A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Avonex® in Subjects With Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Percentage of Participants With a Clinical Response
研究概览
简要总结
The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of ulcerative colitis (UC) for ≥6 months
- •20 cm active disease at Screening endoscopy
- •Must have active UC with a Mayo Score/Disease Activity Index (DAI) of 6 to 13 points and moderate to severe disease on endoscopy (Mayo endoscopic score of at least 2) despite prior or concomitant treatment
- •Colonoscopy within past 5 years for extent of disease and to exclude polyps
- •For subjects with UC for more than 10 years, colonoscopy with appropriate biopsies within 1 year prior to Screening to exclude dysplasia and neoplasia.
- •Must be willing and able to practice effective birth control during the study and for 1 month after the last dose of study treatment.
排除标准
- •Diagnosis of indeterminate colitis or Crohn's disease
- •Need for imminent surgery
- •Diagnosis of primary sclerosing cholangitis or toxic megacolon
- •Hemoglobin ≤9 g/dL
- •White blood cell count < 3500 cells/mm^3
- •Lymphocyte count <1000 cells/µL
- •Platelet count <100,000 cells/µL
- •Female subjects who are pregnant or who wish to become pregnant during the study, or who are lactating
- •Known symptomatic colonic stricture
- •Stool cultures positive for enteric infection
- •History of malignant disease
- •History of major abdominal surgery (e.g., gastrectomy) within past 5 years
- •History of small bowel or colonic obstruction or resection
- •History of drug or alcohol abuse (as defined by the Investigator) within 2 years prior to Screening
- •Use of anti-diarrheal agents during the screening period
- •Previous participation in this study
- •Previous treatment with interferon beta or other interferon products
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Interferon beta-1a
Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
干预措施: BG9418 (Interferon beta-1a) (Drug)
Placebo
Placebo IM injection twice weekly for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With a Clinical Response
时间窗: Baseline and Week 8
Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.
次要结局
- Number of Participants With Adverse Events (AEs)(Up to 16 weeks)
- Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8(Baseline and Week 8)