Treatment of UC With Novel Therapeutics

Официальное название

Treatment of Ulcerative Colitis With Novel Therapeutics

Обзор

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.

Вмешательства

• Препарат BRS201
  Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug and placebo in a 3:2 randomized order; 3 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks.
• Препарат Placebo
  Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug and placebo in a 3:2 randomized order; 3 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks.

Первичные конечные точки

• Reduction of H2S metabolites in plasma [Срок оценки: 4 weeks]

Вторичные конечные точки (6)

• Simple Clinical Colitis Activity Index (SCCAI) [Срок оценки: 12 weeks]
• Plasma nitrite, nitrate, or nitrosothiol [Срок оценки: 8 weeks]
• Normalization of fecal calprotectin lab measurements [Срок оценки: 4 weeks]
• Change in fecal calprotectin lab measurements [Срок оценки: 4 weeks]
• Partial Mayo score [Срок оценки: 4 weeks]
• Measurement of sulfur metabolites in urine [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Chestnut Hill

Идентификаторы

NCT: NCT06420375 · 2025P000585

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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