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

NCT06353828 | Active Not Recruiting Phase 2

• 1 other identifier: ICBD-UC-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Full Mayo Score

  The Mayo Score is used to assess the severity of ulcerative colitis and can range from 0-12, with higher scores indicating worse severity.

  12 weeks

Secondary Outcomes (4)

• Change in Partial Mayo Score

  12 weeks

• Change in patient reported outcome (PRO-UC)

  12 weeks

• Change in endoscopic Mayo subscore in distal 15 cm of anus

  12 weeks

• Change in the length of the inflamed colon

  12 weeks

Study Arms (2)

IcBD-01

EXPERIMENTAL

IcBD-01 is a novel Cannabidiol enema formulation

Drug: CBD, synthetic form

placebo

PLACEBO COMPARATOR

placebo enema formulation

Drug: Placebo

Interventions

CBD, synthetic form DRUG

Cannabidiol enema

IcBD-01

Placebo DRUG

placebo enema

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Diagnosis of UC at least 3 months prior to the Screening Visit
• Patients who were not treated rectally for UC in the last 3 days.
• UC patients with active disease and being treated with stable doses of biologics (at least 2 months), and/or steroids (at least 1 months) and/or oral mesalazine (at least 2 months at stable dose (4 gr)) or non-treated patients)
• Full Mayo score ≥4 to \< 9 (range: 0-12) prior to enrolment in the study
• Patients that did not respond to Mesalamine treatment.
• Non-pregnant (via negative pregnancy test)/non-breast-feeding women and women with no intention to become pregnant/to breast-feed during the term of the trial and for at least one month after cessation of IcBD-01 treatment
• Male subject with female partner(s) of child-bearing potential (including breastfeeding partner\[s\]) must agree to use contraception throughout the treatment period and for one month after final IMP administration.
• Subject able to provide written informed consent
• Must be able to adhere to the study visit schedule and other protocol requirements

You may not qualify if:

• Diagnosis of severe extensive pancolitis
• Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis
• Complete resection of the colon with the need of a pouch
• Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 4 weeks of screening
• Sexual transmitted diseases
• Using rectal formulations (such as Mesalazine) for the last 3 days
• Subjects who have received any investigational drug or used investigational device in the last 2 months
• Serious psychiatric or psychological disorders
• Active consumption of illicit drugs including cannabis or derivatives for at least 1 months prior to the study
• Patients with short bowel syndrome, symptomatic stricture, abscess, recent history (within the previous 3 months) of abdominal surgery
• Patients with significant cardiac, hepatic, respiratory disease comorbidities or active malignancy
• Renal comorbidity: eGFR\< 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2)
• Patient who is taking immunomodulatory medications for other indication(s)
• Women of child-bearing potential who intend to become pregnant or who are pregnant or breastfeeding or male subjects with female partners who intend to get pregnant or breastfeed during the trial period

Sponsors & Collaborators

• CannaMore Biotechs: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 9, 2024
• Study Start: March 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)