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一项评估巴利纳坦菲在克罗恩病或溃疡性结肠炎参与者中长期安全性、耐受性和有效性的研究（SPECIFI-IBD-LTS）

2026年10月19日 更新者：Sanofi

一项跨国、多中心扩展研究：旨在调查Balinatunfib在成人克罗恩病或溃疡性结肠炎患者中的长期安全性、耐受性及疗效

LTS19689 is a multinational, multicenter extension study to evaluate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn's disease (CD) or ulcerative colitis (UC) who completed the 52-week treatment period (on balinatunfib or placebo) in the parent studies, SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822), respectively.

  • The primary objective of this study is to assess the long-term safety and tolerability of different doses of balinatunfib in participants with CD or UC, as measured by the number and percentage of participants with CD or UC with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the study period.

  • The study will consist of 2 independent cohorts through the study given the distinct nature of each disease:

    • CD Cohort: comprised of CD participants enrolled from SPECIFI-CD (DRI18212).
    • UC Cohort: comprised of UC participants enrolled from SPECIFI-UC (DRI17822).

  • The study will consist of the following study periods for each cohort:

    • A Double-Blind (DB) treatment period of up to 104 weeks for eligible participants from the DB maintenance phases of the respective parent studies.

    • An Open-Label (OL) treatment period of up to 104 weeks for:

      • Eligible participants from either the DB or OL periods of the parent studies,
      • Eligible participants who meet escape criteria at any time during the DB period of the LTS19689.

    • A 2-week follow-up period following the End of Treatment (EOT). The study duration will be up to 107 weeks, with the treatment duration up to 104 weeks.

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)

7

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、510080
        • Investigational Site Number : 1560002
      • Shanghai、中国、200120
        • Investigational Site Number : 1560032
  • 保加利亚
      • Gorna Oryahovitsa、保加利亚、5100
        • Investigational Site Number : 1000001
  • 意大利
    • Milano
      • Milan、Milano、意大利、20132
        • Investigational Site Number : 3800002
  • 捷克语
      • Olomouc、捷克语、779 00
        • Investigational Site Number : 2030001
  • 智利
    • Reg Metropolitana de Santiago
      • Santiago、Reg Metropolitana de Santiago、智利、8331143
        • Investigational Site Number : 1520010
      • Santiago、Reg Metropolitana de Santiago、智利、7500010
        • Investigational Site Number : 1520016
      • Santiago、Reg Metropolitana de Santiago、智利、8380456
        • Investigational Site Number : 1520012
  • 美国
    • Texas
      • Southlake、Texas、美国、76092
        • Texas Digestive Disease Consultants - Southlake- Site Number : 8400005
  • 阿根廷
      • Buenos Aires、阿根廷、1061
        • 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

19年 至 77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:

  • Participants with Crohn's Disease (CD) or ulcerative colitis (UC) who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively:

    • Participants with CD

      1. who complete double-blinded treatment at Week 52 of SPECIFI-CD (DRI18212) study;

      2. who complete open label treatment and achieve the appropriate outcomes at Week 52 of SPECIFI-CD (DRI18212) study.

        OR

    • Participants with UC

      1. who complete double-blinded treatment at Week 52 of SPECIFI-UC (DRI17822) study;
      2. who complete open label treatment and achieve the appropriate outcomes at Week 52 of the SPECIFI-UC (DRI17822) study.

  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding

Exclusion Criteria:

  • Participants with CD who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol.
  • Participants with UC who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol.
  • Participants who developed a new medical condition or a change in status of an established medical condition which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation.
  • Participants who permanently discontinued IMP during the parent study or temporarily discontinued IMP for more than 14 consecutive calendar days by the time of Day 1 of LTS19689.
  • Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to balinatunfib, which in the opinion of the Investigator could indicate that continued treatment with balinatunfib may present an unreasonable risk for the participant.
  • Participants who in the parent study had documented nonadherence to IMP or to standard therapies for CD or UC, or who used a prohibited medication concomitant with IMP or during a temporary IMP discontinuation period.

