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NCT Number: NCT06420375

Treatment of UC With Novel Therapeutics

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.

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Key information

Conditions

Ulcerative Colitis Mild Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location status: Recruiting

Location contact

Joshua Korzenik, MD

PRINCIPAL_INVESTIGATOR

Siani Ellis

CONTACT

[email protected]

617-396-7703

Sophie Mitchell

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

BRS201

Drug

Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug and placebo in a 3:2 randomized order; 3 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

Drug

Groups 1, 2, 3, and 4 will all contain 5 subjects each, with each subject receiving active study drug and placebo in a 3:2 randomized order; 3 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.

Primary outcomes

  1. Reduction of H2S metabolites in plasma

    Time frame: 4 weeks

    The primary endpoint for this study is the capacity of study drug to reduce metabolites of H2S in plasma from baseline (week 0) compared to the end of active treatment (4 weeks)

Secondary outcomes

  1. Simple Clinical Colitis Activity Index (SCCAI)

    Time frame: 12 weeks

    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.

  2. Plasma nitrite, nitrate, or nitrosothiol

    Time frame: 8 weeks

    Correlation between changes in plasma nitrite, nitrate or nitrosothiol levels and fecal calprotectin

  3. Normalization of fecal calprotectin lab measurements

    Time frame: 4 weeks

    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. Change in fecal calprotectin lab measurements

    Time frame: 4 weeks

    Change in fecal calprotectin to < ULN at the end of active treatment

  5. Partial Mayo score

    Time frame: 4 weeks

    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.

  6. Measurement of sulfur metabolites in urine

    Time frame: 8 weeks

    Analysis of urine for measurement of thiosulfate, thiocyanate, nitrate and nitrite

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Korzenik, MD

CONTACT

[email protected]

617 732-6389

Siani Ellis

CONTACT

[email protected]

617-396-7703

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Dartmouth-Hitchcock Medical Center
  • Mercy Medical Center

Registry information

Official study title

Treatment of Ulcerative Colitis With Novel Therapeutics

Acronym: TURTLE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 20, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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