EUCTR2008-004276-49-FR进行中（未招募）1 期
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 199
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
- •Subjects must meet all the inclusion criteria to be eligible:
- •1.Males and females 18-65 years old (inclusive).
- •2.Subjects diagnosed with Crohn’s disease for at least 3 months, which has been appropriately documented and supported by endoscopy or radiology (performed within 36 months prior to screening and after surgical resection), or surgery
- •3.Moderate to severe Crohn's disease patients as determined by a CDAI score of 220-450 (inclusive).
- •4.Subjects with CRP levels above 5 mg/L.
- •5.Subjects willing and able to provide written, informed consent
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any of the following will exclude the subject from entering the study:
- •1.Subjects with a diagnosis of Indeterminate Colitis.
- •2.Subjects with positive results on stool culture for enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter and Clostridia Difficile toxin assay).
- •3.Subjects who have had bowel surgery within the 3 months prior to screening or with planned elective surgery or hospitalization during the course of the study (that may interfere with study compliance or outcome)
- •4.Subjects with clinically significant Short Bowel Syndrome.
- •5.Subjects with clinically significant GI obstructive symptoms.
- •6.Subjects with intra-abdominal abscess.
- •7.Subjects with fistula with clinical or radiological evidence of abscess.
- •8.Subjects with ileostomy, colostomy or who receive parenteral nutrition.
- •9.Subjects with a clinically significant or unstable medical or surgical condition that, in the Investigator’s opinion, would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or imaging.
- •10.Subjects with a =2x upper limit of normal (ULN) serum elevation of either of the following at screening: ALT, AST, GGT, ALKP or direct bilirubin.
- •11.A QTc interval which is > 500 msec
- •12.Subjects with history of any malignancy in the last year, excluding basal cell carcinoma.
- •13.Subjects treated with oral corticosteroids (e.g prednisolone/budesonide), who have initiated this treatment within less than 4 weeks prior to screening
- •14.Subjects treated with more than 20mg/day of prednisolone (or equivalent) or budesonide > 6mg/day for CD at screening, or whose corticosteroid dosage regimen is not stable for at least 2 weeks prior to screening.
- •15.Subjects treated with 5-ASA who are not on stable dose for at least 2 weeks prior to screening.
- •16.Subjects treated with antibiotics for CD who are not on a stable dose for at least 4 weeks prior to screening.
- •17.Subjects treated with 6-MP, AZA or MTX, who have initiated this treatment within 12 weeks prior to screening or who are not on a stable dose for at least 6 weeks prior to screening.
- •18.Subjects treated with Anti-TNFs within 8 weeks prior to screening.
- •19.Subjects treated with cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 2 months prior to screening
- •20.Subjects treated with natalizumab within 6 months prior to screening
- •21.Subjects who have used any other investigational drugs within 3 months prior to screening.
- •22.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (1 month for fluoxetine).
- •23.Use of amiodarone within 2 years prior to screening visit
- •24.Women who are pregnant or nursing at the time of screening, or who intend to be during the study period.
- •25.Women of child-bearing potential who do not practice an acceptable method of birth control.
- •26.A known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
- •27.Subjects unable to comply with the planned schedule of study visits and study procedures.
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