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Treatment of UC With Novel Therapeutics

Description

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 MildUlcerative Colitis
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Related Conditions:

Ulcerative Colitis MildUlcerative Colitis

Study Overview

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Study Details

Study overview

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.

Treatment of Ulcerative Colitis With Novel Therapeutics

Treatment of UC With Novel Therapeutics

Condition
Ulcerative Colitis Mild
Intervention / Treatment

-

Contacts and Locations

Chestnut Hill

Brigham and Women's Hospital, Chestnut Hill, Massachusetts, United States, 02467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.)

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Study Record Dates

2027-07-31