EUCTR2005-004313-15-BE进行中（未招募）1 期
A Phase I/IIa, Double-blind, Randomized, Placebo-controlled, Dose-Escalation Study of NI-0401 in Patients with Moderate to Severe Active Crohn´s Disease
ovImmune S.A.0 个研究点目标入组 60 人开始时间: 2006年6月21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
- 60
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. Men and women ³ 18 and < 70 years of age.
- •2. Crohn’s Disease Activity Index (CDAI) of >220 to <450.
- •3. Detectable plasma CRP level.
- •4. Endoscopic inflammation defined as the presence of any inflammatory mucosal lesion.
- •5. Crohn’s disease of at least 6 months duration, with colitis, ileitis, or ileocolitis, confirmed by endoscopy and histology within 28 days of study day 1.
- •6. Men and women of childbearing potential must use adequate birth control measures until 6 month after receiving study drug.
- •7. If using oral corticosteroids, mesalazine, or sulfasalazine, the start-date must be at least 4 weeks prior to randomization. The dose of oral corticosteroids, mesalazine and/or sulfasalazine must be stable over the 2 weeks preceding randomization. The daily dose of systemic corticosteroids should not be greater than 20 mg of prednisone equivalent or 9 mg budesonide. If using azathioprine or 6-mercaptopurine, the dose must have been stable over the 8 weeks preceding randomization.
- •8. If not using corticosteroids, azathioprine/6-mercaptopurine (6-MP), mycophenolate mofetil, methotrexate at the time of screening, the stop-date for any previous use of these agents must be at least 4 weeks prior to randomization.
- •9. Patients who have received anti-TNF antibody therapy (infliximab, adalimumab, etanercept) must have received their last dosing at least 3 months prior to randomization.
- •10. Patients who have received tacrolimus or cyclosporine must have received their last dosing at least 4 weeks prior to randomization.
- •11. The screening laboratory tests must meet the following criteria:
- •Hb> 8.5 g/dL (5.3 mmol/L)
- •WBC> 3.5 x 109/L
- •Neutrophils > 1.5 x 109/L
- •Platelets> 100 x 109/L
- •SGOT (AST) and alkaline phosphatase levels must be within 2 times the upper limit of normal range
- •12. Patients must be able to adhere to the study visits and protocol requirements.
- •13. Patients must be able to give written informed consent and the consent must be obtained prior to any screening procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Have received or are planned to receive immunization with a live vaccine within 6 weeks prior to receiving study drug and 12 weeks after treatment cessation.
- •2. Isolated small bowel involvement not assessable by endoscopy.
- •3. Ileo-/colostoma or extensive bowel resection (e.g., more than 100 cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy is permitted.
- •4. Bowel surgery within the past three months, except for minor luminal surgery.
- •5. Immediate need for surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
- •6. Known fixed symptomatic stenosis of the small or large intestine.
- •7. Clinically significant abnormalities on chest X-ray or electrocardiogram.
- •8. Concomitant disease:
- •a. Current signs or symptoms of severe, progressive or uncontrolled renal (creatinine > 250 mmol/L), hepatic (bilirubin > 25 mmol/L), hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease (including a history of seizure disorders or ongoing chronic active conditions such as chronic active hepatitis)
- •b. Previous diagnosis of, or known, malignancies
- •c. Severe infections, such as hepatitis, pneumonia or pyelonephritis, in the past three months. Less serious infections in the past 3 months, such as acute upper respiratory tract infection (colds) or uncompliant urinary tract infection are permitted at the discretion of the investigator
- •d. Active infection requiring antibiotic therapy
- •e. Serum anti HCV positive, serum HBsAg positive, serum anti-HIV positive
- •f. History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of acute CMV or EBV, active Pneumocystic Carinii
- •g. History of active tuberculosis (TB) or currently undergoing treatment for TB. Patients with a positive TB skin test or chest x-ray are ineligible. Patients with a history of bacille Calmette Guerin (BCG) vaccination and a newly positive TB skin test or a chest X-ray showing fibrotic lesions consistent with previous TB are ineligible. The PPD skin test must be read between 48 and 72 hours
- •h. Stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium Difficile toxin within 4 weeks prior to randomisation
- •9. Female patients who are pregnant or breast-feeding.
- •10. A psychiatric, addictive, or any disorder that comprises ability to give truly informed written consent for participation in this study.
- •11. Hypersensitivity to any component of the drug product.
- •12. Not available for follow-up assessment.
- •13. Has undergone or is undergoing treatment with another investigational drug or approved therapy for investigational use within 3 months prior to entry in this study
- •14. Has previously participated in this study
研究者
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