分钟、增运动4分钟、日加1杯蔬菜和一份全谷物，则健康寿命可延长约4年。• 联合效应: 结果凸显综合改善的重要性：只改善睡眠需延长60%时间才达同效果，而单改饮食不足以显著影响寿命。三管齐下的小调整便可达到可观收益，表明睡眠、运动、饮食在健康延年上有协同作用。适用与避坑:• 适用场景: 适合感觉难以坚持“大改造”的普通人群，将目标拆解为小任务。比如每天提早上床5-10分钟或午睡补眠，饭后快走2分钟，正餐添一份时令蔬菜等。这些小改变更易融入日常且长期坚持。• 注意事项: 小改变累计效应需长期坚持才能体现。切勿因为效果“不立竿见影”而放弃。并非人人都只需最小量调整：研究对象是习惯较差者，若本身已接近推荐值（如睡7小时、运动30分钟），再小幅增加收益会递减。标签: 长寿 / 健康习惯 / 营养 / 睡眠来源: Scientific American（《科苑》）健康编辑 Lauren J. Young时间: 2026-01-25 ~10:00 PT引用: 这项对英国近6万人8年随访发现：*每天额外5分钟睡眠+2分钟中等强度锻炼+每天几口蔬菜*，可令寿命延长约1年；若睡眠增24分钟、锻炼增4分钟、日添1杯蔬菜+1份全谷，则“健康寿命”延长约4年。单独增加睡眠60%才能达类似效果，强调了睡眠、运动、膳食的小幅齐改善最有效。相关: Lancet 同期另一分析（含美/瑞/挪数据）同样指出，每日多5分钟中速步行死亡风险可降10%，再次证明“小步慢跑”式改变也有重大意义。【实验数据】【科研转述】【非医疗建议】【医疗问题请咨询医生】【新闻转述】LSD单剂可缓解焦虑12周一句话结论:一项严谨的IIb期临床试验表明，一次口服100微克剂量的LSD（麦角酸）可使广泛性焦虑障碍患者的焦虑评分在12周内显著下降约7.6分，疗效明显优于安慰剂且维持时间长。为什么重要:当前焦虑症治疗需每日服药且副作用累积，而迷幻药LSD单次用药却展现出长效治疗潜力。这为难治性焦虑提供全新思路，推动精神科向“一次药＋长期疗效”模式探索。但LSD属管制药物，此发现亦引发对安全、医疗监管模式的新讨论。关键要点:• 试验设计: 该随机临床试验招募了198名中重度广泛性焦虑障碍（GAD）成人。受试者在医疗监护下单次服用不同剂量LSD（25、50、100、200 µg）或安慰剂，无额外心理治疗介入。主要疗效指标为标准焦虑评分(GAD-7)较基线变化。• 主要结果: 100 µg组焦虑症状显著改善：12周时约65%患者焦虑缓解（≥50%减分），远高于安慰剂30.8%。与安慰剂相比，100和200 µg剂量组的GAD-7评分额外降低约5-6分。100 µg被确定为最佳效益风险剂量：疗效显著且不良反应可控。• 安全考量: 高剂量LSD引发的感知改变（幻觉、视觉扭曲）在用药当天几乎100%发生。但研究观察到这些短暂效应并未导致严重不良事件，也可能与治疗作用相关。无持续性认知或情感副作用报告。不过LSD药效持续8-12小时，需要医疗环境监督以确保安全。适用与避坑:• 医疗应用: 该疗法目前仅在临床试验框架内进行，不可自行尝试。预期今年将启动更大规模III期试验。如最终证明有效安全，未来可能在受控医疗环境下用于难治性焦虑（需专家评估筛选适合患者）。• 风险提示: LSD属I类管制物，美国非法使用可能导致法律后果和健康风险。切勿擅自服用“微剂量”LSD企图自疗焦虑，因药品纯度、剂量难控且无专业陪伴，可能诱发惊恐或行为危险。任何调整焦虑治疗方案都应咨询精神科专业人士。标签: 焦虑 / 精神健康 / 迷幻疗法 / 临床试验来源: JAMA Psychiatry 2025;82(1):62-70 (Holze et al.)；ABC News 报道时间: 2025-10-21 ~11:00 PT引用: JAMA刊登IIb期试验结果：单次服用100 µg LSD后，患者GAD-7焦虑评分在12周随访时平均降低约5-6分，而安慰剂组改善有限。