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Lunsekimig (SAR443765) 在患有中度至重度哮喘的成人参与者中的长期安全性和有效性评估。 (AIRPHRODITE)

2026年9月18日 更新者：Sanofi

一项开放标签扩展研究，旨在评估参加 DRI16762 研究的中度至重度哮喘成年参与者皮下注射 Lunsekimig 的长期安全性和有效性

This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig.

The study duration will be up to 148 weeks with a treatment duration being up to 144 weeks.

研究概览

地位

邀请报名

条件

干预/治疗

研究类型

介入性

注册 (估计的)

900

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100144
        • Investigational Site Number : 1560011
      • Changchun、中国、130021
        • Investigational Site Number : 1560010
      • Changsha、中国、410015
        • Investigational Site Number : 1560017
      • Chengde、中国、067020
        • Investigational Site Number : 1560021
      • Guangzhou、中国、510150
        • Investigational Site Number : 1560009
      • Guangzhou、中国、510000
        • Investigational Site Number : 1560053
      • Guangzhou、中国、510163
        • Investigational Site Number : 1560001
      • Guiyang、中国、550002
        • Investigational Site Number : 1560037
      • Hefei、中国、230032
        • Investigational Site Number : 1560006
      • Hohhot、中国、010050
        • Investigational Site Number : 1560014
      • Lanzhou、中国、730000
        • Investigational Site Number : 1560030
      • Nanchang、中国、330006
        • Investigational Site Number : 1560007
      • Pingxiang、中国、337055
        • Investigational Site Number : 1560002
      • Shanghai、中国、200433
        • Investigational Site Number : 1560013
      • Shenyang、中国、110004
        • Investigational Site Number : 1560015
      • Taiyuan、中国、030001
        • Investigational Site Number : 1560057
      • Tianjin、中国、300211
        • Investigational Site Number : 1560055
      • Wenzhou、中国、325027
        • Investigational Site Number : 1560005
      • Wuhan、中国、430030
        • Investigational Site Number : 1560003
      • Wuhan、中国、430030
        • Investigational Site Number : 1560022
      • Xuzhou、中国、221006
        • Investigational Site Number : 1560004
      • Yangzhou、中国、225000
        • Investigational Site Number : 1560016
      • Zhanjiang、中国、524004
        • Investigational Site Number : 1560012
  • 以色列
      • Ashkelon、以色列、7830604
        • Investigational Site Number : 3760006
      • Haifa、以色列、3104802
        • Investigational Site Number : 3760001
      • Haifa、以色列、3436212
        • Investigational Site Number : 3760008
      • Jerusalem、以色列、9103102
        • Investigational Site Number : 3760003
      • Jerusalem、以色列、9112001
        • Investigational Site Number : 3760002
      • Petah Tikva、以色列、4941492
        • Investigational Site Number : 3760010
      • Rehovot、以色列、7610001
        • Investigational Site Number : 3760004
      • Tel Aviv、以色列、6423906
        • Investigational Site Number : 3760007
  • 加拿大
    • Ontario
      • Ajax、Ontario、加拿大、L1S 2J5
        • Investigational Site Number : 1240013
      • Hamilton、Ontario、加拿大、L8N 4A6
        • Investigational Site Number : 1240003
    • Quebec
      • Sherbrooke、Quebec、加拿大、J1H 5N4
        • Investigational Site Number : 1240004
      • Trois-Rivières、Quebec、加拿大、G8T 7A1
        • Investigational Site Number : 1240001
  • 匈牙利
      • Mosonmagyaróvár、匈牙利、9200
        • Investigational Site Number : 3480004
  • 南非
      • Benoni、南非、1500
        • Investigational Site Number : 7100004
      • Benoni、南非、1500
        • Investigational Site Number : 7100005
      • Cape Town、南非、7530
        • Investigational Site Number : 7100003
      • Cape Town、南非、7700
        • Investigational Site Number : 7100002
      • Durban、南非、4001
        • Investigational Site Number : 7100001
      • Pretoria、南非、0157
        • Investigational Site Number : 7100006
  • 印度
      • Calicut、印度、673008
        • Investigational Site Number : 3560007
      • Hyderabad、印度、500084
        • Investigational Site Number : 3560009
      • Kanpur、印度、208001
        • Investigational Site Number : 3560008
      • Nagpur、印度、441203
        • Investigational Site Number : 3560001
      • Pune、印度、411057
        • Investigational Site Number : 3560004
  • 台湾
      • Taipei、台湾、110
        • Investigational Site Number : 1580003
  • 土耳其（türkiye）
      • Bursa、土耳其（türkiye）、16059
        • Investigational Site Number : 7920006
      • Istanbul、土耳其（türkiye）、34098
        • Investigational Site Number : 7920002
      • Istanbul、土耳其（türkiye）、34854
        • Investigational Site Number : 7920003
      • Kayseri、土耳其（türkiye）、38039
        • Investigational Site Number : 7920007
      • Kirikkale、土耳其（türkiye）、71100
        • Investigational Site Number : 7920008
      • Mersin、土耳其（türkiye）、33070
        • Investigational Site Number : 7920001
      • İzmit、土耳其（türkiye）、41001
