A Randomized, Single-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ABBV-382 in Healthy Adult Chinese Volunteers

The main objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single subcutaneous (SC) and intravenous (IV) doses of ABBV-382 in healthy adult Chinese volunteers.

开始日期2024-10-08

申办/合作机构

AbbVie, Inc.

NCT06032546

/ Terminated临床2期

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living With HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption

Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body.
Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. In Part 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness). In Part 2, eligible participants will be placed in an open-label arm to receive Budigalimab. Approximately 160 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide.
In Part 1, participants will receive 4 doses of intravenous (IV) budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. In Part 2, participants will receive 4 doses of open-label subcutaneous (SC) Budigalimab for a 6 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 112 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 112 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2023-10-12

申办/合作机构

AbbVie, Inc.

NCT04554966

/ Completed临床1期

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ABBV-382 in Persons Living With HIV-1 (PLWH)

Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV infection is considered to be a chronic disease requiring lifelong therapy. This study will evaluate how safe ABBV-382 is and how it is absorbed, distributed and eliminated from the body in adult participants with HIV-1 infection.
ABBV-382 is an investigational drug being developed for the treatment of HIV-1 infection. This study takes place in 2 parts. In Part A, participants with HIV-1 and no history of combination antiretroviral therapy (cART) or who are off cART for more than 3 months will be enrolled to receive ABBV-382. In Part B, participants with no virus in their blood and on maintenance cART will be enrolled into one of the intravenous (IV) or subcutaneous (SC) groups. In the IV groups, participants will receive either placebo or ABBV-382 whereas participants in the SC group will receive ABBV-382. There is 1 in 3 chance that participants will receive placebo (no drug) in Part B IV groups. The IV group in Part B is double-blinded which means neither the study doctors nor the participants will know who will be given study drug or placebo. Around 52 adult participants with HIV-1 infection will be enrolled at approximately 21 sites across the United States, including Puerto Rico.
Participants in Part A will receive an intravenous (IV) dose of ABBV-382 on Day 1. Participants in Part B will receive an IV or SC dose of ABBV-382 or placebo on Days 1, 29 and 57.
There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and presence of side effects.

开始日期2021-04-16

申办/合作机构

AbbVie, Inc.

