NL-OMON39870已完成3 期
A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn*s Disease - GSK CCX114643
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1. Male or female subjects aged *18 years
- •2. Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications
- •3. Crohn*s disease for >4 months duration, which has been confirmed by diagnosis prior to study entry, with small bowel and/or colonic involvement
- •4. Current evidence of moderately-to-severely active disease defined by a CDAI score of *220**450 at baseline (Week 0)
- •5. Confirmation of active disease by
- •i. Elevated CRP (*3mg/L, the upper limit of normal (ULN) for the highly sensitive CRP test) at screening or
- •ii. Elevated levels of faecal calprotectin (>200*g/g stool) at Screening or
- •iii. Ileocolonscopy with documentation of a minimum of 3 nonanastomotic ulcerations(each > 5 mm in diameter) consistent with CD, within 3 months prior to Screening.
- •6. History of inadequate response and/or intolerance/adverse event leading to discontinuation of at least one of the following treatments for Crohn*s disease: corticosteroids or immunosuppressants
- •7. Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn*s disease. The number of subjects who have received treatment in the past with an anti-TNF for Crohn*s disease and discontinued due to loss or lack of efficacy will be limited to 50% of
- •those randomised.
- •8. Demonstrated ability to comply with Crohn*s disease symptom recording using the IVRS.
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1 Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for coeliac disease (elevated anti-tissue transglutaminase antibodies)
- •2 Diagnosis of ulcerative or indeterminate colitis
- •3 Fistulae with abscesses, or fistulae likely to require surgery during the course of the study period
- •4 Bowel surgery, other than appendectomy, within 12 weeks prior to screening and/or has planned surgery or deemed likely to need surgery for CD during the study period
- •5 Extensive colonic resection, subtotal or total colectomy
- •6 Presence of ileostomies, colostomies or rectal pouches
- •7 Fixed symptomatic stenoses of small bowel or colon
- •8 Diagnosis of short bowel syndrome or chronic diarrhoea related to malabsorption and/or multiple bowel re-sections for Chron's disease
- •9 Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medications
- •10 Use of prohibited medications, within their specified timeframes and throughout the study.
- •11 Positive immunoassay for C. difficile
- •12 Known HIV infection
- •13 Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
- •14 Subjects who have received immunisation with a live vaccine e.g. measles, mumps, rubella (each as in MMR vaccine), oral polio, varicella, yellow fever, within 4 weeks of screening and throughout the study, with the exception of influenza vaccine
- •15 Confirmed positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test or positive Hepatitis C test result
- •16 Confirmed positive result for QuantiFERON TB Gold test.
- •17 Current sepsis or infections requiring intravenous antibiotic therapy > 2 weeks
- •18 Previous infections characterised by opportunistic pathogens, and/or dissemination suggestive of clinically significant immunocompromise
- •19 The subject exhibits evidence of hepatic dysfunction, viral hepatitis, or exhibits serum ALT (SGPT) and/or AST (SGOT) values *2 times the upper limit of normal; has a total bilirubin value >1.5 times the upper limit of normal (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%); has alkaline phosphatase >1.5 times the upper limit of normal; has current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH); has known hepatic or biliary abnormalities with the exception of Gilbert*s syndrome or asymptomatic gallstones
- •20 QTc *450 msec (*480msec for those with Bundle Branch Block)
- •21 Congenital or acquired immunodeficiency or has evidence of immunocompromise manifested by current opportunistic infection
- •22 Current evidence of, or has been treated for a malignancy within the past five years (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or any cancer in situ that has been resected)
- •23 History of evidence of adenomatous colonic polyps that have not been removed.
- •24 History of evidence of colonic mucosal dysplasia
- •25 If female, is pregnant, has a positive pregnancy test or is breast-feeding
- •26 Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study
- •27 Medical history of sensitivity to any of the
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