A Phase 1b, Open-label, Randomized, Multicenter, Active Comparator Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Combination of APG777 + APG990 in Adults With Moderate-to-Severe Atopic Dermatitis

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults with moderate-to-severe atopic dermatitis (AD), in comparison to dupilumab. The duration of the study will be approximately 82 weeks for each participant and will consist of a Screening Period (up to 6 weeks), Treatment Period (Baseline-Week 24), and Follow-up Period (Week 28-Week 76).

开始日期2025-06-04

申办/合作机构

Apogee Therapeutics, Inc.

NCT07003425

/ Recruiting临床2期

A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777

This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).
The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.
This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.

开始日期2025-05-14

申办/合作机构

Apogee Therapeutics, Inc.

NCT06920901

/ Active, not recruiting临床1期

A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma.
The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.

开始日期2025-03-27

申办/合作机构

Apogee Therapeutics, Inc.

100 项与祖米洛基巴特相关的临床结果

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100 项与祖米洛基巴特相关的转化医学

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100 项与祖米洛基巴特相关的专利（医药）

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项与祖米洛基巴特相关的文献（医药）

2026-03-23·Cureus 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.

2025-12-01·CTS-Clinical and Translational Science

A First‐in‐Human, Single‐ and Multiple‐Dose Study of APG777 , a Half‐Life‐Extended Anti‐ IL ‐13 Monoclonal Antibody, in Healthy Volunteers

Article

作者: Thankamony, Sai ; Winter, Erica ; Nograles, Kristine ; Zhang, Zhi‐Qiang ; Lim, Xiu Qin ; Dillinger, Lukas ; Dambkowski, Carl L. ; Xu, Jiahong

ABSTRACT:

Interleukin (IL)‐13 plays a central role in Type 2 inflammation, contributing to the pathogenesis of atopic dermatitis, asthma, and related inflammatory diseases. APG777 is a novel anti‐IL‐13 monoclonal antibody engineered for improved pharmacokinetics and reduced dosing frequency. This first‐in‐human, randomized, double‐blind, placebo‐controlled phase 1 study evaluated the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple subcutaneous doses of APG777 in healthy adults. Forty participants were enrolled in single ascending dose (300–1200 mg) and multiple dose (300 mg × 2) cohorts. APG777 was well tolerated, with only mild‐to‐moderate treatment‐emergent adverse events, predominantly unrelated to the study drug. No serious or severe drug‐related treatment‐emergent adverse events occurred. Following single doses, APG777 exhibited dose‐proportional increases in Cmax and area under the curve, with a terminal half‐life ranging from 75.3 to 77.5 days across the dose range tested. Immunogenicity was low, with anti‐drug antibodies detected in 23.3% of treated participants, generally without impact on pharmacokinetics or safety. APG777 led to rapid and durable inhibition of the IL‐13‐driven biomarkers phosphorylated signal transducer and activator of transcription 6 (pSTAT6), thymus and activation‐regulated chemokine (TARC), and immunoglobulin E (IgE), with near‐complete suppression of pSTAT6 observed for up to 12 months post‐dose. The safety and optimized pharmacokinetic profile of APG777 supports evaluation of extended dosing intervals (every 3–6 months) and higher exposures, which could improve outcomes and reduce injection burden in patients with Type 2 inflammatory diseases including atopic dermatitis and asthma.

2025-12-01·INTERNATIONAL JOURNAL OF TOXICOLOGY

Preclinical Safety of APG777, A Novel Extended Half-Life Anti-Interleukin-13 Monoclonal Antibody, in Cynomolgus Monkeys

Article

作者: Rubio, Daniel ; Badger, Drew ; Zhu, Eric ; Funk, Kathleen A. ; Thurston, Archie ; Dambkowski, Carl L. ; York, Kristina A.

