drugset / Trial / NCT05852574

CP101 for the Treatment of Ulcerative Colitis

NCT05852574 ↗

Phase 1 Active not recruiting 30 enrolled Brigham and Women's Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a dose ranging exploratory phase 1 pilot study to assess engraftment, safety, and efficacy of CP101, an oral microbiome therapeutic, in participants with active mild-to-moderate Ulcerative colitis. A total of 30 patients who meet eligibility criteria will be randomized 1:1 to either a short or extended induction dosing with CP101. An assessment of the microbiome will occur at baseline, Day 6, Week 4, Week 8, Week 12, Week 16, and Week 24.

Timeline

Start
2023-09-01
Primary completion
2024-11-21
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CP101 Other / unclassified 5 unknown Oral

Indications