100 项与 ABBV-382 相关的临床结果

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100 项与 ABBV-382 相关的转化医学

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100 项与 ABBV-382 相关的专利（医药）

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项与 ABBV-382 相关的新闻（医药）

2026-06-10

·雪球

艾伯维公司2026财年年报业绩会议总结

一、开场介绍会议时间：2026财年主持人说明：由高盛分析师AsadHaider主持，目的为探讨艾伯维公司未来5-10年的定位、治疗领域、业务线及潜在增长支柱。管理层发言摘要：RobertA.Michael（董事会主席兼首席执行官）：强调公司战略延续性，重点为快速恢复增长；去年在修美乐（Humira）美国专利保护到期仅两年后即超过峰值销售额，未来将聚焦免疫学、肿瘤学、神经科学、美学及肥胖症四大增长驱动力。RoopalThakkar（执行副总裁、研发部主管、首席科学官）：重点介绍肿瘤学管线进展，提及ASCO会议上Temab-A（c-Met靶向ADC）、etentamig（多发性骨髓瘤TCE）等资产的积极数据。ScottT.Reents（执行副总裁、首席财务官）：概述第一季度业绩强劲，Skyrizi和Rinvoq保持23%增长，上调全年财务指引。二、财务业绩分析核心财务数据第一季度业绩：超出预期3亿美元，实现两位数增长；Skyrizi和Rinvoq：两者均增长23%，全年指引分别上调1亿美元；神经科学领域：整体增长17%，呈现广泛增长态势；营收与利润：报告营收增长10%，运营增长略高于9%，全年收益增长超过14%。关键驱动因素收入增长主要由Skyrizi和Rinvoq的持续增长驱动，两者上市第八年仍保持超20%增速；神经科学领域多产品贡献增长，成为公司第三大支柱；投资效率提升，在推动增长的同时实现利润增长。三、业务运营情况分业务线表现免疫学：Skyrizi和Rinvoq在炎症性肠病（IBD）、银屑病等领域市场份额高，Skyrizi一线治疗数据强劲，Rinvoq标签扩展后可在生物制剂治疗后使用；推进联合疗法（如α4β7+Skyrizi），克罗恩病内镜缓解效果翻倍。肿瘤学：ASCO会议上公布Temab-A（c-MetADC）在头颈癌、卵巢癌的积极数据，计划推进剂量优化和关键试验；etentamig（BCMATCE）在多发性骨髓瘤中CRS发生率0%，预计今年晚些时候公布III期数据；PD-1/VEGF联合疗法（与荣昌生物合作）在非小细胞肺癌中数据积极，计划加速III期。神经科学：三大垂直领域（精神病学、偏头痛、帕金森病）均具备超50亿美元峰值潜力，目前市场模型低估约10亿美元；Vraylar、偏头痛药物等产品增长强劲。美学及肥胖症：与Gubra合作的amylin类药物聚焦持久性和差异化，1期试验显示10%体重减轻，计划在BMI≥35患者中推进1b/2期；肥胖症与美学业务协同，覆盖患者完整美学旅程。研发投入与成果免疫学管线：布局TL1A、TREM-1、IRAK4等新机制，与Capstan合作体内CAR-T平台（B细胞耗竭），推进α4β7（ABBV-382）联合疗法；IL-23长效药物进入临床，探索延长给药周期。肿瘤学管线：三特异性TCE、KRAS抑制剂（与Kestrel合作）、PSMAADC（969）等资产推进，969在前列腺癌五线患者中ORR达45%，PFS15个月，计划进入III期。神经科学管线：cycloplastogenbretisilocin（抑郁症）、emraclidine（Cerevel合作）、下一代Aβ抗体（阿尔茨海默病）等资产处于临床阶段。市场拓展：暂无信息运营效率：暂无信息四、未来展望及规划短期目标（2026年及近期）财务目标：维持Skyrizi和Rinvoq的23%增长，实现两位数营收和利润增长；研发推进：启动α4β7联合疗法的2b期试验，探索加速III期；推进肿瘤学资产（Temab-A、etentamig）的关键试验，公布PD-1/VEGF联合疗法在非小细胞肺癌的更多数据。中长期战略（未来5-10年）核心领域：以免疫学、肿瘤学、神经科学、美学为四大支柱，拓展肥胖症领域，每个领域均目标贡献超50亿美元峰值销售额；管线策略：通过联合疗法（如Skyrizi+TL1A）和外部创新（业务发展交易）补充管线，应对专利到期风险（Rinvoq专利至2037年）；政策应对：关注340B计划滥用、最惠国待遇立法等政策风险，推动解决欧洲不公平定价做法。五、问答环节要点公司定位与增长支柱问：未来5-10年公司定位及增长支柱？答：延续“快速恢复增长”战略，四大支柱为免疫学（Skyrizi/Rinvoq）、肿瘤学（新兴管线）、神经科学（三大垂直领域）、美学及肥胖症；肿瘤学将成为重要增长部分，目前市场对其管线潜力低估。业务发展与资本部署问：如何看待后期或上市后资产的交易机会？答：不排除此类交易，重点关注免疫学、肿瘤学、神经科学、美学及肥胖症领域的差异化资产；过去两年已投入80亿美元收购管线，未来将继续补充长期增长驱动力。肥胖症市场机会问：肥胖症领域的差异化机会及商业策略？答：聚焦持久性（70%患者因不良事件1年后停药），amylin类药物1期数据显示10%体重减轻，计划在高BMI患者中推进；结合美学渠道（与医美中心合作），覆盖患者体重管理及美学需求。外部运营环境与政策风险问：关注哪些监管及政策挑战？答：重点关注最惠国待遇立法（反对，认为破坏创新生态）、340B计划滥用（支持试点解决）、欧洲不公平定价（需政府介入解决）。财务指引与管线潜力问：是否提供中期财务指引？答：暂无计划，但指出Skyrizi/Rinvoq峰值潜力被市场低估（模型预期低于公司内部预测），神经科学三大领域各被低估约10亿美元，肿瘤学资产（Temab-A、etentamig）峰值潜力达数十亿美元（当前模型仅10亿美元）。六、总结发言管理层强调公司战略聚焦“四大增长驱动力+肥胖症”，通过内部研发与外部创新（业务发展交易）构建管线深度；财务表现强劲，第一季度超预期，Skyrizi和Rinvoq持续增长，神经科学成为第三大支柱；肿瘤学管线潜力显著，ASCO会议数据验证Temab-A、etentamig等资产价值，未来将成为重要增长引擎；长期目标为在免疫学、肿瘤学、神经科学等领域保持领先，通过联合疗法和差异化资产应对竞争与专利到期风险，同时关注政策环境变化，保护创新生态。查看业绩会议全文

