A multinational double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of CCX282_B in subjects with moderate to severe Crohn?s disease

ChemoCentryx, Inc. (USA)0 个研究点目标入组 423 人开始时间: 2008年5月30日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Male or female subjects, at least 18 years old
•2. Active, moderate to severe Crohn?s disease
•3. CDAI between 250 and 450
•4. Fasting serum C-reactive proterin (CRP) concentration above 7.5 mg/L
•5. If on therapy for Crohn?s disease, must have been on a stable treatment regimen for at least four weeks
•6. If a female of childbearing potential, or if a male whose partner is a woman of childbearing potential, the subject must agree to use adequate contraception during the study
•7. The subject must be willing and able to give written informed consent and comply with the requirements of the study protocol
•8. No more than 100 cm small bowel resection
•9. If taking oral antibiotics chronically, must have continuous use for at least four weeks prior to randomisation and at stable doses for at least two weeks prior to randomisation

•1. If female, the subject is pregnant or breastfeeding
•2. Use of cyclosporin, tacrolimus, sirolimus, or mycophenolate mofetil and/or greater than 20 mg prednisone or a prednisone-equivalent, parenteral glucocorticoids or corticotrophin, or any experimental treatment for Crohn's disease within four weeks prior to study entry
•3. Tumour necrotising factor (TNF) inhibitor or natalizumab use during 12 weeks prior to study entry
•4. History or presence of any medical or psychiatric condition or disease, or laboratory abnormality that may place the subject at unacceptable risk for study participation and completion
•5. Bowel surgery within 12 weeks prior to randomisation and/or planned or likely to require bowel surgery during the study
•6. Presence of symptomatic obstructive stricture
•7. Active tuberculosis, hepatitis B, C and/or human immunodeficiency virus (HIV) infection
•8. History of any form of cancer within five years prior to study entry except for localised tumours that have been resected successfully
•9. History of infection requiring intravenous antibiotics, a serious infection within 12 weeks of randomisation
•10. Ulcerative or indeterminate colitis

发起方

ChemoCentryx, Inc. (USA)