A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 629
- 主要终点
- Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
研究概览
简要总结
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of CD
- •Moderately to severely active CD
- •Bodyweight >= 40 kilogram (kg)
- •Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
- •Males and females of childbearing potential must meet protocol criteria for contraception requirements
排除标准
- •Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
- •Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
- •Diagnosis of short gut or short bowel syndrome
- •Presence of an ileostomy, colostomy or ileoanal pouch
- •Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- •Presence of abdominal or perianal abscess
- •Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with >3 openings
- •Current diagnosis or suspicion of primary sclerosing cholangitis
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- •Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
- •History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening
- •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
研究组 & 干预措施
Arm 1: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
干预措施: Afimkibart (Drug)
Arm 2: Afimkibart
Participants will receive afimkibart IV followed by afimkibart SC injection.
干预措施: Afimkibart (Drug)
Arm 3: Placebo
Participants will receive placebo IV followed by placebo SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
时间窗: At Week 52
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
Percentage of Participants with Endoscopic Response
时间窗: At Week 52
Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
次要结局
- Average of Daily Abdominal Pain Scores in the Past Week (APS)(Baseline through Week 12)
- Percentage of Participants with Corticosteroid-free Clinical Remission(At Week 52)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Score(Baseline to Week 12 and Week 52)
- Percentage of Participants with Symptomatic Remission(At Week 52)
- Percentage of Participants with Clinical Remission(At Week 12)
- Percentage of Participants with Ulcer-free Endoscopy(At Week 52)
- Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)(Baseline through Week 12)
- Maintenance of Clinical Remission(At Weeks 12 and 52)
- Maintenance of Endoscopic Response(At Weeks 12 and 52)
- Percentage of Participants with Endoscopic Remission(At Week 52)
- Bowel Urgency(Baseline through Week 12 and Week 52)
- Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52(At Week 52)
- Fatigue(Baseline to Week 12 and Week 52)
- Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants(At Week 52)
- Percentage of Participants with Clinical Response(At Week 12)
- Overall Change in CD Symptoms(Baseline to Weeks 2, 6, 12 and 52)
- Incidence and Severity of Adverse Events (AEs)(Up to 70 Weeks after Baseline)
- Percentage of Participants with Symptomatic Response(At Week 12)
- Percentage of Participants with a Presence of Draining Fistulas(Baseline through Week 12 and Week 52)
- Overall Severity in CD Symptoms(Baseline to Weeks 2, 6, 12 and 52)
- Change in General Well-being(Baseline through Week 52)
- Percentage of Participants with Endoscopic Response(At Week 12)
- Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants(At Week 52)
- Percentage of Participants with Symptomatic Remission(At Week 12)
- Percentage of Participants with Endoscopic Remission(At Week 12)
- Percentage of Participants with Ulcer-free Endoscopy(At Week 12)
- Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants(At Week 12)
- Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants(At Week 12)