DRKS00010101已完成2 期
A multi-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - Future-010
niversitätsklinikum Schleswig-Holstein (UKSH)0 个研究点目标入组 20 人开始时间: 2016年7月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •The patient is able and willing to give written informed consent
- •=18 years of age
- •Negative QuantiFERON-TB Gold In-Tube test within 3 months before
- •Diagnosis of IBD >3 months prior to Visit 2
- •Active IBD as confirmed by a CRP =5 mg/L and/or Calprotectin 250 mg/kg
- •Previous treatment for IBD using conventional, non-biologic therapy for at least 3 months which has been stable for at least 14 days prior to Visit 2
- •Full colonoscopy with serial biopsies with no signs of malignancy during screening
排除标准
- •Current diagnosis of fulminant disease foreseeably needing hospitalization
- •Discontinued use of AZA, 6-MP or MTX within 28 days of Visit 2
- •Any need of parenteral therapies (except iron infusions).
- •Treatment with more than two different types of biologics drugs or any biologic which is not an anti-TNF molecule or vedolizumab.
- •Treatment with a biologic agent within 30 days or 5 half-lives prior to Visit 2 (whichever is longer).
- •Treatment with cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Visit 2.
- •Treatment with i.v. corticosteroids within 14 days prior to Screening or during the Screening Period.
- •More than 20 mg (prednisolone equivalent) of oral corticosteroids within the last 28 days or not on a stable dose at least 14 days prior to Visit 2.
- •Infections (including diverticulitis) requiring treatment with i.v. antibiotics, i.v. antivirals, or i.v. antifungals within 60 days prior to Visit 2 or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Visit 2.
- •Disease limited to the rectum, extending <15 cm past the anal verge
- •History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or is planning bowel surgery
- •Moderate to severe anaemia (haemoglobin <9 g/dL)
- •History of clinically significant drug or alcohol abuse during the previous year, as judged by the Investigator
- •Treatment with any investigational medicinal product (IMP) within 30 days or 5 half-lives prior to Visit 2 (whichever is longer).
- •Women of childbearing potential who test positive for pregnancy
- •Breast-feeding, or lactating woman
- •Known hypersensitivity to any component of FE 999301
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