2024-513014-35-00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 ULCERATIVE COLITIS
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
- 107
- 主要终点
- 1. Clinical remission, defined as mMS ≤ 2 with stool frequency subscore (SFS) = 0 or 1, rectal bleeding subscore (RBS) = 0, and ES = 0 or 1, at Week 12 and at week 52
研究概览
简要总结
To evaluate the efficacy of afimkibart compared with placebo in inducing and maintaining clinical remission
研究设计
- 分配方式
- Randomized
- 主要目的
- Study periods
- 盲法
- Double (Investigator, Subject, Carer, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 to ≤80 years at the time of signing Informed Consent Form, with bodyweight ≥ 40 kg.
- •Confirmed active UC diagnosis, active UC with moderately to severely active disease confirmed by endoscopy (flexible sigmoidoscopy or colonoscopy), and active UC confirmed by endoscopy
- •Moderately to severely active UC
- •Screening for colorectal cancer (CRC) for all participants (performed according to local standards)
- •Inadequate response, loss of response, and/or intolerance to prior conventional therapy (aminosalicylates, corticosteroids and/or immunosuppressants) while being naïve to advanced therapy (biologics or targeted small molecules, e.g., Approved anti-tumor necrosis factor [TNF], Approved anti-interleukin [IL]-12/IL-23, Approved anti-integrin, Approved sphinsosine-1-phosphate [S1P] receptor modulators, Approved JAK inhibitors, etc.) OR inadequate response, loss of response, and/or intolerance to prior advanced therapy
排除标准
- •Severe UC as evidenced by any of the following: – Hospitalization for the treatment of UC ≤ 4 weeks prior to randomization or, in the physician's judgement, is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) during the study – Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months) of toxic megacolon, or bowel perforation. – Prior extensive colonic resection, subtotal, or total colectomy, or planned surgery for UC during the study
- •Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease
- •Presence of an ostomy or ileoanal pouch
- •Current diagnosis or suspicion of primary sclerosing cholangitis
- •Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
- •Known exposure to anti-TL1A (afimkibart/RO7790121 [RVT-3101]/PF- 06480605) or any type of anti-TL1A therapy
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 mMS ≤ 2 with stool frequency subscore (SFS) = 0 or 1, rectal bleeding subscore (RBS) = 0, and ES = 0 or 1, at Week 12 and at week 52
1. Clinical remission, defined as mMS ≤ 2 with stool frequency subscore (SFS) = 0 or 1, rectal bleeding subscore (RBS) = 0, and ES = 0 or 1, at Week 12 and at week 52
次要结局
- 20. Among biomarker-defined subgroups of participants: Endoscopic improvement at Week 52
- 21. Bowel urgency from baseline through Week 52
- 22. Abdominal pain from baseline through Week 52
- 29. Incidence and severity of adverse events leading to study treatment discontinuation
- 30. Incidence and severity of adverse events of special interest
- 6. Histologic remission, defined as Geboes < 2B at Week 12
- 7. Histologic-endoscopic mucosal improvement, defined as Geboes ≤ 3.1 and ES = 0 or 1, at Week 12
- 8. Histologic-endoscopic remission, defined as Geboes < 2B and ES = 0 or 1, at Week 12
- 9. Maintenance of remission, defined as clinical remission at both Weeks 12 and 52
- 17. Among biomarker-defined subgroups of participants: Clinical remission at Week 12
- 18. Among biomarker-defined subgroups of participants: Clinical remission at Week 52
- 19. Among biomarker-defined subgroups of participants: Endoscopic improvement at Week 12
- 1. Partial modified Mayo Score (pmMS), defined as SFS + RBS, from baseline to Week 2
- 2. Endoscopic improvement, defined as ES = 0 or 1, at Week 12
- 3. Endoscopic remission, defined as ES = 0, at Week 12
- 4. Clinical response, defined as a decrease in mMS of at least 2 points and 30% from baseline and either a decrease in RBS ≥ 1 or RBS = 0 or 1, at Week 12
- 5. Histologic improvement, defined as Geboes ≤ 3.1 at Week 12
- 10. Corticosteroid-free remission, defined as clinical remission at Week 52 and no use of corticosteroids for UC at least 8 weeks prior to Week 52
- 11. Endoscopic improvement at Week 52
- 12. Endoscopic remission at Week 52
- 13. Histologic improvement at Week 52
- 14. Histologic remission at Week 52
- 15. Histologic-endoscopic mucosal improvement at Week 52
- 16. Histologic-endoscopic remission at Week 52
- 23. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12 and Week 52
- 24. Inflammatory Bowel Disease Questionnaire (IBDQ) from baseline to Week 12 and Week 52
- 25. Overall change in UC symptoms, as measured by Patient Global Impression of Change (PGIC), from baseline to Week 2, Week 12, and Week 52
- 26. Overall severity in UC symptoms, as measured by Patient Global Impression of Severity (PGIS), from baseline to Week 2, Week 12, and Week 52
- 27. Incidence and severity of adverse events
- 28. Incidence and severity of serious adverse events
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (107)
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