ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This trial tests a new oral live biotherapeutic designed to affect inflammation and the gut microbiome in Crohn’s disease. Early‑phase safety and pharmacodynamic results could influence future development of microbiome‑based therapies for people with active Crohn’s disease.
Who Should Pay Attention
Adults with active Crohn’s disease considering clinical trial participation; clinicians and researchers interested in microbiome therapies and early‑phase IBD drug development.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 1
Enrollment40 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a Phase 1, randomized, double-blind, placebo-controlled study testing R-3750, an oral live biotherapeutic (engineered Lactococcus lactis expressing SlpA), in adults with active Crohn’s disease. About 40 participants will be randomized 1:1 to R-3750 (9E10 CFU/day) or matching placebo for 12 weeks, with safety follow-up through Day 168.
Primary focus is safety (adverse events); secondary assessments include clinical activity (CDAI, HBI), endoscopic response, inflammatory biomarkers, microbiome composition, immune and metabolomic measures. The trial is NOT YET RECRUITING and is a Phase 1 study centered on safety and pharmacodynamics rather than efficacy.
Eligibility requires adult participants (18–80) with active Crohn’s disease and objective evidence of inflammation (CRP, fecal calprotectin, biopsy, or endoscopy). The intervention is an enteric‑coated oral capsule containing the engineered live biologic; an independent Medical Monitor and a DMC will oversee safety.
If you’re considering participation, note this is an early-stage trial primarily assessing safety and biological effects; it does not imply proven clinical benefit. Discuss trial suitability, risks of live biotherapeutics, and contraceptive requirements with the study team or your clinician.
Keep In Mind
This is a Phase 1, NOT YET RECRUITING study with planned enrollment of ~40 subjects focused on safety and pharmacodynamic endpoints. As a trial record, this summarizes planned design and outcomes and does not report results. The investigational product is a live engineered bacterium (enteric‑coated oral capsule), which has specific eligibility and contraception requirements.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorRise Therapeutics LLC
Trial IDNCT07791888
Study typeInterventional
Trial phasePhase 1
Enrollment40 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 28, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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