Ulcerative Colitis · Ulcerative Colitis Chronic · Ulcerative Colitis Chronic Mild · Ulcerative Colitis Chronic Moderate
Phase 1 Study of R-3750 for Mild to Moderate Ulcerative Colitis
This Phase 1 study is investigating the safety, tolerability, drug exposure, and clinical activity of orally taken R-3750 in adults with mild to moderate ulcerative colitis.
Registry title: R-3750 in Patients With Mild to Moderate Ulcerative Colitis
5 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–65 Years
- Treatment
- R-3750
- Design
- Not provided
- Central study contact
- Janet Stephens, PhD6504178556jstephens@risetherapeutics.com
- Sponsor
- Rise Therapeutics LLC
Research question
How safe and tolerable is orally taken R-3750, and what drug-exposure and clinical-activity findings are observed in people with mild to moderate ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 65.
- The study is looking for people whose ulcerative colitis was confirmed by colonoscopy and tissue examination.
- The study is looking for people with mild to moderate ulcerative colitis, defined in the registry as a Modified Mayo Disease Activity Index score of 3 to 9.
- The study is looking for people taking a stable aminosalicylate dose, with no medication change during the four weeks before enrollment.
- The registry lists recruiting locations in California, Florida, and Minnesota.
Participation overview
What participation may involve
Participants take oral R-3750 and complete ulcerative-colitis assessments; the study also evaluates blood and stool measures. What participation may involve: - Take an oral dose or doses of the probiotic R-3750. - Provide patient-reported and physician-scored measures of ulcerative colitis. - Provide blood and stool samples for evaluations of inflammation and stool levels of R-3750. - Complete the Inflammatory Bowel Disease Questionnaire at the beginning and at later assessment times. - People in the expansion cohort must have flexible sigmoidoscopy unless results from an endoscopy completed within three months before enrollment are available.
Study interventions
What participants may receive or do
- R-3750: The registry describes R-3750 as a probiotic taken by mouth.
Study design
How the comparison works
This is an open-label, single-group Phase 1 treatment study with an estimated enrollment of 36 participants. The registry marks allocation as not applicable because the study uses one intervention group. The study is open-label, meaning the registry reports no masking. The registry describes a single intervention group and does not describe a separate comparator group.
Reported activities
Procedures and tests
- Patient-reported ulcerative-colitis assessments
- Physician-scored ulcerative-colitis assessments
- Blood evaluations of inflammation
- Stool evaluations of inflammation and R-3750 levels
- Inflammatory Bowel Disease Questionnaire assessments
- For the expansion cohort, flexible sigmoidoscopy or review of an endoscopy completed within three months before enrollment
- Screening may include confirmation of liver enzyme levels because significant laboratory abnormalities can exclude participation.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 65 years old.
- Participants must be able to give written informed consent.
- Ulcerative colitis must have been confirmed by colonoscopy and histology.
- Ulcerative colitis must be mild to moderate, defined as a Modified Mayo Disease Activity Index score of 3 to 9.
- Participants must be on a stable aminosalicylate dose, with no medication change during the four weeks before enrollment, and must not plan to start another new medication besides the study drug.
- Participants with reproductive potential must agree to the specified birth-control precautions; men must also avoid sperm donation during the study and for at least 30 days after dosing.
- People in the expansion cohort need flexible sigmoidoscopy unless an endoscopy completed within three months before enrollment is available.
- Participants must refrain from all vaccinations during the study period.
Possible reasons someone may not be able to join
- Pregnancy, planned pregnancy, or breastfeeding excludes participation.
- Severe ulcerative colitis, defined as a Modified Mayo Disease Activity Index score of 10 or higher, excludes participation.
- Any active or recent infection, including chronic hepatitis B, hepatitis C, or HIV, excludes participation.
- Active or recent chronic chest infection with bronchiectasis or sinusitis, or COVID-19 infection within the past three months, excludes participation.
- Use within the past three months of immunosuppressants, anticancer drugs, or any ulcerative-colitis therapy other than an aminosalicylate excludes participation.
- An investigational drug received within the past three months, or within five half-lives if longer, excludes participation.
