EUCTR2017-004230-28-BE进行中（未招募）1 期
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy
SCS Boehringer Ingelheim Comm. V0 个研究点目标入组 127 人开始时间: 2018年1月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 127
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 18 - 75 years, at date of signing informed consent, males or females
- •2. Diagnosis of ulcerative colitis = 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
- •3. Moderate to severe activity (total MCS 6 to 12 with a RBS = 1 AND an SFS = 1 AND mESS = 2 within 7-28 days prior to first dose)
- •4. Endoscopic activity extending proximal to the rectum (= 15 cm from anal verge)
- •5.Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNF? agonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past as per definition in the CTP Appendix 10.6
- •6. May be receiving a therapeutic dose of the following:
- •- Oral 5-ASA compounds, provided that dose has been stable for at least the 4 weeks immediately prior to randomisation, and/or
- •- Oral corticosteroids (= 20 mg per day of prednisone or equivalent), provided that dose has been stable for the 2 weeks immediately prior to randomisation, and/or
- •- Oral budesonide (= 9 mg per day ) or beclomethasone dipropionate (= 5 mg per day), provided that dose has been stable for the 2 weeks immediately prior to randomisation, and/or
- •- Azathioprine, 6-MP or methotrexate, provided that dose has been stable for the 8 weeks immediately prior to randomisation.
- •- Probiotics (e.g. S. boulardii) provided that dose has been stable for the 4 weeks immediately prior to randomisation.
- •7. Patients with extensive colitis or pancolitis of >10 years duration or family history of colorectal cancer or personal history of increased colorectal cancer risk must have had a negative colorectal cancer screening within <1 year prior to enrolment (otherwise to be done during screening colonoscopy).
- •8. Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
- •9. Signed and dated written informed consent for 1368.5, in accordance with GCP and local legislation prior to admission into the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Evidence of abdominal abscess at screening
- •2. Evidence of fulminant colitis or toxic megacolon at screening
- •3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •4. Treatment with:
- •any non-biologic medication (e.g. cyclosporine, tacrolimus or mycophenolate mofetil, intavenous corticosteroids, tofacitinib),
- •any biologic treatment with a TNFa antagonist (adalimumab, infliximab, golimumab) or vedolizumab within 8 weeks prior to randomisation
- •rectal 5-ASA, parenteral or rectal corticosteroids (incl. budesonide) within 2 weeks prior to screening
- •any investigational non-biologic drug for UC (including but not limited to JAK inhibitors, S1P modulators) within 30 days prior to randomisation
- •any investigational biologic for UC (including but not limited to ustekinumab and other IL-23 inhibitors) within 12 weeks prior to randomisation (except etrolizumab: within 8 weeks prior to randomisation)
- •any prior exposure to BI 655130, natalizumab or rituximab
- •5. Positive stool examinations for C. difficile or other intestinal pathogens < 30 days prior to screening
- •6. have had previous surgery or are anticipated to require surgical intervention for UC
- •7. Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed
- •8. Primary sclerosing cholangitis
- •9. Faecal transplant = 30 days prior to randomisation
- •10. Increased risk of infectious complications (e.g. recent pyogenic infection, any congenital
- •or acquired immunodeficiency (e.g. HIV), past organ or stem cell transplantation)
- •11. Live or attenuated vaccination within 6 weeks prior to screening
- •12. Active or latent TB: Patients with a positive TB test during screening are
- •excluded, unless:
- •Patient had previous diagnosis of active or latent TB and has completed appropriate treatment per local practise /guidelines within the last 3 years and at least 6 months before first administration of trial medication under this protocol (patients may be re-screened once to meet this criterion)
- •A positive QuantiFERON TB (Patients with suspected false positive or indeterminate QuantiFERON TB result may be re-tested once)
- •If Quantiferon not available or providing indeterminate results after repeat testing tuberculin skin test should be performed: Tuberculin skin test positive reaction =10mm (=5mm if receiving =15mg/d prednisone or its equivalent)
- •13. Relevant chronic or acute infections including active turberculosis, human immunodeficiency virus (HIV) or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.
- •14. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin, or history of cervical cancer in situ (treated >3years); patients with remote history of malignancy (<10 years prior) may be considered and have to be discussed with sponsor case-by-case
- •15. Major surgery (major according to the investigator’s assessment) performed within 12 weeks prior to randomization or planned during study conduct, e.g. hip replacement.
- •16. Pathological safety lab parameters: haemoglobin < 9 g/dL, total white blood count (WBC) < 3000 cells/µl, neutrophils < 1000 cells/µl, thrombocytes < 100.000/µl, creatinine = 2 mg/dL, total bilirubin > 2 x ULN with ratio of direct/indirect >1 (patients with Gilbert’s syndrome are not excluded), Alkaline Phosphata
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