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更新于：2026-05-30
Lepzacitinib
更新于：2026-05-30
概要
基本信息
在研机构 |
最高研发阶段临床前 |
首次获批日期- |
最高研发阶段(中国)临床前 |
特殊审评- |
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结构/序列
分子式C18H21N5O3 |
InChIKeyQQOPOYMFJLUSBI-GFCCVEGCSA-N |
CAS号2321488-47-3 |
关联
2
项与 Lepzacitinib 相关的临床试验NCT05432596
A Phase 2b, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis (AD)
This is a Phase 2b study to determine the safety, tolerability, pharmacokinetic (PK), and efficacy of ATI-1777 in patients 12 to 65 years old with mild to severe Atopic Dermatitis. Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 weeks.
开始日期2022-05-11 |
申办/合作机构 |
NCT04598269
A Phase 2a, Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of participants with moderate or severe atopic dermatitis (AD).
开始日期2020-09-30 |
申办/合作机构 |
100 项与 Lepzacitinib 相关的临床结果
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100 项与 Lepzacitinib 相关的转化医学
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100 项与 Lepzacitinib 相关的专利（医药）
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1
项与 Lepzacitinib 相关的文献（医药）2024-03-01·JID innovations : skin science from molecules to population health
ATI-1777, a Topical Jak1/3 Inhibitor, May Benefit Atopic Dermatitis without Systemic Drug Exposure: Results from Preclinical Development and Phase 2a Randomized Control Study ATI-1777-AD-201
Article
作者: Blinn, James ; Forman, Seth ; Walker, Neal ; Anderson, David ; Hope, Heidi ; Hirsch, Jeff ; Barnes, Brad ; Burt, David ; Tucker, Stephen ; Gordon, David ; Mnich, Steve ; Xu, Canxin ; Sudzina, John ; Smith, Walter ; Monahan, Joseph ; Loh, Chin-Yi ; Changelian, Paul ; Dick, Evan ; Hockerman, Susan ; Raoof, Tooraj ; Kostecki, Kourtney ; Jacobsen, Jon
Introduction:
Atopic dermatitis, a chronic, pruritic skin disease, affects 10-30% of children and up to 14% of adults in developed countries. ATI-1777, a potent and selective Jak1/3 inhibitor, was designed with multiple sites of metabolism to deliver local efficacy in the skin and limit systemic exposure. In preclinical studies, ATI-1777 selectively inhibited Jak1/3 with limited systemic exposure and without any adverse effects.
Primary objective:
The primary goal of this study was to assess the preliminary clinical efficacy of ATI-1777 topical solution in adults with moderate or severe atopic dermatitis.
Design:
ATI-1777-AD-201, a phase 2a, first-in-human, randomized, double-blind, vehicle-controlled, parallel-group study, evaluated the efficacy, safety, tolerability, and pharmacokinetics of ATI-1777 topical solution in 48 participants with atopic dermatitis over 4 weeks.
Primary endpoint:
The primary endpoint was a reduction of a modified Eczema Area and Severity Index score from baseline.
Results:
