EUCTR2005-003827-38-DE进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •The subject must meet all of the following inclusion criteria in order to enter the study:
- •1.Male or female, at least 18 years of age.
- •2.At study entry the subject has active, moderate to severe Crohn’s disease with evidence of small bowel and/or colonic disease. Radiographs, radiologist reports, or endoscopy reports documenting evidence of Crohn’s disease must be placed in the subject’s study file and available during study monitoring and inspection of study records. CDAI at study entry must be between 250 and 450, inclusive. Fasting serum CRP concentration during the Screening Period must be above 7.5 mg/L.
- •3.If the subject has been receiving therapy for Crohn’s disease (methotrexate, azathioprine, 6-mercaptopurine, and/or up to 20 mg per day of prednisone or prednisone-equivalent), s/he must be on a stable regimen of this medication(s) beginning at least four weeks prior to study entry (randomization) and is expected to continue on a stable dose of these medications throughout at least the first 196 days. Glucocorticoid doses could be tapered after the Study Day 57 visit, and must be tapered after the Study Day 113 visit (see section 9.4.6). 5-ASA therapy for Crohn’s disease is allowed during the study.
- •4.No more than 100 cm of the subject’s small bowel has been resected based on medical history and patient records.
- •5.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 364 days of the study drug administration. Adequate contraception is defined as use by the female partner of any form of hormonal contraception or intra-uterine device, or use by at least one of the partners of a barrier method of contraception with a spermicide. Promise of abstinence alone is not considered adequate contraception.
- •6.The subject is willing and able to provide written Informed Consent prior to screening and to comply with the requirements of the study protocol.
- •7.If taking oral antibiotics chronically, the subject must have been using these continuously for at least 4 weeks prior to randomization and at stable doses for at least 2 weeks prior to randomization.
- •All subjects who complete the 12-week induction period of the study will be eligible to enter the active treatment period. Subjects who are in the 28-day follow-up period at the time of implementation of Amendment 1 of the protocol, will also be allowed to enter the 4-week active treatment period following their Day 113F visit. These subjects may come in early for their Day 113F visit. Subjects who have completed the study by the time of implementation of Amendment 1 of the protocol, will also be allowed to enter the 4-week active treatment period, if they are within 3 months after completing the study. These subjects must come to the study center for a Day 113F2 visit. All subjects must sign written informed consent to continue in the active treatment period of the study.
- •The subject must meet all the following criteria to continue in the maintenance period of the study:
- •1.CDAI decrease from baseline (measured during screening period) to Day 113 of at least 70 points;
- •2.If the subject has been receiving therapy for Crohn’s disease (methotrexate, azathioprine, 6-mercaptopurine, and/or up to 20 mg per day of prednisone or prednisone-equivalent), s/he must be on a stable regimen of this medication(s) from Day 113 through at least Day 197. Glucocorticoid doses m
排除标准
- •Subjects who meet any of the following exclusion criteria may not enter the study:
- •1.If female, the subject is pregnant or has a positive pregnancy test, or is breast feeding;
- •2.Medical history of hypersensitivity to any of the components of the CCX282-B formulation (microcrystalline cellulose, polyvinyl pyrrolidone, sodium lauryl sulphate, colloidal silicon dioxide, crospovidone, or sodium stearyl fumarate);
- •3.The subject used cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil and/or greater than 20 mg prednisone or a prednisone-equivalent during the 4 weeks prior to study entry;
- •4.The subject received treatment with a TNF inhibitor (e.g., infliximab or adalimumab) or natalizumab within 12 weeks prior to study entry;
- •5.The subject has received parenteral glucocorticoids or corticotrophin within 4 weeks prior to study entry;
- •6.The subject received an experimental treatment for Crohn’s disease within 4 weeks prior to study entry;
- •7.The subject has a known symptomatic obstructive stricture, had bowel surgery (other than appendectomy) within 12 weeks prior to randomization and/or the subject is planned or deemed likely to require abdominal surgery related to Crohn’s disease during the study period;
- •8.Subjects with ileostomies, colostomies, or rectal pouches;
- •9.The subject has evidence of short bowel syndrome requiring enteral or parenteral nutritional supplementation or total parenteral nutrition;
- •10.The subject has evidence of hepatitis B, hepatitis C, and/or the human immunodeficiency virus (HIV) infection based on virology tests;
- •11.The subject has evidence of active tuberculosis. Chest radiographs may be acquired to rule out tuberculosis. Alternatively a screening test could be done (tuberculin skin test, QuantiFERON-TB Gold test, or T-SPOT™.TB test) to rule out TB. If the screening test is positive, chest radiographs must be obtained to rule out TB.
- •12.The subject has a history of any infection requiring intravenous antibiotics, a serious local infection (e.g., cellulitis or abscess), systemic infection (e.g., pneumonia, septicemia), or gastrointestinal infection within 12 weeks of randomization;
- •13.Has a diagnosis of ulcerative or indeterminate colitis;
- •14.The subject has a history or presence of illicit drug use and/or alcohol abuse within the year prior to study entry;
- •15.The subject has a history or presence of any form of cancer within the 5 years prior to study entry, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis, and
- •16.The subject has a history or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation and may prevent the subject from completing the study.
研究者
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