NL-OMON36043已完成2 期
A two-part, multi-centre, randomized, placebo-controlled, double-blind study, of TRK-170 for the treatment of Crohn's disease. - 170CDT01
Toray Industries, Inc. Europe Office0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- •Patient has to meet all of the following criteria to be eligible to enter the study:
- •1) Male and female patients aged 18 to 50 years
- •2) Patient has a diagnosis of CD at least 4 months prior but not more than 10 years before screening. The diagnosis should have been confirmed by endoscopic findings including histological examination
- •3) Patient has had disease activity with lesions in the colon within the past 12 months before dosing, as confirmed by ileocolonoscopy
- •4) Patient with moderately active CD at time of screening defined as a CDAI score of between 220 and 450
- •5) Patient has stable disease activity (stable for * 2 weeks prior to screening) and not foreseen to require treatment with high dose steroids or other short term, potent treatments (e.g. tumour necrosis factor (TNF) * inhibitors) during the study period
- •6) Patient has an increased CRP level (> upper limit of normal) at screening, as a sign of active disease, as judged by the Investigator
- •7) Patient with a body weight of greater than 50 kg but less than 120 kg
- •8) Patient willing and able to participate in the study and provide signed informed consent
- •9) Patient agrees to use adequate contraceptive measures, in other words,
- •Female patient who has not been post-menopausal for more than 3 months or female patients of childbearing potential must use adequate contraception (i.e. a method with less than 1% failure rate [e.g. diaphragm or condom used in combination with spermicidal cream, sterilization, an intrauterine device, or a vasectomised partner]) during and for at least three months after the last dose of investigational product (IP). Females using hormonal contraception methods must also use an additional contraception method (as described above) during and for at least three months after the study has ended
- •Male patient who agrees to use condoms in combination with spermicidal cream during the study and for three months after the last dose of IP, or patients who have a female partner using adequate contraception as described above
排除标准
- •Patient meeting any of the following criteria will not be permitted to enter the study:
- •1) Increased risk of hypersensitivity or allergy to the IP or placebo product as judged by the Investigator
- •2) Patient has had a clinically significant illness within 4 weeks prior to screening, at the Investigator*s discretion, or history of any severe liver disease with cirrhosis, active hepatitis or chronic hepatitis
- •3) Patient with clinically significant deviations in laboratory values as determined by the Investigator, high level(s), e.g., 2X upper limit of normal of ALT, AST, ALP, GGT or total bilirubin at screening indicative of hepatic impairment. Laboratory values >3X upper limit of normal will be a strict criteria for exclusion
- •4) Patient who had a serious infection within 3 months, opportunistic infection within one month, or current signs or symptoms of severe, progressive or uncontrolled disease
- •5) Severe renal impairment defined as a predicted creatinine clearance of 30 mL/min or less, based on the Cockroft-Gault equation
- •6) Patient has a history of cancer or lymphoproliferative disease within the last 5 years
- •7) History of substance or alcohol abuse within the past one year prior to screening
- •8) Positive viral test result for hepatitis B or C or HIV 1 or 2 or positive pre-study testing for major drugs of abuse or excessive alcohol consumption
- •9) Chest X-ray positive or suspected positive for active tuberculosis
- •10) Female patient currently pregnant or breast-feeding or intending to become pregnant during the study or within three months after the last dose of IP
- •11) Female patient of childbearing age (unless surgically sterile) without a negative urine pregnancy test at screening and at enrolment
- •12) Patient currently has gastrointestinal disease (GI) other than CD (e.g., ulcerative colitis, short bowel syndrome, malabsorption, intestinal obstruction). This includes patients with an ostomy, ileal pouch, a previous ileo-rectal anastomosis, a history of procto-colectomy but not subtotal colectomy, draining fistula or abscess or are receiving enteral nutrition via a feeding tube or parenteral nutrition
- •13) Treatment with immunosuppressants or anti-cancer drugs (e.g., azathioprine, 6-MP, 6 thioguanin, methotrexate, mycophenolate mofetil, sirolimus (rapamycin), tacrolimus, thalidomide, cyclophosphamide, or cyclosporine) within the last 3 months prior to screening
- •14) Treatment with intravenous (IV)/rectal steroids for CD, antibiotics (e.g., metronidazole or ciprofloxacin) or continued repeated use of nonsteroidal anti inflammatory agents (NSAIDs) within 2 weeks prior to screening
- •15) Treatment with Tysabri® or inhibitors of TNF-* within 8 weeks prior to screening
- •16) Treatment with a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.4 g/day or higher (not exceeding the approved dose) within 1 week prior to screening
- •17) Patient who changed the dose of oral corticosteroids within 2 weeks prior to screening or ongoing treatment with prednisolone exceeding 25 mg/day or corresponding doses of other corticosteroids
- •18) Patient who stopped using oral corticosteroids within 4 weeks prior to screening
- •19) Patient has previous treatment failure or had an inadequate response or intolerance to biologic drugs for CD (e.g., Tysabri® or inhibitors of TNF-*)
- •20) Patient who had a previous gastrointestinal surgical procedure (except appendectomy and ileocecal resectio
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