Study of Novel Therapeutics for Acute Remedy of Colitis

Launched by BRIGHAM AND WOMEN'S HOSPITAL · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Study of Novel Therapeutics for Acute Remedy of Colitis, is testing a new medication, BRS201, for adults with severe ulcerative colitis who haven’t responded to other treatments. The study will last for 12 weeks and includes taking the medication orally twice a day for 4 weeks, along with some participants receiving the drug through an IV. Those who join will need to visit the study site seven times, where they will provide blood, stool, and urine samples for tests. At the beginning and end of the study, some participants may also have a flexible sigmoidoscopy, a procedure to examine the colon.

To participate, patients should have a confirmed diagnosis of ulcerative colitis for more than three months and must be experiencing a severe flare-up. They should also have had limited success with standard treatments, such as steroids. However, certain health conditions and medications could exclude individuals from joining, such as uncontrolled high blood pressure, severe kidney or liver issues, or a history of specific cancers. If you or a loved one is interested, it’s essential to review these criteria carefully to see if you qualify for this trial.

Gender

ALL

Eligibility criteria

• 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.