R-3750 in Patients With Mild to Moderate Ulcerative Colitis

Launched by RISE THERAPEUTICS LLC · Dec 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new probiotic called R-3750 to see if it is safe and well-tolerated in adults with mild to moderate ulcerative colitis, a condition that causes inflammation in the digestive tract. Participants in the trial will take R-3750 as a pill and will share information about their symptoms and well-being. Doctors will also check their blood and stool to assess any inflammation and how the probiotic affects their condition.

To join the study, participants must be between 18 and 65 years old and have a confirmed diagnosis of ulcerative colitis that is not too severe. They should be stable on their current medication and not planning to change it during the study. It’s important for participants to avoid certain medications and vaccines during the trial, and women who can become pregnant must agree to use birth control. Those who qualify will have regular check-ins and monitoring throughout the study to ensure their safety.

Gender

ALL

Eligibility criteria

• 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