Crohn Disease (CD)Phase 1NCT07791888
R-3750 in Patients With Crohn's Disease
A Phase 1 study testing R-3750 in people with Crohn Disease (CD), run by Rise Therapeutics LLC.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, clinical activity, and pharmacodynamic effects of R-3750 in adults with active Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- R-3750
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Mar 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years, inclusive, at the time of informed consent.
- Able and willing to provide written informed consent and comply with study procedures and study visits.
- Documented diagnosis of Crohn's disease with symptoms/onset of disease at least 3 months prior to Screening.
- Active Crohn's disease defined by Harvey-Bradshaw Index (HBI) score between 5 and 15 at Screening.
- Evidence of active inflammatory disease, defined by at least one of the following: CRP ≥5 mg/L, fecal calprotectin ≥50 µg/g, biopsy-verified inflammation, or endoscopic evidence of active inflammation.
- Women of childbearing potential must have a negative pregnancy test at Screening and before dosing and agree to use highly effective contraception during the study and for at least 3 months after the last dose.
- Men with partners of childbearing potential must agree to use contraception according to institutional requirements during the study and for at least 3 months after the last dose.
Who cannot join
- Crohn's disease in clinical remission, including HBI <5 or CDAI <150 at Screening.
- Severe Crohn's disease requiring urgent escalation of therapy, hospitalization, or surgery in the opinion of the Investigator.
- Imminent risk of scheduled intestinal surgery, including clinically significant stenosis, strictures, internal fistula, abscess, or obstructive complications.
- History of partial or incomplete bowel obstruction within 6 months prior to Screening; current stoma, ileostomy, colostomy, or anticipated need for ostomy during the study; diagnosis of short bowel syndrome or clinically significant malabsorptive condition; uncontrolled chronic diarrhea due to a condition other than Crohn's disease; or bowel resection within 3 months prior to Screening.
- Subjects with prior bowel resection may be eligible if, in the opinion of the Investigator and Sponsor, the remaining bowel anatomy is adequate for study participation and interpretation of study endpoints.
- History (past 6 months) or current Clostridioides difficile infection, clinically significant enteric infection, other active infection or chronic infection requiring ongoing antimicrobial treatment.
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- Treatment with antibiotics within 2 weeks prior to Day 1 or expected during the study period.
- Use of biologic, targeted synthetic, or systemic immunomodulatory/immunosuppressive therapy for Crohn's disease within the 4 weeks washout period prior to Day 1, unless specifically permitted. Stable doses of aminosalicylates, budesonide, or low-dose systemic corticosteroids are permitted if stable for at least 2 weeks prior to Day 1 and expected to remain stable during the treatment period. Low-dose systemic corticosteroids are defined as prednisone ≤20 mg/day or equivalent.
- Use of probiotics or live biotherapeutic products within 2 weeks prior to Day 1.
- Severe comorbidities, including uncontrolled diabetes, clinically significant cardiopulmonary failure, severe liver disease, severe renal disease, or other clinically significant condition that would place the subject at risk or confound study interpretation.
- Abnormal hepatic function, including ALT or ALP >2.5 × ULN, liver cirrhosis, portal hypertension, or clinically significant active liver disease.
- Abnormal renal function, including cystatin C >ULN or other clinically significant renal abnormality.
- Known active blood-borne infection, including HIV, active hepatitis A, B, or C infection, or tuberculosis.
- History of malignancy within 5 years prior to Day 1, except adequately treated non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Pregnant, breastfeeding, or planning to become pregnant during the study. Clinically significant mental disorder, substance use disorder, alcohol or drug addiction that may interfere with participation or compliance.
- Participation in another interventional clinical trial within 30 days prior to Day 1 or simultaneous participation in another interventional clinical trial.
- Any significant disease, disorder, laboratory abnormality, or circumstance that, in the opinion of the Investigator, may put the subject at risk, affect study results, or interfere with study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Christian F Freguia, PhD contact
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Clinical Activity, and Pharmacodynamic Effects of R-3750 in Patients With Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, clinical activity, and pharmacodynamic effects of R-3750 in adults with active Crohn's disease. Approximately 40 participants will be randomized 1:1 to receive R-3750 or matching placebo orally once daily for 12 weeks. Participants will be followed for safety, clinical response, and durability of response through approximately Day 168. Assessments will include adverse events, Crohn's disease activity, endoscopic response, patient-reported outcomes, inflammatory biomarkers, microbiome composition, and pharmacodynamic measures.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled Phase 1 study designed to evaluate the safety, tolerability, clinical activity, and pharmacodynamic effects of R-3750 in adults with active Crohn's disease.
Approximately 40 participants will be randomized in a 1:1 ratio to receive either R-3750 at a dose of 9E10 colony-forming units (CFU) per day or matching placebo administered orally once daily for 12 weeks. Participants, investigators, study site personnel involved in outcome assessments, and Sponsor personnel involved in study conduct and assessment will remain blinded to treatment assignment.
Eligible participants will be adults 18 to 80 years of age with active Crohn's disease, defined by a Harvey-Bradshaw Index (HBI) score of 5 to 15 and objective evidence of active inflammatory disease based on C-reactive protein (CRP), fecal calprotectin, biopsy-verified inflammation, and/or endoscopic assessment.
The study consists of a screening period, a 12-week treatment period from Day 1 through Day 84, and a safety follow-up period through approximately Day 168.
Safety and tolerability will be evaluated through the assessment of adverse events and serious adverse events, clinical laboratory parameters, vital signs, and physical examinations. Clinical activity will be evaluated using measures including the Crohn's Disease Activity Index (CDAI) and HBI. Additional assessments will evaluate clinical remission, endoscopic response, patient-reported outcomes, inflammatory biomarkers, microbiome composition, immune phenotypes, metabolomic profiles, and other pharmacodynamic measures.
An independent Medical Monitor will review available safety data on an ongoing basis, and a Data Monitoring Committee (DMC) will review cumulative safety data during the study.
- Conditions
- Crohn Disease (CD)
- Being tested
- R-3750, Placebo
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease, IBD, R-3750, Lactoccoccus lactis, Gut Microbiome
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-3750Drug
R-3750 DP is a live biotherapeutic product consisting of Lactococcus lactis engineered to express Surface Layer Protein A (SlpA), formulated in enteric-coated capsules for oral administration. Participants randomized to R-3750 will receive 9E10 colony-forming units (CFU) per day orally once daily from Day 1 through Day 84.
PlaceboDrug
Matching placebo will be administered orally once daily from Day 1 through Day 84.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: R-3750, 9E10 CFU/day orally once daily for 12 weeks | Experimental | Participants randomized to the experimental arm will receive R-3750 at a dose of 9E10 colony-forming units (CFU) per day, administered orally once daily from Day 1 through Day 84 (12 weeks). Receives: Drug: R-3750 |
| Arm 2: Matching placebo orally once daily for 12 weeks | Placebo comparator | Participants randomized to the placebo comparator arm will receive matching placebo administered orally once daily from Day 1 through Day 84 (12 weeks). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events.
Number of participants experiencing one or more treatment-emergent adverse events following administration of R-3750 or placebo.
Measured: From first dose through Day 168 end of study
Secondary outcomes (1)
Number of participants with serious adverse advents
Number of particpants experiencing one or more serious adverse events following administration of R-3750 or placebo.
Measured: From first dose through Day 168 end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: R-3750, 9E10 CFU/day orally once daily for 12 weeks Arm 2: Matching placebo orally once daily for 12 weeks
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rise Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791888
- Sponsor's protocol ID
- RISE-3750-01CD
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 28 Aug 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 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Clinical Activity, and Pharmacodynamic Effects of R-3750 in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT07791888
- Acronym / sponsor ID
- RISE-3750-01CD
- Conditions
- Crohn Disease (CD)
- Keywords
- Crohn's Disease, Inflammatory Bowel Disease, IBD, R-3750, Lactoccoccus lactis, Gut Microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rise Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 28 Aug 2026 (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.
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, clinical activity, and pharmacodynamic effects of R-3750 in adults with active Crohn's disease. Approximately 40 participants will be randomized 1:1 to receive R-3750 or matching placebo orally once daily for 12 weeks. Participants will be followed for safety, clinical response, and durability of response through approximately Day 168. Assessments will include adverse events, Crohn's disease activity, endoscopic response, patient-reported outcomes, inflammatory biomarkers, microbiome composition, and pharmacodynamic measures.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled Phase 1 study designed to evaluate the safety, tolerability, clinical activity, and pharmacodynamic effects of R-3750 in adults with active Crohn's disease.
Approximately 40 participants will be randomized in a 1:1 ratio to receive either R-3750 at a dose of 9E10 colony-forming units (CFU) per day or matching placebo administered orally once daily for 12 weeks. Participants, investigators, study site personnel involved in outcome assessments, and Sponsor personnel involved in study conduct and assessment will remain blinded to treatment assignment.
Eligible participants will be adults 18 to 80 years of age with active Crohn's disease, defined by a Harvey-Bradshaw Index (HBI) score of 5 to 15 and objective evidence of active inflammatory disease based on C-reactive protein (CRP), fecal calprotectin, biopsy-verified inflammation, and/or endoscopic assessment.
The study consists of a screening period, a 12-week treatment period from Day 1 through Day 84, and a safety follow-up period through approximately Day 168.
Safety and tolerability will be evaluated through the assessment of adverse events and serious adverse events, clinical laboratory parameters, vital signs, and physical examinations. Clinical activity will be evaluated using measures including the Crohn's Disease Activity Index (CDAI) and HBI. Additional assessments will evaluate clinical remission, endoscopic response, patient-reported outcomes, inflammatory biomarkers, microbiome composition, immune phenotypes, metabolomic profiles, and other pharmacodynamic measures.
An independent Medical Monitor will review available safety data on an ongoing basis, and a Data Monitoring Committee (DMC) will review cumulative safety data during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1: R-3750, 9E10 CFU/day orally once daily for 12 weeks Arm 2: Matching placebo orally once daily for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Arm 1: R-3750, 9E10 CFU/day orally once daily for 12 weeks | Experimental | Drug: R-3750Participants randomized to the experimental arm will receive R-3750 at a dose of 9E10 colony-forming units (CFU) per day, administered orally once daily from Day 1 through Day 84 (12 weeks). |
| Arm 2: Matching placebo orally once daily for 12 weeks | Placebo comparator | Drug: PlaceboParticipants randomized to the placebo comparator arm will receive matching placebo administered orally once daily from Day 1 through Day 84 (12 weeks). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years, inclusive, at the time of informed consent.
- Able and willing to provide written informed consent and comply with study procedures and study visits.
- Documented diagnosis of Crohn's disease with symptoms/onset of disease at least 3 months prior to Screening.
- Active Crohn's disease defined by Harvey-Bradshaw Index (HBI) score between 5 and 15 at Screening.
- Evidence of active inflammatory disease, defined by at least one of the following: CRP ≥5 mg/L, fecal calprotectin ≥50 µg/g, biopsy-verified inflammation, or endoscopic evidence of active inflammation.
Key exclusion criteria (17 listed)
- Crohn's disease in clinical remission, including HBI <5 or CDAI <150 at Screening.
- Severe Crohn's disease requiring urgent escalation of therapy, hospitalization, or surgery in the opinion of the Investigator.
- Imminent risk of scheduled intestinal surgery, including clinically significant stenosis, strictures, internal fistula, abscess, or obstructive complications.
- History of partial or incomplete bowel obstruction within 6 months prior to Screening; current stoma, ileostomy, colostomy, or anticipated need for ostomy during the study; diagnosis of short bowel syndrome or clinically significant malabsorptive condition; uncontrolled chronic diarrhea due to a condition other than Crohn's disease; or bowel resection within 3 months prior to Screening.
- Subjects with prior bowel resection may be eligible if, in the opinion of the Investigator and Sponsor, the remaining bowel anatomy is adequate for study participation and interpretation of study endpoints.
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-3750R-3750 DP is a live biotherapeutic product consisting of Lactococcus lactis engineered to express Surface Layer Protein A (SlpA), formulated in enteric-coated capsules for oral administration. Participants randomized to R-3750 will receive 9E10 colony-forming units (CFU) per day orally once daily from Day 1 through Day 84. | Drug | Arm 1: R-3750, 9E10 CFU/day orally once daily for 12 weeks |
| PlaceboMatching placebo will be administered orally once daily from Day 1 through Day 84. | Drug | Arm 2: Matching placebo orally once daily for 12 weeks |
Primary outcome
Number of Adverse Events.
Time frame: From first dose through Day 168 end of study
Number of participants experiencing one or more treatment-emergent adverse events following administration of R-3750 or placebo.
1 secondary outcome
Number of participants with serious adverse advents
Time frame: From first dose through Day 168 end of study
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 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Christian F Freguia, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R-3750 in people with Crohn Disease (CD), run by Rise Therapeutics LLC.
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 17 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: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 L Stephens, PhD (650-417-8556, jstephens@risetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events. (time frame: From first dose through Day 168 end of study). 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 28 Aug 2026.