CTRI/2024/08/072601招募中2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Crohn’s Disease (GARNET)
PSI CRO Pharma India Pvt Ltd16 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年9月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 16
- 主要终点
- Proportion of participants with endoscopic response at Week 14 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 induction therapy with 2 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 Maintenance Extension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
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 sub score greater than or equal to 4 and hs- CRP >5 mg/L
- •Has an SES-CD score of greater than or equal to 6 (or an SES-CD score of greater than or equal to 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)
- •Agrees to abide by the study guidelines and requirements
- •Capable of giving signed informed consent.
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 greater than 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.
结局指标
主要结局
Proportion of participants with endoscopic response at Week 14 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%
时间窗: Baseline to Week 14
次要结局
- Proportion of participants with clinical response at Week 14 determined using the Crohns Disease Activity Index CDAI.(The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical response is defined as a reduction from baseline CDAI score by more than or equal to 100 points or a CDAI score of less than 150 points.)
- Proportion of participants with clinical remission at Week 14 determined using the CDAI.(The CDAI is a composite of subscores for clinical and laboratory findings, and patient-reported CD symptoms. Clinical remission is defined as a CDAI score of less than 150 points.)
研究者
Dr Radhika Bobba
PSI CRO Pharma India Private Limited
研究点 (16)
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