Ulcerative Colitis study: BRS201
Official title Study of Novel Therapeutics for Acute Remedy of Colitis
ClinicalTrials.gov ID: NCT06420492
What this study is testing
What is BRS201?
BRS201 is an investigational oral medication being studied as a potential treatment for acute ulcerative colitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the new drug BRS201 helps improve symptoms of acute ulcerative colitis.
- Who it's for
- The study is looking for adults with severe ulcerative colitis who have not responded to previous treatments.
- What's involved
- Participants will take an oral medication twice daily for 4 weeks and may receive an IV dose. They will also provide blood, stool, and urine samples and may have a flexible sigmoidoscopy (a test to look inside the colon) at the start and end.
- Time commitment
- The study lasts 12 weeks and requires 8 visits to the study site.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Severe outpatient or hospitalized for an acute UC flare
- 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
- Patients with primary sclerosing cholangitis are eligible to enroll
You likely can't join if
- 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
See the full eligibility criteria
- Severe outpatient or hospitalized for an acute UC flare
- 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
- Patients with primary sclerosing cholangitis are eligible to enroll
- Patients will have failed 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of \> 6
- Patients who are taking 20mg or less of oral prednisone and plan to stay at that dose during their participation in the study
- Anti-TNF agents are permissible if the patient has been taking them for at least 10 weeks and anticipates to maintain a steady for the duration of the study.
- Rinvoq (Upadacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.
- Xeljanz (Tofacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.
- Other biologics are permissible if the subject has been taking the medication for at least 10 weeks and anticipates to maintain a steady dose for the duration of the study
- 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
- Patients who have a confirmed malignancy or cancer within 5 years
- Congenital or acquired immunodeficiencies
- Other comorbidities including: Diabetes mellitus, systemic lupus
- 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
- Rinvoq (Upadacitinib): people will be excluded from this study if their last dose of this medication was administered within 4 weeks.
- Xeljanz (Tofacitinib): people will be excluded from this study if their last dose of this medication was administered within 4 weeks.
- Other Medications: people will be excluded from this study if they stopped taking any other medications for ulcerative colitis within 8 weeks.
The study team makes the final eligibility decision.
Where it is enrolling
- Chestnut Hill, Massachusetts, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chestnut Hill, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.