A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
报名条件(概要)
- 年龄:12 Years – 不限
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
United States、Japan
药品与企业信息
其他名称:Placebo for PF-07275315
Subcutaneous Injections at required timepoints
Subcutaneous Injections at required timepoints during initial treatment period.
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
Dupilumab
Sanofi-Aventis U.S. LLC
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema is a condition which can cause dryness, itching, and redness of your skin. The study is seeking participants who: * Are aged 12 years or older. * Were confirmed to have atopic dermatitis (AD) at least 12 months ago. * Are not having an effective treatment result from medicines that are applied on skin for AD. * Are considered by their doctors to have moderate to severe AD. The study treatment period will be 52 weeks. During the 24-week initial treatment period, participants will be randomized to one of three study treatments - tilrekimig, dupilumab, or placebo. Placebo does not have any medicine in it but looks just like the medicine being studied. These treatments will be randomized based on a 2:2:1 ratio. This means out of 1375 participants, about 550 participants will receive tilrekimig, 550 will receive dupilumab, and 275 will receive placebo. This will be followed by a 28-week maintenance period. The last dose of study treatment will be administered at week 48. Some participants will join the long-term extension (LTE) study C4531008 at week 52. A long-term extension study is an additional study that some participants may be able to join after completing the study if they are interested and meet eligibility requirements. It allows researchers to continue collecting information about how well the study medicine works. It also helps them assess how safe it is when used for a longer period of time. Participants who do not join this study will enter a 12-week safety follow-up period. This period ends 16 weeks after their last dose of study treatment.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Pfizer CT.gov Call CenterClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
问自己是否符合条件、如何预筛
我的病情档案
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema ClinicalTrials.gov Identifier: NCT07783425 Sponsor: Pfizer Investigational product: Tilrekimig, Dupilumab, Placebo for Tilrekimig, Placebo for Dupilumab About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema 试验编号:NCT07783425 申办方:Pfizer 研究药物:Tilrekimig、Dupilumab、Placebo for Tilrekimig、Placebo for Dupilumab 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。