        • Investigational Site Number : 7920005
  • 墨西哥
      • Chihuahua City、墨西哥、31000
        • Investigational Site Number : 4840002
      • Durango、墨西哥、34000
        • Investigational Site Number : 4840003
      • Veracruz、墨西哥、91900
        • Investigational Site Number : 4840008
    • Nuevo León
      • Monterrey、Nuevo León、墨西哥、66465
        • Investigational Site Number : 4840004
    • Querétaro
      • San Juan del Río、Querétaro、墨西哥、76800
        • Investigational Site Number : 4840005
    • Yucatán
      • Mérida、Yucatán、墨西哥、97070
        • Investigational Site Number : 4840007
  • 巴西
      • Rio de Janeiro、巴西、22241-180
        • CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
      • São Paulo、巴西、05403-000
        • Incor - Instituto do Coracao- Site Number : 0760011
    • Estado de Bahia
      • Salvador、Estado de Bahia、巴西、40060-330
        • Associacao Proar- Site Number : 0760003
    • Goiás
      • Goiânia、Goiás、巴西、74605-020
        • Universidade Federal de Goias- Site Number : 0760007
    • Paraná
      • Curitiba、Paraná、巴西、80030-110
        • CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
    • Pernambuco
      • Recife、Pernambuco、巴西、50070-550
        • Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760009
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90610-000
        • Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
    • Santa Catarina
      • Blumenau、Santa Catarina、巴西、89030-101
        • Hospital Dia do Pulmão- Site Number : 0760005
  • 德国
      • Leipzig、德国、04347
        • Investigational Site Number : 2760001
      • Mainz、德国、55128
        • Investigational Site Number : 2760005
  • 意大利
    • Roma
      • Rome、Roma、意大利、00168
        • Investigational Site Number : 3800010
  • 日本
      • Fukushima、日本、960-1295
        • Investigational Site Number : 3920008
      • Kyoto、日本、610-0113
        • Investigational Site Number : 3920006
      • Kyoto、日本、612-8555
        • Investigational Site Number : 3920009
      • Miyazaki、日本、889-1692
        • Investigational Site Number : 3920012
    • Kagawa-ken
      • Sakaidechō、Kagawa-ken、日本、762-8550
        • Investigational Site Number : 3920002
    • Tokyo
      • Chūō、Tokyo、日本、104-0031
        • Investigational Site Number : 3920011
    • Yamaguchi
      • Ube、Yamaguchi、日本、755-8505
        • Investigational Site Number : 3920005
  • 智利
    • Biobio
      • Concepción、Biobio、智利、4070094
        • Investigational Site Number : 1520013
    • Maule Region
      • Talca、Maule Region、智利、3465584
        • Investigational Site Number : 1520001
    • Reg Metropolitana de Santiago
      • Recoleta、Reg Metropolitana de Santiago、智利、8420000
        • Investigational Site Number : 1520015
      • Santiago、Reg Metropolitana de Santiago、智利、7500587
        • Investigational Site Number : 1520006
      • Santiago、Reg Metropolitana de Santiago、智利、7500692
        • Investigational Site Number : 1520005
      • Santiago、Reg Metropolitana de Santiago、智利、7500698
        • Investigational Site Number : 1520004
      • Santiago、Reg Metropolitana de Santiago、智利、7750495
        • Investigational Site Number : 1520002
    • Valparaiso
      • Quillota、Valparaiso、智利、2260877
        • Investigational Site Number : 1520008
      • Viña del Mar、Valparaiso、智利、2531172
        • Investigational Site Number : 1520011
      • Viña del Mar、Valparaiso、智利、2540364
        • Investigational Site Number : 1520012
  • 波兰
      • Chęciny、波兰、26-060
        • Investigational Site Number : 6160004
    • Greater Poland Voivodeship
      • Poznan、Greater Poland Voivodeship、波兰、60-693
        • Investigational Site Number : 6160001
  • 美国
    • Arizona
      • Chandler、Arizona、美国、85224
        • Chandler Clinical Research Trials- Site Number : 8400075
      • Tucson、Arizona、美国、85712
        • Tucson Clinical Research Institute- Site Number : 8400085
    • Colorado
      • Aurora、Colorado、美国、80014
        • Allianz Research Institute - Aurora- Site Number : 8400026
      • Wheat Ridge、Colorado、美国、80033
        • Western States Clinical Research- Site Number : 8400014
    • Florida
      • Boynton Beach、Florida、美国、33435
        • Helix Biomedics- Site Number : 8400114
      • Cutler Bay、Florida、美国、33157
        • Beautiful Minds Clinical Research Center- Site Number : 8400049
      • Hialeah、Florida、美国、33010
        • Qway Research - Hialeah- Site Number : 8400015
      • Miami、Florida、美国、33184
        • High Quality Research- Site Number : 8400039
      • Miami、Florida、美国、33186
        • Innovations Biotech- Site Number : 8400040
      • Miami、Florida、美国、33186
        • New Access Medical Center- Site Number : 8400043
      • Miami、Florida、美国、33135
        • Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048
      • Miami Lakes、Florida、美国、33014
        • Deluxe Health Center- Site Number : 8400045
      • Pembroke Pines、Florida、美国、33025
        • Tellabio International Research Services- Site Number : 8400083
      • Pembroke Pines、Florida、美国、33029
        • Alfa Medical Research LLC- Site Number : 8400146
      • Pensacola、Florida、美国、32503
        • Avanza Medical Research Center- Site Number : 8400135
      • Saint Cloud、Florida、美国、34769
        • Ilumina Medical Research- Site Number : 8400095
      • Sarasota、Florida、美国、34239
        • Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
    • Georgia
      • Cordele、Georgia、美国、31015
        • Private Practice - Dr. David Kavtaradze- Site Number : 8400081
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham & Women's Hospital- Site Number : 8400034
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan Health System - Ann Arbor- Site Number : 8400004
    • Missouri
      • St Louis、Missouri、美国、63141
        • Midwest Clinical Research Center - St. Louis- Site Number : 8400006
    • North Carolina
      • Charlotte、North Carolina、美国、28287
        • Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
    • Ohio
      • Toledo、Ohio、美国、43617
        • Asthma & Allergy Center - Toledo- Site Number : 8400017
    • Oklahoma
      • Edmond、Oklahoma、美国、73034
        • OK Clinical Research- Site Number : 8400021
    • Pennsylvania
      • DuBois、Pennsylvania、美国、15801
        • Clinical Research Associates of Central Pennsylvania- Site Number : 8400116
      • Pittsburgh、Pennsylvania、美国、15241
        • Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
    • Texas
      • Austin、Texas、美国、78759
        • Orion Clinical Research- Site Number : 8400001
      • Boerne、Texas、美国、78006
        • South Texas Medical Research Institute - TTS Research- Site Number : 8400010
      • Dallas、Texas、美国、75246
        • Baylor University Medical Center- Site Number : 8400002
      • El Paso、Texas、美国、79903
        • Western Sky Medical Research- Site Number : 8400023
      • McKinney、Texas、美国、75069
        • Metroplex Pulmonary and Sleep Center- Site Number : 8400022
  • 英国
      • Bradford、英国、BD9 6DA
        • Investigational Site Number : 8260008
      • Chertsey、英国
        • Investigational Site Number : 8260005
      • London、英国、W1G 8HU
        • Investigational Site Number : 8260011
    • Cambridgeshire
      • Cambridge、Cambridgeshire、英国、CB2 2QQ
        • Investigational Site Number : 8260001
    • Glasgow City
      • Glasgow、Glasgow City、英国、G12 0YN
        • Investigational Site Number : 8260004
  • 西班牙
      • Madrid、西班牙、28007
        • Investigational Site Number : 7240008
      • Madrid、西班牙、28010
        • Investigational Site Number : 7240011
    • Catalunya [Cataluña]
      • Barcelona、Catalunya [Cataluña]、西班牙、08017
        • Investigational Site Number : 7240009
  • 阿根廷
      • Buenos Aires、阿根廷、1121
        • Investigational Site Number : 0320005
      • Buenos Aires、阿根廷、1414
        • Investigational Site Number : 0320004
      • Buenos Aires、阿根廷、1425
        • Investigational Site Number : 0320001
      • Buenos Aires、阿根廷、1122
        • Investigational Site Number : 0320012
      • Buenos Aires、阿根廷、1425
        • Investigational Site Number : 0320011
      • La Plata, Buenos Aires、阿根廷、B1904CUL
        • Investigational Site Number : 0320003
      • Mendoza、阿根廷、5500
        • Investigational Site Number : 0320009
      • Mendoza、阿根廷、5500
        • Investigational Site Number : 0320015
      • Santa Fe、阿根廷、3000
        • Investigational Site Number : 0320010
    • Buenos Aires
      • Berazategui、Buenos Aires、阿根廷、1886
        • Investigational Site Number : 0320007
      • Lobos、Buenos Aires、阿根廷、7240
        • Investigational Site Number : 0320013
    • Santa Fe Province
      • Rosario、Santa Fe Province、阿根廷、2000
        • Investigational Site Number : 0320002
      • Rosario、Santa Fe Province、阿根廷、2000
        • Investigational Site Number : 0320006
      • Rosario、Santa Fe Province、阿根廷、2000
        • Investigational Site Number : 0320020
    • Tucumán Province
      • San Miguel de Tucumán、Tucumán Province、阿根廷、4000
        • Investigational Site Number : 0320008
  • 韩国
    • Seoul-teukbyeolsi
      • Seoul、Seoul-teukbyeolsi、韩国、03722
        • Investigational Site Number : 4100001
      • Seoul、Seoul-teukbyeolsi、韩国、03080
        • Investigational Site Number : 4100002
      • Seoul、Seoul-teukbyeolsi、韩国、05030
        • Investigational Site Number : 4100004
      • Seoul、Seoul-teukbyeolsi、韩国、05505
        • Investigational Site Number : 4100006
      • Seoul、Seoul-teukbyeolsi、韩国、06351
        • Investigational Site Number : 4100005

