EUCTR2016-000205-36-DE进行中（未招募）1 期
A Single-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
niversity Hospital Schleswig-Holstein (UKSH)0 个研究点开始时间: 2016年3月14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
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.The patient is able and willing to give written informed consent before any trial-related procedures are performed and to comply with the requirements of this trial protocol.
- •2.=18 years of age.
- •3.Negative QuantiFERON-TB Gold In-Tube test within 3 months before screening (if this has not been performed, QuantiFERON-TB Gold In-Tube test must be obtained and confirmed as negative during the Screening Period).
- •4.Diagnosis of IBD >3 months prior to Visit 2.
- •5.Active IBD as confirmed by a CRP =5 mg/L.
- •6.Active moderate to severe mucosal inflammation despite use of mesalamine (5-ASAs), Budesonide (up to 9 mg/d), and/or the immunosuppressants AZA, 6-MP, and MTX evidenced by:
- •a.UC patients: colonoscopy with a Mayo endoscopic appearance subscore =2 at baseline.
- •b.CD patients: CDAI > 220 with active mucosal inflammation (Simple Endoscopic Score for Crohn’s disease [SES-CD] =7 if ileum can be intubated. SES-CD =5 if ileum is not intubatable).
- •7.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.
- •8.Full colonoscopy with serial biopsies with no signs of malignancy during screening (which serves as baseline). This can be done anytime between Day -4 and Day 0 (i.e. immediately before Visit 2). Full colonoscopy is required in all CD patients. In UC patients, a full colonoscopy is required only if no prior, fully documented procedure with serial biopsies is available from the past 6 months.
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Current diagnosis of fulminant disease foreseeably needing hospitalisation.
- •2.Discontinued use of AZA, 6-MP or MTX within 28 days of Visit 2.
- •3.Any need of parenteral therapies (except iron infusions).
- •4.Treatment with more than two different types of biologics drugs or any biologic which is not an anti-TNF molecule or vedolizumab.
- •5.Treatment with a biologic agent within 30 days or 5 half-lives prior to Visit 2 (whichever is longer).
- •6.Treatment with cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Visit 2.
- •7.Treatment with IV corticosteroids within 14 days prior to Screening or during the Screening Period.
- •8.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.
- •9.Any topical therapy of disease relevant lesions with corticosteroids in the last 10 days before Visit 2.
- •10.Treatment with aminosalicylates for less than 90 days prior to Visit 2, not on a stable dose for at least 28 days prior to Visit 2, or discontinued use within 28 days of Visit 2.
- •11.Treatment with any investigational medicinal product (IMP) within 30 days or 5 half-lives prior to Visit 2 (whichever is longer).
- •12.The patient received a live attenuated vaccine =28 days prior to Visit 2.
- •13.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.
- •14.Active infection including Clostridium difficile infection. The latter diagnosis should be based on a positive Clostridium difficile toxin assay.
- •15.History of listeria, psoriasis, histoplasmosis, chronic or active hepatitis B (as defined by presence of hepatitis B surface antigen [HBsAg]) or C infection (defined by presence of hepatitis C virus [HCV] RNA or positive hepatitis C antibody [anti-HCV]), human immunodeficiency virus, congenital immune deficiency, progressive multifocal leukoenchephalopathy, or central nervous system demyelinating disease.
- •16.Presence or history of active tuberculosis (TB) or latent TB infection where appropriate anti TB therapy cannot be documented.
- •17.If clinical suspicion of cytomegalovirus, cytomegalovirus testing should be undertaken. Patients with intestinal mucosa biopsy positive for cytomegalovirus at screening are to be excluded.
- •18.Immune deficiency demonstrated by neutropenia (absolute neutrophil count <1500/µL); or lymphopenia (absolute lymphocyte count <500/µL).
- •19.Moderate to severe anaemia (haemoglobin <9 g/dL).
- •20.Thrombocytopenia (platelet count <75 000/µL).
- •21.Serum creatinine >2 mg/dL.
- •22.History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix. If the Screening colonoscopy shows evidence of dysplasia or a malignancy, the patient is not eligible.
- •23.Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis (serum transaminases >2.5 x upper limit of normal [ULN], alkaline phosphatase >2.5 x ULN, or abnormalities in synthetic liver function tests judged by the investigator to be clinically significant), or a diagnosis of primary sclerosing cholangitis, serum transaminases >3 x ULN, alkaline phosphatase >3 x ULN, or abnormalities in synthetic liver function tests (total bilirubin >1.5 x ULN) judged by the investiga
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