Study of Novel Therapeutics for Acute Remedy of Colitis

Ulcerative Colitis Clinical Trial

— SHARC  

Official title:

Study of Novel Therapeutics for Acute Remedy of Colitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420492
• Other study ID #: Unknown (Pending approval)
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2024
• Source: Brigham and Women's Hospital
• Contact: Joshua Korzenik, MD
• Phone: 617 732-6389
• Email: jkorzenik[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks 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. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Severe outpatient or hospitalized for an acute UC flare

• 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

• Total Mayo score of > 6

• Patients with primary sclerosing cholangitis are eligible to enroll

• Patients will have failed 3 days of IV steroids or 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of > 6

• Anticipated to be administered ustekinumab, vedolizumab or 6-MP/azathioprine as their subsequent medication.

Exclusion Criteria:

• History of uncontrolled hypertension with systolic BP > 140 and systolic BP > 90

• Chronic kidney disease as defined by GFR <60mL/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

• Patients who have a confirmed malignancy or cancer within 5 years

• Congenital or acquired immunodeficiencies

• Other comorbidities including: Diabetes mellitus, systemic lupus

• 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, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10 and interleukin-11) and anti-TNF agents within the past six weeks

• Patients are planned to be started on a fast- acting medication including an anti-TNF agent (infliximab, adalimumab, golimumab, certolizumab), on a JAKi (upadacitinib, tofacitinib)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis
• Ulcerative Colitis Chronic Moderate
• Ulcerative Colitis Chronic Severe

Intervention

Drug:
• BRS201
Groups 1, 2, and 3 will all contain 5 subjects each, with each subject receiving active study drug for four weeks.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mayo Score	The primary endpoint for this study is change in Total Mayo Score with improvement being a reduction in 3 points and remission being a score of 0 or 1 from day 0 to end of week 4 (at second flexible sigmoidoscopy).	4 weeks
Secondary	Simple Clinical Colitis Activity Index (SCCAI)	Clinical symptoms assessed by SCCAI which measures patient reported outcomes on a scale of 0 to 19, where a higher score indicates more severe activity and active disease is a score of 5 or more.	12 weeks
Secondary	Plasma nitrite, nitrate, or nitrosothiol	Correlation between changes in plasma nitrite, nitrate or nitrosothiol level in relation to calprotectin	8 weeks
Secondary	Normalization of fecal calprotectin lab measurements	The capacity of study drug to normalize fecal calprotectin levels from baseline (week 0) compared to end of active treatment (4 weeks) and at week 6.	8 weeks
Secondary	Reduction in fecal calprotectin lab measurements	Reduction in fecal calprotectin to < ULN at the end of active treatment	4 weeks