Ulcerative Colitis Chronic MildPhase 1NCT05666960
R-3750 in Patients With Mild to Moderate Ulcerative Colitis
A Phase 1 study testing R-3750 in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by Rise Therapeutics LLC at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic
- What is being tested?
- R-3750
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Feb 2023to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
AP Medical Research LLC
Miami, Florida, 33165
Simon Gomez, BS, 305-400-8899, simon@apmedresearch.com
Idania Fernandez, MD
- Recruiting
Edward Jenner Research Group, LLC
Plantation, Florida, 33317
Rosario Beltran, 954-676-7440, r.beltran@edwardjmedicalresearch.com
Shadi Tarazi, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Patricia Kammer, 507-538-1827, kammer.patricia@mayo.edu
Darrel Pardi, MD
- Recruiting
Adtremed Research Clinic
Tampa, Florida, 33634
Yulio Aguila, CRC, 813-999-1950, yaguila@adtremed.com
Suyet de la Morena-Perez, BS, CRC, (813) 999-1950, suyetperez@adtremed.com
- Recruiting
Amicis Research Center
Valencia, California, 91355
Crystal Baltazar, 818-639-8822, cbaltazar@amicisresearch.com
Robert Moghimi, MD
About this study
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
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
- Being tested
- R-3750
- Keywords
- Colitis
- Medical subject headings
- Colitis, Ulcerative, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-3750Drug
Probiotic
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the tolerability of R-3750
To assess the number of participants with treatment-realated adverse events after taking R-3750 (probiotic)
Measured: 6 weeks
Secondary outcomes (1)
Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start27 Feb 2023
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis Chronic MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rise Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, University of Colorado, Denver
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666960
- Sponsor's protocol ID
- RISE R-3750-01
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05666960
- Acronym / sponsor ID
- RISE R-3750-01
- Conditions
- Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic, Ulcerative Colitis
- Keywords
- Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Rise Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, University of Colorado, Denver
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-3750Probiotic | Drug | – |
Primary outcome
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)
1 secondary outcome
Clinical Response based on Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R-3750 in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by Rise Therapeutics LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Stephens, PhD (6504178556, jstephens@risetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the tolerability of R-3750 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.