2026-05-01

·allsci.com

AbbVie Q1’26 Earnings Call: Skyrizi combo doubles remission rates in refractory Crohn’s

During AbbVie’s Q1 2026 earnings conference call, held April 29, 2026, executives discussed the decision to accelerate Phase III development of the Skyrizi (risankizumab) plus ABBV-382 combination in inflammatory bowel disease after interim data showed double the endoscopic remission rate of either monotherapy in a highly refractory Crohn’s disease population. The company has also pulled forward its obesity Phase II program and signaled an earlier-than-expected regulatory submission for etentamig in multiple myeloma. Key Strategic Signals Skyrizi + ABBV-382 Combination: Interim data from AbbVie’s Crohn’s disease platform study showed the combination of Skyrizi (risankizumab) and ABBV-382, an anti-alpha 4 beta 7 antibody, achieved approximately 42% endoscopic remission at week 24 in a population where 82% had failed prior advanced therapies — double the rate observed with either monotherapy. Chief Scientific Officer Roopal Thakkar said the company observed a non-flat exposure-response relationship for ABBV-382, meaning patients with higher drug exposures fared better, and that a Phase IIb study initiating this summer will test a higher dose of ABBV-382 in combination with Skyrizi. AbbVie said it is simultaneously evaluating Phase III acceleration options and will evaluate Skyrizi in combination with ABBV-382 and separately with its extended half-life TL1A antibody, with ulcerative colitis (UC) included alongside Crohn’s disease. The Skyrizi plus lutikizumab cohort within the same platform study was discontinued after failing to differentiate meaningfully from Skyrizi monotherapy. Etentamig regulatory timeline advanced: AbbVie said it now expects to submit etentamig, its B-cell maturation antigen (BCMA) bispecific antibody, for regulatory review by the end of 2026 — earlier than previously guided. The Phase III monotherapy trial in third-line-plus multiple myeloma is tracking ahead of schedule, with a response rate readout anticipated in the third quarter of 2026 and the potential for a concurrent interim progression-free survival (PFS) analysis. If that interim PFS analysis is positive, AbbVie said regulatory submissions would follow in the same year. Thakkar also said plans are underway for a Phase III study evaluating etentamig in combination with pomalidomide in second-line-plus patients, including those previously exposed or refractory to anti-CD38 antibodies or who have lost response to a BCMA-directed CAR-T or antibody-drug conjugate (ADC). ABBV-295 obesity program accelerated: ABBV-295, a long-acting amylin analog with a half-life of approximately 270 hours, produced approximately 10% weight loss after 12 weeks in a multiple ascending dose study conducted predominantly in male, non-obese participants with a mean body mass index of approximately 29. AbbVie said the Phase II program has been pulled forward to the third quarter of 2026, with interim Phase I data in obese patients expected later this year. Thakkar noted the molecule signals through both amylin and calcitonin receptors, and said the pharmacodynamic profile supports potential monthly dosing in the maintenance setting, drawing an analogy to Skyrizi’s durable efficacy beyond its 28-day half-life. AbbVie also flagged active interest in external business development to complement ABBV-295 with additional obesity mechanisms, including oral agents and assets that preserve lean muscle mass. Analyst Pressure Points IBD combination positioning and competitive durability: JPMorgan analyst Christopher Schott pressed management on where the Skyrizi plus ABBV-382 combination fits in the treatment sequence — specifically whether it would be a second-line option post-Skyrizi or could reach the frontline. Thakkar said AbbVie does not intend to restrict the combination to refractory patients, noting that the platform study already enrolled patients who had previously received Skyrizi, vedolizumab, and Rinvoq (upadacitinib), and that frontline IBD use is commercially and clinically relevant given the risk of irreversible gut damage with uncontrolled inflammation. Schott also asked more broadly about AbbVie’s ability to sustain its immunology competitive position given increasing pipeline activity across the sector. Chief Executive Officer Robert Michael pointed to recent business development transactions — including Capstan Therapeutics for in vivo CAR-T B-cell depletion, Nimble Therapeutics for oral peptides, and additions of TL1A and IRAK4 mechanisms — as evidence that AbbVie is building depth beyond Skyrizi and Rinvoq for the next decade. RemeGen PD-1/VEGF bispecific differentiation: Deutsche Bank analyst James Shin pressed Thakkar on how RC-148, the PD-1/VEGF bispecific antibody acquired through the RemeGen agreement, can differentiate given its later entry into a field already occupied by established competitors. Thakkar said AbbVie’s strategy is not to develop RC-148 as a standalone asset but to deploy it as a combination partner for Temab-A, the company’s c-MET ADC, across colorectal, lung, and ovarian cancers — framing the asset’s value as contingent on ADC combinations rather than monotherapy positioning. Forward-Looking Catalysts Q3 2026 — etentamig Phase III response rate readout: The Phase III trial evaluating etentamig monotherapy in third-line-plus multiple myeloma is expected to deliver a response rate readout in the third quarter of 2026, with a potential concurrent interim PFS analysis. AbbVie said a positive interim PFS result would trigger regulatory submissions by year-end, making this the most time-sensitive oncology catalyst on the company’s near-term calendar. The trial’s ahead-of-schedule pace reduces execution risk on that timeline. H2 2027 readout for Temab-A colorectal cancer Phase III: Following AbbVie’s decision to pivot the next-generation c-Met directed ADC telisotuzumab adizutecan (Temab-A) colorectal cancer pivotal strategy from c-MET-selected monotherapy to an all-comers combination with bevacizumab, the company said it expects an initial data readout from the Phase III trial in the second half of 2027. The strategic rationale cited was a 30% objective response rate and 97% confirmed disease control rate for Temab-A plus bevacizumab versus 0% and 70%, respectively, for Lonsurf (trifluridine/tipiracil) plus bevacizumab as the comparator, with responses observed regardless of c-MET expression level. AbbVie also said Temab-A received its first breakthrough therapy designation as a monotherapy in second-line-plus EGFR wild-type non-squamous non-small cell lung cancer (NSCLC), with a Phase III trial in that setting in planning. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

临床2期临床3期临床结果突破性疗法临床1期

2025-12-15

·医者纵横

【医学前沿】ROTAC技术：开启抗病毒治疗的新纪元

Oncologist Link 链接 · 交流 · 合作每年冬天都是流感的高发季节，今年冬天上海流感疫情正处于高发期，预计在12月上中旬达到峰值。目前流感病毒检测阳性率已超过50%，甲型H3N2是主要流行毒株。除了已有的抗病毒药物外，新的药物技术在抗病毒药物开发中也开始崭露头角。蛋白水解靶向嵌合体（PROTAC）技术通过诱导靶蛋白与E3泛素连接酶结合，实现对致病蛋白的选择性降解，为传统"不可成药"靶点提供了全新解决方案。2025年，PROTAC技术在抗病毒领域取得突破性进展，特别是在HIV、流感病毒等治疗中展现出独特优势。抗病毒PROTAC药物的作用机制 PROTAC分子由三部分组成：靶蛋白结合域：特异性识别病毒蛋白或宿主依赖因子 E3连接酶结合域：招募细胞内的泛素-蛋白酶体系统连接链：连接两个功能域，优化空间构象这种双功能分子通过"事件驱动"的催化机制，理论上可实现低于化学计量比的药物浓度，显著降低脱靶效应。在抗病毒应用中，PROTAC可同时靶向病毒复制周期中的多个关键蛋白，如HIV的逆转录酶、整合酶，或流感的RNA聚合酶复合体。 2025年核心研究进展 1. HIV潜伏库清除 ASC22联合西达本胺方案：通过PROTAC降解组蛋白去乙酰化酶（HDAC），激活潜伏的HIV病毒库，同时利用PD-L1抗体增强免疫应答，在临床前模型中实现病毒库的持续控制。 ABBV-382：靶向α4β7整合素的PROTAC分子，阻断病毒与宿主细胞的结合，已完成1期临床验证，展现出独特的免疫调节机制。 2. 流感病毒RNA聚合酶抑制 NEK7降解剂：Monte Rosa Therapeutics开发的分子胶PROTAC，通过降解NLRP3炎症小体关键蛋白，同时抑制病毒复制和过度炎症反应，在动物模型中显示双重抗病毒效果。 TBK1靶向PROTAC：针对流感病毒逃逸宿主免疫的关键蛋白，通过降解TBK1阻断病毒复制，临床前研究显示对多种流感亚型有效。 3. 冠状病毒治疗 3CL蛋白酶PROTAC：针对SARS-CoV-2主蛋白酶设计，通过CRBN连接酶介导降解，在体外实验中展现出比传统抑制剂更强的广谱抗冠状病毒活性。 ACE2受体调节剂：通过PROTAC技术调控宿主细胞受体表达，阻断病毒入侵通路，为预防性治疗提供新思路。技术突破与挑战创新设计策略 AI辅助优化：利用深度学习预测PROTAC分子的三元复合物稳定性，将设计周期缩短60%以上。组织特异性递送：开发肝靶向PROTAC载体，显著提高抗病毒药物的生物利用度。现存挑战透膜效率：大分子PROTAC的细胞摄入机制尚未完全阐明，CD346蛋白的发现为透膜研究提供了新方向。耐药性问题：病毒蛋白的快速突变可能产生降解抗性，需开发多靶点PROTAC。安全性评估：长期蛋白降解对宿主细胞的影响需进一步验证。临床转化现状截至2025年12月，全球已有3款抗病毒PROTAC药物进入临床阶段： MRT-8102：针对NLRP3炎症小体的分子胶PROTAC，已完成1期安全性评估 ABBV-382：HIV治疗候选药物，正在开展联合用药临床试验抗流感PROTAC：处于临床前研究阶段，预计2026年申报IND PROTAC技术为抗病毒治疗带来三大变革：1.突破传统抑制剂限制：可靶向降解不可逆结合蛋白；2.联合治疗优势：单个分子可同时降解病毒蛋白和宿主依赖因子；3.长效给药潜力：通过优化连接链设计，有望实现每周一次给药。随着E3连接酶库的不断扩充和递送技术的进步，PROTAC技术或将在未来5-10年内重塑抗病毒药物研发格局，为应对新发突发传染病提供更有效的武器。 THANKS FOR READING 文稿 | 转眼编辑 | 沈香统筹 | 清水苏版权声明本文由“医者纵横”发布未经允许，谢绝转载，违者必究阅读原文，回看往期专栏

蛋白降解靶向嵌合体临床结果

100 项与 ABBV-382 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
克罗恩病	临床2期	美国	AbbVie, Inc.	2024-09-04
克罗恩病	临床2期	奥地利	AbbVie, Inc.	2024-09-04
克罗恩病	临床2期	比利时	AbbVie, Inc.	2024-09-04
克罗恩病	临床2期	保加利亚	AbbVie, Inc.	2024-09-04
克罗恩病	临床2期	加拿大	AbbVie, Inc.	2024-09-04
克罗恩病	临床2期	克罗地亚	AbbVie, Inc.	2024-09-04
克罗恩病	临床2期	捷克	AbbVie, Inc.	2024-09-04
克罗恩病	临床2期	丹麦	AbbVie, Inc.	2024-09-04
克罗恩病	临床2期	爱沙尼亚	AbbVie, Inc.	2024-09-04
克罗恩病	临床2期	芬兰	AbbVie, Inc.	2024-09-04