NCT06353828

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

A Phase 2a, Randomized, Double-blind, Placebo Controlled Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of IcBD-01 Enema for the Treatment of Active Ulcerative Colitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: CannaMore Biotechs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study consists of 2 stages: Stage 1. Feasibility - Open label stage: Up to fourteen patients will be enrolled in this stage and receive a CBD enema formulation for 12 weeks treatment period. If results of this stage prove to be safe and with clinical effect (reduction of 3 points in full Mayo score in at least 50% of patients), the study will proceed to stage 2. Stage 2. Randomized, placebo controlled blinded stage: Subjects will be randomized in a 2:1 ratio and receive the drug/placebo enema for a 12 weeks treatment period. Patients will be assessed for full Mayo score on visit 1 and week 12, and partial Mayo score every visit. Patients will assessed by a clinician using the self reported outcome (PRO) scale every visit. Sigmoidoscopy will be performed at baseline and week 12.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	CBD, synthetic form	Cannabidiol enema
DRUG	Placebo	placebo enema

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-04-01
• Completion: 2025-04-01
• First posted: 2024-04-09
• Last updated: 2024-04-09

Locations

1 site across 1 country: Israel