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一项研究评估SAR445399在中度至重度化脓性汗腺炎成年受试者中的疗效与安全性 (CLAROS)

2026年10月15日 更新者：Sanofi

一项随机、双盲、安慰剂对照的2期剂量探索研究，旨在评估SAR445399在中重度化脓性汗腺炎患者中的疗效和安全性

This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa.

The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa.

The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

144

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。

学习联系方式

  • 姓名：Trial Transparency email recommended (Toll free for US & Canada)
  • 电话号码：option 6 800-633-1610
  • 邮箱：Contact-US@sanofi.com

学习地点

  • 中国
      • Beijing、中国、100730
        • 招聘中
        • Investigational Site Number : 1560001
      • Changsha、中国、410011
        • 招聘中
        • Investigational Site Number : 1560003
      • Hangzhou、中国、310009
        • 招聘中
        • Investigational Site Number : 1560006
      • Shanghai、中国、200040
        • 招聘中
        • Investigational Site Number : 1560004
      • Wuhan、中国、430022
        • 招聘中
        • Investigational Site Number : 1560002
  • 加拿大
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3M 3Z4
        • 招聘中
        • Investigational Site Number : 1240016
    • Ontario
      • Mississauga、Ontario、加拿大、L4W 0C2
        • 招聘中
        • Investigational Site Number : 1240015
      • Richmond Hill、Ontario、加拿大、L4B 1L1
        • 招聘中
        • Investigational Site Number : 1240001
      • Toronto、Ontario、加拿大、M2N 3A6
        • 招聘中
        • Investigational Site Number : 1240014
    • Quebec
      • Montreal、Quebec、加拿大、H1Y 3L1
        • 招聘中
        • Investigational Site Number : 1240010
      • Sherbrooke、Quebec、加拿大、J1G 1X9
        • 招聘中
        • Investigational Site Number : 1240002
    • Saskatchewan
      • Regina、Saskatchewan、加拿大、S4V 1R9
        • 招聘中
        • Investigational Site Number : 1240013
      • Saskatoon、Saskatchewan、加拿大、S7K 0H6
        • 招聘中
        • Investigational Site Number : 1240011
  • 匈牙利
      • Budapest、匈牙利、1085
        • 招聘中
        • Investigational Site Number : 3480002
      • Gyula、匈牙利、5700
        • 招聘中
        • Investigational Site Number : 3480005
      • Kaposvár、匈牙利、7400
        • 招聘中
        • Investigational Site Number : 3480003
      • Szeged、匈牙利、6720
        • 招聘中
        • Investigational Site Number : 3480004
  • 土耳其（türkiye）
      • Buca、土耳其（türkiye）、35390
        • 招聘中
        • Investigational Site Number : 7920006
      • Istanbul、土耳其（türkiye）、34093
        • 招聘中
        • Investigational Site Number : 7920001
      • Istanbul、土耳其（türkiye）、34899
        • 招聘中
        • Investigational Site Number : 7920005
      • Izmir、土耳其（türkiye）、35540
        • 招聘中
        • Investigational Site Number : 7920004
      • Manisa、土耳其（türkiye）、45030
        • 招聘中
        • Investigational Site Number : 7920002
      • Samsun、土耳其（türkiye）、55139
        • 招聘中
        • Investigational Site Number : 7920003
  • 巴西
      • São Paulo、巴西、05651-901
        • 招聘中
        • Hospital Israelita Albert Einstein- Site Number : 0760004
    • Estado de Bahia
      • Salvador、Estado de Bahia、巴西、41820-020
        • 招聘中
        • Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
    • São Paulo
      • Campinas、São Paulo、巴西、13083-888
        • 招聘中
        • Hospital das Clinicas da UNICAMP- Site Number : 0760002
  • 德国