Reduction was significantly greater in the ATI-1777-treated group on day 28 than in vehicle-treated group (percentage reduction from baseline = 74.45% [standard error = 6.455] and 41.43% [standard error = 6.189], respectively [P < .001]). Average plasma concentrations of ATI-1777 were <5% of the half-maximal inhibitory concentration of ATI-1777 for inhibiting Jak1/3. No deaths or serious adverse events were reported.
Conclusion:
Topical ATI-1777 does not lead to pharmacologically relevant systemic drug exposure and may reduce clinical signs of atopic dermatitis.
Trial Registration:
The study was registered at ClinicalTrials.gov with the number NCT04598269.
41
项与 Lepzacitinib 相关的新闻（医药）2026-05-21
特应性皮炎（atopic dermatitis，AD）是一种慢性复发性、瘙痒性、炎症性皮肤病，以多形性湿疹性皮损为主要特征。虽然AD的病因和发病机制尚不完全清楚，但目前研究认为，变应原刺激、免疫学异常、皮肤屏障功能障碍、皮肤菌群紊乱和反复瘙抓刺激等因素是该病发病的重要环节。过敏性疾病患者的早期首发症状通常是AD和（或）食物过敏，而后或同时患有过敏性鼻炎、过敏性结膜炎和哮喘等特应性疾病，这种现象称为特应性进程。
2022版《特应性皮炎基层诊疗指南》指出，一般的AD治疗包括外用药物：
外用糖皮质激素（topi-cal corticosteroid，TCS）；
外用钙调磷酸酶抑制剂（topical calcineurin inhibitor，TCI）；
系统治疗：如口服抗组胺药物、免疫抑制剂、糖皮质激素等、紫外线疗法、抗微生物治疗和中医中药治疗等；
这些常常因安全性差、不良反应多、患者激素恐惧和依从性差等问题而使临床使用受限，故仍有部分AD患者尤其是中度至重度患者，治疗难以达到临床治愈的效果。
随着近些年对AD免疫学机制中相关炎症细胞、细胞因子及信号通路的深入研究，安全性好、不良反应少、临床疗效佳的新兴药物（如生物制剂和小分子靶向药物）相继面世，并逐渐进入医患的视野。这些药物具有更高选择性、更高安全性、应用前景广等特点，为AD患者带来新的希望。本文就国内外在AD治疗中已应用临床和部分尚处于临床研究阶段的生物制剂和小分子靶向药物的应用进展进行综述。
生物制剂
AD患者皮肤屏障功能往往存在受损或功能异常，使得变应原和微生物侵入皮肤，激活局部免疫反应，致使角质形成细胞等产生胸腺基质淋巴生成素（thymic stromal lymphopoie，TSLP）等炎症介质，进一步活化辅助型T细胞2（T helper 2 cell，Th2），产生白细胞介素-4（interleukin-4，IL-4）、白细胞介素-13（interleukin-13，IL-13）和白细胞介素-31（interleukin-31，IL-31）等炎症因子并介导炎症和瘙痒产生。
生物制剂可以靶向作用于以上炎症细胞和细胞因子，阻断炎症反应通路，减轻AD炎症和瘙痒症状，目前国内外已上市和部分尚处于临床研究阶段生物制剂的用法用量汇总见表1。
表1 治疗AD的靶向药物
1
度普利尤单抗（Dupilumab）
度普利尤单抗（Dupilumab），商品名为达必妥（赛诺菲，法国），是一种全人源化的抗白细胞介素-4受体α（interleukin-4 receptor α，IL-4Rα）抗体，可以阻断IL-4和IL-13信号传导。
根据一项开放标签扩展研究显示，度普利尤单抗治疗中度至重度成年AD患者的安全性和有效性长达4年，且剂量由300mg qw转为300mg q2w后的疗效仍可维持，因此可作为中重度AD患者的持续长期治疗用药。
其不良反应大多数为轻中度，常见为鼻咽炎、上呼吸道感染、口腔疱疹、结膜炎、注射部位反应和头痛。
2
曲罗芦单抗（Tralokinumab）
曲罗芦单抗（Tralokinumab），商品名为Adbry/Adtralza（利奥制药，丹麦），是一种人源化抗IL-13的免疫球蛋白G4（immunoglobulin G4，IgG4）单克隆抗体，可以抑制白细胞介素-13受体α1（interlenukin-13 receptorα1，IL-13Rα1）/IL-4Rα受体复合物形成。
根据Ⅲ期临床试验（ECZTEND）的中期分析显示，中重度成人AD患者使用曲罗芦单抗2年后，达到湿疹面积及严重程度指数（eczema area and severity index，EASI）较基线改善至少75%（EASI-75）的患者比例高达82.5%，疾病严重程度得到持续改善和长期控制，且安全性良好，不良反应大多数为轻度至中度，常见为病毒和上呼吸道感染、结膜炎和注射部位反应。
3
奈莫利珠单抗（Nemolizumab）
奈莫利珠单抗（Nemolizumab），商品名为Nemluvio（高德美，美国），是人源化抗白细胞介素-31受体α（interleukin-31 receptorα，IL-31Rα）的IgG单克隆抗体，可以抑制IL-31和IL-31Rα的结合。
两项Ⅲ期临床试验（ARCADIA 1、ARCADIA 2）研究表明，青少年和成年中重度AD患者使用奈莫利珠单抗联合TCS/TCI治疗16周后达到EASI-75的患者占比分别为43.5%和42.1%，达到研究者整体评分（investigator global assessment，IGA）0/1的患者占比分别为35.6%和37.7%，对比安慰剂联合TCS/TCI治疗组疗效差异显著。
其不良反应多为轻度至中度，常见为感染和皮肤或皮下组织疾病，包括鼻咽炎以及AD加重。
4
来瑞组单抗（Lebrikizumab）
来瑞组单抗（Lebrikizumab），商品名为Ebgliss（礼来，美国），也是一种针对IL-13的高亲和力（IgG4）单克隆抗体。
根据Ⅲ期临床试验（ADHERE）的结果，青少年中重度AD患者使用来瑞组单抗联合TCS治疗16周后，有69.5%的患者达到了EASI-75。
一项长达52周的成人中重度AD患者临床试验结果显示，达到EASI-75或更高水平的患者约占80%。
其不良反应大多为轻中度，主要包括结膜炎、鼻咽炎、头痛和注射部位反应和头痛。
5
司普奇拜单抗（Stapokibart，CM 310）
司普奇拜单抗（Stapokibart），商品名为康悦达（康诺亚生物医药科技（成都）有限公司，中国），是一种靶向IL-4Rα的人源化IgG4单克隆抗体。
