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一项研究SAR441566对溃疡性结肠炎患者的疗效和安全性的研究 (SPECIFI-UC)

2026年10月16日 更新者：Sanofi

第二阶段，跨国，多中心，随机，双盲，安慰剂对照，剂量范围的研究，以评估SAR441566在中度到重度溃疡性结肠炎的成年人中的疗效和安全性

This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.

This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.

Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study).

  • The study duration will be up to 59 weeks.
  • The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.
  • The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

170

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
      • Guangzhou、中国、510655
        • Investigational Site Number : 1560002
      • Hangzhou、中国、310016
        • Investigational Site Number : 1560001
      • Huizhou、中国、516001
        • Investigational Site Number : 1560003
      • Huizhou、中国、516001
        • Investigational Site Number : 1560017
      • Jiazhuang、中国、050000
        • Investigational Site Number : 1560004
      • Linhai、中国、317000
        • Investigational Site Number : 1560014
      • Luoyang、中国、471003
        • Investigational Site Number : 1560008
      • Shanghai、中国、200120
        • Investigational Site Number : 1560005
      • Wuhan、中国、430014
        • Investigational Site Number : 1560011
  • 乔治亚州
      • Tbilisi、乔治亚州、0160
        • Investigational Site Number : 2680003
      • Tbilisi、乔治亚州、0144
        • Investigational Site Number : 2680002
      • Tbilisi、乔治亚州、0180
        • Investigational Site Number : 2680001
  • 保加利亚
      • Burgas、保加利亚、8000
        • Investigational Site Number : 1000001
      • Rousse、保加利亚、7002
        • Investigational Site Number : 1000003
      • Sofia、保加利亚、1612
        • Investigational Site Number : 1000002
  • 克罗地亚
      • Osijek、克罗地亚、31000
        • Investigational Site Number : 1910001
  • 加拿大
    • Nova Scotia
      • Kentville、Nova Scotia、加拿大、B4N 0A3
        • Investigational Site Number : 1240004
    • Ontario
      • Ajax、Ontario、加拿大、L1S 7K7
        • Investigational Site Number : 1240006
      • Richmond Hill、Ontario、加拿大、L4C 9M7
        • Investigational Site Number : 1240005
    • Quebec
      • Québec、Quebec、加拿大、G1N 4V3
        • Investigational Site Number : 1240001
  • 匈牙利
      • Budapest、匈牙利
        • Investigational Site Number : 3480001
  • 南非
      • Cape Town、南非、7405
        • Investigational Site Number : 7100002
      • Cape Town、南非、7708
        • Investigational Site Number : 7100001
      • KwaDukuza、南非、4449
        • Investigational Site Number : 7100004
      • Pretoria、南非、0157
        • Investigational Site Number : 7100005
      • Pretoria、南非、0002
        • Investigational Site Number : 7100003
  • 印度
      • Hyderabad、印度、500082
        • Investigational Site Number : 3560005
      • Jaipur、印度、302001
        • Investigational Site Number : 3560003
      • Jaipur、印度、302004
        • Investigational Site Number : 3560009
      • Kolkata、印度、700020
        • Investigational Site Number : 3560002
      • Ludhiana、印度、141002
        • Investigational Site Number : 3560004
      • Secunderabad、印度、500003
        • Investigational Site Number : 3560007
      • Surat、印度、395002
        • Investigational Site Number : 3560001
      • Visakhapatnam、印度、530040
        • Investigational Site Number : 3560010
  • 土耳其（türkiye）
      • Istanbul、土耳其（türkiye）、34899
        • Investigational Site Number : 7920002
      • Izmir、土耳其（türkiye）、35100
        • Investigational Site Number : 7920003
      • Mersin、土耳其（türkiye）、33070
        • Investigational Site Number : 7920001
  • 奥地利
      • Salzburg、奥地利、5020
        • Investigational Site Number : 0400002
      • Vienna、奥地利、1090
        • Investigational Site Number : 0400001
  • 巴西
