EUCTR2005-004313-15-GB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: 2008年5月19日最近更新:
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
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 and having exhausted all other possible treatment options.
- •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. Women of childbearing potential and their partners are required to use two forms of contraception. Men with partners of child bearing potential are required to use barrier contraception, in addition to their partners using another method. Acceptable forms of contraception are as follows:
- •- Barrier methods: condoms, diaphragms, cervical caps
- •- Hormonal contraceptives: combination or progesterone only; includes depot contraceptives
- •- Intrauterine methods: intrauterine devices or systems
- •7. If using oral corticosteroids, mesalazine, or sulfasalazine, the start-date must be at least 4 weeks prior to study day 1. The dose of oral corticosteroids, mesalazine and/or sulfasalazine must be stable over the 2 weeks preceding study day 1. The daily dose of systemic corticosteroids should not be greater than 20 mg of prednisone equivalent or 9 mg budesonide. If using azathioprine, 6-mercaptopurine or methotrexate the dose must have been stable over the 8 weeks preceding study day 1.
- •8. If not using corticosteroids, azathioprine (AZA), 6-mercaptopurine (6-MP), mycophenolate mofetil or methotrexate (MTX) at the time of screening, the stop-date for any previous use of these agents must be at least 4 weeks prior to study day 1.
- •9. Patients who have received anti-TNF antibody therapy (infliximab, adalimumab, etanercept) must have received their last dosing at least 3 months prior to study day 1.
- •10. Patients who have received tacrolimus or cyclosporine must have received their last dosing at least 4 weeks prior to study day 1.
- •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 study day 1
- •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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