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participants who completed the treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol

  • Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:

    • For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone
    • For Study ACT18301: LABA with or without LTRA

  • Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures

  • Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And:

For female participants:

  • incapable of becoming pregnant, or
  • not pregnant or breast feeding
  • no eggs donation or cryopreserving eggs

For male participants:

-- No sperm donation or cryopreserving sperm

- Capable of giving signed informed consent

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures
  • Participant who was diagnosed with a new pulmonary disease which may impair lung function
  • Current smoker or active vaping of any products and/or marijuana smoking
  • Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
  • History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
  • Participants who are receiving prohibited concomitant medications
  • Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Lunsekimig

Participants will receive subcutaneous injection of lunsekimig according to established dosing interval
药品：Lunsekimig
  • Pharmaceutical form: Solution for injection in vial or pre-filled syringe (PFS)
  • Route of administration: Subcutaneous injection
其他名称：
  • SAR443765

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)
大体时间：From study baseline to week 148

Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
From study baseline to week 148

次要结果测量

结果测量
措施说明
大体时间
Annualized rate of asthma exacerbation events
大体时间：From study baseline to weeks 48, 96 and 144
From study baseline to weeks 48, 96 and 144
Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
大体时间：From parent study baseline to weeks 48, 96 and 144
From parent study baseline to weeks 48, 96 and 144
Serum lunsekimig concentrations
大体时间：From study baseline to week 144
From study baseline to week 144
Incidence and titer of anti-drug antibodies (ADA) against lunsekimig
大体时间：From study baseline to week 144
From study baseline to week 144
Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score
大体时间：From parent study baseline to weeks 48, 96 and 144

The ACQ-5 is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has five questions on the asthma symptoms and patients are asked to recall how their asthma has been during the previous week and to respond on a 7-point scale for each question (0 = no impairment, 6 = maximum impairment). The ACQ-5 score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.
From parent study baseline to weeks 48, 96 and 144
Proportion of participants with ≥0.5-point reduction in each ACQ-5 score as compared to parent study baseline score
大体时间：From parent study baseline to weeks 48, 96 and 144

Defined as ACQ-5 responder analysis
From parent study baseline to weeks 48, 96 and 144
Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activites for 12 years and older (AQLQ[S] +12) domain and total scores
大体时间：From parent study baseline to weeks 48, 96 and 144

The AQLQ(S) + 12 was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to adolescents and adults ≥12 years of age as a result of their asthma. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7. Higher scores indicate better quality of life.
From parent study baseline to weeks 48, 96 and 144

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sanofi

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月30日

初级完成 (估计的)

2031年1月20日

研究完成 (估计的)

2031年1月20日

研究注册日期

首次提交

2024年9月20日

首先提交符合 QC 标准的

2024年9月20日

首次发布 (实际的)

2024年9月24日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LTS17231
  • 2025-522896-27 (注册表标识符：CTIS)
  • U1111-1303-3645 (注册表标识符：ICTRP)
  • 2025 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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