RECRUITING

Treatment of UC With Novel Therapeutics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Treatment of Ulcerative Colitis With Novel Therapeutics

Quick Facts

Study Start:2025-05-27
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06420375

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to give consent
  2. * Patients with a confirmed diagnosis of UC for \> 3 months
  3. * History of ≥ 15 cm of colonic involvement as confirmed by colonoscopy
  4. * Disease activity based on calprotectin \> 200
  5. * Allowed medications: mesalamine and sulfasalazine
  6. * Patients with primary sclerosing cholangitis are eligible to enroll
  1. * History of uncontrolled hypertension with systolic BP \> 140 and systolic BP \> 90
  2. * Chronic kidney disease as defined by GFR \<55mL/min
  3. * Impaired hepatic function (transaminases elevated \> 2.5 x ULN) unless due to PSC
  4. * Evidence of C. difficile (Negative test result within 1 month is acceptable)
  5. * Infectious Colitis or drug induced colitis
  6. * Crohn's Disease or Indeterminate colitis
  7. * Decompensated liver disease
  8. * Patients who are pregnant or breastfeeding
  9. * Use of rectal therapies
  10. * Patients who have a confirmed malignancy or cancer within 5 years
  11. * Congenital or acquired immunodeficiencies
  12. * Other comorbidities including: Diabetes mellitus, systemic lupus
  13. * High likelihood of colectomy in the next 2 months
  14. * Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial
  15. * Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
  16. * 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.)

Contacts and Locations

Study Contact

Joshua Korzenik, MD
CONTACT
617 732-6389
jkorzenik@bwh.harvard.edu
Siani Ellis
CONTACT
617-396-7703
sellis13@bwh.harvard.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2025-05-27
Study Completion Date2027-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis Mild
  • Ulcerative Colitis