一项针对中国成人中重度AD患者的Ⅲ期临床试验结果显示，治疗52周后，司普奇拜单抗组达到EASI-75、EASI-90、IGA0/1且下降≥2分和峰值瘙痒数字评定量表（peak pruritus numerical rating scale，PP-NRS）改善≥4分的患者比例分别高达92.5%、77.1%、67.3%和67.3%。
其不良反应多为轻中度，其中结膜炎发生率仅为5.3%。
6
诺卡替利单抗（Rocatinlimab，AMG 451）
诺卡替利单抗（Rocatinlimab）（安进，美国），是一种全人源抗OX40的IgG1单克隆抗体，通过抑制OX40/OX40L通路，从而抑制AD的Th2型炎症反应。
一项针对中重度成人AD患者的Ⅱb期临床试验结果显示，治疗16周后，诺卡替利单抗600mg q2w组、600mg q4w组、300mg q2w组和150mg q4w组患者的EASI分别降低57.4%、49.7%、61.1%和48.3%，且停药20周后依旧能维持疗效。
其常见不良反应包括发热、鼻咽炎、寒战、头痛、口疮性溃疡和恶心。
小分子靶向药物
小分子靶向药物通常是指分子量<1kDa的靶向药物，口服、外用途径给药方便快捷且相对成本更低，具有起效快、高应答、耐受性好、更经济便捷等特点。目前国内外已上市和部分尚处于临床研究阶段小分子靶向药物的用法用量汇总见表1。
1
Janus激酶（janus kinase，JAK）抑制剂
Janus激酶信号转导和转录激活因子（JAK-STAT）信号通路由JAK1、JAK2、JAK3及酪氨酸蛋白激酶2（tyrosine kinase 2，TYK2）和信号转导和转录激活因子（signal transducers and activators of transcription，STAT）组成，参与细胞的增殖、分化、凋亡及免疫调节等，可调节许多与AD发病相关的细胞和细胞因子。值得注意的是，FDA对所有JAK抑制剂都提出了“黑框警告”，提示使用中可能会出现血液系统、恶性肿瘤等严重不良事件，临床上用药前后要注意动态监测血常规、肝肾功能、血脂、凝血功能、结核杆菌感染、乙肝和丙肝病毒感染、胸部放射影像检查等，以确保用药安全。
（1）巴瑞替尼（Baricitinib）
巴瑞替尼（Baricitinib），商品名为艾乐明（Olumiant）（礼来，美国），是一种选择性JAK1/2抑制剂，是首个被批准用于治疗AD的JAK抑制剂。
一项巴瑞替尼联合局部TCS治疗>2岁的儿童和青少年中重度AD患者的Ⅲ期临床试验（BREEZE-AD PEDS）显示，第16周时，巴瑞替尼组达到vIGA0/1、EASI-75、EASI-90、特应性皮炎评分（SCORing atopic dermatitis，SCORAD）-75和NRS改善≥4分等主要终点的患者比例显著高于安慰剂组。
常见的不良反应包括腹痛、痤疮、头痛、腹泻、鼻咽炎和上呼吸道感染，未发现严重不良事件。
（2）乌帕替尼（Upadacitinib）
乌帕替尼（Upadacitinib），商品名为瑞福（Rinvoq）（艾伯维，爱尔兰），是一种口服高选择性JAK1抑制剂。
一项中重度青少年AD患者使用乌帕替尼临床试验的荟萃分析表明，乌帕替尼15mg和30mg组的患者在EASI-75、NRS改善≥4分和IGA0/1方面显著优于安慰剂组。虽然与安慰剂组相比，15mg和30mg乌帕替尼组不良反应发生率增加，但严重不良事件方面的安全性没有显著差异。
其不良反应多为轻中度，包括上呼吸道感染、痤疮、单纯疱疹、头痛、肌酸磷酸激酶水平升高、带状疱疹、贫血和中性粒细胞减少等。
（3）阿布昔替尼（Abrocitinib）
阿布昔替尼（Abrocitinib），商品名为希必可（Cibinqo）（辉瑞，德国），也是一种口服的第二代高选择性的JAK1抑制剂。
一项中重度青少年和成人AD患者使用阿布昔替尼的系统综述和荟萃分析结果显示，阿布昔替尼组患者较安慰剂组在IGA、EASI、NRS和特应性皮炎/湿疹自我检查评分量表（patient-oriented eczema measure，POEM）方面有显著统计学差异。
不良反应多为轻中度，主要有恶心、头痛、痤疮等。
（4）艾玛昔替尼（Ivarmacitinib，SHR0302）
艾玛昔替尼（Ivarmacitinib），商品名为艾速达（江苏恒瑞医药股份有限公司，中国），是国内自主研发的第二代口服高选择性JAK1抑制剂。
一项Ⅱ期临床试验结果表明，中重度AD患者治疗第12周后，艾玛昔替尼4mg组、8mg组分别有26%和54%、51%和74%、66%和74%患者达到IGA0/1、EASI-75和NRS-3，而安慰剂组分别为5.7%、23%和23%。
其不良反应可见血肌酸磷酸激酶升高、血压升高、上呼吸道感染、毛囊炎等，艾玛昔替尼8mg组不良反应的发生率较高，但未见严重不良反应。
（5）ICP-332
ICP-332是一种口服的高选择性的TYK2抑制剂。
一项Ⅱ期试验评价了口服ICP-332 80mg或120mg在中重度AD患者中的疗效和安全性，治疗4周后，ICP-332 80mg组和120mg组患者的EASI较基线改善平均百分比达到78.2%和72.5%，且ICP-332 80mg组中分别有44.0%的患者达到EASI-90和36.0%的患者达到IGA0/1且较基线改善≥2分，均显著优于安慰剂组。
其不良反应为轻度或中度，包括高尿酸血症、高胆固醇血症、凝血酶时间延长和纤维蛋白原水平降低，未出现严重不良事件。
（6）迪高替尼（Delgocitinib）
迪高替尼（Delgocitinib），商品名为Corectim（鸟居制药，日本），是全球首个局部外用的泛JAK抑制剂。
一项长达52周的开放标签Ⅲ期临床研究评估了6~24个月的日本AD婴儿使用迪高替尼软膏的有效性和安全性，治疗期间，患儿的改良湿疹面积和严重程度指数评分（modified eczema area and severity index，mEASI）较基线改善百分比呈持续下降趋势。
常见不良反应为常见的婴幼儿疾病，如鼻咽炎、发热、手足口病和呼吸道合胞病毒感染等。
（7）芦可替尼（Ruxolitinib）
芦可替尼（Ruxolitinib），商品名为Opzelura（因塞特，美国），是一种外用的第一代JAK1/2抑制剂。
Ⅲ期临床研究（TRuE-AD3）评估了0.75%和1.5%芦可替尼乳膏在2~11岁AD患儿中的疗效和安全性，治疗8周，芦可替尼0.75%组和1.5%组AD患儿达到IGA0/1比例分别为36.6%和56.5%，均高于安慰剂组。
其常见的不良反应为鼻咽炎和上呼吸道感染，其中常见与治疗相关的不良反应为局部烧灼感。
（8）布雷西替尼（Brepocitinib）
布雷西替尼（Brepocitinib）是一种外用小分子TYK2/JAK1抑制剂。
一项Ⅱb期临床试验探究了布雷西替尼乳膏治疗轻度至中度AD患者的疗效和安全性，治疗6周后，3%布雷西替尼qd组达到IGA0/1或改善≥2分的患者比例最高，占44.4%；0.1%布雷西替尼qd组和bid组的EASI较基线改善最显著。