- Use of steroid drugs to treat ulcerative colitis, such as prednisone above 20 mg per day, excludes participation.
- Probiotic use within the previous week or during the trial excludes participation.
- Treatment with systemic broad-spectrum antibiotics during the past two months excludes participation.
- A history of anaphylaxis or allergy to probiotics excludes participation.
- Significant laboratory abnormalities, including aspartate aminotransferase or alanine aminotransferase above 1.5 times the upper limit of normal, exclude participation.
Important unknowns
What the record does not make clear
- The registry does not state how many study visits are required, how often they occur, or which visits must be in person.
- The outcomes are assessed over six weeks, but the registry does not explicitly state each participant's total time in the study.
- The criteria require a stable aminosalicylate dose and restrict starting other medication, but the registry does not fully describe how background treatment is managed during the study.
- The registry does not explain what treatment is available if ulcerative colitis worsens during the study.
- Flexible sigmoidoscopy is required for the expansion cohort unless a recent endoscopy is available, but the registry does not explain who enters that cohort or whether another endoscopy occurs later.
- The registry does not state which study-related care is paid for or billed to insurance.
- The registry does not state whether participants are compensated.
- The registry does not state whether travel expenses or lodging are supported.
- The registry does not state whether any visits or assessments can be completed remotely.
- The registry lists five locations as recruiting, but the current availability of a particular cohort or opening at each site must be confirmed.
- The secondary-outcome description says higher item scores mean less bowel trouble but then labels a total score of 32 as better and 224 as worse, so the intended scoring direction is unclear.
Before contacting the site
Questions for the study team
- What is the exact R-3750 dosing schedule, including the number of doses and whether dosing occurs at home or at the site?
- What is the full visit schedule, and which visits require travel to the study site?
- How long does participation last from screening through the final follow-up?
- Which ulcerative-colitis medicines may continue during the study, and what happens if a medication change becomes medically necessary?
- What happens if ulcerative-colitis symptoms worsen, and what rescue treatment is permitted?
- Would I be in the expansion cohort, and exactly when would flexible sigmoidoscopy or another endoscopy be required?
- Which costs are covered, is compensation offered, and is travel support available?
- How should the Inflammatory Bowel Disease Questionnaire score be interpreted in this study?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and how does that compare with the study's mild-to-moderate disease requirement?
- Would keeping my aminosalicylate dose stable during the study be medically appropriate for me?
- Would any of my current or recent medicines conflict with the study's restrictions on steroids, immunosuppressants, biologic therapies, antibiotics, or probiotics?
- What approved treatment alternatives should I consider alongside learning more about this Phase 1 study?
- What risks would delayed vaccination create for me if the study requires avoiding all vaccinations during participation?
- How should you and the research team coordinate monitoring and treatment if my symptoms worsen or laboratory results change?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate ulcerative colitis. Patients will take an oral dosage of probiotic (R-3750) and provide patient-reported and physician scored measures of their colitis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.
Study design and administration
- Organization
- Rise Therapeutics LLC
- Organization class
- Industry
- Organization study ID
- RISE R-3750-01
- Lead sponsor
- Rise Therapeutics LLC
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Interventions
Drug
R-3750
Probiotic
Eligibility
18 Years–65 Years
All
Not accepted
Inclusion criteria (7)
- 18-65 years of ageRegistry-derived · unreviewed
- Ability to provide written informed consentRegistry-derived · unreviewed
- Confirmed diagnosed with UC by colonoscopy and histology and suffering from mild to moderate UC as defined by MMDAI with score of 3-9Registry-derived · unreviewed
- On a stable dose of aminosalicylate (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than the study drugRegistry-derived · unreviewed
