A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)

开始日期2025-08-13

申办/合作机构-

NCT06698796

/ Recruiting临床3期

The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis [DM] or polymyositis [PM]).
Idiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.
DM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.
These disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.
This study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.
The study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.
There will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.

开始日期2025-01-22

申办/合作机构

Pfizer Inc.

NCT05879718

/ Terminated临床2期

A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF 06823859 IN ADULT PARTICIPANTS WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS

The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms.
This study is seeking for participants who:
* are adults of 18 years of age or older.
* are confirmed to have CLE or SLE with involvement of the skin.
* have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of at least 8.
About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug). About 32 are grouped to receive the active study medicine and 16 are to receive placebo. They will be receiving the treatments by intravenous infusion (injected directly into the veins).
At week 16 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response will continue to receive placebo till week 40. All participants will have last follow-up visit at Week 60.
The study will compare participants receiving PF-06823859 to participants who receive placebo. This will help us see if PF-06823859 is safe and effective to treat CLE or SLE with skin symptoms and improve participant's CLASI-A score. Participants will take part in this study for about 65 weeks. This includes up to a 5-week selection period, a 12-week Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period.

开始日期2023-07-07

申办/合作机构

Pfizer Inc.

100 项与 Dazukibart 相关的临床结果

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100 项与 Dazukibart 相关的转化医学

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100 项与 Dazukibart 相关的专利（医药）

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项与 Dazukibart 相关的文献（医药）

2026-04-01·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Dazukibart for the treatment of severe TIF1γ ‐positive juvenile dermatomyositis

Letter

作者: Bodemer, Christine ; Tiriau, Soizic ; Sugrue, Jamie ; Bondet, Vincent ; Moreau, Thomas R. J. ; Duffy, Darragh ; Foray, Anne‐Perrine ; Rodéro, Mathieu P. ; Fournier, Benjamin ; Gitiaux, Cyril ; Quartier, Pierre ; Bader‐Meunier, Brigitte ; Frémond, Marie‐Louise ; Welfringer‐Morin, Anne

2025-11-01·CURRENT OPINION IN RHEUMATOLOGY

Updates in juvenile dermatomyositis: pathogenesis and therapy

Review

作者: Sabbagh, Sara E. ; Coss, Samantha L. ; Kim, Hanna

Purpose of review:

This review provides updates on juvenile dermatomyositis pathogenesis and treatment.

Recent findings:

JDM pathogenesis research updates in genetic risk factors include C4 copy number. Studies clarify myositis-specific autoantibodies’ (MSA) role in disease pathogenesis and more myositis-associated antibody (MAA) clinical associations. Recent studies validate an interferon (IFN)-regulated gene score and an IFN-related monocyte surface protein marker, SIGLEC-1. Vasculopathy and mitochondrial dysfunction evidence increases, both with ties to IFN. Studies point to not only T and B cells, but monocytes, macrophages, and neutrophils as dysregulated in JDM. Regarding treatment, there are growing reports of success with therapies targeting IFN-signaling (Janus kinase inhibitors), dazukibart (anti-IFN-beta), and anifrolumab (anti-IFNAR1). Chimeric antigen receptor (CAR) T-cell therapy targeting B-cells in a growing number of adult myositis patients and one JDM patient have dramatic reports of achieving drug-free remission.

Summary:

Growing evidence show genetic markers, MSA, IFN, vasculopathy, varied immune cells, and mitochondrial dysfunction having important roles in JDM pathogenesis. Some refractory patients show benefit with newer IFN pathway-targeted therapies and cellular CAR-T-cell therapy. Further collaborative research on disease pathogenesis, treatment targets, and innovate clinical trial design is needed to increase access to more efficacious treatments in JDM.

2025-08-01·Clinical Pharmacology in Drug Development

Pharmacokinetics, Safety, and Tolerability of Single‐Dose Dazukibart in Healthy Adults in China and Japan: Results From 2 Randomized, Double‐Blind, Phase 1 Studies

Article

作者: Hu, Shuiyi ; Takazawa, Kenji ; Sano, Yamato ; Prybylski, John ; Li, Haiyan ; Chen, Naihan ; Luo, Xin ; Wang, Xiaohong ; Tabira, Junichi ; Yoshimatsu, Hiroki ; Chu, Myron

Abstract:

Dazukibart is a humanized monoclonal antibody selectively targeting interferon‐β. The pharmacokinetics (PK), safety, tolerability, and immunogenicity of dazukibart were evaluated in 2 double‐blind, randomized, placebo‐controlled, single‐dose, Phase 1 studies in healthy adults in China (Study 1: N = 18; dazukibart 900 mg = 15; placebo = 3) and Japan (Study 2: N = 12; Cohort 1: dazukibart 300 mg = 5, placebo = 1; and Cohort 2: dazukibart 900 mg = 5, placebo = 1). PK parameters were assessed after dosing in Study 1 and Study 2, and no significant differences were observed between PK findings among participants in both studies. A biphasic decline in dazukibart serum concentrations was observed in both studies. Exposures increased dose proportionally in Study 2. Body weight, but not race, was identified as an independent covariate of exposure using population PK modeling (including data from a Phase 1 US study [NCT02766621]). No deaths/discontinuations or serious/severe adverse events were observed, mostly mild adverse events were reported. No participants in Study 1 were antidrug antibody positive; 20.0% in Study 2 were positive for treatment‐induced antidrug antibodies and neutralizing antibodies. PK parameters and immunogenicity rates were consistent with the US study, and no new safety signals were identified.

项与 Dazukibart 相关的新闻（医药）

2026-05-06

·药研网

辉瑞终止多项管线，包括CD47、TLR7、TCE等

5月5日，据Fierce Biotech报道，辉瑞在最新公布的Q1财报中确认，已正式放弃收购自Trillium Therapeutics的最后一款处于临床阶段的候选药物——maplirpacept，这标志着辉瑞斥资23亿美元对Trillium Therapeutics的两款CD47抑制剂押注全部打水漂，此外，辉瑞还终止了多个项目的开发。 23亿美元打水漂时间追溯到2021年8月，辉瑞宣布以22.6亿美元的价格收购Trillium Therapeutics，获得了后者旗下两款处于临床开发阶段的CD47靶向药物——TTI-622（后更名为maplirpacept）和TTI-621（后更名为ontorpacept）。 ontorpacept曾进入软组织肉瘤的II期临床试验，但去年辉瑞便宣布停止其临床开发，当时给出的理由是战略管线优先级的调整。另一核心资产maplirpacept也同样命运多舛。该CD47抑制剂联合Incyte公司的Monjuvi及百时美施贵宝公司的Revlimid治疗B细胞淋巴瘤的中期研究，因招募困难于去年被叫停。辉瑞曾坚持推进该药物针对血液癌症的I期和II期研究，但在5月5日的一季报中宣布，基于整体管线战略考量，彻底终止CD47药物maplirpacept在血液癌症领域的临床研究。至此，辉瑞的两款CD47候选药物已全部终止。公司强调，这一决定并非出于安全性或监管问题。作为抗肿瘤免疫治疗领域热门靶点之一，CD47抗体一直被行业喻为PD1/PDL1抗体之后，肿瘤免疫领域的下一个“明星”。尽管该靶点理论潜力巨大，但成药之路注定处处荆棘，目前尚无一款针对CD47受体的相关药物获批上市。辉瑞的研发历程一波三折，这并非个例，Gilead同样在此折戟。2020年，吉利德曾斥资49亿美元收购Forty Seven及其核心资产CD47抗体magrolimab。然而，在历经多年试验失败、美国FDA叫停临床试验甚至出现患者死亡事件后，吉利德最终于2024年彻底放弃了magrolimab的开发。吉利德放弃CD47单抗：身价49亿美元的陨落 2023年1月，Arch Oncology终止CD47抗体AO-176项目研发；8月，ALX Oncology终止SIRPα融合蛋白Evorpacept治疗MDS、急性髓系白血病（AML）的两项临床研究；9月，艾伯维终止与I-Mab就CD47抗体lemzoparlimab的合作协议……辉瑞、吉利德留出来的空窗期待交给后人填补。辉瑞砍掉多款在研管线辉瑞在Q1财报中确认，更新后的研发管线中共有7个项目被终止开发。除maplirpacept外，还有下列项目已终止： HER2 ADC disitamab vedotin在HER2表达的局部晚期或转移性实体瘤（II期）；抗IFN-β抗体 dazukibart（PF-06823859）狼疮方向（II期） PD-L1靶向ISAC项目PF-08046037晚期实体瘤（I期），这是一种载有TLR7激动剂有效载荷的新型偶联药物。靶向EGFR的TCE双抗PF-08046052针对晚期实体瘤的研发（I期）。据悉，此举属于“商业决策”，与安全性问题无关。该疗法领域是今年行业热门并购领域，但辉瑞研发管线中似乎未列出任何其他TCE药物。 TF-ADC TIVDAK（tisotumab vedotin）复发或转移性宫颈癌方向（TV-205）（I期）痤疮外用药物PF-07905428（I期）。该终止决定是基于“包括I期研究结果和研发管线优先级调整在内的综合因素”。在精简管线的同时，辉瑞推进或新增10个项目，整体在研管线数量从102个缩减至96个。图源: 辉瑞官网 End 声明：本公众号所发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者，欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿请联系商务合作稿件征集点击了解详情往期回顾 2026全球肥胖药企十强出炉一文读懂抗体：结构、分类与ADCC/ ADCP/ CDC机制

