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
1 other identifier
interventional
36
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2023
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
January 29, 2026
January 1, 2026
3.3 years
December 1, 2022
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the tolerability of R-3750
To assess the number of participants with treatment-realated adverse events after taking R-3750 (probiotic)
6 weeks
Secondary Outcomes (1)
Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
6 weeks
Interventions
Probiotic
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rise Therapeutics LLClead
- Mayo Cliniccollaborator
- University of Colorado, Denvercollaborator
Study Sites (4)
Amicis Research Center
Valencia, California, 91355, United States
AP Medical Research LLC
Miami, Florida, 33165, United States
Edward Jenner Research Group, LLC
Plantation, Florida, 33317, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2022
First Posted
December 28, 2022
Study Start
February 27, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
January 29, 2026
Record last verified: 2026-01