A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 385
- 试验地点
- 325
- 主要终点
- Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).
详细描述
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has signs/symptoms of CD for at least 90 days prior to screening
- •Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points
- •Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)
- •Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase [JAK] inhibitors, applicable investigational products)
排除标准
- •Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC
- •Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
- •Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome
- •Is currently receiving total parenteral nutrition, tube feeding, or a formula diet
- •Has positive findings on a subjective neurological screening questionnaire
- •Has a concurrent, clinically significant, serious, unstable comorbidity
- •Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors
- •Is currently participating in any other interventional study or has received any investigational therapy within 30 days
- •Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057
- •Unable to attend study visits or comply with study procedures
- •Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease
研究组 & 干预措施
Group 6 (Part B)
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
干预措施: MORF-057 (Drug)
Group 6 (Part B)
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
干预措施: Placebo (Drug)
Group 3 (Part A)
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
干预措施: Placebo (Drug)
Group 4 (Part B)
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
干预措施: MORF-057 (Drug)
Group 5 (Part B)
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
干预措施: MORF-057 (Drug)
Group 1 (Part A)
Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
干预措施: MORF-057 (Drug)
Group 2 (Part A)
Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
干预措施: MORF-057 (Drug)
Group 3 (Part A)
Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
干预措施: MORF-057 (Drug)
结局指标
主要结局
Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD)
时间窗: Baseline to Week 14
The SES-CD is an endoscopic scoring system for evaluating CD activity. Endoscopic response is defined as an SES-CD decrease from baseline of ≥50%
次要结局
- Proportion of participants with clinical response at Week 14 as determined using the Crohn's Disease Activity Index (CDAI)(Baseline to Week 14)
- Proportion of participants with clinical remission at Week 14 as determined using the CDAI.(Baseline to Week 14)