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NOT YET RECRUITING
NCT07791888
PHASE1

R-3750 in Patients With Crohn's Disease

Sponsor: Rise Therapeutics LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-11-01

Completion Date

2029-03-31

Last Updated

2026-08-28

Healthy Volunteers

No

Interventions

DRUG

R-3750

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.

DRUG

Placebo

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