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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change from baseline in Full Mayo Score
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IcBD-01
IcBD-01 is a novel Cannabidiol enema formulation
干预措施: CBD, synthetic form (Drug)
placebo
placebo enema formulation
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Full Mayo Score
时间窗: 12 weeks
The Mayo Score is used to assess the severity of ulcerative colitis and can range from 0-12, with higher scores indicating worse severity.
次要结局
- Change in Partial Mayo Score(12 weeks)
- Change in patient reported outcome (PRO-UC)(12 weeks)
- Change in the length of the inflamed colon(12 weeks)
- Change in endoscopic Mayo subscore in distal 15 cm of anus(12 weeks)