Treatment of UC With Novel Therapeutics

Launched by BRIGHAM AND WOMEN'S HOSPITAL · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called BRS201 to see if it can help patients with mild ulcerative colitis, a condition that causes inflammation in the intestines. The study will last for 12 weeks and will involve participants taking the study drug for 4 weeks and a placebo (a non-active pill) for another 4 weeks, in a random order. Participants will need to visit the study site 7 times, where they will take the medication twice daily, keep a log of their doses, and provide blood, stool, and urine samples for testing.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with ulcerative colitis for more than 3 months, with a specific level of disease activity. They should not have certain health issues, such as uncontrolled high blood pressure or chronic kidney disease, and they cannot be pregnant or breastfeeding. This trial aims to find a new treatment option for those currently only using medications like mesalamine. If you're considering participation, it's a chance to help advance treatment options while closely monitoring your health with the support of the study team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.)