Treatment of UC With Novel Therapeutics
Recruiting · NCT06420375 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.)
Where it is running
1 location listed across 1 US state.
- Brigham and Women's Hospital - Chestnut Hill, Massachusetts, United States