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R-3750 in Patients With Mild to Moderate Ulcerative Colitis | Clinical Trials | Clareo Health

RECRUITINGPHASE1

R-3750 in Patients With Mild to Moderate Ulcerative Colitis

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

NCT05666960•Rise Therapeutics LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (4)

Amicis Research Center

Valencia, California, United States

AP Medical Research LLC

Miami, Florida, United States

Edward Jenner Research Group, LLC

Plantation, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

February 27, 2023

Primary Completion Date

July 1, 2026

Completion Date

October 1, 2026

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Ulcerative Colitis Chronic MildUlcerative Colitis Chronic ModerateUlcerative Colitis ChronicUlcerative Colitis

Interventions

R-3750

DRUG

Contacts

Janet Stephens, PhD

CONTACT

6504178556 jstephens@risetherapeutics.com

Christian Freguia, PhD

CONTACT

2159231818 cfreguia@risetherapeutics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Inclusion Criteria

Exclusion Criteria

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