A Phase 2b, 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 Ulcerative Colitis (EMERALD-2)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 102
- 主要终点
- Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS)
研究概览
简要总结
This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).
详细描述
This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of three active dose regimens of MORF-057 plus a placebo regimen in study participants with moderately to severely active UC. After completion of the 12-week Induction Period, participants may be switched to a different active MORF-057 regimen during the Maintenance Period. Those randomized into the placebo group in the Induction Period will be switched to receive an active MORF-057 regimen during the Maintenance Period.
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
- Triple (Participant, Care Provider, Investigator)
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 moderate to severe UC for at least 3 months prior to Screening
- •Has evidence of UC extending at least 15 cm from the anal verge
- •Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase [JAK] antagonists, or sphingosine-1-phosphate [S1P] receptor agonists)
- •Subject has no prior exposure to approved or investigational anti-integrin therapies
- •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 Crohn's disease or has clinical findings suggestive of Crohn's disease
- •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
- •Participation in any other interventional study or 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
研究组 & 干预措施
MORF-057 200 mg BID
Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks.
干预措施: MORF-057 (Drug)
MORF-057 100 mg BID
Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks.
干预措施: MORF-057 (Drug)
MORF-057 100 mg QD-M
Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks.
干预措施: MORF-057 (Drug)
Placebo
Participants received an oral dose of matching placebo for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS)
时间窗: Week 12
* The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease. * Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of \< or =1; and an endoscopy subscore of \< or =1 without friability.
次要结局
- Percentage of Participants in Clinical Response as Determined Using the Modified Mayo Clinic Score (mMCS)(Week 12)