2024-513053-69-00招募中3 期
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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 348
- 试验地点
- 126
- 主要终点
- 1. Clinical remission, defined as CDAI < 150,
研究概览
简要总结
To evaluate the efficacy of afimkibart compared with placebo in maintaining response
研究设计
- 分配方式
- Na
- 主要目的
- Safety Follow-Up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria Age ≥18 to ≤ 80 years at the time of signing Informed Consent Form
- •General Inclusion Criteria Bodyweight ≥ 40 kg
- •Crohn's Disease-Specific Inclusion Criteria Confirmed diagnosis of CD with supportive clinical, endoscopic and histopathological evidence
- •Crohn's Disease-Specific Inclusion Criteria Moderately to severely active CD, meeting all of the following: - CDAI ≥ 220 and ≤ 450 - SES-CD of ≥ 6 (or ≥ 4 for isolated ileal disease) -
- •Crohn's Disease-Specific Inclusion Criteria Involvement of ileum and/or colon, with at least four colonic segments traversable by an endoscope or a pediatric endoscope, or three segments for patients who have undergone a bowel resection among the following segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- •Crohn's Disease-Specific Inclusion Criteria Screening for colorectal cancer (CRC) during or prior to screening for all participants (performed according to local standards) with risk factors for bowel cancer a surveillance ileocolonoscopy must be performed within 12 months prior to screening. For all other patients, must be up-to date with CRC surveillance (according to CRC risks and local standards) Screening ileocolonoscopy can be used for CRC surveillance (following local guidelines) and results must be available prior to randomization Any adenomatous polyps must be completely removed according to routine practice prior to their first dose of study drug.
排除标准
- •Inflammatory Bowel Disease Exclusion Criteria Participant with a history of ≥ 3 bowel resections > 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
- •Inflammatory Bowel Disease Exclusion Criteria Diagnosis of short gut or short bowel syndrome
- •Medical History Exclusion Criteria Lack of peripheral venous access
- •Medical History Exclusion Criteria Significant uncontrolled medical comorbidity (such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders [excluding CD]), psychiatric, or other condition that in the opinion of the investigator, would confound the study results, compromise patient safety, interfere with the potential participant's provision of informed consent, or compliance with trial procedures.
- •Infection or Infection Risk Exclusion Criteria Any clinically significant infection < 4 weeks prior to randomization that has not resolved, and/or that required hospitalization, and/or IV antibiotics Any clinically significant infection that was opportunistic in nature is not permitted within 3 months prior to randomization
- •Infection or Infection Risk Exclusion Criteria Confirmation of HIV infection (e.g., positive HIV test) at screening
研究组 & 干预措施
RO7790121
Test
干预措施: RO7790121 (Drug)
RO7790121 Placebo
Placebo
干预措施: RO7790121 Placebo (Drug)
结局指标
主要结局
1. Clinical remission, defined as CDAI < 150,
1. Clinical remission, defined as CDAI < 150,
2. Endoscopic response, defined as decrease in SES-CD from baseline ≥ 50%,
2. Endoscopic response, defined as decrease in SES-CD from baseline ≥ 50%,
次要结局
- 1. Clinical remission, as defined above,
- 2. Endoscopic response, as defined above,
- 3. Symptomatic remission,
- 4. Endoscopic remission,
- 5. Ulcer-free endoscopy,
- 6. SF, from baseline
- 7. APS, from baseline
- 8. Endoscopic remission,
- 9. Symptomatic remission,
- 10. Corticosteroid-free clinical remission,
- 11. Maintenance of clinical remission,
- 12. Maintenance of endoscopic response,
- 13. Clinical remission and endoscopic remission,
- 14. Ulcer-free endoscopy,
- 15. Bowel urgency, from baseline
- 24. Overall change in CD symptoms,
- 25. Overall severity in CD symptoms,
- 26. General well-being, from baseline
- 27. Incidence and severity of the following: - Adverse events
- 28. Incidence and severity of the following: - Serious adverse events
- 29. Incidence and severity of the following: - Adverse events leading to study treatment discontinuation
- 30. Incidence and severity of the following: - Adverse events of special interest
- 31. Presence of draining fistulas
- 23. Symptomatic response,
- 16. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline
- 17. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline
- 18. Clinical remission
- 19. Clinical remission
- 20. Endoscopic response
- 21. Endoscopic response
- 22. Clinical response,
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (126)
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