RECRUITING

R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Conditions

Ulcerative Colitis Chronic Mild Ulcerative Colitis Chronic Moderate Ulcerative Colitis Chronic Ulcerative Colitis Colitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-27

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05666960

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Janet Stephens, PhD

CONTACT

6504178556

jstephens@risetherapeutics.com

Christian Freguia, PhD

CONTACT

2159231818

cfreguia@risetherapeutics.com

Study Locations (Sites)

University of Colorado School of Medicine

Aurora, Colorado, 80045

United States

AP Medical Research LLC

Miami, Florida, 33165

United States

Mayo Clinic

Rochester, Minnesota, 55902

United States

Collaborators and Investigators

Sponsor: Rise Therapeutics LLC

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 Registration Dates

Study Start Date2023-02-27

Study Completion Date2025-10

Study Record Updates

Study Start Date2023-02-27

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Colitis

Additional Relevant MeSH Terms

Ulcerative Colitis Chronic Mild
Ulcerative Colitis Chronic Moderate
Ulcerative Colitis Chronic
Ulcerative Colitis