Interleukin-13 (IL-13) is a cytokine implicated in the pathophysiology of type 2 inflammatory diseases and is a clinically validated target in atopic dermatitis. APG777 is a humanized IgG1 monoclonal antibody with an optimized pharmacokinetic profile. APG777 has high affinity to IL-13 and includes a triple amino acid modification (the “YTE” modification) in its Fc region that is designed to extend its half-life. The current study examined the safety and potential toxicity of APG777 when given by once-weekly subcutaneous injection for 27 weeks to cynomolgus monkeys, and the potential reversibility of any findings following a 2-month recovery period. Toxicokinetic characteristics of APG777 were also determined. APG777 exhibited dose-proportional systemic exposure, with a half-life of approximately 28 days. No APG777-related adverse effects were noted in clinical observations, body weight, ophthalmology, electrocardiogram readings, neurologic parameters, hematology, coagulation, clinical chemistry, urinalysis, organ weights, or histopathology. Anti-drug antibodies were not detected in any APG777-exposed animals. Drug accumulation was evident over the study duration; however, there were no APG777-related adverse findings in any of the parameters analyzed. The no-observed-adverse-effect level (NOAEL) was 150 mg/kg/week. These findings provide preclinical evidence supporting continued clinical development of APG777 for IL-13-mediated diseases. The extended half-life of APG777 suggests potential benefits in reducing dosing frequency compared with existing IL-13-targeting therapies, which could improve treatment adherence and patient outcomes. The safety and efficacy of APG777 are currently being investigated in a Phase 2 clinical trial (NCT06395948) in patients with moderate-to-severe atopic dermatitis.

