An Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 5
- 主要终点
- Proportion of Patients Who After Study Completion Achieve Clinical Response Defined by at Least a 3point Decrease & 30% Reduction From Baseline in Mayo Score Plus ≥ 1 Point Decrease in Rectal Bleeding Sub-score or Absolute Rectal Bleeding Subscore of ≤ 1
研究概览
简要总结
The objective of the proposed study is to determine whether BL-7040 demonstrates clinical efficacy in patients with inflammatory bowel disease (IBD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 to
- •Moderately active ulcerative colitis as defined by Mayo score of ≥ 5 and ≤ 9 within 9 days of first day of study treatment.
- •Diagnosis of ulcerative colitis ≥ 3 months prior to study entry.
- •Endoscopic sub-score of ≥ 2 and rectal bleeding sub-score of ≥ 1 on the Mayo score and endoscopic evidence of disease activity a minimum of 20 cm from the anal verge, determined within 9 days of first day of study treatment.
- •Female patients must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control or declare that they are abstaining from sexual intercourse, from the screening visit through the study termination visit or be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal. Postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.
- •Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment
排除标准
- •Diagnosis of indeterminate colitis or clinical findings suggestive of Crohn's disease.
- •Subjects with ulcerative proctitis.
- •A diagnosis of ischemic colitis, fulminant colitis or toxic megacolon.
- •Evidence of bowel infection.
- •Body temperature ≥ 38°C at screening.
- •Evidence of abdominal abscess at the initial screening visit.
- •Extensive colonic resection, subtotal or total colectomy.
- •Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •Receiving non-permitted IBD therapies
- •History of or current peptic ulcer disease.
- •Pregnant or lactating women.
- •Chronic hepatitis B or C infection or HIV seropositivity.
- •Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.
- •Drug or alcohol abuse (by history).
- •Patients participating in any other clinical trials.
- •Patients with inability to communicate well with the Investigators and staff (i.e., language problem, poor mental development or impaired cerebral function).
研究组 & 干预措施
A synthetic oligonucleotide for treatment of IBD.
BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
干预措施: BL-7040 (Drug)
结局指标
主要结局
Proportion of Patients Who After Study Completion Achieve Clinical Response Defined by at Least a 3point Decrease & 30% Reduction From Baseline in Mayo Score Plus ≥ 1 Point Decrease in Rectal Bleeding Sub-score or Absolute Rectal Bleeding Subscore of ≤ 1
时间窗: From Baseline to day 34 (end of treatment period)
Mayo score assesses stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment. It is assessed according to the following parameters: Stool frequency (subscore 0-3) 0: Normal number of stools for patient 1. 1 to 2 stools per day more than normal 2. 3 to 4 stools more than normal 3. \> or = to 5 stools more than normal Rectal bleeding (subscore 0-3) 0: No blood seen 1. Streaks of blood with stool less than half the time 2. Obvious blood with stool most of the time 3. Blood alone passes Endoscopic findings (subscore 0-3) 0: Normal or inactive disease 1 Mild Disease (erythema, decreased vascular pattern, mild friability) 2: Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) 3: Severe Disease (spontaneous bleeding, ulceration) Physician's Global Assessment (subscore 0-3) 0: Normal 1. Mild disease 2. Moderate disease 3. Severe disease
次要结局
- Proportion of Patients With Mucosal Healing After Completion of Study Treatment Defined as Reduction in Endoscopy Subscore of ≥ 1 From Baseline & an Absolute Endoscopy Subscore of ≤ 1 Assessed by Flexible Sigmoidoscopy.(5 weeks following first administration)