R-3750 in Patients With Mild to Moderate Ulcerative Colitis

January 27, 2026 updated by: Rise Therapeutics LLC

A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Valencia, California, United States, 91355
        • Recruiting
        • Amicis Research Center
        • Principal Investigator:
          • Robert Moghimi, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33165
        • Recruiting
        • AP Medical Research LLC
        • Contact:
        • Principal Investigator:
          • Idania Fernandez, MD
      • Plantation, Florida, United States, 33317
        • Recruiting
        • Edward Jenner Research Group, LLC
        • Contact:
        • Principal Investigator:
          • Shadi Tarazi, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Darrel Pardi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

  • 18-65 years of age
  • Ability to provide written informed consent
  • Confirmed diagnosed with UC by colonoscopy and histology and suffering from mild to moderate UC as defined by MMDAI with score of 3-9
  • 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 drug
  • 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)
  • For the expansion cohort, a flexible sigmoidoscopy is required, unless an endoscopy was completed within 3 months from enrollment is available
  • 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)

EXCLUSION CRITERIA:

  • Pregnancy, planned pregnancy, breastfeeding women
  • Evidence of severe UC disease (MMDAI score greater than or equal to 10)
  • Evidence of any active or recent infection including chronic infectious disease such as Hepatitis B, C, or HIV
  • Evidence of any active or recent chronic chest infection with bronchiectasis or sinusitis, or covid-19 infection in the past 3 months
  • 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 months
  • Received an investigational drug within 3 months (or 5 half-lives, whichever is longer) before study entry
  • Use of steroidal drugs to treat UC (e.g., prednisone >20 mg/day)
  • Use of probiotics within the last one (1) week and during the trial.
  • Treatment with systemic broad-spectrum antibiotics in the past 2 months
  • Major active systemic autoimmune disease other than UC
  • History of anaphylaxis or allergies to probiotics
  • History of alcohol or drug abuse within the past 2 years
  • History of stroke, or any cerebrovascular disease requiring medication/treatment
  • History of cancer, apart from successfully treated basal cell carcinoma or in situ carcinoma of the cervix >1 year prior to enrollment
  • Significant laboratory abnormalities, including liver transaminases (AST or ALT) > 1.5X the upper limit of normal.
  • Second degree or higher heart block or clinically significant arrythmia
  • 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 risk
  • Any condition or circumstance that, in the opinion of the Principal Investigator, would compromise the safety of the subject or the quality of study data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rise Therapeutics LLC

Collaborators

University of Colorado, Denver
Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RISE R-3750-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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