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

NCT06353828 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-04-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CBD, synthetic form

Cannabidiol enema

DRUG

Placebo

placebo enema

Sponsors & Collaborators

  • CannaMore Biotechs

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-04-01
Completion
2025-04-01

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353828 on ClinicalTrials.gov