RightFit
RecruitingPhase 2

Treatment of UC With Novel Therapeutics

Treatment of Ulcerative Colitis With Novel Therapeutics

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 7 visits
  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well BRS201 treats active, mild ulcerative colitis (UC), a disease that causes swelling and sores in the large intestine. The study lasts 12 weeks and includes 7 visits at the study site. Participants take BRS201 pills for 4 weeks and placebo pills (with no active drug) for 4 weeks, in an order chosen by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You can give consent to join the study.
  • You have had a confirmed UC diagnosis for more than 3 months.
  • A colonoscopy, a test using a camera inside the large intestine, has shown UC affecting at least 15 centimeters of it.
  • Your calprotectin level, a stool test for swelling in the intestine, is above 200.
  • You may take mesalamine or sulfasalazine.
  • You may join if you have primary sclerosing cholangitis (PSC), a disease that damages the bile ducts.

Who can't join

  • You have uncontrolled high blood pressure, chronic kidney disease with a kidney filtering rate below 55 mL/min, or a history or risk of certain heart or blood vessel problems, including stroke.
  • You have high liver enzyme levels (more than 2.5 times the normal limit), unless caused by PSC, or liver disease that keeps your liver from working properly.
  • You have a C. difficile infection, intestine swelling caused by an infection or medicine, Crohn’s disease, or colitis whose type is unclear. A negative C. difficile test within 1 month is accepted.
  • You are pregnant or breastfeeding, or have had confirmed cancer within 5 years.
  • You have a condition that weakens your immune system, diabetes, or lupus.
  • You use treatments placed in the rectum, or you are likely to need surgery to remove your large intestine within 2 months.
  • You joined another treatment trial in the past 30 days or will be in one during this study.
  • You take a medicine the study does not allow, such as vitamin C, prednisone, or medicines that change immune system activity. Some UC medicines, including biologics, JAK inhibitors, and Velsipity, are not allowed within the past 6 weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.)

Study sites (1)

MA