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).
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
연구 연락처 백업
- 이름: Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below.
- 전화번호: 888-662-6728 (U.S. and Canada)
- 이메일: global-roche-genentech-trials@gene.com
연구 장소
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Tennessee
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Cordova, Tennessee, 미국, 38018
- 모병
- Gastro One
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Afimkibart
Participants will receive afimkibart administered as subcutaneous (SC) injection. |
Afimkibart will be administered as SC injection.
다른 이름들:
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위약 비교기: Placebo
Participants will receive placebo adminsitered as SC injection. |
Placebo will be administered as SC injection. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Percentage of Participants With Clinical Remission
기간: At Week 12
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At Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Stool Frequency Subscore (SFS)
기간: From Baseline up to Week 12
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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
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Change From Baseline in Rectal Bleeding Subscore (RBS)
기간: From Baseline up to Week 12
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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
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Percentage of Participants With Symptomatic Response
기간: At Week 4
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At Week 4
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Percentage of Participants With Endoscopic Improvement
기간: At Week 12 and Week 24
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At Week 12 and Week 24
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Percentage of Participants With Endoscopic Remission
기간: At Week 12 and Week 24
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At Week 12 and Week 24
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Percentage of Participants With Clinical Response
기간: At Week 12
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At Week 12
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Percentage of Participants With Histologic-Endoscopic Mucosal Improvement
기간: At Week 12 and Week 24
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At Week 12 and Week 24
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Percentage of Participants With Clinical Remission
기간: At Week 24
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At Week 24
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Percentage of Participants With Maintenance of Remission
기간: At Week 12 and Week 24
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At Week 12 and Week 24
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Percentage of Participants With Histologic Improvement
기간: At Week 24
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At Week 24
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Change From Baseline in Bowel Urgency
기간: From Baseline through Week 12 and Week 24
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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
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Change From Baseline in Abdominal Pain
기간: From Baseline through Week 12 and Week 24
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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
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Change From Baseline in Fatigue
기간: From Baseline through Week 12 and Week 24
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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
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Change From Baseline in Health-Related Quality of Life
기간: From Baseline through Week 12 and Week 24
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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
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Change From Baseline in Overall UC Symptoms
기간: Baseline, Week 2, Week 12 and Week 24
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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
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Change From Baseline in Overall Severity in UC Symptoms
기간: Baseline, Week 2, Week 12 and Week 24
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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
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Incidence and Severity of Adverse Events (AEs)
기간: From Baseline up to approximately 42 Weeks
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From Baseline up to approximately 42 Weeks
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공동 작업자 및 조사자
수사관
- 연구 책임자: Clinical Trials, Hoffmann-La Roche
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CA46523
- 2026-526684-37-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
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