Study of Novel Therapeutics for Acute Remedy of Colitis

Study of Novel Therapeutics for Acute Remedy of Colitis (NCT06420492) is a Phase 2 interventional studying Ulcerative Colitis and Ulcerative Colitis Chronic Moderate, sponsored by Brigham and Women's Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks 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 8 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. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ulcerative Colitis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - Accepted medications: - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion 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 * Accepted medications: * 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 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 * 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 * Prohibited medications: * Rinvoq (Upadacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation. * Xeljanz (Tofacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation. * Other Medications: Subjects will be excluded from this study if they stopped taking any other medications for ulcerative colitis within 8 weeks. If subjects have stopped taking the medication and their last dose was more than 8 weeks prior to enrollment, they will be eligible for participation.

Treatments Being Tested

DRUG

BRS201

Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug for four weeks.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06420492), the sponsor (Brigham and Women's Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06420492 clinical trial studying?

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks 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 8 study visits, all of which wi… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06420492?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06420492?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06420492. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06420492. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.