328

项与祖米洛基巴特相关的新闻（医药）

2026-10-16

·微信

扩版图、拓纵深：乌帕替尼斑秃新适应症获批力助艾伯维改写IMSD治疗格局

近日，瑞福®（乌帕替尼）在中国获批用于治疗12岁及以上青少年和成人重度斑秃患者，迎来国内第9个获批适应症，也成为国内覆盖适应症最多的JAK抑制剂。但比“第9个”这个数字更值得关注的，是它背后正在发生的变化：在重度斑秃领域，治疗目标进一步向SALT=0（头皮毛发完全再生）迈进；在患者覆盖上，创新治疗持续向青少年乃至更低年龄人群延伸。不仅如此，其在中国用于成人和12岁及以上青少年非节段型白癜风的新适应症即将获批。把视角再拉远一步，从特应性皮炎、斑秃到白癜风，再到下一代免疫介导炎症性皮肤病（IMSD）管线，艾伯维中国皮肤领域的布局正在形成更清晰的接续。 01 从SALT≤20到SALT=0，斑秃治疗进入新阶段斑秃（AA）是一种不可预测的自身免疫性疾病，临床可表现为多种脱发模式，包括头皮突发圆形斑片状脱发，直至累及头皮、面部、眉毛及睫毛的全身毛发完全脱落。尤其是重度斑秃，不仅治疗难度更大，也会对患者的外观、心理状态及生活质量带来持续影响。流行病学数据显示，中国斑秃患病率约为0.27%，对应患者总数接近400万人，其中约30%为重度斑秃，超过100万人。斑秃患者过去主要依赖糖皮质激素和免疫抑制剂等传统疗法，传统治疗方案虽可在部分患者中实现短期应答，但长期使用不良反应累及多系统，患者耐受性差，难以支撑长期规范治疗，对重度患者效果有限且副作用明显。也正是在这一背景下，以JAK抑制剂为代表的靶向治疗开始改变重度斑秃的治疗路径。今年4月，艾伯维公布的两项III期UP-AA研究（n=1399）显示，乌帕替尼两个剂量组均达到主要终点：在第24周时，接受乌帕替尼15 mg和30 mg治疗的成人和青少年重度斑秃患者中，分别有45.2%和55.0%达到80%或以上的头皮毛发覆盖率，即SALT评分≤20，而接受安慰剂治疗的患者中仅有1.5%和3.4%达到该终点。此次研究中值得关注的是：治疗目标进一步向更高水平推进。UP-AA研究首次将SALT=0，即头皮毛发完全再生，纳入关键次要终点。第24周，30 mg组约20%的患者实现SALT=0，眉毛和睫毛再生情况也显著优于安慰剂组。从SALT≤20到SALT=0，背后体现的是重度斑秃治疗目标的进一步提升。另外，瑞福®也是国内又一款覆盖12岁及以上青少年重度斑秃患者的系统治疗药物，进一步拓展了青少年患者的治疗选择。对于疾病负担较重、长期管理需求突出的年轻患者而言，这不仅意味着多了一种新的治疗方案，也意味着重度斑秃治疗正在向更高水平的毛发再生和生活质量改善迈进。 02 扩版图、拓纵深：国内首个覆盖9个免疫领域适应症的靶向药物，乌帕替尼推动更高治疗目标落地在国内，加上此次获批斑秃，乌帕替尼共获批9个适应症。从疾病领域拓展来看，乌帕替尼已覆盖了免疫介导炎症性疾病的主要病种，形成了从皮肤（特应性皮炎、斑秃）、风湿免疫（类风湿关节炎、银屑病关节炎、强直性脊柱炎、放射学阴性中轴型脊柱关节炎、巨细胞动脉炎）到炎症性肠病（溃疡性结肠炎、克罗恩病）的完整治疗版图，成为中国免疫领域覆盖适应症最多的靶向药物。乌帕替尼治疗白癜风也已经被列入国家优先审评品种名单，有望今年获批第十个适应症。此外，乌帕替尼治疗版图的“广度”不仅停留在开拓新的免疫疾病领域，同时也将治疗进一步覆盖到更低年龄的患者。 9月23日，乌帕替尼的多关节型幼年特发性关节炎（pJIA）儿童适应症已在欧盟获批，覆盖2岁及以上患者。为了适配更低年龄儿童的用药需求，乌帕替尼还开发了口服溶液剂型。今年7月，其拟用于2岁及以上多关节型幼年特发性关节炎和幼年银屑病关节炎的口服溶液剂型被中国国家药品审评中心纳入优先审评程序，这也是瑞福®第五次获得优先审评资格。在不断拓展治疗“广度”的同时，乌帕替尼也在持续挖掘治疗“纵深”，推动更高治疗目标落地。以免疫介导炎症性皮肤病为例，在特应性皮炎中，乌帕替尼获批前，虽已有外用药、传统系统治疗和生物制剂，但部分患者仍难兼顾皮损与瘙痒控制。随着乌帕替尼等靶向药物获批应用，治疗正在从症状改善进一步走向以最小疾病活动度（MDA）为代表的多维度疾病控制，同时追求皮损清除或基本清除、无或几乎无瘙痒，让更多患者脱离瘙痒及皮损困扰，走向自在人生。在重度斑秃中，既往糖皮质激素等传统治疗存在停药易复发的局限，乌帕替尼又在研究中达成SALT=0的关键次要终点，治疗目标已进一步推进至头皮毛发完全再生。在白癜风领域，乌帕替尼于今年7月获欧盟批准，成为欧盟首个且唯一获批用于非节段型白癜风的系统药物。10月1日，艾伯维公布的两项3期临床研究Viti-Up-1和Viti-Up-2最新结果显示，患者接受乌帕替尼（15 mg，每日一次）治疗至第76周，面部和全身复色持续改善；子研究还发布了联合NB-UVB光疗的数据，为优化联合治疗方案开辟了重要路径。目前，其用于成人和12岁及以上青少年非节段型白癜风的上市申请已在中国进入优先审评程序，一旦获批，RINVOQ将成为国内首个用于白癜风的靶向系统药物，为患者带来具有临床意义的疾病控制和长期复色。凭借广泛适应症和强劲市场表现，乌帕替尼也已成为全球最畅销的JAK抑制剂之一。整体来看，乌帕替尼的拓展不只是简单增加适应症数量：一边是在疾病种类、患者年龄和治疗目标上继续扩大覆盖范围，另一边则是在特应性皮炎、重度斑秃、白癜风等疾病中不断向更高治疗目标推进，两条路径共同构成了其免疫治疗版图的继续延伸。 03 下一代产品蓄势，艾伯维持续加码皮肤免疫未来当下，在IMSD（免疫介导炎症性皮肤病）领域，艾伯维布局清晰。乌帕替尼先以特应性皮炎建立成熟的临床应用基础，再通过此次重度斑秃获批进入毛发免疫疾病领域，而正在中国推进审评的非节段型白癜风，则有望成为下一块重要拼图，逐步形成从炎症性皮肤病、毛发疾病到色素性疾病的连续布局。艾伯维也在为下一代产品提前补位。2026年6月，艾伯维宣布以约109亿美元收购Apogee，将多款处于临床阶段的、用于皮肤免疫相关疾病的候选产品纳入自身管线，为未来皮肤免疫领域建立新的产品梯队。其中，其核心押注超长半衰期抗IL‑13单抗Zumilokibart（APG777）。在2026欧洲皮肤病与性病学会年会（EADV）上，艾伯维以Late‑Breaker口头报告，该研究评估了 zumilokibart 对中重度特应性皮炎 (AD) 成年患者的疗效。据Ⅱ期APEX‑Part‑B剂量探索研究16周顶线结果呈阳性：三个给药组全部抵达主要终点，选定中剂量进入Ⅲ期开发，有望实现每季度甚至半年一次维持给药，改写AD生物制剂给药范式。单品的成功只是起点，艾伯维的真正底气在于已构建起多机制、全覆盖、强协同的免疫产品集群。