      • Blankenfelde-Mahlow、德国、15831
        • 招聘中
        • Investigational Site Number : 2760004
      • Darmstadt、德国、64283
        • 招聘中
        • Investigational Site Number : 2760007
      • Dresden、德国、01307
        • 招聘中
        • Investigational Site Number : 2760006
      • Merzig、德国、66663
        • 招聘中
        • Investigational Site Number : 2760005
      • Regensburg、德国、93053
        • 招聘中
        • Investigational Site Number : 2760003
      • Rostock、德国、18055
        • 招聘中
        • Investigational Site Number : 2760002
  • 意大利
      • Brescia、意大利、25123
        • 招聘中
        • Investigational Site Number : 3800004
      • Chieti、意大利、66100
        • 招聘中
        • Investigational Site Number : 3800001
      • Pisa、意大利、56126
        • 招聘中
        • Investigational Site Number : 3800006
    • Ancona
      • Torette、Ancona、意大利、60020
        • 招聘中
        • Investigational Site Number : 3800002
    • Ferrara
      • Cona、Ferrara、意大利、44124
        • 招聘中
        • Investigational Site Number : 3800005
    • Milano
      • Garbagnate Milanese、Milano、意大利、20024
        • 招聘中
        • Investigational Site Number : 3800007
      • Milan、Milano、意大利、20132
        • 招聘中
        • Investigational Site Number : 3800003
  • 日本
      • Tokyo、日本、173-8610
        • 招聘中
        • Investigational Site Number : 3920001
      • Tokyo、日本、160-0023
        • 招聘中
        • Investigational Site Number : 3920002
    • Aichi-ken
      • Nagoya、Aichi-ken、日本、467-8602
        • 招聘中
        • Investigational Site Number : 3920004
    • Ibaraki
      • Tsukuba、Ibaraki、日本、305-8576
        • 招聘中
        • Investigational Site Number : 3920005
    • Saitama
      • Koshigaya、Saitama、日本、343-0845
        • 招聘中
        • Investigational Site Number : 3920003
  • 比利时
      • Brussels、比利时、1070
        • 招聘中
        • Investigational Site Number : 0560002
      • Ghent、比利时、9000
        • 招聘中
        • Investigational Site Number : 0560001
      • Liège、比利时、4000
        • 招聘中
        • Investigational Site Number : 0560004
  • 法国
      • Lille、法国、59020
        • 招聘中
        • Investigational Site Number : 2500005
      • Lille、法国、59037
        • 招聘中
        • Investigational Site Number : 2500006
      • Nantes、法国、44093
        • 招聘中
        • Investigational Site Number : 2500002
      • Paris、法国、75010
        • 招聘中
        • Investigational Site Number : 2500004
      • Rouen、法国、76031
        • 招聘中
        • Investigational Site Number : 2500003
  • 澳大利亚
    • New South Wales
      • Sydney、New South Wales、澳大利亚、2010
        • 招聘中
        • Investigational Site Number : 0360001
    • South Australia
      • Woodville、South Australia、澳大利亚、5011
        • 招聘中
        • Investigational Site Number : 0360003
    • Western Australia
      • South Perth、Western Australia、澳大利亚、6151
        • 招聘中
        • Investigational Site Number : 0360002
  • 瑞典
      • Uppsala、瑞典、752 37
        • 招聘中
        • Investigational Site Number : 7520002
      • Örebro、瑞典、701 85
        • 招聘中
        • Investigational Site Number : 7520001
  • 美国
    • Arizona
      • Scottsdale、Arizona、美国、85260
        • 招聘中
        • Scottsdale Clinical Trials- Site Number : 8400006
    • California
      • North Hollywood、California、美国、91606
        • 主动，不招人
        • Carbon Health - North Hollywood - NoHo West- Site Number : 8400017
