Recruiting
Phase 1

R-3750

Sponsor:

Rise Therapeutics LLC

Code:

NCT05666960

Conditions

Ulcerative Colitis Chronic Mild

Ulcerative Colitis Chronic Moderate

Ulcerative Colitis Chronic

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

R-3750

Study Details

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.

Conditions

Ulcerative Colitis Chronic Mild

Ulcerative Colitis Chronic Moderate

Ulcerative Colitis Chronic

Ulcerative Colitis

Study ID

NCT05666960

Start date

Feb 27, 2023

Status verified date

Jun, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

R-3750

Probiotic

Primary outcome measure

  • To assess the tolerability of R-3750 [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Janet Stephens, PhD

6504178556jstephens@risetherapeutics.com

Christian Freguia, PhD

2159231818cfreguia@risetherapeutics.com

Locations

Amicis Research Center

Recruiting

Valencia, California, United States, 91355

Contacts

Crystal Baltazar

818-639-8822cbaltazar@amicisresearch.com

Principal Investigator:

Robert Moghimi, MD

AP Medical Research LLC

Recruiting

Miami, Florida, United States, 33165

Contacts

Simon Gomez, BS

305-400-8899simon@apmedresearch.com

Principal Investigator:

Idania Fernandez, MD

Edward Jenner Research Group, LLC

Recruiting

Plantation, Florida, United States, 33317

Contacts

Rosario Beltran

954-676-7440r.beltran@edwardjmedicalresearch.com

Principal Investigator:

Shadi Tarazi, MD

Adtremed Research Clinic

Recruiting

Tampa, Florida, United States, 33634

Contacts

Yulio Aguila, CRC

813-999-1950yaguila@adtremed.com

Suyet de la Morena-Perez, BS, CRC

(813) 999-1950suyetperez@adtremed.com

Principal Investigator:

Moraima I Batista-Carmona, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Patricia Kammer

507-538-1827kammer.patricia@mayo.edu

Principal Investigator:

Darrel Pardi, MD

More Information

Sponsor

Rise Therapeutics LLC

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Colitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rise Therapeutics LLC on 2026-06-12.