2026-10-13

·FierceBiotech

Biotech builder Paragon imports Apogee's top brass after AbbVie buyout

It’s been a busy morning for Paragon Labs. In addition to installing several members of the former leadership team of AbbVie-acquired Apogee Therapeutics, Paragon has seen its hypertension-focused spinout Velaris Therapeutics enter the public markets through an acquisition by Nasdaq-listed Alaunos Therapeutics. Four months after AbbVie announced its $10.9 billion deal to buy Apogee for its late-phase eczema drug zumilokibart, it seems like Paragon has taken its pick of the biotech’s top talent. This includes Michael Henderson, M.D., who headed up Apogee until the sale and will now take up the same role at Paragon. Henderson will be joined at Paragon by his Apogee colleagues, namely head of R&D Carl Dambkowski, M.D., chief business and financial officer Dan Mulreany, chief legal officer Matt Batters and chief people officer Emily Cox. The Apogee alumni are no strangers to Paragon. In fact, zumilokibart was originally developed at Paragon before the Boston-based biotech drug discovery hub spun out Apogee to take the anti-IL-13 antibody forward. “At Apogee, we learned a tremendous amount about what it takes to translate Paragon-discovered programs into clinical-stage medicines,” Henderson said in an Oct. 13 release. “We now have an opportunity to apply those lessons to clinical development, regulatory strategy and execution from the very start, as Paragon's programs take shape,” the newly appointed CEO said. “That means bringing all of these insights to make decisions even earlier, so the companies that license Paragon's most promising assets can bring them to patients even faster,” Henderson added. Paragon was founded by life sciences investment firm Fairmount in 2021. As well as Apogee, Paragon has spun out biotechs like inflammatory bowel disease-focused Spyre Therapeutics and Oruka Therapeutics, whose long-acting plaque psoriasis candidate could pose a threat to AbbVie’s Skyrizi. Paragon had some other news to share about another one of its spinouts, Velaris Therapeutics, which has been acquired by Nasdaq-listed Alaunos Therapeutics. The combined company will be focused on Velaris’ pipeline of ActRIIA-Fc ligand traps and complementary biologics designed to address signaling imbalances that drive remodeling of blood vessels in the lungs in multiple cardiopulmonary conditions. These plans will be bankrolled by a $350 million private placement led by Fairmount, which is expected to fund the combined company into 2029. Velaris’ pipeline comes from Paragon and is headed up by VLR199, an ActRIIA-Fc ligand trap designed to improve on Merck & Co.’s activin signaling inhibitor Winrevair as a treatment for pulmonary arterial hypertension (PAH). Henderson, who has also been appointed president of Velaris, said the company aims to “transform the treatment of pulmonary hypertension, starting with PAH.” “We’ve built a capital-efficient plan to rapidly achieve proof-of-concept in PAH and demonstrate value,” Henderson added. “With a pipeline built to provide optionality around ligand traps, to address complementary signaling pathways, and to offer compelling follow-on opportunities beyond PAH, we are excited for this next chapter.”