常见的不良反应为鼻咽炎和AD恶化，且发生频率无剂量依赖性，无严重不良反应事件。
（9）ATI-1777
ATI-1777是一种JAK1/3抑制剂局部外用溶液。
一项Ⅱ期临床试验显示，治疗第4周时，治疗组达到EASI-75和IGA0/1且改善≥2分的中重度成人AD患者占比分别为65%和39%，而安慰剂组为24%。
治疗中未见严重不良事件。
2
磷酸二酯酶Ⅳ（phosphodiesterase-4，PED-4）
抑制剂磷酸二酯酶Ⅳ（PED-4）是一种关键的细胞内酶，PDE-4抑制剂通过抑制白细胞中PDE-4的活性来增加cAMP的浓度，降低炎症相关细胞因子的表达。
（1）克立硼罗（Crisaborole）
克立硼罗（Crisaborole），商品名为舒坦明（Staquis）（安纳考尔，美国），是首个非激素外用PDE-4抑制剂。
一项为期52周的Ⅲ期临床试验（CrisADe CONTROL）结果显示，克立硼罗组患者较安慰剂组的中位无复发时间更长、平均无发作天数更久且平均发作次数较低。
最常见的不良反应为给药部位疼痛。克立硼罗避免了TCS和TCI的常见不良反应和限制性（不可用于皮肤薄嫩部位和褶皱部位），是一种潜在的缓解AD发作和长期维持治疗的选择。
（2）地法米司特（Difamilast）
地法米司特（Difamilast），商品名为Moizerto（大冢制药，日本），是一种高选择性的PDE-4B抑制剂。
一项为期52周的针对3～24个月日本AD婴儿的Ⅲ期临床试验中期报告显示，地法米司特组达到EASI-75患者占比78.1%、IGA缓解率为63.4%，不良反应大多为轻度或中度。
常见的不良反应为鼻咽炎和胃肠炎，未报告药物相关和导致停药的不良反应。
（3）罗氟司特（Roflumilast）
罗氟司特（Roflumilast），商品名为Zoryve（阿库图斯，美国），是一种不含类固醇的新一代外用PDE-4抑制剂。
两项为期4周的Ⅲ期临床试验（INTEGUMENT-1和INTEGU-MENT-2）显示，两项试验中罗氟司特组达到IGA0/1且较基线改善≥2分的6岁及以上儿童和成人轻中度AD患者占比分别为32.0%和28.9%、达到EASI-75的患者占比分别为43.2%和42%，均高于安慰剂组。
不良反应大多数为轻中度，常见的有头痛、恶心、应用部位疼痛、腹泻和呕吐。
（4）阿普米司特（Apremilast）
阿普米司特（Apremilast），商品名为欧泰乐（Otezla）（安进，美国），是一种新型口服PDE-4抑制剂。
一项阿普米司特联合度普利尤单抗治疗顽固性中重度AD患者的临床研究显示，治疗16周时，患者NRS和EASI较基线的平均百分比变化显著。
阿普米司特联合度普利尤单抗可能是一种对顽固性AD患者有效的治疗方法。
（5）依硼米司特（Idrebormilast，PF-07038124）
依硼米司特（Idrebormilast）是一种局部外用PDE-4抑制剂。
一项Ⅱa期临床研究显示，第6周时，依硼米司特治疗组达到IGA 0/1且较基线减少≥2分和达到NRS-4的轻中度AD成人患者比例分别为44%和41%，均高于安慰剂组，且治疗组和安慰剂组发生的不良事件没有显著差异。
3
治疗性芳香烃受体调节剂（therapeutic arly hydrocarbon receptor modulating agent，TAMA）
治疗性芳香烃受体调节剂是一种芳香烃受体（aryl hydrocarbon receptor，AhR）激动剂，可以调控T细胞的分化，降低Th2型炎症细胞因子表达，达到治疗作用。
（1）本维莫德（Benvitimod）/Tapinarof
本维莫德（Benvitimod）/Tapinarof，商品名为泽立美（上海泽德曼医药科技有限公司，中国），是一种局部外用TA-MA。
根据为期8周的Ⅲ期临床试验结果显示，本维莫德组中达到IGA 0/1且基线改善≥2分的成人和2岁以下儿童AD患者比例分别为45.4%和46.4%、达到EASI-75的患者比例分别为55.8%和59.1%、达到NRS-4的患者比例分别为56%和53%，均显著优于安慰剂组。
本维莫德不良反应大多为轻中度，常见的有毛囊炎、头痛和鼻咽炎等。
4
瞬时受体电位香草酸亚型1（transient receptor potential vanilloid，TRPV1）拮抗剂
瞬时受体电位（transient receptor potential，TPR）通道家族是一类参与感觉传导的离子通道，其中的TRPV1在瘙痒信号的传导中发挥着重要作用。
（1）Asivatrep（PAC-14028）
Asivatrep是一种外用TRPV1拮抗剂。
一项Ⅲ期临床试验结果显示，治疗8周后，Asivatrep组中达到IGA 0/1的≥12岁的轻中度AD患者占比36.0%、EASI评分平均降低44.3%，均高于安慰剂组。
其最常见的药物不良反应为鼻咽炎、荨麻疹和烧灼感，未报告严重不良事件。
总结
随着AD发病机制研究的深入和逐渐清晰，国内外研究者已发掘出很多精准治疗AD的靶点，针对不同靶点有很多生物制剂和小分子靶向药物逐渐问市。其中许多药物已被临床研究证实有显著的临床疗效。
目前已在国内获批用于治疗AD的生物制剂和小分子靶向药物：度普利尤单抗、司普奇拜单抗、乌帕替尼、阿布昔替尼和克立硼罗和本维莫德。
仅在国外获批用于治疗AD的药物：曲罗芦单抗、来瑞组单抗、奈莫利珠单抗、巴瑞替尼、迪高替尼、芦可替尼、地法米司特和罗氟司特。
目前在临床试验中表现较突出的生物制剂和小分子靶向药物：诺卡替利单抗、艾玛昔替尼ICP-332、布雷西替尼、ATI-1777、阿普米司特、依硼米司特和Asivatrep。
这些药物虽已显示出显著的临床疗效，但其长期使用和对AD患者的安全性和有效性仍需要进一步的临床数据来证明。拮抗TSLP/IL-13的双特异性抗体CM512、拮抗IL-4/IL-13/TSLP的双特异性抗体PF-07275315和PF-07264660已处于Ⅱ期临床招募中，未来拮抗多个靶点或者联合用药治疗AD或成为可能。
这些已应用于临床的新兴药物相比常规治疗更精准、更安全、更有效，但目前国内患者可选择的药物种类仍较少、对于新兴药物治疗AD的长期安全性、有效性尚不完全清楚，仍需要更多、更长期、更广泛的药物研究和临床试验数据和结论的支持，来应对不同严重程度、不同年龄层、不同临床表型和不同种族背景AD患者的治疗需求及药物所带来的不良反应。期望在不久的将来，医生可以根据患者症状、临床表型、炎症因子和信号通路等的不同为每个AD患者制订个体化的治疗方案，达到AD精准治疗。
参考文献：
[1]王欣钰,吕明珠,毛广宇,等.国内外生物制剂和小分子靶向药物治疗特应性皮炎新进展[J].内蒙古医科大学学报,2025,47(05):543-550.DOI:10.16343/j.cnki.issn.2095-512x.2025.05.014.