65% LSD组患者症状缓解≥半数，对比安慰剂仅30.8%。药后当天大部分人出现一过性感知改变，作用持续8-12小时但未阻碍长期抗焦虑效果。相关: 这项MindMed公司赞助的研究未配套心理治疗，暗示药物本身即可赋予长效抗焦虑效应。专家称其设计严谨、结果“令人印象深刻”，并指LSD时长可达12小时，建议日后治疗应在医疗机构进行以确保安全。【实验数据】【科研转述】【非医疗建议】【非上市药物】【医疗问题请咨询医生】2026医美科技趋势:深层焕肤, AI赋能一句话结论:在2025年末美国皮肤外科年会上，多位专家展望2026年医美热点：新一代微创焕肤技术（如Acclaro装置）可更深层重塑胶原且恢复期更短；激光“打孔”(Laser Coring)崭露头角用于顽固皱纹治疗但仍待改进恢复；AI智能广泛融入镭射脉冲调控等，提高疗效精准度。为什么重要:医美技术推陈出新正改变“抗衰老”方案。从业者需紧跟前沿以提供最新安全高效服务。消费者亦应知晓这些创新，以在追求美容时作出更明智选择。这些趋势还反映皮肤科逐步与全身抗衰理念接轨，未来或出现“皮肤+整体健康”一体化护理。关键要点:• 胶原重塑新设备: 专家Tina Alster提到一款名为Acclaro的新型点阵微针设备，可较传统射频/镭射更深“钻入”真皮诱导胶原新生。其针对口周细纹和粗大毛孔效果突出，且仅需局麻，术后恢复更快。• Laser Coring激光打孔: Mary Lupo医生强调了UltraClear铥激光平台的多功能性。它既可实现无恢复期的浅表换肤“三维奇迹”（3D Miracle），又可提供深入真皮的激光打孔疗法处理顽固皱纹和瘢痕。Alster表示目前仍关注打孔后的愈合改善，但安全性提升后此技术将更受瞩目。• AI与再生医学: Daniel Schlessinger指出，AI算法已用于调整镭射脉冲间隔、能量等参数，量身定制治疗方案，提升安全系数。同时“抗衰老医学”理念渗入皮肤科，预计未来医生将整合激光、注射等治疗与营养补充、激素调节等全身疗法，为患者提供全面的青春管理。适用与避坑:• 求美者: 若考虑2026年进行换肤抗衰，可咨询医生这些新技术的适用性。Acclaro等适合聚焦改善细纹、毛孔且耐受微创的患者。Laser coring针对深皱但需谨慎，确保由有经验医生操作且做好恢复管理。AI辅助的个性化方案值得关注，但应避免被营销噱头误导，选择正规机构。• 从业者: 建议皮肤科医生和医美机构及时培训掌握新设备，尤其注意新技术的安全界限。比如激光打孔能量深浅、频次需基于循证调整，AI参数建议先验证可靠性。对于再生医学跨学科手段，要谨记合法合规使用补充剂或药物，确保整体抗衰概念的实施在科学证据框架内。标签: 抗衰 / 医美 / 技术创新 / AI应用来源: Dermatology Times (NewBeauty特约 Tatiana Bido 采访三位皮肤科权威)时间: 2026-01-23 ~15:00 PT引用: “下一代焕肤设备正在实现更深层次的胶原重塑，伴随更短恢复期”；“激光打孔(UltraClear)被视为明年值得关注的新技术，但专家仍对其恢复期保持观望”；“AI正日益影响皮肤治疗，从镭射脉冲调控到个性化疗程规划”。相关: 另一趋势是“所有肤色通吃”的设备受青睐。专家强调2026年器械必须兼顾不同肤色安全有效，以拓展患者群并提升机构收益。此外微创线雕、脂肪填充等再生疗法也在融合传统医美，为患者提供更自然的年轻化效果。【非医疗建议】【医疗问题请咨询医生】【新闻转述】间歇快食时段无关功效,控制热量是关键一句话结论: 发表在 Science Translational Medicine 的对照试验发现，无论将每日进食窗口安排在早间(8时-16时)还是午后(13时-21时)，对代谢健康指标影响几乎无差异，间歇性禁食(IF)之所以有益主要归功于总热量减少，而非进食时段本身。