A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis (AMETRINE-SC)
A Phase III, Multicenter, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究联系人备份
- 姓名：Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below.
- 电话号码：888-662-6728 (U.S. and Canada)
- 邮箱：global-roche-genentech-trials@gene.com
学习地点
-
-
Tennessee
-
Cordova、Tennessee、美国、38018
- 招聘中
- Gastro One
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Confirmed diagnosis of UC.
- Moderately to severely active UC assessed by modified Mayo Score (mMS).
- Bodyweight >= 40 kilogram (kg).
- Up to date with colorectal cancer (CRC) screening performed according to local standards.
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy.
- Females of childbearing potential must meet protocol criteria for contraception requirements.
Exclusion Criteria:
- Currently known complications of UC (e.g. fulminant colitis, toxic megacolon).
- Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis.
- Presence of an ostomy or ileoanal pouch.
- Current diagnosis or suspicion of primary sclerosing cholangitis.
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study.
- Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed.
- History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer.
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV).
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB.
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy.
学习计划
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：Afimkibart
Participants will receive afimkibart administered as subcutaneous (SC) injection. |
Afimkibart will be administered as SC injection.
其他名称：
|
|
安慰剂比较：Placebo
Participants will receive placebo adminsitered as SC injection. |
Placebo will be administered as SC injection. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Percentage of Participants With Clinical Remission
大体时间：At Week 12
|
At Week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Stool Frequency Subscore (SFS)
大体时间：From Baseline up to Week 12
|
The Stool Frequency Subscore (SFS) is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal) |
From Baseline up to Week 12
|
|
Change From Baseline in Rectal Bleeding Subscore (RBS)
大体时间：From Baseline up to Week 12
|
The Rectal Bleeding Subscore (RBS) is measured on a scale from 0 (no blood seen) to 3 (blood alone passed) |
From Baseline up to Week 12
|
|
Percentage of Participants With Symptomatic Response
大体时间：At Week 4
|
At Week 4
|
|
|
Percentage of Participants With Endoscopic Improvement
大体时间：At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Endoscopic Remission
大体时间：At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Clinical Response
大体时间：At Week 12
|
At Week 12
|
|
|
Percentage of Participants With Histologic-Endoscopic Mucosal Improvement
大体时间：At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Clinical Remission
大体时间：At Week 24
|
At Week 24
|
|
|
Percentage of Participants With Maintenance of Remission
大体时间：At Week 12 and Week 24
|
At Week 12 and Week 24
|
|
|
Percentage of Participants With Histologic Improvement
大体时间：At Week 24
|
At Week 24
|
|
|
Change From Baseline in Bowel Urgency
大体时间：From Baseline through Week 12 and Week 24
|
Bowel urgency will be assessed using two self-reported items over the past 24 hours: presence of bowel urgency (Yes/No) and severity on an 11-point numerical rating scale from 0 (no urgency) to 10 (worst possible urgency) |
From Baseline through Week 12 and Week 24
|
|
Change From Baseline in Abdominal Pain
大体时间：From Baseline through Week 12 and Week 24
|
Abdominal pain will be assessed using two self-reported items over the past 24 hours: presence of abdominal pain (Yes/No) and severity on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain) |
From Baseline through Week 12 and Week 24
|
|
Change From Baseline in Fatigue
大体时间：From Baseline through Week 12 and Week 24
|
Change in fatigue will be assessed by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue |
From Baseline through Week 12 and Week 24
|
|
Change From Baseline in Health-Related Quality of Life
大体时间：From Baseline through Week 12 and Week 24
|
Change in health-related quality of life will be assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) score. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life |
From Baseline through Week 12 and Week 24
|
|
Change From Baseline in Overall UC Symptoms
大体时间：Baseline, Week 2, Week 12 and Week 24
|
Change in overall UC symptoms will be assessed by Patient Global Impression of Change (PGIC). PGIC measures overall change in ulcerative colitis symptoms from "Much better" to "Much worse" |
Baseline, Week 2, Week 12 and Week 24
|
|
Change From Baseline in Overall Severity in UC Symptoms
大体时间：Baseline, Week 2, Week 12 and Week 24
|
Change in overall severity of UC symptoms will be assessed by Patient Global Impression of Severity (PGIS). PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe" |
Baseline, Week 2, Week 12 and Week 24
|
|
Incidence and Severity of Adverse Events (AEs)
大体时间：From Baseline up to approximately 42 Weeks
|
From Baseline up to approximately 42 Weeks
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CA46523
- 2026-526684-37-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.