A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 62
- 主要终点
- Clinical Remission
研究概览
简要总结
The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.
详细描述
This was a Phase IIb study in patients with moderate to severe left-sided ulcerative colitis. Patients either received cobitolimod 31 mg, 125 mg or 250 mg at two occasions or 125 mg or placebo at four occasions during a 3-weeks period. To ensure blindness, patients received active treatment at two occasions and placebo at the other two occasions. Blood, stool, and tissue samples was collected at various time points throughout the study to evaluate safety and efficacy. Primary endpoint was evaluated at week 6.
Duration of participation for patients was approximately 12 weeks (from screening to final follow-up visit).
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 old
- •Established diagnosis of Ulcerative Colitis (UC)
- •Moderately to severely active left sided UC assessed by central reading
- •Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use
- •Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance
- •Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:
- •Immunomodulators
- •Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins
排除标准
- •Suspicion of differential diagnosis
- •Acute fulminant UC and/or signs of systemic toxicity
- •UC limited to the rectum (disease which extend <15 cm above the anal verge)
- •History of malignancy
- •History or presence of any clinically significant disorder
- •Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators
- •Treatment with rectal GCS, 5-ASA/SP or tacrolimus
- •Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)
- •Serious active infection
- •Gastrointestinal infections
- •Currently receiving parenteral nutrition or blood transfusions
- •Females who are lactating or have a positive serum pregnancy test
- •Women of childbearing potential not using reliable contraceptive methods
- •Concurrent participation in another clinical study
- •Previous exposure to cobitolimod
研究组 & 干预措施
Cobitolimod Dose 2x31 mg
Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions
干预措施: cobitolimod (Drug)
Placebo
Placebo at four occasions
干预措施: Placebo (Drug)
Cobitolimod Dose 2x125 mg
Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions
干预措施: cobitolimod (Drug)
Cobitolimod Dose 4x125 mg
Dose 125 mg of cobitolimod, at 4 occasions
干预措施: cobitolimod (Drug)
Cobitolimod Dose 2x250 mg
Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions
干预措施: cobitolimod (Drug)
结局指标
主要结局
Clinical Remission
时间窗: 6 weeks after first treatment
Patients with clinical remission at Week 6 (yes=1, no=0), defined by Modified Mayo sub scores, i) rectal bleeding of 0, ii) stool frequency of 0 or 1 (with at least one point decrease from Baseline, Week 0), and iii) endoscopy score of 0 or 1 (excluding friability).
次要结局
- Modified Clinical Remission(Week 6)
- Symptomatic Remission(Week 6)
- Clinical Response(Week 6)
- Endoscopic Remission(Week 6)
- Histological Remission(Week 6)