- For women of childbearing potential or men with a partner of childbearing potential, agree to use birth control methods (including hormonal contraceptives, intrauterine device (IUD) or hormone releasing system (IUS), vasectomy) and men will refrain from donating sperm during the study and at least 30 days after dosing (per FDA guidelines)Registry-derived · unreviewed
- For the expansion cohort, a flexible sigmoidoscopy is required, unless an endoscopy was completed within 3 months from enrollment is availableRegistry-derived · unreviewed
- Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio)Registry-derived · unreviewed
Exclusion criteria (18)
- Pregnancy, planned pregnancy, breastfeeding womenRegistry-derived · unreviewed
- Evidence of severe UC disease (MMDAI score greater than or equal to 10)Registry-derived · unreviewed
- Evidence of any active or recent infection including chronic infectious disease such as Hepatitis B, C, or HIVRegistry-derived · unreviewed
- Evidence of any active or recent chronic chest infection with bronchiectasis or sinusitis, or covid-19 infection in the past 3 monthsRegistry-derived · unreviewed
- Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, ozanimod, tofacitinid, upadacitinib, tacrolimus, cyclophosphamide, or cyclosporine or any other therapy that is not an aminosalicylate within the last 3 monthsRegistry-derived · unreviewed
- Received an investigational drug within 3 months (or 5 half-lives, whichever is longer) before study entryRegistry-derived · unreviewed
- Use of steroidal drugs to treat UC (e.g., prednisone \>20 mg/day)Registry-derived · unreviewed
- Use of probiotics within the last one (1) week and during the trial.Registry-derived · unreviewed
- Treatment with systemic broad-spectrum antibiotics in the past 2 monthsRegistry-derived · unreviewed
- Major active systemic autoimmune disease other than UCRegistry-derived · unreviewed
- History of anaphylaxis or allergies to probioticsRegistry-derived · unreviewed
- History of alcohol or drug abuse within the past 2 yearsRegistry-derived · unreviewed
- History of stroke, or any cerebrovascular disease requiring medication/treatmentRegistry-derived · unreviewed
- History of cancer, apart from successfully treated basal cell carcinoma or in situ carcinoma of the cervix \>1 year prior to enrollmentRegistry-derived · unreviewed
- Significant laboratory abnormalities, including liver transaminases (AST or ALT) \> 1.5X the upper limit of normal.Registry-derived · unreviewed
- Second degree or higher heart block or clinically significant arrythmiaRegistry-derived · unreviewed
- Any other clinically significant renal, hepatic, hematological or other disease or laboratory abnormality which, in the opinion of the investigator, would interfere with the conduct, the interpretation of the safety signals or results of the trial, or would place the subject at unacceptable riskRegistry-derived · unreviewed
- Any condition or circumstance that, in the opinion of the Principal Investigator, would compromise the safety of the subject or the quality of study dataRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
To assess the tolerability of R-3750
Time frame: 6 weeks
To assess the number of participants with treatment-realated adverse events after taking R-3750 (probiotic)
Secondary outcome
Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
Time frame: 6 weeks
To assess the number of participants that show improvements in the ulcerative colitis disease severity by collecting IBDQ. The scores are based on a numbering system from one (1) to seven (7) where seven (7) is the least about of trouble with your bowels and one (1) is the most. The numbers are totaled to provide a total score from 32 to 224. Where 32 is a better outcome and 224 is a worse outcome. This is compared from the beginning and again at different times to see if there are any changes to your microbiome before and after taking R-3750 (probiotic).
Recruiting locations in the United States
Amicis Research Center
RecruitingValencia, California, 91355, United States
Crystal Baltazar818-639-8822cbaltazar@amicisresearch.com
Robert Moghimi, MD
AP Medical Research LLC
RecruitingMiami, Florida, 33165, United States
Simon Gomez, BS305-400-8899simon@apmedresearch.com
Idania Fernandez, MD
Edward Jenner Research Group, LLC
RecruitingPlantation, Florida, 33317, United States
Rosario Beltran954-676-7440r.beltran@edwardjmedicalresearch.com
Shadi Tarazi, MD
Adtremed Research Clinic
RecruitingTampa, Florida, 33634, United States
Yulio Aguila, CRC813-999-1950yaguila@adtremed.com
Suyet de la Morena-Perez, BS, CRC(813) 999-1950suyetperez@adtremed.com
Moraima I Batista-Carmona, MD
Mayo Clinic
RecruitingRochester, Minnesota, 55902, United States
Patricia Kammer507-538-1827kammer.patricia@mayo.edu
Darrel Pardi, MD
Central study contacts
Registry dates
- First posted
- Dec 28, 2022
- Primary completion
- Jul 2026
- Overall completion
- Oct 2026
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.