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Trial record 1 of 1 for:    NCT05666960
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R-3750 in Patients With Mild to Moderate Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT05666960
Recruitment Status : Recruiting
First Posted : December 28, 2022
Last Update Posted : April 4, 2023
Sponsor:
Collaborators:
Mayo Clinic
University of Colorado, Denver
Information provided by (Responsible Party):
Rise Therapeutics LLC

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Chronic Mild Ulcerative Colitis Chronic Moderate Ulcerative Colitis Chronic Ulcerative Colitis Drug: R-3750 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 27, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: R-3750
    Probiotic

Outcome Measures
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Primary Outcome Measures :
  1. To assess the tolerability of R-3750 [ Time Frame: 6 weeks ]
    To assess the number of participants with treatment-realated adverse events after taking R-3750 (probiotic)


Secondary Outcome Measures :
  1. Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores [ Time Frame: 6 weeks ]
    To assess the number of participants that show improvements in the ulcerative colitis disease severity by collecting IBDQ. The scores are based on a numbering system from one (1) to seven (7) where seven (7) is the least about of trouble with your bowels and one (1) is the most. The numbers are totaled to provide a total score from 32 to 224. Where 32 is a better outcome and 224 is a worse outcome. This is compared from the beginning and again at different times to see if there are any changes to your microbiome before and after taking R-3750 (probiotic).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 2 weeks
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05666960


Contacts
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Contact: Janet Stephens, PhD 6504178556 jstephens@risetherapeutics.com
Contact: Christian Freguia, PhD 2159231818 cfreguia@risetherapeutics.com

Locations
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United States, Colorado
University of Colorado School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Keanna Capener    303-724-8974    Keanna.Capener@cuanschutz.edu   
Principal Investigator: Waseem Ahmed, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Patricia Kammer    507-538-1827    kammer.patricia@mayo.edu   
Principal Investigator: Darrel Pardi, MD         
Sponsors and Collaborators
Rise Therapeutics LLC
Mayo Clinic
University of Colorado, Denver
More Information
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Responsible Party: Rise Therapeutics LLC
ClinicalTrials.gov Identifier: NCT05666960    
Other Study ID Numbers: RISE R-3750-01
First Posted: December 28, 2022    Key Record Dates
Last Update Posted: April 4, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rise Therapeutics LLC:
Colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases