Clinical trial NCT06420375: Treatment of UC With Novel Therapeutics
Official title: Treatment of Ulcerative Colitis With Novel Therapeutics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis Mild
Ulcerative Colitis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

Brief summary: 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Reduction of H2S metabolites in plasma
timeFrame: 4 weeks
Secondary outcomes:
measure: Simple Clinical Colitis Activity Index (SCCAI)
timeFrame: 12 weeks
measure: Plasma nitrite, nitrate, or nitrosothiol
timeFrame: 8 weeks
measure: Normalization of fecal calprotectin lab measurements
timeFrame: 4 weeks
measure: Change in fecal calprotectin lab measurements
timeFrame: 4 weeks
measure: Partial Mayo score
timeFrame: 4 weeks
measure: Measurement of sulfur metabolites in urine
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: