A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Clinical Response at Week 8 Based on Mayo Score
研究概览
简要总结
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.
详细描述
A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed ulcerative colitis at least 90 days prior randomisation.
- •Men or women age 18 - 75 years.
- •Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization.
- •Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day
- •Nonsterilized males or sterilized males who are ≤1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception.
排除标准
- •Pregnant or breastfeeding women.
- •History of colostomy.
- •Current diagnosis of indeterminate colitis, Crohn's disease, ischemic colitis, fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited to the rectum (ulcerative proctitis).
- •Hepatitis B, C or HIV.
- •History of cancer.
研究组 & 干预措施
1
tralokinumab (CAT-354) sc injection
干预措施: tralokinumab (Drug)
2
placebo sc injection
干预措施: placebo (Drug)
结局指标
主要结局
Clinical Response at Week 8 Based on Mayo Score
时间窗: Eight week treatment period
Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
次要结局
- Change From Baseline in C - Reactive Protein(From baseline to Week 4, 8, 12, 16, 20, and 24.)
- Change in Mayo Score From Baseline to Week 8(Eight week treatment period)
- Mucosal Healing at Week 8 Based on Mayo Score(Eight week treatment period)
- Clinical Remission at Week 8 Based on Mayo Score(Eight week treatment period)
- Change From Baseline in Partial Mayo Score(From baseline to Week 4, 8, 12, 16, 20, and 24.)
- Change From Baseline in Modified Riley Score(Eight week treatment period)
- Change From Baseline in Albumin(From baseline to Week 4, 8, 12, 16, 20, and 24.)
- Change From Baseline in Calprotectin(From baseline to Week 4, 8, 12, 16, 20, and 24.)
- Serum Concentration of Tralokinumab(Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.)
- Immunogenicity(Pre-dose sampling at baseline, Week 8, 12, 16, and 24.)