并购

2026-10-10

·得码学苑

EADV 2026丨LBN专场深度解读：从双特异性抗体到5年长程数据，谁将引领下一代AD疗法？

在2026年欧洲皮肤病与性病学会（EADV）年会LBN（Late-Breaking News）专场上，多项针对中重度特应性皮炎（AD）的前沿临床研究重磅公布，涵盖了双特异性抗体、半衰期延长型单抗以及长期随访数据，为AD治疗策略的优化提供了重要循证依据。本文将对四项关键研究进行系统梳理与深度解读。 01 Lunsekimig：双靶点抑制TSLP与IL-13的初步探索 Robert Bissonnette教授汇报的VELVET Ⅱb期研究，评估了新型五价双特异性NANOBODY®分子lunsekimig（SAR443765）在中重度AD患者中的疗效与安全性。该分子同时阻断胸腺基质淋巴生成素（TSLP）和IL-13——AD炎症的两个关键驱动因子。研究纳入对局部治疗应答不足或不适合局部治疗的成人（18–80岁）中重度AD患者，按3:1:3:1:3:1随机分配至lunsekimig 300mg每4周（Q4W，n=37）或匹配安慰剂、300mg每2周（Q2W，n=36）或匹配安慰剂、600mg每4周（Q4W，n=38）或匹配安慰剂，三个安慰剂组合并为统一安慰剂组（n=39）。主要终点为从基线至第24周EASI评分的百分比变化。关键次要终点包括EASI-75应答率、vIGA-AD 0/1且较基线改善≥2分的比例，以及每周平均PP-NRS较基线下降≥4分的比例。多重校正采用预设分层检验序列，单侧α=0.025。基线人口学与疾病特征在各组间均衡。主要终点未达到统计学显著性，但所有lunsekimig治疗组EASI下降幅度均数值上大于安慰剂（表1）：300mg Q4W组平均变化-67.7%，300mg Q2W组-61.9%，600mg Q4W组-53.8%，而安慰剂组为-43.7%。关键次要终点方面，安慰剂校正后的EASI-75应答率在300mg Q4W、300mg Q2W、600mg Q4W组分别为44.5%、41.1%、21.9%；安慰剂校正后的vIGA-AD 0/1应答率分别为25.0%、24.0%、8.9%。其他次要终点同样显示lunsekimig优于安慰剂。PP-NRS未见具有临床意义的差异。表1 lunsekimig在第24周的疗效安全性方面，lunsekimig耐受性良好。合并lunsekimig组中，严重不良事件、重度治疗期不良事件（TEAE）及导致停药TEAE的发生率均低于5%。最常见的TEAE为注射部位反应。结论指出，虽然主要终点未达成，但lunsekimig在多项皮肤清除与疾病严重度指标上显示出具有临床意义的数值改善，且所有剂量均耐受良好。研究认为有必要进一步探索TSLP/IL-13双重抑制在AD中的作用。 02 Zumilokibart：半衰期延长型抗IL-13抗体实现快速且显著的疗效 Melinda Gooderham教授汇报的APEX Part B剂量方案探索研究，评估了新型半衰期延长型抗IL-13抗体zumilokibart（APG777）在中重度AD成人患者中的疗效与安全性。该药物通过仅需诱导期4次给药、维持期每年仅2或4次给药的设计，实现早期峰值与持久暴露。在针对成人中重度AD的Ⅱ期 APEX Part A 概念验证研究中，zumilokibart 治疗可迅速改善皮肤体征和瘙痒，并且在每 12 周和每 24 周一次给药方案下，临床应答可持续至第 52 周。 APEX Part B是一项随机、双盲、安慰剂对照的Ⅱ期研究，纳入EASI≥16、vIGA-AD≥3、BSA≥10%的成人患者（N=346），按1:1:1:1分配至低、中、高剂量zumilokibart方案或安慰剂组，诱导期16周。中剂量方案与APEX Part A探索的诱导方案一致。主要终点为第16周EASI-75应答率。次要终点包括：EASI较基线的百分比变化、vIGA-AD 0/1且较基线改善≥2分、EASI-90、EASI-100以及瘙痒数字评分量表改善≥4分（I-NRS4）。缺失数据采用MCMC多重插补，因使用补救药物或疗效不足导致停药者按无应答处理。结果显示，所有三个zumilokibart剂量组均达到主要终点，第16周EASI-75应答率分别为：低剂量组50.5%、中剂量组65.9%、高剂量组61.6%，而安慰剂组仅23.4%，所有p<0.001（图1）。