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NCT06353828Recruitment Completed

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
CannaMore BiotechsPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
CBD, synthetic form
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
CannaMore Biotechs
Location
Kfar Saba, Israel
Timeline & enrollment
Phase
Phase 2
Start date
Mar 01, 2023
End date
Apr 01, 2025
Enrollment
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 colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06353828
Type
Non-Device Trial
About this record

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.