[2]中华医学会，中华医学会杂志社，中华医学会皮肤性病学分会，等.特应性皮炎基层诊疗指南（2022年）[J].中华全科医师杂志，2022,21(7):609-619.
[3]王丹,罗晓燕.特应性进程的机制及治疗进展[J].中国实用儿科杂志，2021,36(9):665-672.
[4]吴悠，张菡，王睿，等.小分子药物治疗特应性皮炎的研究进展[J].临床皮肤科杂志，2024,53(2):118-122.
[5]BECK L A, DELEURAN M, BISSONNETTE R, et al. Dupilumab provides acceptable safety and sustained efficacy for up to 4 years in an open-label study of adults with moderate-tosevere stopic dermatitis[J]. Am J Clin Dermatol, 2022, 23(3):393-408.
[6]SILVERBERG J I, WOLLENBERG A, REICH A, et al.Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis(ARCADIA 1 and ARCADIA 2):results from two replicate, doubleblind, randomised controlled phase 3 trials[J]. Lancet, 2024,404(10451):445-460.
[7]LIANG J, HU F, DAN M, et al. Safety and efficacy of nemolizumab for atopic dermatitis with pruritus:a systematic review and meta-regression analysis of randomized controlled trials[J].Front Immunol, 2022, 13:825312.
[8]其他略.
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临床研究临床结果
2025-05-08
- Multiple Catalysts in Immuno-Inflammatory Indications Anticipated in 2025 and 2026 - - Expected Cash Runway Extended Through the First Half of 2028 - - Phase 2 Results Received to Date from Chinese Partner CTTQ Provide Clinical Evidence of Enhanced Potency of Bosakitug (ATI-045) and Opportunity for Development Partnerships - - Investigational New Drug (IND) Application for Bispecific Antibody ATI-052 Cleared by U.S. Food and Drug Administration - WAYNE, Pa., May 08, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the first quarter of 2025 and provided a corporate update. “We are entering into a potentially transformative multi-year period for Aclaris, with important milestones throughout our business that we believe will position us for future growth,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “Ensuring successful and timely execution of our clinical programs is our priority, and given the realities of today’s financial market environment, it’s imperative that we continue to do so in a manner that efficiently utilizes our capital. As such, we’ve announced that further global development of bosakitug - our uniquely potent anti-TSLP monoclonal antibody - in respiratory indications will be dependent on partnerships. Regarding our internal programs, we expect to initiate new clinical trials with bosakitug; ATI-2138, our highly selective oral ITK/JAK3 inhibitor; and ATI-052, our potential best-in-class bispecific anti-TSLP/IL-4R antibody, for which we recently received IND clearance from the FDA. Work is also ongoing toward next-generation small molecule kinase inhibitors and biologic antagonists of immuno-inflammatory pathways to further expand our pipeline and continue our innovative work in I&I.” “Importantly, we have the cash we believe we need to execute our plan,” continued Dr. Walker. “Our expected cash runway now extends through the first half of 2028, and we will continue to practice rigorous financial stewardship with a goal of extending our runway further by exploring additional non-dilutive opportunities.” First Quarter 2025 Highlights and Recent Updates Pipeline: Bosakitug (ATI-045): Investigational Anti-TSLP monoclonal antibody Aclaris Expects to Initiate Enrollment in Placebo-Controlled Two-Arm Phase 2 Trial in Atopic Dermatitis (AD) in the Second Quarter of 2025: Based on the potency of bosakitug observed in preclinical and clinical studies to date, including the compelling results of the Phase 2a single arm trial in AD, Aclaris intends to initiate a two-arm placebo-controlled Phase 2 trial of bosakitug in approximately 90 patients with moderate-to-severe AD in the second quarter of 2025. This trial is designed to evaluate the Company’s anti-TSLP therapeutic in a placebo-controlled setting in a time- and cost-efficient manner.Results from CTTQ’s Phase 2 Trials in Respiratory Indications Support Further Development: The totality of the results received to date from Aclaris’ regional partner, Chia Tai Tianqing Pharmaceutical Group, Co., Ltd. (CTTQ) from their Phase 2 trials of bosakitug in Chinese patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and severe asthma provide additional clinical evidence of the enhanced potency of bosakitug. CTTQ has announced that they are conducting Phase 3 clinical trials of bosakitug in both indications and are currently conducting a Phase 2 trial in chronic obstructive pulmonary disease (COPD). CTTQ is responsible for the disclosure and presentation of the results of their clinical trials.Aclaris Intends to Seek Partners to Develop Bosakitug in Respiratory Indications: Aclaris’ clinical focus for bosakitug will remain on dermatological immuno-inflammatory indications. Further global (excluding China) development in respiratory indications is dependent on entering into potential partnerships. ATI-2138: Investigational oral covalent ITK/JAK3 inhibitor Top Line Results from Phase 2a Trial in AD Expected in June 2025: Dosing is complete in the single arm Phase 2a open-label trial of ATI-2138 designed to investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 in patients with moderate-to-severe AD. The Company expects to report top line results in June 2025. Potential target indications under consideration include alopecia areata (AA) and vitiligo. ATI-052: Investigational bispecific anti-TSLP/IL4R monoclonal antibody Announced Clearance of ATI-052 Investigational New Drug (IND) Application and Plan to Initiate Phase 1 Trial: Aclaris announced that the U.S. Food and Drug Administration cleared its IND application for ATI-052 in April 2025. The Company expects to initiate the placebo-controlled Phase 1a/1b trial evaluating single and multiple ascending doses of ATI-052, followed by a proof-of-concept portion in an undisclosed indication, in the second quarter of 2025. (press release here) Next Generation Kinase and Cytokine Signaling Pathway Inhibitor Development: Confirmed Plan for Next IND Submission: Preclinical work