Ulcerative Colitis MildPhase 2TURTLENCT06420375
Treatment of UC With Novel Therapeutics
A Phase 2 study testing BRS201 in people with Ulcerative Colitis Mild and Ulcerative Colitis, run by Brigham and Women's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis Mild, Ulcerative Colitis
- What is being tested?
- BRS201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2025to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Siani Ellis, 617-396-7703, sellis13@bwh.harvard.edu
Sophie Mitchell, smitchell22@bwh.harvard.edu
About this study
Official title: Treatment of Ulcerative Colitis 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.
- Conditions
- Ulcerative Colitis Mild, Ulcerative Colitis
- Being tested
- BRS201, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRS201Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: BRS201 Arm | Active comparator | In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO (2.4g with 120mg oral butyrate twice daily (240mg daily) for 4 weeks.
In Group 2 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks.
In Group 3 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 2.5g dose of study drug at initiation.
In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective. Receives: Drug: BRS201 |
| Placebo Comparator: Placebo Arm | Placebo comparator | In Group 1 of the study, subjects will take oral placebo at 1.2g daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks.
In Group 2 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks.
In Group 3 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 100mg dose of cyanocobalamin at initiation.
In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of H2S metabolites in plasma
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)
Measured: 4 weeks
Secondary outcomes (6)
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.
Measured: 12 weeks
Plasma nitrite, nitrate, or nitrosothiol
Correlation between changes in plasma nitrite, nitrate or nitrosothiol levels and fecal calprotectin
Measured: 8 weeks
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).
Measured: 4 weeks
Change in fecal calprotectin lab measurements
Change in fecal calprotectin to < ULN at the end of active treatment
Measured: 4 weeks
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.
Measured: 4 weeks
Measurement of sulfur metabolites in urine
Analysis of urine for measurement of thiosulfate, thiocyanate, nitrate and nitrite
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start27 May 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis MildStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mercy Medical Center, Dartmouth-Hitchcock Medical Center
- Responsible party
- Principal investigator, Joshua Korzenik, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420375
- Sponsor's protocol ID
- 2025P000585
- Acronym
- TURTLE
- Status last verified
- Jul 2026
- First submitted
- 6 May 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ulcerative Colitis With Novel Therapeutics
- ClinicalTrials.gov ID
- NCT06420375
- Acronym / sponsor ID
- TURTLE / 2025P000585
- Conditions
- Ulcerative Colitis Mild, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Mercy Medical Center, Dartmouth-Hitchcock Medical Center
- Study start
- 27 May 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: BRS201 Arm | Active comparator | Drug: BRS201In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO (2.4g with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 3 of the study, subjects will take oral study drug at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 2.5g dose of study drug at initiation. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective. |
| Placebo Comparator: Placebo Arm | Placebo comparator | Drug: PlaceboIn Group 1 of the study, subjects will take oral placebo at 1.2g daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 3 of the study, subjects will take oral placebo at 1.2g twice daily, PO (2.4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 100mg dose of cyanocobalamin at initiation. In Group 4 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRS201Groups 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. | Drug | Active Comparator: BRS201 Arm |
| PlaceboGroups 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. | Drug | Placebo Comparator: Placebo Arm |
Primary outcome
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)
6 secondary outcomes
Simple Clinical Colitis Activity Index (SCCAI)
Time frame: 12 weeks
Plasma nitrite, nitrate, or nitrosothiol
Time frame: 8 weeks
Normalization of fecal calprotectin lab measurements
Time frame: 4 weeks
Change in fecal calprotectin lab measurements
Time frame: 4 weeks
Partial Mayo score
Time frame: 4 weeks
Measurement of sulfur metabolites in urine
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BRS201 in people with Ulcerative Colitis Mild and Ulcerative Colitis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Korzenik, MD (617 732-6389, jkorzenik@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of H2S metabolites in plasma (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.