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90035903
        • Hospital de Clinicas de Porto Alegre- Site Number : 0760002
      • Porto Alegre、Rio Grande do Sul、巴西、90160-093
        • Hospital Ernesto Dornelles- Site Number : 0760003
  • 希腊
      • Athens、希腊、124 62
        • Investigational Site Number : 3000003
      • Athens、希腊、106 76
        • Investigational Site Number : 3000001
      • Heraklion、希腊、711 10
        • Investigational Site Number : 3000002
  • 德国
      • Berlin、德国、10117
        • Investigational Site Number : 2760005
      • Berlin、德国、14050
        • Investigational Site Number : 2760008
      • Duisburg、德国、47055
        • Investigational Site Number : 2760010
      • Frankfurt、德国、60590
        • Investigational Site Number : 2760009
      • Hanover、德国、30625
        • Investigational Site Number : 2760003
      • Tübingen、德国、72076
        • Investigational Site Number : 2760011
      • Ulm、德国、89081
        • Investigational Site Number : 2760006
  • 意大利
      • Alessandria、意大利、15100
        • Investigational Site Number : 3800007
      • Palermo、意大利、90127
        • Investigational Site Number : 3800009
      • Pisa、意大利、56124
        • Investigational Site Number : 3800004
    • Genova
      • Genoa、Genova、意大利、16132
        • Investigational Site Number : 3800006
    • Milano
      • Milan、Milano、意大利、20132
        • Investigational Site Number : 3800002
      • Rozzano、Milano、意大利、20089
        • Investigational Site Number : 3800003
    • Napoli
      • Naples、Napoli、意大利、80131
        • Investigational Site Number : 3800008
    • Padova
      • Padua、Padova、意大利、35128
        • Investigational Site Number : 3800001
    • Roma
      • Rome、Roma、意大利、00161
        • Investigational Site Number : 3800011
    • Torino
      • Turin、Torino、意大利、10126
        • Investigational Site Number : 3800010
  • 捷克语
      • Olomouc、捷克语、779 00
        • Investigational Site Number : 2030001
      • Ostrava、捷克语、710 00
        • Investigational Site Number : 2030002
  • 日本
      • Hiroshima、日本、734-8530
        • Investigational Site Number : 3920012
      • Kagoshima、日本、892-0843
        • Investigational Site Number : 3920016
      • Niigata、日本、950-1104
        • Investigational Site Number : 3920001
      • Osaka、日本、530-0011
        • Investigational Site Number : 3920010
      • Tokyo、日本、108-8642
        • Investigational Site Number : 3920015
    • Chiba
      • Kashiwa、Chiba、日本、277-0871
        • Investigational Site Number : 3920005
    • Hiroshima
      • Kure、Hiroshima、日本、737-0811
        • Investigational Site Number : 3920014
    • Hokkaido
      • Sapporo、Hokkaido、日本、004-0041
        • Investigational Site Number : 3920003
      • Sapporo、Hokkaido、日本、065-0033
        • Investigational Site Number : 3920007
    • Iwate
      • Yahaba、Iwate、日本、028-3695
        • Investigational Site Number : 3920009
    • Kanagawa
      • Yokohama、Kanagawa、日本、220-0041
        • Investigational Site Number : 3920013
    • Tokyo
      • Bunkyo-Ku、Tokyo、日本、113-8510
        • Investigational Site Number : 3920002
      • Kodaira、Tokyo、日本、187-8510
        • Investigational Site Number : 3920011
    • Yamanashi
      • Kofu、Yamanashi、日本、400-0027
        • Investigational Site Number : 3920006
  • 智利
    • Reg Metropolitana de Santiago
      • Santiago、Reg Metropolitana de Santiago、智利、8330034
        • Investigational Site Number : 1520003
      • Santiago、Reg Metropolitana de Santiago、智利、7500010
        • Investigational Site Number : 1520002
      • Santiago、Reg Metropolitana de Santiago、智利、8331143
        • Investigational Site Number : 1520001
  • 比利时
      • Ghent、比利时、9000
        • Investigational Site Number : 0560002
      • Leuven、比利时、3000
        • Investigational Site Number : 0560001
  • 法国
      • Nice、法国、06202
        • Investigational Site Number : 2500003
      • Toulouse、法国、31059
        • Investigational Site Number : 2500001
      • Vandœuvre-lès-Nancy、法国、54511
        • Investigational Site Number : 2500002
  • 波兰
    • Lesser Poland Voivodeship
      • Oświęcim、Lesser Poland Voivodeship、波兰、32-600
        • Investigational Site Number : 6160008
    • Lower Silesian Voivodeship
      • Wroclaw、Lower Silesian Voivodeship、波兰、53-034
        • Investigational Site Number : 6160005
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、03-580
        • Investigational Site Number : 6160004
      • Warsaw、Masovian Voivodeship、波兰、04-501
        • Investigational Site Number : 6160001
    • Podkarpackie Voivodeship
      • Rzeszów、Podkarpackie Voivodeship、波兰、35-055
        • Investigational Site Number : 6160002
  • 澳大利亚
    • South Australia
      • Kurralta Park、South Australia、澳大利亚、5037
        • Investigational Site Number : 0360003
    • Victoria
      • Richmond、Victoria、澳大利亚、3121
        • Investigational Site Number : 0360005
  • 罗马尼亚
      • Constanța、罗马尼亚、900673
        • Investigational Site Number : 6420001
  • 美国
    • Arizona
      • Sun City、Arizona、美国、85351
        • GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003
    • Connecticut
      • Bristol、Connecticut、美国、06010
        • Bristol Hospital- Site Number : 8400017
    • Florida
      • Clermont、Florida、美国、34711
        • Novum Research- Site Number : 8400018
      • Kissimmee、Florida、美国、34741
        • Clinical Research of Osceola- Site Number : 8400012
      • Miami Lakes、Florida、美国、33016
        • Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002
      • Tampa、Florida、美国、33609
        • GCP Clinical Research- Site Number : 8400016
    • Illinois
      • Glenview、Illinois、美国、60026
        • GI Alliance - Glenview- Site Number : 8400005
      • Gurnee、Illinois、美国、60031
        • Illinois Gastroenterology Group- Site Number : 8400004
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan Health System - Ann Arbor- Site Number : 8400010
    • New York
      • New York、New York、美国、10029
        • Icahn School of Medicine at Mount Sinai- Site Number : 8400001
      • Queens Village、New York、美国、11428
        • Queens Village Primary Medical Center- Site Number : 8400011
    • Ohio
      • Lima、Ohio、美国、45805
        • NexGen Research- Site Number : 8400020
    • Pennsylvania
      • Uniontown、Pennsylvania、美国、15401
        • Frontier Clinical Research - Uniontown- Site Number : 8400006
    • South Carolina
      • Charleston、South Carolina、美国、29401
        • Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008
    • Texas
      • Katy、Texas、美国、77494
        • Gastro Health & Nutrition- Site Number : 8400007
      • Lubbock、Texas、美国、79424
        • SI Research Associates- Site Number : 8400019
      • Southlake、Texas、美国、76092
        • Texas Digestive Disease Consultants - Southlake- Site Number : 8400015
    • Washington
      • Seattle、Washington、美国、98195
        • University of Washington Medical Center- Site Number : 8400014
      • Tacoma、Washington、美国、98405
        • Washington Gastroenterology - Tacoma- Site Number : 8400009
  • 阿根廷
      • Buenos Aires、阿根廷、1061
        • Investigational Site Number : 0320001
      • Buenos Aires、阿根廷、1006
        • Investigational Site Number : 0320003
      • Buenos Aires、阿根廷、1023
        • Investigational Site Number : 0320002
      • Buenos Aires、阿根廷、1125
        • Investigational Site Number : 0320005
    • Tucumán Province
      • San Miguel de Tucumán、Tucumán Province、阿根廷、4000
        • Investigational Site Number : 0320004