2026-05-06

·BioPlus

2026Q1管线：Pfizer终止7项

Pfizer在2026Q1财报中披露，相比2月版本管线，有7个项目停止开发，同时有10个项目推进或新增；整体管线数量由102个降至96个。（更多MNC的2026Q1管线调整见2026 Q1管线调整：6家MNC，有哪些重大变化？）终止项目方面，辉瑞自2026年2月3日以来终止7项，主要集中在肿瘤管线，涉及血液肿瘤、HER2表达实体瘤等： II期终止3项：maplirpacept（TTI-622，CD47-SIRPα融合蛋白）血液肿瘤；HER2 ADC disitamab vedotin在HER2表达的局部晚期或转移性实体瘤方向停止开发；抗IFN-β抗体dazukibart（PF-06823859）在狼疮方向停止开发。 I期终止4项：PD-L1靶向ISAC项目PF-08046037（PDL1-TLR7）晚期实体瘤；PF-08046052（EGFR×TCRDV2双特异性抗体）晚期实体瘤，该项目原研是Lava Therapeutics，2022年转让给了Seagen ；Tissue Factor ADC TIVDAK（tisotumab vedotin）在复发或转移性宫颈癌（TV-205）停止开发；另有机制未披露的PF-07905428用于痤疮停止开发。管线推进方面，2026年2月4日至5月5日期间，新进入II期和III期的项目包括： 1个项目推进至II期：tilrekimig（PF-07275315，anti-IL-4×IL-13×TSLP三抗）COPD适应症Advanced to phase 2，临床登记信息为临床2/3期开展中（NCT07363694）。 2个项目推进至III期：肿瘤方面PF-08634404（PD1×VEGF双抗）的一线NSCLC开发Advanced to phase 3，覆盖鳞状和非鳞状两个队列/适应症；疫苗方面则是PF-07872412用于儿童肺炎球菌感染开发推进到III期。欢迎大家加入BioPlus Partners微信交流群&Linkedin，共同探讨。 Linkedin 微信群入群申请联系人：Lisa 邮箱：lisa.li@bp-bioplus.com 电话：18662346610（同微信）入群申请，请先添加Lisa微信，并分享名片入群画像：Biotech/药厂研发/BD、投资机构、临床医生等入群福利：不定时行业资料包分享近期会议点击图片，跳转会议详情参会报名 1. 免费审核门票（仅限生物医药投资人、Biotech/药企、临床/院校科学家，不含餐，不含私董会）免费门票获取（微信朋友圈集21个赞，报名时上传截图，可获取门票） 2. 会议门票500元（含两天公开会议，含5月22日午餐，不含私董会）； 3. 晚宴门票2000元（含两天公开会议，含5月21日晚餐，5月22日午餐，不含私董会）

临床3期财报疫苗临床2期临床终止

2026-05-05

·EndPoints

Pfizer cuts final Trillium-related program, but R&D spend jumps on cancer, obesity studies