is ongoing to develop next-generation ITK inhibitors, which the Company expects to provide the basis for new INDs starting in 2026.Development of Novel Bispecific Antibodies Targeting Certain Cytokine Pathways Underway: Preclinical work is ongoing to develop next-generation bispecific antibodies utilizing the bosakitug anti-TSLP binding region paired with binding fragments targeting other undisclosed cytokine signaling pathways. Corporate: Expected Cash Runway Extends Through the First Half of 2028 and Fully Funds Preclinical and Clinical Development Plans: During the first quarter of 2025, Aclaris took certain steps to focus its pipeline investments while extending its cash runway further. In doing so, the Company continues to prioritize clinical execution and achievement of development milestones, all of which Aclaris expects to be funded by the Company’s current cash runway. Aclaris ended the first quarter of 2025 with $190.5 million in cash, cash equivalents, and marketable securities providing balance sheet strength to execute on its development plan. Aclaris' cash management policy is focused on capital preservation and holding a portfolio of securities with short-term maturities. The investment portfolio is composed of fixed income securities, primarily high-credit quality corporate debt and U.S. government securities.Injunction Against Sun Pharmaceuticals Lifted, Providing Aclaris with a Potential Additional Opportunity for Non-Dilutive Financing: In 2023, Aclaris granted Sun Pharma exclusive rights under certain patents for, among other things, the use of deuruxolitinib, Sun Pharma’s JAK inhibitor, to treat AA. The agreement included an upfront payment of $15.0 million, regulatory and commercial milestones, and royalties. In 2024, Incyte Corporation was granted a preliminary injunction against Sun Pharma, blocking Sun Pharma from launching its product LEQSELVI®. In April 2025, a U.S. Appeals Court lifted the injunction. As Aclaris has successfully executed similar financings in the past, the Company may seek to monetize this financial asset to provide additional non-dilutive financing.Provided Update on Senior Leadership: Jesse W. Hall, M.D. has been appointed as Chief Medical Officer. Dr. Hall brings decades of experience in all phases of drug development, from early development through global regulatory filings and approvals, Phase IV post-marketing surveillance obligations, and commercial launch support to Aclaris. He most recently served as Chief Medical Officer for AltruBio where he was responsible for leadership of all clinical and medical functions. (press release here) First Quarter 2025 Financial Results As of March 31, 2025, Aclaris had cash, cash equivalents and marketable securities of $190.5 million compared to $203.9 million as of December 31, 2024. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the first half of 2028, without giving effect to any potential business development transactions or financing activities. Net loss was $15.1 million for the first quarter of 2025 compared to $16.9 million for the first quarter of 2024. Total revenue was $1.5 million for the first quarter of 2025 compared to $2.4 million for the first quarter of 2024. The decrease was primarily driven by the sale of a portion of royalty payments under the Company’s agreement with Eli Lilly and Company to OCM IP Healthcare Portfolio IP, an investment vehicle for Ontario Municipal Employees Retirement System (OMERS), in July 2024. Research and development (R&D) expenses were $11.6 million for the quarter ended March 31, 2025 compared to $9.8 million for the prior year period. The increase was primarily driven by expenses related to the Company’s bosakitug program, specifically preclinical and clinical development expenses associated with startup activities for a Phase 2 trial in AD. The increase was partially offset by a reduction in development expenses for zunsemetinib and lepzacitinib and lower compensation-related expenses. General and administrative (G&A) expenses were $6.1 million for the quarter ended March 31, 2025 compared to $6.8 million for the corresponding prior year period. The decrease was primarily due to a reduction in personnel expenses as a result of lower headcount and lower termination benefits. About Aclaris Therapeutics, Inc. Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on X (formerly Twitter) at @AclarisTx and on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding its plans for its development programs for bosakitug, ATI-2138 and ATI-052, including the anticipated timing for the initiation of its Phase 2 trial of bosakitug in AD and its Phase 1 trial of ATI-052, the timing for reporting the results of its Phase 2a trial of ATI-2138 in AD, and its plans to explore additional future indications for ATI-2138 including AA and vitiligo, its plans for its preclinical development programs and timing of IND submissions, its plans to monetize the Sun Pharma financial asset, and the sufficiency of its cash, cash equivalents and marketable securities to fund its operations through the first half of 2028. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the “Risk Factors” section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2024, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Aclaris Therapeutics Contacts: Kevin BalthaserChief Financial Officer(484) 329-2178kbalthaser@aclaristx.com Will RobertsSenior Vice PresidentCorporate Communications and Investor Relations(484) 329-2125wroberts@aclaristx.com Aclaris Therapeutics, Inc.Condensed Consolidated Statements of Operations(unaudited, in thousands, except share and per share data)
Three Months Ended March 31, 2025 2024
Revenues:
Contract research $445 $657 Licensing 1,010 1,741 Total revenue 1,455 2,398
Costs and expenses:
Cost of revenue(1) 506 809 Research and development(1) 11,584 9,845 General and administrative(1) 6,139 6,844 Licensing 1,010 1,031 Revaluation of contingent consideration 300 2,800 Total costs and expenses 19,539 21,329 Loss from operations (18,084) (18,931)
