2024-512558-40-00招募中2 期
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 24
- 主要终点
- Serious adverse event (SAEs) that are related to VE202 or VE202 placebo
研究概览
简要总结
• To evaluate the efficacy of 8 weeks of treatment with VE202 in terms of endoscopic response at Day 56 • To evaluate the safety of VE202 in Part 1 and Part 2 of the study
研究设计
- 研究类型
- Interventional
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
- 是
入选标准
- •Able and willing to provide written informed consent prior to initiation of any study specific procedure or drug administration and understands the potential risks and benefits of study enrollment and study drug administration. When appropriate, informed consent may be provided by a legally authorized representative (LAR).
- •If a male patient (according to sex assignment at birth): ‒ If not vasectomized, agrees to wear a condom when engaging in sexual intercourse with any partner of childbearing potential from the time of enrollment until 3 months after the last dose of study drug ‒ Agrees not to donate sperm for purpose of reproduction from the time of enrollment until 3 months after the last dose of study drug
- •Able and willing to follow study procedures (eg, comply with study visits and procedures, provide blood and stool samples).
- •18 to 75 years of age.
- •Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
- •Active mild to moderate UC, as defined by the following: a. Disease that extends at least 15 cm from the anal verge b. A modified Mayo score of 4 to 8 with: i. Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy ii. Rectal bleeding score of ≥ 1
- •Is up to date with current local colorectal cancer surveillance recommendations (eg, has had a surveillance colonoscopy within 12 months if indicated based on extent and duration of UC); this may be performed during screening.
- •Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulators for the treatment of UC
- •If receiving corticosteroids, dose must be stable for at least 4 weeks and be no higher than 10 mg QD prednisone (or prednisone equivalent) or budesonide 9 mg QD.
- •Doses of other allowable UC medications must be stable for at least 8 weeks before randomization.
- •If a female patient (according to sex assignment at birth): ‒ Is not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to hysterectomy, bilateral oophorectomy, or bilateral tubal ligation ‒ If of childbearing potential, must have a negative pregnancy test and agree to either remain celibate or use a highly effective form of birth control (as defined in Appendix 1) from the time of enrollment until 3 months after the last dose of study drug ‒ Agrees not to donate eggs (ova, oocytes) for purposes of assisted reproduction from the time of enrollment until 3 months after the last dose of study drug ‒ Is not breastfeeding
排除标准
- •Known history of CD or indeterminate colitis
- •Receipt of FMT or other fecal-derived preparation within 6 months prior to randomization
- •Use of systemic or non-absorbable oral antibiotics within the prior 4 weeks before randomization or anticipated within the study period
- •Use of probiotics within the prior 2 weeks before randomization (consumption of food products such as yogurt, kombucha, kimchi, and kefir is permissible)
- •Receipt of herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of mint, turmeric, or other herbal teas is permissible)
- •Active drug or alcohol abuse
- •Active colonic dysplasia
- •A known diagnosis of primary sclerosing cholangitis
- •Allergy to VE202 or any of its components
- •Allergy to vancomycin or any of its components
- •A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
- •Known or suspected toxic megacolon, abdominal abscess, and/or small bowel ileus at the time of screening
- •Any other anatomic or medical contraindication to flexible sigmoidoscopy
- •Evidence of an active infection
- •Recent fever, defined as > 38.0 °C (rectal equivalent) within 3 days prior to randomization
结局指标
主要结局
Serious adverse event (SAEs) that are related to VE202 or VE202 placebo
Serious adverse event (SAEs) that are related to VE202 or VE202 placebo
Endoscopic response rate defined as a reduction of 1 point or more in Mayo endoscopic subscore on flexible sigmoidoscopy from baseline to Day 56
Endoscopic response rate defined as a reduction of 1 point or more in Mayo endoscopic subscore on flexible sigmoidoscopy from baseline to Day 56
Grade ≥ 3 Treatment-emergent adverse event (TEAEs) that are related to VE202 or VE202 placebo
Grade ≥ 3 Treatment-emergent adverse event (TEAEs) that are related to VE202 or VE202 placebo
次要结局
未报告次要终点
研究者
Dr. Steven Shiff
Scientific
Vedanta Biosciences Inc.
研究点 (24)
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