中、高剂量组疗效相似，低剂量组临床活性相对较低。中剂量与高剂量组在所有次要终点上均显著优于安慰剂（表2）。值得注意的是，中剂量组早在第1周EASI百分比变化即显著优于安慰剂，第2周I-NRS即显著改善。图1 第16周时，各剂量组及安慰剂组的EASI-75应答率表2 第16周的疗效结局指标安全性方面，至第16周各治疗组不良事件发生率均衡。安慰剂组TEAE发生率为67.0%，低、中、高剂量组分别为75.6%、60.0%、67.8%；严重TEAE发生率分别为2.3%、2.3%、1.2%、3.4%。最常见的TEAE（任一治疗组发生率≥5%）包括鼻咽炎、头痛、非感染性结膜炎、上呼吸道感染、特应性皮炎加重及尿路感染。结论强调，zumilokibart治疗在第16周实现快速且统计学显著的皮肤病变与瘙痒改善，部分患者达到完全皮肤清除，安全性特征与已获批的IL-13或IL-4/IL-13靶向疗法基本一致。这些数据支持选择中剂量方案进入Ⅲ期开发，并进一步评估每12周或每24周维持给药在成人中重度AD中的应用。 03 Lebrikizumab 5年长期数据：持续疗效与稳定安全性 Stephan Weidinger教授汇报的ADlong长期扩展试验，报告了lebrikizumab（一种IL-13抑制剂）治疗中重度AD长达5年的疗效与安全性数据。纳入来自母试验（ADvocate1、ADvocate2、ADhere、ADore）的成年与青少年（12-17岁，≥40kg）患者，无论第16周应答如何，均可进入ADjoin 100周扩展研究。完成ADjoin后，德国与波兰的患者继续进入ADlong（NCT05916365）为期2年（108周）的开放标签扩展，接受lebrikizumab 250mg每4周（Q4W）给药，若未维持临床获益，研究者可酌情上调至每2周（Q2W）。允许局部糖皮质激素用于AD急性发作。主要终点为因TEAE导致的停药（以暴露校正发生率EAIR/100人年报告）。疗效终点包括基线及第108周的EASI-75、IGA 0/1、EASI-90、EASI≤7、瘙痒NRS≤4及瘙痒NRS 0/1。因疗效不足而停药者按无应答插补，其他脱落/缺失数据采用多重插补。共174名ADjoin完成者入组ADlong（来自ADvocate1 n=59、ADvocate2 n=36、ADhere n=23、ADore n=56）。在ADlong期间，因TEAE停药的EAIR/100人年为2.0（n=5）；任何TEAE的EAIR为70.8，其中轻度/中度/重度分别为11.2/33.2/2.3；严重TEAE的EAIR为2.9。无死亡报告。疗效方面，ADlong基线时，93.1%患者维持或达到EASI-75，第108周时为92.9%；IGA 0/1基线为70.7%，第108周为66.7%；EASI-90基线为79.9%，第108周为73.8%；EASI≤7基线为92.5%，第108周为89.8%；瘙痒NRS≤4基线为78.3%，第108周为78.0%；瘙痒NRS 0/1基线为31.6%，第108周为31.7%。有39/174（22.4%）患者经历了至少一次上调至Q2W，其中9/39（23.1%）后又回到Q4W。结论指出，lebrikizumab长期安全性特征与既往研究一致，在长达5年的暴露中，TEAE相关停药率低，无新安全信号。绝大多数ADlong患者（至5年lebrikizumab暴露）在第108周仍以Q4W给药维持高水平的皮肤与瘙痒应答。 04 Lebrikizumab在手部与足部特应性皮炎中的突破性疗效 Patrick Brunner教授汇报的ADTouch Ⅲb期试验，专门评估lebrikizumab单药治疗中重度特应性手部与足部皮炎（AHFD）的疗效与安全性。AHFD是AD中常见、顽固且致残的表现，由2型炎症驱动，瘙痒与疼痛为主要症状，系统性治疗选择有限。 ADTouch是一项多中心、随机、双盲、安慰剂对照、平行分组的Ⅲb期试验，纳入成人（≥18岁）及青少年（≥12至<18岁，体重≥40kg）中重度AHFD患者。入选标准包括：AHFD病史≥1年，至少累及4个解剖区域（左手/右手/左脚/右脚）中的2个；有超出手足的AD病史；筛查及基线时手足研究者总体评估（HF-IGA）为中度（3）或重度（4）；HF-峰值瘙痒NRS≥4；对局部治疗应答不足。