为什么重要:这为近年来炙手可热的IF饮食提供了科学校准。它纠正了社交媒体上关于“早吃/晚吃哪个更燃脂”之争，强调热量赤字才是减肥降糖的核心。同时提示节食族不必过度纠结进食时段，可灵活选择符合自身作息的方案，从而更易坚持。关键要点:• 研究设计: 美国一项交叉试验招募31名超重女性，让每人分别执行2周“早间进食”(8am-4pm)和2周“晚间进食”(1pm-9pm)的16:8 IF方案，中间有清除期。两阶段饮食种类和热量严格匹配，每日均摄入相同热量和营养构成。期间频繁监测血糖、脂代谢和炎症等指标。• 代谢结果: 提前/推迟进食窗口对空腹血糖、胰岛素敏感性、血脂和炎症指标均无显著差异。两个时段方案下代谢指标的细微变化都不明显，显示只要总热量和营养一致，进食时段并不额外改变机体代谢状态。• 其他影响: 唯一差异是进食时段影响了受试者生物钟：晚间进食组参与者内在昼夜节律向后移约40分钟，并且倾向于更晚入睡起床。睡眠时长及质量有些许影响，但对代谢无长期不利效果。适用与避坑:• 实用建议: 想尝试IF减肥者应优先确保热量摄入低于消耗。进食窗口可根据自身生活安排选择早段或晚段，遵循规律即可。无需迷信“过午不食”或“一早进餐提高代谢”此类说法，关键是守住每日总热量和营养均衡。• 注意事项: 尽管进食时间弹性大，但长期深夜进食仍不建议，因为晚睡晚起可能影响社交和工作。此外个体差异存在，如有些人晚吃会睡眠不佳，需因人调整。如在IF过程中出现严重饥饿、头晕等，应及时就医评估，不要勉强坚持。标签: 减肥 / 营养 / 间歇性禁食 / 生物节律来源: Science Translational Medicine 2026论文；Women's Health 杂志报道时间: 2026-01-07 ~10:30 PT引用: 新研究表明，IF饮食窗口设在早上或下午对减肥代谢效果差别不大，健康益处主要来自热量摄入减少而非用餐时段本身。参与者代谢指标如胰岛素敏感性在早/晚进食方案间无显著变化，之前IF益处的研究多归因于热量限制。相关: 近期一项荟萃分析也发现，与正常饮食相比，16:8 IF在6-12个月内的减重并无统计优势，但IF组因自发性摄食减少而达到类似减重效果。这进一步支持“吃得少才是王道”，时间安排只是次要因素。【实验数据】【科研转述】【非医疗建议】【医疗问题请咨询医生】【新闻转述】NIVEA润肤霜百年首改配方更可持续一句话结论: 德国拜尔斯道夫公司宣布对其百年经典“NIVEA Crème”首次重大配方改革，推出天然触感的“NIVEA Creme Natural Touch”系列，以生物可降解成分和可再生原料替代石化成分，兼顾消费者情感与净零环保目标。为什么重要:NIVEA蓝罐自1911年诞生以来配方几乎未变，是几代消费者的记忆。此次改方标志传统品牌向可持续转型的里程碑。既能满足现代用户对“纯净美容”的期待，又显示大企业在气候承诺(Net Zero 2045)下的创新实践，对行业老字号有示范意义。关键要点:• 升级亮点: 新版NIVEA采用植物来源的油脂替代矿物油，乳化剂和防腐体系也换成易生物降解的天然选项，保留了经典滋润度和膏体质地。包装容器部分由回收塑料制成，可循环再生。GM兼任研发总监Christian Haensch称其“在传承与创新间找到平衡”。• 市场定位: 新系列并非替代原版，而是作为环保升级版上线，以满足注重成分纯净及环保的年轻消费群。拜尔斯道夫称这体现公司Net Zero 2045路线图的一环，希望以此引领护肤品传统与可持续并行的新潮流。• 情感营销: 品牌强调Natural Touch不仅是配方调整，更承载了与消费者的情感延续。宣传中打出“传统与责任携手”的口号，旨在让老用户安心尝试新配方，同时吸引注重环保的新用户群体。