Treatment of Ulcerative Colitis With Novel Therapeutics
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction of H2S metabolites in plasma
研究概览
简要总结
This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with active mild ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as a crossover study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blinded study.
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
- •Ability to give consent
- •Patients with a confirmed diagnosis of UC for > 3 months
- •History of ≥ 15 cm of colonic involvement as confirmed by colonoscopy
- •Disease activity based on calprotectin > 200
- •Allowed medications: mesalamine and sulfasalazine
- •Patients with primary sclerosing cholangitis are eligible to enroll
排除标准
- •History of uncontrolled hypertension with systolic BP > 140 and systolic BP > 90
- •Chronic kidney disease as defined by GFR <55mL/min
- •Impaired hepatic function (transaminases elevated > 2.5 x ULN) unless due to PSC
- •Evidence of C. difficile (Negative test result within 1 month is acceptable)
- •Infectious Colitis or drug induced colitis
- •Crohn's Disease or Indeterminate colitis
- •Decompensated liver disease
- •Patients who are pregnant or breastfeeding
- •Use of rectal therapies
- •Patients who have a confirmed malignancy or cancer within 5 years
- •Congenital or acquired immunodeficiencies
- •Other comorbidities including: Diabetes mellitus, systemic lupus
- •High likelihood of colectomy in the next 2 months
- •Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial
- •Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
- •Prohibited medications: Vitamin C, prednisone, immune modulators (including but not limited to azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10, interleukin-11, and Omvoh or mirikizumab-mrkz) and biologics within the past six weeks including anti-TNF agents within the past six weeks, vedolizumab within the past six weeks, ustekinumab Risankizumab), a JAKi (tofacitinib or upadacitinib), or Velsipity (etrasimod) within the past 6 weeks. (The aim is to treat people who are having disease activity and just on mesalamine.)
研究组 & 干预措施
Placebo Comparator: Placebo Arm
In Group 1 of the study, subjects will take oral placebo at 1.2g daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks.
In Group 2 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks.
In Group 3 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 100mg dose of cyanocobalamin at initiation.
In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.
干预措施: Placebo (Drug)
Active Comparator: BRS201 Arm
In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO (2.4g with 120mg oral butyrate twice daily (240mg daily) for 4 weeks.
In Group 2 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks.
In Group 3 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 2.5g dose of study drug at initiation.
In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.
干预措施: BRS201 (Drug)
结局指标
主要结局
Reduction of H2S metabolites in plasma
时间窗: 4 weeks
The primary endpoint for this study is the capacity of study drug to reduce metabolites of H2S in plasma from baseline (week 0) compared to the end of active treatment (4 weeks)
次要结局
- Simple Clinical Colitis Activity Index (SCCAI)(12 weeks)
- Plasma nitrite, nitrate, or nitrosothiol(8 weeks)
- Normalization of fecal calprotectin lab measurements(4 weeks)
- Change in fecal calprotectin lab measurements(4 weeks)
- Partial Mayo score(4 weeks)
- Measurement of sulfur metabolites in urine(8 weeks)
研究者
Joshua Korzenik
MD-Director, Brigham and Women's Hospital Crohn's and Colitis Center
Brigham and Women's Hospital