Other income:
Interest income 2,166 1,990 Non-cash royalty income 833 — Total other income 2,999 1,990 Net loss $(15,085) $(16,941)Net loss per share, basic and diluted $(0.12) $(0.24)Weighted average common shares outstanding, basic and diluted 122,390,303 71,074,858
(1) Amounts include stock-based compensation expense as follows:
Cost of revenue $219 $252 Research and development 1,185 (29)General and administrative 2,131 1,866 Total stock-based compensation expense $3,535 $2,089 Aclaris Therapeutics, Inc.Selected Consolidated Balance Sheet Data(unaudited, in thousands, except share data)
March 31, December 31, 2025 2024
Cash, cash equivalents and marketable securities $190,525 $203,896Total assets $198,094 $220,327Total current liabilities $21,514 $31,596Total liabilities $54,028 $64,773Total stockholders' equity $144,066 $155,554Common stock outstanding 108,265,529 107,850,124 Aclaris Therapeutics, Inc.Selected Consolidated Cash Flow Data(unaudited, in thousands)
Three Months Ended March 31, 2025 2024
Net loss $(15,085) $(16,941)Depreciation and amortization 128 243 Stock-based compensation expense 3,535 2,089 Revaluation of contingent consideration 300 2,800 Changes in operating assets and liabilities (1,935) (9,006)Net cash used in operating activities $(13,057) $(20,815)
临床2期临床申请临床1期财报引进/卖出
2024-11-06
– First Patient Dosed in ATI-2138 Phase 2a Trial in Atopic Dermatitis As Previously Announced;Top-line Data Anticipated in First Half of 2025 – WAYNE, Pa., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2024 and provided a corporate update. "The third quarter of 2024 marked an important milestone for Aclaris with the dosing of our first patient in the Phase 2a trial of ATI-2138 for moderate to severe atopic dermatitis," said Dr. Neal Walker, Interim President & CEO and Chair of the Board of Directors of Aclaris. "This milestone, combined with our robust financial position, underscores our commitment to executing a capital-efficient development strategy." Research and Development Highlights: ITK Inhibitor Programs ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor Atopic Dermatitis (ATI-2138-AD-201): This Phase 2a open-label trial to investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 in patients with moderate to severe atopic dermatitis (AD) is ongoing. Aclaris continues to expect top-line data in the first half of 2025. ITK Selective Compound Aclaris is progressing a second generation ITK selective inhibitor to development candidate selection for autoimmune indications. Lepzacitinib (ATI-1777), an investigational topical “soft” JAK 1/3 inhibitor In January 2024, Aclaris reported positive top-line results from its Phase 2b trial of lepzacitinib in AD.Aclaris is currently seeking a global development and commercialization partner for this program (excluding Greater China). As previously announced, in 2022 Aclaris granted Pediatrix Therapeutics exclusive rights to develop and commercialize lepzacitinib in Greater China. Zunsemetinib (ATI-450), an investigational oral small molecule MK2 inhibitor Aclaris plans to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib as a potential treatment for pancreatic cancer and metastatic breast cancer. Aclaris expects these trials to be primarily funded by grants awarded to Washington University. Financial Highlights: Liquidity and Capital Resources As of September 30, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $173.4 million compared to $181.9 million as of December 31, 2023. Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund its operations into 2028, without giving effect to any potential business development transactions, financing activities or the outcome of its strategic review. Financial Results Third Quarter 2024 Net loss was $7.6 million for the third quarter of 2024 compared to $29.3 million for the third quarter of 2023.Total revenue was $4.3 million for the third quarter of 2024 compared to $9.3 million for the third quarter of 2023. The decrease was primarily driven by higher milestones earned during the prior year period compared to the current year period.Research and development (R&D) expenses were $6.0 million for the quarter ended September 30, 2024 compared to $23.9 million for the prior year period. The $17.9 million decrease was primarily the result of: Zunsemetinib development expenses associated with clinical trials in 2023, and drug candidate manufacturing costs;Costs associated with lepzacitinib preclinical development activities and a Phase 2b clinical trial for AD which was completed in January 2024;ATI-2138 development expenses, including costs associated with a Phase 1 multiple ascending dose (MAD) trial which was completed in September 2023 and other preclinical activities, which were partially offset by clinical development expenses associated with a Phase 2a clinical trial which commenced in August 2024; andLower compensation-related expenses due to a decrease in headcount and higher forfeiture credits. General and administrative (G&A) expenses were $5.7 million for the quarter ended September 30, 2024 compared to $7.1 million for the corresponding prior year period. The decrease was primarily due to a reduction in compensation-related expenses due to lower headcount and higher forfeiture credits.Licensing expenses were $1.8 million for the quarter ended September 30, 2024 compared to $7.3 million for the corresponding prior year period. The decrease was primarily due to higher milestones earned during the prior year period compared to the current year period.Revaluation of contingent consideration resulted in a $0.8 million loss for the quarter ended September 30, 2024 compared to a loss of $1.7 million for the prior year period. Year-to-date 2024 Net loss was $35.5 million for the nine months ended September 30, 2024 compared to $87.0 million