适用与避坑:• 适用人群: 喜爱NIVEA经典滋润霜但介意矿物油、防腐剂的消费者可尝试新版本，质地亲肤滋润却无厚重油感。敏感肌在试用时留意与原版肤感区别，如有不适可停用反馈。• 避坑: 新版虽更天然，但并非完全不含可能致敏成分，天然植物提取物也可能过敏。购买时认准正规渠道“Natural Touch”标识，不要被杂牌模仿误导。对追求绝对纯天然的消费者，新版仍含少量合成成分以确保稳定，需正确理解“可持续”并非等于“100%纯天然”。标签: 护肤 / 经典品牌 / 可持续 / 配方升级来源: CosmeticsDesign Europe 报道 (Beiersdorf德瑞总经理访谈)时间: 2026-01-28 ~07:00 PT引用: Beiersdorf高管称“NIVEA Creme Natural Touch不只是延伸产品，更是我们Net Zero 2045承诺的体现”，新配方实现了传统与可持续的结合。NIVEA研发负责人强调“这不仅是一个系列延展，更是情感传承与创新责任同行的象征”。相关: 雅诗兰黛也在2025年更新“小棕瓶”精华配方，增加植物萃取并减塑包装，凸显高端品牌也在响应环保潮流。NIVEA作为大众市场领军，此次举措或将带动更多开架老牌启动配方革新，实现“情怀+环保”双赢。【新闻转述】返回搜狐，查看更多

专利到期并购

100 项与 Amlitelimab 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
中度特应性皮炎	临床3期	美国	Sanofi	2023-11-08
中度特应性皮炎	临床3期	中国	Sanofi	2023-11-08
中度特应性皮炎	临床3期	阿根廷	Sanofi	2023-11-08
中度特应性皮炎	临床3期	澳大利亚	Sanofi	2023-11-08
中度特应性皮炎	临床3期	巴西	Sanofi	2023-11-08
中度特应性皮炎	临床3期	加拿大	Sanofi	2023-11-08
中度特应性皮炎	临床3期	智利	Sanofi	2023-11-08
中度特应性皮炎	临床3期	法国	Sanofi	2023-11-08
中度特应性皮炎	临床3期	德国	Sanofi	2023-11-08
中度特应性皮炎	临床3期	希腊	Sanofi	2023-11-08

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临床结果

适应症

分期

评价

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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


NCT06130566 (COAST 1, NEWS) 人工标引	临床3期	特应性皮炎	-	Amlitelimab Q4W	糧膚壓齋鑰構鑰遞鹹窪(遞膚製獵膚齋襯廠艱壓) = 襯遞夢網壓衊醖膚淵糧醖鹽齋廠鑰廠觸壓繭選 (糧觸齋夢網鏇夢簾糧構 ) 更多	积极	2025-09-06
				Amlitelimab Q12W	糧膚壓齋鑰構鑰遞鹹窪(遞膚製獵膚齋襯廠艱壓) = 蓋鹹鏇醖選觸襯顧簾糧醖鹽齋廠鑰廠觸壓繭選 (糧觸齋夢網鏇夢簾糧構 ) 更多
NEWS 人工标引	临床2期	特应性皮炎	-	amlitelimab	顧淵膚積範艱鬱衊夢淵(蓋窪襯遞醖餘製積糧簾) = 鬱顧衊衊餘簾選獵艱願衊淵糧夢製鏇淵鹽網顧 (鑰蓋夢蓋廠襯醖壓壓壓 ) 达到更多	不佳	2025-09-04
				Placebo	顧淵膚積範艱鬱衊夢淵(蓋窪襯遞醖餘製積糧簾) = 選膚餘選獵簾蓋鹹夢醖衊淵糧夢製鏇淵鹽網顧 (鑰蓋夢蓋廠襯醖壓壓壓 ) 达到更多
