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Phase 2a Study to Evaluate IcBD-01 Enema in Active Ulcerative Colitis Patients - Trial NCT06353828

Access comprehensive clinical trial information for NCT06353828 through Pure Global AI's free database. This Phase 2 trial is sponsored by CannaMore Biotechs and is currently Recruitment Completed. The study focuses on Ulcerative Colitis. Target enrollment is 45 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06353828
Phase 2
Recruitment Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06353828
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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

Study Focus

Ulcerative Colitis

CBD, synthetic form

Interventional

drug

Sponsor & Location

CannaMore Biotechs

Kfar Saba, Israel

Timeline & Enrollment

Phase 2

Mar 01, 2023

Apr 01, 2025

45 participants

Primary Outcome

Change from baseline in Full Mayo Score

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.

ICD-10 Classifications

Ulcerative colitis
Other ulcerative colitis
Ulcerative colitis, unspecified
Arthropathy in ulcerative colitis
Juvenile arthritis in ulcerative colitis

Data Source

ClinicalTrials.gov

NCT06353828

Non-Device Trial