for the nine months ended September 30, 2023.Total revenue was $9.5 million for the nine months ended September 30, 2024 compared to $13.7 million for the nine months ended September 30, 2023. The decrease was primarily driven by higher milestones earned during the prior year period compared to the current year period.R&D expenses were $24.6 million for the nine months ended September 30, 2024 compared to $71.7 million for the corresponding prior year period. The $47.1 million decrease was primarily the result of: Zunsemetinib development expenses associated with clinical trials in 2023, and drug candidate manufacturing costs;Costs associated with lepzacitinib preclinical development activities and a Phase 2b clinical trial for AD which was completed in January 2024;ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial which was completed in September 2023 and other preclinical activities, which were partially offset by clinical development expenses associated with a Phase 2a clinical trial which commenced in August 2024; andLower compensation-related expenses due to a decrease in headcount and higher forfeiture credits. G&A expenses were $17.2 million for the nine months ended September 30, 2024 compared to $24.2 million for the prior year period. The decrease was primarily due to a reduction in compensation-related expenses due to lower headcount and higher forfeiture credits and the recognition of bad debt expense recorded in the prior year period from Aclaris’ determination that collection of amounts due from EPI Health are uncertain as a result of their filing for Chapter 11 bankruptcy protection.Licensing expenses were $4.1 million for the nine months ended September 30, 2024 compared to $9.0 million for the prior year period. The decrease was primarily due to higher milestones earned during the prior year period compared to the current year period.Revaluation of contingent consideration resulted in a $3.8 million loss for the nine months ended September 30, 2024 compared to a gain of $0.6 million for the corresponding prior year period. About Aclaris Therapeutics, Inc. Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding its plans for its development programs, including its plans to seek a development and commercialization partner for lepzacitinib, the clinical development of ATI-2138, including the timing of top-line data, its plan to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib, the sufficiency of its cash, cash equivalents and marketable securities to fund its operations into 2028, as well as its strategic review. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2023, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Aclaris Therapeutics, Inc.Condensed Consolidated Statements of Operations(unaudited, in thousands, except share and per share data) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023Revenues:
Contract research $645 $705 $1,926 $2,469 Licensing 3,701 8,577 7,583 11,210 Total revenue 4,346 9,282 9,509 13,679
Costs and expenses:
Cost of revenue (1) 654 848 2,087 2,698 Research and development (1) 5,956 23,876 24,560 71,738 General and administrative (1) 5,653 7,091 17,249 24,198 Licensing 1,754 7,344 4,070 8,955 Revaluation of contingent consideration 800 1,700 3,800 (600)Total costs and expenses 14,817 40,859 51,766 106,989 Loss from operations (10,471) (31,577) (42,257) (93,310)Other income:
Interest income 1,991 2,316 5,850 6,320 Non-cash royalty income 894 — 894 — Total other income 2,885 2,316 6,744 6,320 Net loss $(7,586) $(29,261) $(35,513) $(86,990)Net loss per share, basic and diluted $(0.11) $(0.41) $(0.50) $(1.25)Weighted average common shares outstanding, basic and diluted 71,381,731 70,807,934 71,249,813 69,452,495 (1) Amounts include stock-based compensation expense as follows:
Cost of revenue $232 $347 $707 $1,119 Research and development 1,124 3,072 2,192 9,168 General and administrative 1,648 2,529 5,097 8,989 Total stock-based compensation expense $3,004 $5,948 $7,996 $19,276 Aclaris Therapeutics, Inc.Selected Consolidated Balance Sheet Data(unaudited, in thousands, except share data) September 30, 2024 December 31, 2023Cash, cash equivalents and marketable securities $173,436 $181,877 Total assets $182,394 $197,405 Total current liabilities $18,816 $30,952 Total liabilities $52,243 $40,226 Total stockholders’ equity $130,151 $157,179 Common stock outstanding 71,417,513 70,894,889 Aclaris Therapeutics, Inc.Selected Consolidated Cash Flow Data(unaudited, in thousands) Nine Months Ended Nine Months Ended September 30, 2024 September 30, 2023Net loss $(35,513) $(86,990)Depreciation and amortization 664 635 Stock-based compensation expense 7,996 19,276 Revaluation of contingent consideration 3,800 (600)Changes in operating assets and liabilities 11,916 (3,885)Net cash used in operating activities $(11,137) $(71,564)
Aclaris Therapeutics Contact: investors@aclaristx.com
临床2期财报引进/卖出临床1期临床结果
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 轻度特应性皮炎 | 临床2期 | 美国 | 2022-05-11 | |
| 中度特应性皮炎 | 临床2期 | 美国 | 2020-09-30 | |
| 重度特应性皮炎 | 临床2期 | 美国 | 2020-09-30 | |
| 特应性皮炎 | 临床前 | 中国 | 2024-04-18 | |
| 斑秃 | 临床前 | 美国 | 2018-12-31 | |
| 白癜风 | 临床前 | 美国 | 2018-12-09 |
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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 |
|---|
临床2期 | 250 | (2% BID) | 鑰網製膚蓋鏇齋淵鬱範(獵襯願構艱膚衊艱鏇觸) = 鏇網餘網鬱齋鹽網艱窪 壓夢蓋蓋遞膚鑰鏇範膚 (鏇淵鏇窪窪鑰構齋糧鬱 ) 更多 | 积极 | 2024-01-10 | ||
(2% QD) | 鑰網製膚蓋鏇齋淵鬱範(獵襯願構艱膚衊艱鏇觸) = 艱齋積艱糧膚餘鑰鬱選 壓夢蓋蓋遞膚鑰鏇範膚 (鏇淵鏇窪窪鑰構齋糧鬱 ) 更多 | ||||||
临床2期 | 50 | (ATI-1777) | 獵膚鏇築鹹壓鹹網選繭(獵衊範簾鏇壓觸築製範) = 網糧醖繭範繭繭顧鹽醖 築願觸積廠網選範憲壓 (遞蓋鬱醖鏇襯夢廠壓繭, 6.455) 更多 | - | 2023-09-28 | ||
Vehicle (Vehicle) | 獵膚鏇築鹹壓鹹網選繭(獵衊範簾鏇壓觸築製範) = 襯獵齋築顧觸糧窪範鬱 築願觸積廠網選範憲壓 (遞蓋鬱醖鏇襯夢廠壓繭, 6.189) 更多 | ||||||
临床2期 | 50 | 構觸衊襯築鹽襯壓壓獵(獵淵窪淵觸夢艱製鏇構) = 淵壓衊齋鏇糧製製廠範 壓襯觸願淵餘鬱選壓獵 (構選鹽簾鹽蓋簾鏇齋獵 ) 更多 | 积极 | 2021-06-08 | |||
Placebo | 構觸衊襯築鹽襯壓壓獵(獵淵窪淵觸夢艱製鏇構) = 襯齋夢夢遞顧窪艱憲築 壓襯觸願淵餘鬱選壓獵 (構選鹽簾鹽蓋簾鏇齋獵 ) 更多 |
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