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：非随机化
  • 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：CD cohort: balinatunfib dose regimen 1

Participants will receive balinatunfib dose regimen 1
药品：balinatunfib

Pharmaceutical form:Tablet -Route of administration:Oral

其他名称：
  • SAR441566
实验性的：CD cohort: balinatunfib dose regimen 2

Participants will receive balinatunfib dose regimen 2
药品：balinatunfib

Pharmaceutical form:Tablet -Route of administration:Oral

其他名称：
  • SAR441566
实验性的：CD cohort: balinatunfib dose regimen 3

Participants will receive balinatunfib dose regimen 3
药品：balinatunfib

Pharmaceutical form:Tablet -Route of administration:Oral

其他名称：
  • SAR441566
安慰剂比较：CD cohort: Placebo

Participants will receive balinatunfib-matching placebo
药品：balinatunfib-matching placebo

Pharmaceutical form:Tablet -Route of administration:Oral
实验性的：UC cohort: balinatunfib dose regimen 1

Participants will receive balinatunfib dose regimen 1
药品：balinatunfib

Pharmaceutical form:Tablet -Route of administration:Oral

其他名称：
  • SAR441566
实验性的：UC cohort: balinatunfib dose regimen 2

Participants will receive balinatunfib dose regimen 2
药品：balinatunfib

Pharmaceutical form:Tablet -Route of administration:Oral

其他名称：
  • SAR441566
实验性的：UC cohort: balinatunfib dose regimen 3

Participants will receive balinatunfib dose regimen 3
药品：balinatunfib

Pharmaceutical form:Tablet -Route of administration:Oral

其他名称：
  • SAR441566
安慰剂比较：UC cohort: Placebo

Participants will receive balinatunfib-matching placebo
药品：balinatunfib-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
大体时间
克罗恩病受试者中发生治疗期不良事件（TEAEs）、严重不良事件（SAEs）及特别关注不良事件（AESIs）的例数
大体时间：直至研究结束（约106周）
直至研究结束（约106周）
患有溃疡性结肠炎的受试者中出现治疗期不良事件（TEAE）、严重不良事件（SAE）及特别关注不良事件（AESI）的例数
大体时间：直至研究结束（约106周）
直至研究结束（约106周）

次要结果测量

结果测量
措施说明
大体时间
Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
大体时间：Week 52

Endoscopic remission is defined as SES-CD ≤4 points (SES CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD subscore >1 point from baseline. The SES-CD evaluates 4 endoscopic items (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Week 52
Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
大体时间：Week 104

Endoscopic remission is defined as SES-CD ≤4 points (SES CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD subscore >1 point from baseline. The SES-CD evaluates 4 endoscopic items (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Week 104
Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
大体时间：Week 52

Clinical remission is defined as CDAI <150. The CDAI score is composed of eight items: 3 of them (abdominal pain, stool frequency and general well-being) completed by the participant and the others (use of anti-diarrheal medications, extraintestinal complications, palpable abdominal mass, hematocrit levels, and body weight) assessed and reported by the clinician. The CDAI is derived from summing up the weighted individual scores of eight items. Scores on the CDAI scale range from 0 to 600, with higher scores indicating more severe disease.
Week 52
Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
大体时间：Week 104

Clinical remission is defined as CDAI <150. The CDAI score is composed of eight items: 3 of them (abdominal pain, stool frequency and general well-being) completed by the participant and the others (use of anti-diarrheal medications, extraintestinal complications, palpable abdominal mass, hematocrit levels, and body weight) assessed and reported by the clinician. The CDAI is derived from summing up the weighted individual scores of eight items. Scores on the CDAI scale range from 0 to 600, with higher scores indicating more severe disease.
Week 104
Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
大体时间：Week 52

Clinical remission by modified Mayo score (mMS) is defined as a mMS score of 0 to 2, including stool frequency (SF) of 0 or 1, rectal bleeding (RB) subscore of 0, and centrally read modified Mayo Endoscopic Subscore [mMES] of 0 or 1 (score of 1 modified to exclude 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 52
Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
大体时间：Week 104

Clinical remission by modified Mayo score (mMS) is defined as a mMS score of 0 to 2, including stool frequency (SF) of 0 or 1, rectal bleeding (RB) subscore of 0, and centrally read modified Mayo Endoscopic Subscore [mMES] of 0 or 1 (score of 1 modified to exclude 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 104

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)

2026年5月19日

初级完成 (实际的)

2026年9月29日

研究完成 (实际的)

2026年10月15日

研究注册日期

首次提交

2025年10月27日

首先提交符合 QC 标准的

2025年10月27日

首次发布 (实际的)

2025年10月29日

研究记录更新

最后更新发布 (实际的)

2026年10月22日

上次提交的符合 QC 标准的更新

2026年10月19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

  • LTS19689
  • 2025-522511-42 (注册表标识符：CTIS)
  • U1111-1321-1765 (注册表标识符：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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