R-3750 in Patients With Crohn's Disease

NCT07791888 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: RISE-3750-01CD
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Crohn Disease (CD)

Keywords

Crohn's Disease; Inflammatory Bowel Disease; IBD; R-3750; Lactoccoccus lactis; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events.

  Number of participants experiencing one or more treatment-emergent adverse events following administration of R-3750 or placebo.

  From first dose through Day 168 end of study

Secondary Outcomes (1)

• Number of participants with serious adverse advents

  From first dose through Day 168 end of study

Other Outcomes (3)

• Number of Participants with Clinically Significant Abnormal Clinical Laboratory Results

  From baseline through Day 168 end of study

• Number of Participants with Clinically Significant Abnormal Vital Signs

  From baseline through Day 168 end of study

• Number of Participants with Clinically Significant Abnormal Physical Examination Findings

  From baseline through Day 168 end of study

Study Arms (2)

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).

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).

Drug: Placebo

Interventions

R-3750 DRUG

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.

Arm 1: R-3750, 9E10 CFU/day orally once daily for 12 weeks

Placebo DRUG

Matching placebo will be administered orally once daily from Day 1 through Day 84.

Arm 2: Matching placebo orally once daily for 12 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Rise Therapeutics LLC: lead

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Janet L Stephens, PhD

CONTACT

650-417-8556; jstephens@risetherapeutics.com

Christian F Freguia, PhD

CONTACT

215-923-1818

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1: R-3750, 9E10 CFU/day orally once daily for 12 weeks Arm 2: Matching placebo orally once daily for 12 weeks

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08