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 至 75年 (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 are eligible to be included in the study only if all of the following criteria apply:

  • Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent

  • Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period

  • Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent >15 cm from the anal verge

  • Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"):

    1. History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR
    2. History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC

  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

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

  • Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
  • Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study
  • Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study
  • Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools
  • Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines
  • Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) at the screening visit
  • Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
  • Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
  • Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
  • History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit.
  • If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
  • Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug
  • Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral/intramuscular anti-infectives within 14 days prior to the screening visit
  • Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
  • Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
  • Participants who received fecal microbial transplantation within 30 days prior to screening
  • Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
  • Participants who received IV corticosteroids within 14 days prior to screening or during screening period
  • Screening laboratory and other analyses show abnormal results.

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：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：SAR441566 dose regimen 1

Participants will receive SAR441566 dose regimen 1
药品：SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
实验性的：SAR441566 dose regimen 2

Participants will receive SAR441566 dose regimen 2
药品：SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
实验性的：SAR441566 dose regimen 3

Participants will receive SAR441566 dose regimen 3
药品：SAR441566

Pharmaceutical form: Tablet Route of administration: Oral
安慰剂比较：Placebo

Participants will receive SAR441566-matching placebo
药品：SAR441566 matching Placebo

Pharmaceutical form: Tablet Route of administration: Oral

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
Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)
大体时间：Week 12

Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore >1 (stool frequency [SF] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding [RB] of 0 and modified Mayo Endoscopic Subscore [mMES] of 0 or 1 where 1 does not include friability).

Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Week 12

次要结果测量

结果测量
措施说明
大体时间
选定访问时血浆predose浓度的SAR441566
大体时间：直到第52周
直到第52周
选定访问时的血浆药物后浓度的SAR441566
大体时间：直到第52周
直到第52周
在归纳和维护治疗期间，患有任何治疗伴随不良事件（TEAE）的参与者数量
大体时间：直到第52周
直到第52周
在开放标签治疗期间，有任何治疗伴随不良事件（TEAE）的参与者数量
大体时间：从第12周到第52周
从第12周到第52周
Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)
大体时间：Week 12

Clinical response by modified Mayo score (mMS) is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1.

Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Week 12
Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)
大体时间：Week 12

Clinical response by full Mayo score (MS) is defined as a decrease from baseline in the MS of ≥3 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1.

The MS (also referred to as the full Mayo Score) is a composite index designed to measure ulcerative colitis (UC) disease activity and consists of 4 subscores: RB and SF, which are patient-reported subscores, Physician's global assessment (PGA), and endoscopic findings. Individual items are rated 0 to 3, giving the composite score a maximum of 12, with higher scores indicating greater disease severity.
Week 12
Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)
大体时间：Week 12

Clinical remission by full Mayo score (MS) is defined as a MS ≤2 with no score >1.
Week 12
Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12
大体时间：Week 12

Patient-reported outcome 2 (PRO2) remission is defined as PRO2 score ≤1 with rectal bleeding (RB) of 0, and endoscopic remission is defined as mMES of 0.

PRO2 score is defined as the sum of Mayo SF and RB subscores.
Week 12
Proportion of participants achieving endoscopic remission at Week 12
大体时间：Week 12

Endoscopic remission is defined as mMES of 0.
Week 12
Change from baseline in PRO2 from randomization to Week 12
大体时间：From Baseline to Week 12

PRO2 score is defined as the sum of the Mayo SF and RB subscores.
From Baseline to Week 12
Proportion of participants achieving endoscopic response at Week 12
大体时间：Week 12

Endoscopic response is defined as mMES decrease of at least 1 point.
Week 12
Proportion of participants achieving endoscopic improvement at Week 12
大体时间：Week 12

Endoscopic improvement is defined as mMES of 0 or 1 where 1 does not include friability.
Week 12
Proportion of participants achieving HEMI at Week 12
大体时间：Week 12

Histologic endoscopic mucosal improvement (HEMI) is defined by achievement of modified Mayo endoscopic improvement (mMES of 0 or 1 where 1 does not include friability) and histological improvement (original Geboes Score [OGS] ≤3.1).
Week 12
Proportion achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12
大体时间：Week 12

Inflammatory Bowel Disease Questionnaire (IBDQ) remission is considered as an IBDQ-32 total score ≥170 points.

IBDQ is designed to capture the patient's experience of IBD on 4 domains of functioning and well-being: bowel and systemic symptoms and emotional and social function. The total IBDQ score ranges from 32 to 224 which indicates better quality of life.
Week 12
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 12
大体时间：Week 12

Inflammatory Bowel Disease Questionnaire (IBDQ) response is defined as an increase from baseline in the total IBDQ score in the range of 16 to 32 points.
Week 12

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)

2025年3月28日

初级完成 (实际的)

2026年8月6日

研究完成 (实际的)

2026年10月12日

研究注册日期

首次提交

2025年3月4日

首先提交符合 QC 标准的

2025年3月4日

首次发布 (实际的)

2025年3月10日

研究记录更新

最后更新发布 (实际的)

2026年10月21日

上次提交的符合 QC 标准的更新

2026年10月16日

最后验证

2026年10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

  • DRI17822
  • U1111-1308-9729 (其他标识符：WHO)
  • 2025-520705-12 (注册表标识符：CTIS)
  • 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

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