NCT05421598 (TIDE-Asthma, Company_Website) 人工标引	临床2期	哮喘辅助	437	Amlitelimab	艱鬱襯艱製鏇窪齋鹽衊(壓鏇製構窪壓鏇獵觸膚) = the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level. 齋網鏇淵壓製蓋積獵鑰 (壓淵淵艱繭壓繭壓積襯 ) 未达到	不佳	2025-04-15
				Placebo
NCT05131477 (STREAM-AD, Pubmed) 人工标引	临床2期	特应性皮炎	580	Amlitelimab (Part 1)	製願蓋夢繭醖築願壓觸(簾襯夢鏇夢醖齋艱衊獵): P-Value = < 0.001	积极	2024-11-08
				Amlitelimab (Part 2)
NCT05131477 (STREAM-AD, GlobeNewswire) 人工标引	临床2期	特应性皮炎	390	amlitelimab (patients with continued treatment)	顧鬱顧網壓膚構獵壓製(糧獵構艱鑰選遞願蓋鏇) = 窪齋膚範製醖鬱鑰襯壓鑰範網顧糧衊糧繭餘襯 (齋製夢顧鑰觸鹽觸鑰膚 ) 更多	积极	2024-03-11
				amlitelimab (patients withdrawn from treatment)	顧鬱顧網壓膚構獵壓製(糧獵構艱鑰選遞願蓋鏇) = 選鏇網遞醖鏇膚顧鹽簾鑰範網顧糧衊糧繭餘襯 (齋製夢顧鑰觸鹽觸鑰膚 ) 更多
NCT05131477 (STREAM-AD, NEWS) 人工标引	临床2期	特应性皮炎	390	amlitelimab	築廠壓憲簾壓醖鹽醖鹽(壓齋製衊顧繭積窪廠廠) = 齋糧淵網糧鏇選遞憲襯獵鹽壓繭顧襯獵齋構齋 (膚憲鬱遞網選製蓋蓋鏇 ) 更多	积极	2023-10-15
				placebo	築廠壓憲簾壓醖鹽醖鹽(壓齋製衊顧繭積窪廠廠) = 鹹鬱網觸醖範壓鹽鏇鹹獵鹽壓繭顧襯獵齋構齋 (膚憲鬱遞網選製蓋蓋鏇 ) 更多
NCT03754309 (AAD2023)	临床2期	特应性皮炎	89	Amlitelimab low-dose	膚製構繭夢選築繭齋蓋(淵鹹網淵築積壓築蓋鏇) = 1 SAE (infected dermal cyst) was reported as possibly related; it resolved and the patient completed the study 觸積積鬱網衊襯齋淵醖 (獵鑰衊願壓衊糧醖艱醖 ) 更多	-	2023-03-17
				Amlitelimab high-dose
NCT03754309 (Phase 2a, EADV2022)	临床2期	特应性皮炎 IL-22	89	Amlitelimab low dose (200 mg loading/100 mg maintenance every 4 weeks [Q4W])	遞淵觸願製襯淵夢壓觸(觸餘壓觸壓夢憲淵願艱) = 蓋鑰簾獵鹹壓觸遞鏇製鬱積憲鹽簾淵窪鹽夢網 (範製鏇繭鹽衊繭鑰窪積 )	积极	2022-09-07
				Amlitelimab high dose (500 mg/250 mg Q4W)	遞淵觸願製襯淵夢壓觸(觸餘壓觸壓夢憲淵願艱) = 壓選鑰廠鑰鏇鑰夢遞鑰鬱積憲鹽簾淵窪鹽夢網 (範製鏇繭鹽衊繭鑰窪積 )
NCT03161288 (Pubmed \| Clin Pharmacol Ther)	临床1期	-	64	KY1005	衊獵顧鬱廠餘襯觸遞廠(淵夢蓋願範餘獵襯艱廠) = No serious adverse events occurred and all adverse events were temporary and of mild or moderate severity. 餘選簾憲壓廠糧糧觸鏇 (積齋顧憲範顧襯壓顧築 ) 更多	-	2022-01-29
				Placebo