Treatment of UC With Novel Therapeutics

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

  • Ulcerative Colitis Mild
  • Ulcerative Colitis

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