Study of Novel Therapeutics for Acute Remedy of Colitis

Phase

Condition

Ulcers

Ulcerative Colitis

Inflammatory Bowel Disease

Treatment

BRS201

Clinical Study ID

NCT06420492

2025P001885

Ages 18-75
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 andstill having a SCCAI of > 6
Patients who are taking 20mg or less of oral prednisone and plan to stay at thatdose during their participation in the study
Accepted medications:
Anti-TNF agents are permissible if the patient has been taking them for atleast 10 weeks and anticipates to maintain a steady for the duration of thestudy.
Rinvoq (Upadacitinib) is permissible if the subject has been taking thismedication for at least 4 weeks and anticipates to maintain a steady dose forthe duration of the study.
Xeljanz (Tofacitinib) is permissible if the subject has been taking thismedication for at least 4 weeks and anticipates to maintain a steady dose forthe duration of the study.
Other biologics are permissible if the subject has been taking the medicationfor at least 10 weeks and anticipates to maintain a steady dose for theduration of the study

Exclusion

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 orsimultaneously 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 lastdose of this medication was administered within 4 weeks. If subjects havestopped taking this medication and their last dose was administered more than 4weeks prior to enrollment, they will be eligible for participation.
Xeljanz (Tofacitinib): Subjects will be excluded from this study if their lastdose of this medication was administered within 4 weeks. If subjects havestopped taking this medication and their last dose was administered more than 4weeks prior to enrollment, they will be eligible for participation.
Other Medications: Subjects will be excluded from this study if they stoppedtaking any other medications for ulcerative colitis within 8 weeks. If subjectshave stopped taking the medication and their last dose was more than 8 weeksprior to enrollment, they will be eligible for participation.

Study Design