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.

Inclusion Criteria: * 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. Exclusion Criteria: * Crohn's disease in clinical remission, including HBI \