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Purpose

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with active mild ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as a crossover study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order 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 7 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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 - Disease activity based on calprotectin > 200 - Allowed medications: mesalamine and sulfasalazine - Patients with primary sclerosing cholangitis are eligible to enroll

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 - Use of rectal therapies - Patients who have a confirmed malignancy or cancer within 5 years - Congenital or acquired immunodeficiencies - Other comorbidities including: Diabetes mellitus, systemic lupus - High likelihood of colectomy in the next 2 months - 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: Vitamin C, prednisone, immune modulators (including but not limited to azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10, interleukin-11, and Omvoh or mirikizumab-mrkz) and biologics within the past six weeks including anti-TNF agents within the past six weeks, vedolizumab within the past six weeks, ustekinumab Risankizumab), a JAKi (tofacitinib or upadacitinib), or Velsipity (etrasimod) within the past 6 weeks. (The aim is to treat people who are having disease activity and just on mesalamine.)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
This is a crossover study in which each participant will receive active medication for a period of time and placebo for a period of time.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is a double-blinded study.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Active Comparator: BRS201 Arm 		In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO (2.4g with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 3 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 2.5g dose of study drug at initiation. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.
  • Drug: BRS201
    Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug and placebo in a 3:2 randomized order; 3 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks.
Placebo Comparator
Placebo Comparator: Placebo Arm 		In Group 1 of the study, subjects will take oral placebo at 1.2g daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 3 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 100mg dose of cyanocobalamin at initiation. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective.
  • Drug: Placebo
    Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug and placebo in a 3:2 randomized order; 3 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks.

Recruiting Locations

Brigham and Women's Hospital
Chestnut Hill, Massachusetts 02467
Contact:
Siani Ellis
617-396-7703
sellis13@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Joshua Korzenik, MD
617 732-6389
jkorzenik@bwh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.