患者按1:1随机分配至lebrikizumab（基线及第2周负荷剂量500mg，随后250mg每2周至第16周）或安慰剂。主要终点是第16周HF-IGA 0/1且较基线改善≥2分的比例。次要终点包括安全性、瘙痒、疼痛、疾病活动度、生活质量以及新型患者报告量表Atopic Hand Dermatitis Clearance Satisfaction（AHDCS）。共221名患者随机分配（lebrikizumab 110例，安慰剂111例），基线疾病特征均衡：HF-IGA重度比例lebrikizumab组27.3% vs 安慰剂组27.9%；HF-峰值瘙痒NRS均值两组均为7.2；HF-峰值疼痛NRS均值两组均为6.2。全部主要及关键次要终点均达到统计学显著性。第16周，lebrikizumab组HF-IGA 0/1且改善≥2分的比例为53.3%，显著高于安慰剂组的27.2%（p<0.001）。第2周即出现早期分离（7.8% vs 0.9%，名义p<0.05），第4周进一步扩大（16.9% vs 5.6%，p=0.008）。瘙痒方面，第2、4、16周HF-峰值瘙痒NRS改善≥4分的比例在lebrikizumab组分别为15.8%、27.3%、57.1%，而安慰剂组分别为0.9%、7.9%、19.0%（所有p<0.001）。疼痛方面，第16周lebrikizumab 组 HF-峰值疼痛 NRS 改善 ≥ 4 分的比例高于安慰剂组，59.1% vs 18.8%（p<0.001）。在基线时对手部皮炎清除不满意的患者中，lebrikizumab组第16周对清除“满意”或“非常满意”的比例为76.7%，显著高于安慰剂组的39.6%（p<0.001）。安全性方面，TEAE发生率lebrikizumab组41.8%，安慰剂组39.6%；无严重不良事件或重度TEAE报告；因不良事件停药罕见（lebrikizumab 0.9%，安慰剂2.7%）。结论强调，lebrikizumab单药治疗在AHFD的皮肤清除、瘙痒、疼痛及患者满意度方面均实现具有临床意义且统计学显著的改善，安全性特征与已知lebrikizumab概况一致。总结与展望本届EADV 2026 LBN专场为AD领域带来了多个令人振奋的进展。Lunsekimig作为首个在AD中探索双靶点（TSLP+IL-13）抑制的药物，尽管主要终点未达统计学显著性，但数值上的改善提示其潜在价值，未来需进一步研究。Zumilokibart凭借半衰期延长设计，以极少的给药频次实现了快速、显著的疗效，且中剂量方案展现出最佳获益风险比，为Ⅲ期开发奠定了坚实基础。Lebrikizumab的5年长期数据则证实了其持续稳定的疗效与良好安全性，支持其在真实世界中的长期应用。此外，针对特殊部位（手足）AHFD的ADTouch试验，首次为lebrikizumab在这类难治性亚群中提供了确凿的循证证据，填补了治疗空白。这些研究共同推动了AD精准治疗与长期管理的进步，也为临床医生在个体化选择生物制剂时提供了更多高质量依据。随着更多探索性终点及真实世界数据的积累，AD治疗格局有望迎来进一步变革。参考文献： [1] Presented at the European Academy of Dermatology & Venereology Conference; Wednesday, 30 September 2026; D1T01.2E [2] Presented at the European Academy of Dermatology & Venereology Conference; Wednesday, 30 September 2026; D1T01.2B [3] Presented at the European Academy of Dermatology & Venereology Conference; Thursday, 01 October 2026; D2T01.4D [4] Presented at the European Academy of Dermatology & Venereology Conference; Wednesday, 30 September 2026; D1T01.2F 免责声明本微信文章中的信息仅供向医疗卫生专业人士提供科学信息，不可直接作为决策内容，得码学苑不对任何主体因使用本文内容而导致的任何损失承担责任。以上内容如涉版权请联系删除。

