EUCTR2017-004230-28-IT进行中（未招募）1 期
A Phase II/III Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Evaluate the Safety and Efficacy of BI 655130 Induction Therapyin patients with moderate-to-severely active ulcerative colitis who havefailed previous biologics therapy -
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 550 人开始时间: 2020年11月5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
- 550
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
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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
- •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
- •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 tuberculosis,
- •human immunodeficiency virus (HIV) infection 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
- 另有 11 项未显示
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