Ulcerative ColitisPhase 2SHARCNCT06420492
Study of Novel Therapeutics for Acute Remedy of Colitis
A Phase 2 study testing BRS201 in people with Ulcerative Colitis and Ulcerative Colitis Chronic Moderate, run by Brigham and Women's Hospital at 2 sites 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 acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis, Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
- What is being tested?
- BRS201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2025to 1 Jun 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
- 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
- Patients with primary sclerosing cholangitis are eligible to enroll
- Patients will have failed 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of > 6
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- Patients who are taking 20mg or less of oral prednisone and plan to stay at that dose during their participation in the study
- Accepted medications:
- Anti-TNF agents are permissible if the patient has been taking them for at least 10 weeks and anticipates to maintain a steady for the duration of the study.
- Rinvoq (Upadacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.
- Xeljanz (Tofacitinib) is permissible if the subject has been taking this medication for at least 4 weeks and anticipates to maintain a steady dose for the duration of the study.
- Other biologics are permissible if the subject has been taking the medication for at least 10 weeks and anticipates to maintain a steady dose for the duration of the study
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
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- 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:
- Rinvoq (Upadacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation.
- Xeljanz (Tofacitinib): Subjects will be excluded from this study if their last dose of this medication was administered within 4 weeks. If subjects have stopped taking this medication and their last dose was administered more than 4 weeks prior to enrollment, they will be eligible for participation.
- Other Medications: Subjects will be excluded from this study if they stopped taking any other medications for ulcerative colitis within 8 weeks. If subjects have stopped taking the medication and their last dose was more than 8 weeks prior to enrollment, they will be eligible for participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet 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
- Recruiting
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Siani Ellis, 617-396-7703, sellis13@bwh.harvard.edu
About this study
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 8 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.
- Conditions
- Ulcerative Colitis, Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
- Being tested
- BRS201
- 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 for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| BRS201 Arm | Experimental | In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO 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.
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. Subjects in Group 4 will undergo two flexible sigmoidoscopies, one at screening and one at week 4. Receives: Drug: BRS201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sulfur Metabolism
The primary measure of dose response will be urinary measures of sulfur metabolism including a > 50% reduction from pretreatment levels sulfate, and thiosulfate.
Measured: 4 weeks
Secondary outcomes (8)
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 level in relation to calprotectin
Measured: 8 weeks
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.
Measured: 8 weeks
Reduction in fecal calprotectin lab measurements
Reduction in fecal calprotectin to < ULN at the end of active treatment
Measured: 4 weeks
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).
Measured: 4 weeks
Tissue Analysis
Analysis of tissue metabolomics and proteomics at day 0 vs day 28;
Measured: 4 weeks
Mitochondria evaluation
Changes in mitochondria on EM evaluation
Measured: 12 weeks
Urine Assays
Urine levels for thiosulfate, thiocyanate, nitrate and nitrite;
Measured: 12 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 start30 Sep 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label study in which everyone will receive active treatment.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Korzenik, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420492
- Sponsor's protocol ID
- 2025P001885
- Acronym
- SHARC
- Status last verified
- Oct 2025
- First submitted
- 6 May 2024
- Last updated
- 20 Oct 2025
- 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 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Novel Therapeutics for Acute Remedy of Colitis
- ClinicalTrials.gov ID
- NCT06420492
- Acronym / sponsor ID
- SHARC / 2025P001885
- Conditions
- Ulcerative Colitis, Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 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 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 8 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label study in which everyone will receive active treatment.
| Arm | Type | Receives |
|---|---|---|
| BRS201 Arm | Experimental | Drug: BRS201In Group 1 of the study, subjects will take oral study drug at 1.2g daily, PO 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. 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. Subjects in Group 4 will undergo two flexible sigmoidoscopies, one at screening and one at week 4. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Patients with primary sclerosing cholangitis are eligible to enroll
Key exclusion criteria (17 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 for four weeks. | Drug | BRS201 Arm |
Primary outcome
Sulfur Metabolism
Time frame: 4 weeks
The primary measure of dose response will be urinary measures of sulfur metabolism including a > 50% reduction from pretreatment levels sulfate, and thiosulfate.
8 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: 8 weeks
Reduction in fecal calprotectin lab measurements
Time frame: 4 weeks
Mayo Score
Time frame: 4 weeks
Tissue Analysis
Time frame: 4 weeks
Mitochondria evaluation
Time frame: 12 weeks
Urine Assays
Time frame: 12 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 20 Oct 2025.
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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.
2 sites 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 and Ulcerative Colitis Chronic Moderate, run by Brigham and Women's Hospital at 2 sites 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 12 inclusion and 17 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Sulfur Metabolism (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 20 Oct 2025.