Phase 2a Study to Evaluate IcBD-01 Enema in Active Ulcerative Colitis Patients

Summary

Ulcerative proctitis can lead to considerable morbidity, and the available treatment options are limited. Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa, possesses potent immunomodulatory and anti-inflammatory properties as described in both acute and chronic animal models of inflammation, including IBD models. Based on positive safety and initial efficacy profiles of CBD found in IBD animal and clinical studies, the main aim of this study is to evaluate the safety, tolerability and efficacy of a novel enema formulation of CBD for the treatment of active ulcerative proctitis.

Timeline

Start

2023-03-01

Primary completion

2024-04-01

Completion

2025-04-01

Drugs

Indications