Treatment of UC With Novel Therapeutics

Ulcerative Colitis Clinical Trial

— TURTLE  

Official title:

Treatment of Ulcerative Colitis With Novel Therapeutics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420375
• Other study ID #: Unknown (Pending approval 2.0)
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 31, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

• Total Mayo score of > 5

• 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 <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

• 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.)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• BRS201
Groups 1, 2, and 3 will all contain 6 subjects each, with each subject receiving active study drug and placebo in a 2:1 randomized order; 4 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
Groups 1, 2, and 3 will all contain 6 subjects each, with each subject receiving active study drug and placebo in a 2:1 randomized order; 4 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.

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	Normalization of fecal calprotectin lab measurements	The primary endpoint for this study is the capacity of study drug to normalize fecal calprotectin levels from baseline (week 0) compared to end of active treatment (4 weeks).	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 levels and fecal calprotectin	8 weeks
Secondary	Change in fecal calprotectin lab measurements	Change in fecal calprotectin to < ULN at the end of active treatment	4 weeks
Secondary	Partial Mayo score	Change in partial Mayo scores from baseline to end of active treatment. The partial Mayo score measures disease activity on a scale of 0 to 9, where a higher score indicates more severe disease activity and a score of 1 or less indicated remission.	4 weeks
Secondary	Measurement of sulfur metabolites in urine	Analysis of urine for measurement of thiosulfate, thiocyanate, nitrate and nitrite	8 weeks