    • Florida
      • Boynton Beach、Florida、美国、33436
        • 招聘中
        • Encore Medical Research of Boynton Beach- Site Number : 8400005
      • Fort Lauderdale、Florida、美国、33308
        • 招聘中
        • FXM Clinical Research - Fort Lauderdale- Site Number : 8400013
      • Fort Myers、Florida、美国、33912
        • 招聘中
        • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400007
      • Hollywood、Florida、美国、33024
        • 招聘中
        • Encore Medical Research - Hollywood- Site Number : 8400004
      • Miami、Florida、美国、33173
        • 招聘中
        • Florida International Research Center- Site Number : 8400002
      • Miami、Florida、美国、33146
        • 招聘中
        • Fxm Clinical Research/Fax Pharma Clinical Research- Site Number : 8400014
      • Miami、Florida、美国、33174
        • 招聘中
        • Florida Research Center- Site Number : 8400009
      • Tampa、Florida、美国、33607
        • 招聘中
        • Advanced Clinical Research Institute- Site Number : 8400021
    • Georgia
      • Cumming、Georgia、美国、30040
        • 招聘中
        • Cleaver Medical Group Dermatology- Site Number : 8400008
      • Fayetteville、Georgia、美国、30214
        • 招聘中
        • First Georgia Physician Group- Site Number : 8400033
    • Illinois
      • Skokie、Illinois、美国、60077
        • 招聘中
        • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400019
    • Indiana
      • Evansville、Indiana、美国、47708
        • 招聘中
        • Deaconess Clinic - Downtown Fourth Street- Site Number : 8400029
    • Kentucky
      • Louisville、Kentucky、美国、40241
        • 招聘中
        • Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400026
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • 招聘中
        • Beth Israel Deaconess Medical Center - Boston- Site Number : 8400001
    • Missouri
      • Kansas City、Missouri、美国、64108
        • 招聘中
        • University Health Dermatology- Site Number : 8400018
    • New York
      • The Bronx、New York、美国、10455
        • 招聘中
        • Equity Medical (LLC)- Site Number : 8400010
    • Oklahoma
      • Tulsa、Oklahoma、美国、74137
        • 招聘中
        • Essential Medical Research- Site Number : 8400015
    • Texas
      • The Woodlands、Texas、美国、77380
        • 招聘中
        • Elligo Health Research/The Woodlands Dermatology Associates- Site Number : 8400020
    • Virginia
      • Norfolk、Virginia、美国、23502
        • 招聘中
        • Virginia Dermatology & Skin Cancer Center- Site Number : 8400024
  • 西班牙
      • Córdoba、西班牙、14004
        • 招聘中
        • Investigational Site Number : 7240001
      • Málaga、西班牙、29016
        • 招聘中
        • Investigational Site Number : 7240004
    • Basque Country
      • Bilbao、Basque Country、西班牙、48013
        • 招聘中
        • Investigational Site Number : 7240002
    • Catalunya [Cataluña]
      • Barcelona、Catalunya [Cataluña]、西班牙、08035
        • 招聘中
        • Investigational Site Number : 7240006
    • Sevilla
      • Seville、Sevilla、西班牙、41009
        • 招聘中
        • Investigational Site Number : 7240005
  • 阿根廷
      • Buenos Aires、阿根廷、1181
        • 招聘中
        • Investigational Site Number : 0320003
      • Buenos Aires、阿根廷、1061
        • 招聘中
        • Investigational Site Number : 0320002
      • Buenos Aires、阿根廷、1023
        • 招聘中
        • Investigational Site Number : 0320001

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

  • Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline
  • Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III.
  • Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit.
  • Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history.
  • Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS; Participants in the biologic-experienced stratum must have documented history of use of at least one dose of biologic therapy for HS.

Exclusion Criteria:

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

  • Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
  • History of recurrent or recent serious infection
  • Known history of or suspected current immunosuppression
  • History of solid organ transplant or stem cell transplant.
  • History of splenectomy
  • History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured.
  • Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable or may interfere with study assessments

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：SAR445399 dose regimen A

Participants will receive SAR445399 dose regimen A.
药品：SAR445399

Pharmaceutical form: Solution for injection -Route of administration: Injection
实验性的：SAR445399 dose regimen B

Participants will receive SAR445399 dose regimen B.
药品：SAR445399

Pharmaceutical form: Solution for injection -Route of administration: Injection
安慰剂比较：Placebo

Participants will receive SAR445399-matching placebo.
药品：Placebo

Pharmaceutical form: Solution for injection -Route of administration: Injection

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
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
大体时间：Up to Week 16

Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count.
Up to Week 16

次要结果测量

结果测量
措施说明
大体时间
从基线至第16周引流性窦道数量百分比变化
大体时间：从基线至第16周
从基线至第16周
基线至第16周引流隧道计数的绝对变化
大体时间：从基线至第16周
从基线至第16周
从基线至第16周化脓性汗腺炎皮肤疼痛数字评定量表（HS-皮肤疼痛NRS）的百分比变化
大体时间：从基线至第16周
从基线至第16周
Number of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms (ECGs) during the double- blinded initial treatment period and the treatment-blinded extension period
大体时间：Up to End of Study (approximately 46 weeks)
Up to End of Study (approximately 46 weeks)
Plasma concentrations of SAR445399 during the double-blinded initial treatment period and the treatment-blinded extension period
大体时间：Up to End of Study (approximately 46 weeks)
Up to End of Study (approximately 46 weeks)
Incidence of anti-drug antibodies (ADA) of SAR445399 at prespecified timepoints during the double-blinded initial treatment period and the treatment-blinded extension period
大体时间：Up to End of Study (approximately 46 weeks)
Up to End of Study (approximately 46 weeks)
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
大体时间：Up to Week 16

Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count)
Up to Week 16
Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4)
大体时间：From baseline to Week 16

The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease.
From baseline to Week 16
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90)
大体时间：Up to Week 16

Hidradenitis Suppurativa Clinical Response 90 is defined as ≥90% reduction from baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count.
Up to Week 16
Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average HS-Skin Pain NRS item 1a from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3
大体时间：From baseline to Week 16

The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period).
From baseline to Week 16
Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score
大体时间：From Baseline to Week 16

The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
From Baseline to Week 16
Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score
大体时间：From Baseline to Week 16

The Hidradenitis Suppurativa Quality of Life (HiSQoL) is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL.
From Baseline to Week 16
Change from baseline to Week 16 in Weekly average HS-SAQ score items
大体时间：From Baseline to Week 16

The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. Each item is scored on a 0 to 10 scale with 0 indicating "no symptom" and 10 indicating "worst symptom possible".
From Baseline to Week 16
Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) total score
大体时间：From Baseline to Week 16

The Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) is an 11-item questionnaire assessing the impact of HS on QoL
From Baseline to Week 16
Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16
大体时间：From Baseline to Week 16

The Peak Pruritus Numerical Rating Scale (PP-NRS) is defined as achieving at least 4-unit reduction from Baseline in weekly average of daily PP-NRS among participants with baseline PP-NRS ≥4)
From Baseline to Week 16
Number of participants with TEAEs AESIs, and SAEs including administration site reactions during the double-blinded initial treatment period and the treatment-blinded extension period
大体时间：Up to End of Study (approximately 46 weeks)

Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs).
Up to End of Study (approximately 46 weeks)

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12月29日

初级完成 (估计的)

2027年9月22日

研究完成 (估计的)

2027年11月19日

研究注册日期

首次提交

2025年11月4日

首先提交符合 QC 标准的

2025年11月4日

首次发布 (实际的)

2025年11月6日

研究记录更新

最后更新发布 (实际的)

2026年10月16日

上次提交的符合 QC 标准的更新

2026年10月15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

  • DRI20674
  • 2025-522695-83-00 (注册表标识符：CTIS)
  • U1111-1322-6148 (其他标识符：WHO-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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