A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 57
- 主要终点
- Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy and safety of OD-07656 in participants with moderately to severely active ulcerative colitis (UC). In addition, the study will evaluate the potential of OD-07656 to enhance the therapeutic benefit of vedolizumab when given after OD-07656.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Has a confirmed diagnosis of ulcerative colitis (UC)
- •Has moderate to severely active UC as defined by the 3-component Modified Mayo clinic score
- •Has an inadequate response, loss of response, or intolerance/medical contraindication to at least one of the following therapies: oral aminosalicylates, corticosteroids, immunosuppressants, anti-tumor necrosis factor biologic, anti-interleukin 12/23 biologic, Janus kinase inhibitors, or sphingosine-1-phosphate (S1P) modulators
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has diagnosis of Crohn's disease or indeterminate colitis
- •Has had extensive colonic resection
- •Has colostomy or ileostomy
- •Has uncontrolled primary sclerosing cholangitis
研究组 & 干预措施
OD-07656 Dosing Regimen 1
Open Label, Oral, twice daily dose
干预措施: OD-07656 (Drug)
OD-07656 Dosing Regimen 1
Open Label, Oral, twice daily dose
干预措施: Vedolizumab (Drug)
OD-07656 Dosing Regimen 2
Randomized, Oral, twice daily dose
干预措施: OD-07656 (Drug)
OD-07656 Dosing Regimen 2
Randomized, Oral, twice daily dose
干预措施: Vedolizumab (Drug)
OD-07656 Dosing Regimen 3
Randomized, Oral, twice daily dose
干预措施: OD-07656 (Drug)
OD-07656 Dosing Regimen 3
Randomized, Oral, twice daily dose
干预措施: Vedolizumab (Drug)
结局指标
主要结局
Change in 3-component modified Mayo Clinic Score (MMCS) from baseline to after treatment with OD-07656
时间窗: Baseline and 12 weeks
The 3-component MMCS ranges from 0 to 9 and is composed of endoscopic assessment, rectal bleeding and stool frequency subscores with each of the components ranging from 0 to 3, with higher scores indicating more severe disease.
Incidence of treatment-emergent adverse events (TEAEs) and treatment discontinuations due to TEAEs with OD-07656 treatment
时间窗: Up to 12 weeks
次要结局
- Proportion of participants who achieve clinical remission(Baseline and 12 weeks)
- Proportion of participants who achieve clinical remission with vedolizumab treatment, following OD-07656 treatment(Baseline and 50 weeks)