Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353828
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-28
Brief Title:
Phase 2a Study to Evaluate IcBD-01 Enema in Active Ulcerative Colitis Patients
Sponsor:
CannaMore Biotechs
Organization:
CannaMore Biotechs
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 21 ratio and receive the drugplacebo 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
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 21 ratio and receive the drugplacebo 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None