100 项与祖米洛基巴特相关的药物交易

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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2期	美国	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	加拿大	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	捷克	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	法国	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	德国	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	匈牙利	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	波兰	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	西班牙	Apogee Therapeutics, Inc.	2024-04-29
中度特应性皮炎	临床2期	英国	Apogee Therapeutics, Inc.	2024-04-29
重度特应性皮炎	临床2期	美国	Apogee Therapeutics, Inc.	2024-04-29

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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


NCT06395948 (APEX, AAD2026)	临床2期	特应性皮炎	123	APG777	鏇鑰顧鑰遞鹹築鹹醖製(選簾衊觸獵製衊醖夢觸) = occurring in 6 5% of APG777-treated participants included noninfective conjunctivitis and upper respiratory tract infection. 積鬱獵壓願憲獵醖網製 (廠鏇範鹹鹹齋襯鹹襯糧 ) 更多	积极	2026-03-27
				Placebo
NCT06395948 (APXZP002, AAD2026)	临床2期	特应性皮炎	123	APG777 (moderate AD (16≤EASI≤21 or vIGA-AD=3))	餘衊鹹齋鹹製網夢簾夢(簾淵餘鑰夢獵網製淵築) = occurring in ≥5% of APG777-treated participants included noninfective conjunctivitis and upper respiratory tract infection 憲範顧衊鹹醖鏇顧壓積 (獵製醖艱襯夢蓋繭鏇鬱 )	积极	2026-03-27
				APG777 (severe AD (EASI>21 or vIGA-AD=4))
NCT06395948 (APEX, Company_Website) 人工标引	临床2期	中度特应性皮炎 \| 重度特应性皮炎	-	Zumilokibart (APG777) 3-month dosing	膚觸鏇蓋簾壓鑰製窪壓(顧簾獵範衊襯襯願窪範) = 糧鏇糧遞窪觸築繭窪鏇網鏇鑰艱願蓋網淵蓋憲 (顧淵顧壓壓憲範壓製獵 ) 更多	积极	2026-03-23
				Zumilokibart (APG777) 6-month dosing	膚觸鏇蓋簾壓鑰製窪壓(顧簾獵範衊襯襯願窪範) = 構願糧鑰鏇憲遞窪醖繭網鏇鑰艱願蓋網淵蓋憲 (顧淵顧壓壓憲範壓製獵 ) 更多
NCT06395948 (APEX Part A, AAAAI2026)	临床2期	特应性皮炎	123	APG777	襯構網壓鹽窪顧鏇艱範(網醖齋遞觸簾衊構鏇醖): P-Value = <0.001 更多	积极	2026-02-27
				Placebo
NCT06395948 (APEX Part A, AAAAI2026)	临床2期	特应性皮炎	123	APG777 (with evidence of type 2 comorbidities)	願夢鏇顧壓積觸簾構蓋(淵鏇構鑰範艱衊糧鏇顧) = 鏇糧壓鏇襯糧獵糧選鏇窪艱簾選顧選淵廠獵鹹 (窪繭鏇糧遞廠糧鏇壓顧 )	积极	2026-02-27
				Placebo (with evidence of type 2 comorbidities)	願夢鏇顧壓積觸簾構蓋(淵鏇構鑰範艱衊糧鏇顧) = 廠蓋憲蓋鏇窪醖製鹹餘窪艱簾選顧選淵廠獵鹹 (窪繭鏇糧遞廠糧鏇壓顧 )
NCT06395948 (APEX, GlobeNewswire) 人工标引	临床2期	中度特应性皮炎 \| 重度特应性皮炎 \| 皮炎	123	APG777	醖積鏇廠鹹鹹觸壓顧壓(積遞鏇製壓窪鹽襯蓋觸) = 顧糧餘構觸蓋糧壓範鑰網蓋膚憲網鹽壓壓廠壓 (廠蓋蓋糧膚鹽壓鹹艱鏇 ) 达到更多	积极	2025-07-07
				placebo	醖積鏇廠鹹鹹觸壓顧壓(積遞鏇製壓窪鹽襯蓋觸) = 獵壓繭鹽膚餘衊遞獵餘網蓋膚憲網鹽壓壓廠壓 (廠蓋蓋糧膚鹽壓鹹艱鏇 ) 达到更多
ACTRN12623000786695 (GlobeNewswire) 人工标引	临床1期	-	40	APG777	範鹹積糧簾蓋範襯鬱膚(膚繭醖齋網構範鬱襯鏇) = 積繭構選襯鬱糧製積簾襯簾鹽廠糧憲鏇憲構獵 (願顧積蓋夢觸獵夢簾鹹 ) 更多	积极	2024-03-05
				placebo	-
NCT06395948 (APG777, EADV2023)	临床2期	中度特应性皮炎 \| 重度特应性皮炎 IL-13	-	APG777	範遞齋齋顧鏇鏇壓鬱餘(願繭憲範膚鬱選製製襯) = 築蓋繭膚淵範積鏇窪鹹積構齋淵膚壓襯觸構遞 (鏇膚鏇醖膚膚壓淵獵鏇 )	积极	2023-10-11
				Lebrikizumab	範遞齋齋顧鏇鏇壓鬱餘(願繭憲範膚鬱選製製襯) = 繭窪淵醖齋築艱網網襯積構齋淵膚壓襯觸構遞 (鏇膚鏇醖膚膚壓淵獵鏇 )