Pfizer has discontinued the final clinical study stemming from its 2021 acquisition of Trillium Therapeutics, funneling cash primarily toward a host of other cancer and obesity studies. The company reported in a pipeline update Tuesday that it ended a Phase 2 program of maplirpacept in patients with hematological malignancies. A spokesperson confirmed there were no additional ongoing studies testing drugs originating from Trillium, acquired by Pfizer in 2021 for roughly $2.25 billion. Two other Phase 2 trials were cut in the quarter: one studying disitamab vedotin in patients with solid tumors, and another testing anti-IFN-beta dazukibart as a lupus treatment. Pfizer took a multibillion-dollar write-down on disitamab vedotin in the previous quarter. Four Phase 1 studies were ended as well. On the whole, Pfizer is pouring more money into development efforts, spending nearly $2.5 billion on R&D in the first quarter, a 13% jump compared to the first quarter of 2025. Much of that money is going toward oncology and obesity-related studies, making the most of its Seagen and Metsera acquisitions, respectively. While it hustles to crack into the US obesity market, Pfizer has bought its way into China first. The company announced in February that it had acquired commercial rights there for a GLP-1 from local biotech Sciwind Biosciences; that drug was approved in March and launched at the end of last month, Pfizer disclosed. Overall, revenue was up only 2% for the quarter, dragged down by the company’s Covid-19 products. Sales of Pfizer’s Covid-19 vaccine Comirnaty were down 59% in the quarter, which Pfizer attributed in part to narrower recommendations in the US that were depressing uptake. Still, the $14.5 billion quarterly revenue beat Wall Street expectations by 5%. Migraine medicine Nurtec continues to be a comeback product for Pfizer, with revenue up more than 40% in the quarter. And with a major patent settlement now in the rearview, Pfizer can count on additional revenue from its Vyndaqel package of amyloidosis-targeted products, which eclipsed $1.6 billion in the quarter. The company announced last week that it staved off generic entry of Vyndamax for two years, extending the patent to 2031. In prepared remarks , CEO Albert Bourla disclosed plans for a new adult pneumococcal vaccine that will target 35 serotypes. He said clinical development is set to start later this year.

疫苗并购上市批准临床1期临床2期

100 项与 Dazukibart 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
皮肌炎	临床3期	美国	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	中国	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	日本	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	阿根廷	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	比利时	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	保加利亚	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	法国	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	德国	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	匈牙利	Pfizer Inc.	2023-05-20
皮肌炎	临床3期	印度	Pfizer Inc.	2023-05-20

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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


NCT05192200 (CTgov)	临床2期	皮肌炎	24	PF-06823859 (PF-06823859 600mg: Skin Cohort)	齋夢積鏇蓋範繭網積網 = 遞窪觸壓蓋窪積獵淵願鑰觸夢鑰窪觸構夢壓憲 (淵顧製廠遞範蓋鹽製淵, 蓋壓襯鑰願獵淵淵醖糧 ~ 膚衊願壓艱夢鑰齋糧鹽) 更多	-	2025-02-06
				PF-06823859 (PF-06823859 600mg: Muscle Cohort)	齋夢積鏇蓋範繭網積網 = 淵顧醖鹹願鬱積壓齋蓋鑰觸夢鑰窪觸構夢壓憲 (淵顧製廠遞範蓋鹽製淵, 繭選遞醖繭醖鑰鑰壓壓 ~ 壓醖鏇艱鏇鹹醖獵製襯) 更多
NCT05037409 (CTgov)	临床1期	-	13	Placebo	襯蓋鏇齋鬱窪齋齋網鬱 = 觸鬱鑰鑰窪齋鏇選觸壓選艱壓築製齋鏇獵膚餘 (顧廠鹽齋繭艱選繭獵願, 膚夢窪構觸淵憲鹽觸獵 ~ 窪獵顧顧襯醖鏇網醖窪) 更多	-	2023-12-15
NCT03181893 (EADV2023)	临床2期	皮肌炎 IFN β	72	PF-06823859 150 mg	鬱鹽淵網鏇壓願鬱壓艱(淵餘襯鬱簾築鹽淵餘蓋) = 鹹鬱憲壓鹽獵鬱淵壓鏇糧顧鏇觸膚鏇構艱壓夢 (糧齋糧鬱獵鏇壓積選鑰 ) 更多	-	2023-10-11
				PF-06823859 600 mg	鬱鹽淵網鏇壓願鬱壓艱(淵餘襯鬱簾築鹽淵餘蓋) = 衊膚簾膚衊糧觸艱襯憲糧顧鏇觸膚鏇構艱壓夢 (糧齋糧鬱獵鏇壓積選鑰 ) 更多
NCT02766621 (Pubmed) 人工标引	临床1期	-	62	PF 06823859	壓鑰製積醖簾觸築艱鑰(廠壓衊獵簾齋膚鬱膚鹽) = No deaths occurred. 繭鑰夢鬱壓鹹構憲窪餘 (鏇獵膚醖廠觸鏇廠顧衊 ) 更多	积极	2021-03-01
				Placebo