NCT06420492RecruitingPhase 2
Study of Novel Therapeutics for Acute Remedy of Colitis
Source: ClinicalTrials.gov · Last updated 20 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 6 May 2024
- Start date
- 30 Sept 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Ulcerative colitis
- NCT number
- NCT06420492
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 30 Sept 2025 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Infectious Colitis or drug induced colitis
- 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.
Other illness
- History of uncontrolled hypertension with systolic BP \> 140 and systolic BP \> 90
- Crohn's Disease or Indeterminate colitis
- Decompensated liver disease
- Patients who have a confirmed malignancy or cancer within 5 years
- Other comorbidities including: Diabetes mellitus, systemic lupus
Lab values
- Chronic kidney disease as defined by GFR \<55mL/min
- Impaired hepatic function (transaminases elevated \> 2.5 x ULN) unless due to PSC
- Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
Other
- Evidence of C. difficile (Negative test result within 1 month is acceptable)
- Patients who are pregnant or breastfeeding
- Congenital or acquired immunodeficiencies
- Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Chestnut Hill | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.