EUCTR2011-002517-11-CZ进行中（未招募）不适用
A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab
CB BIOSCIENCES GmbH0 个研究点目标入组 96 人开始时间: 2012年1月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
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
- •1. An Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.
- •2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake, according to the judgment of the Investigator.
- •3. Subject is male or female, 18 to 65 years of age at Screening.
- •4. Body mass index between 18 and 35kg/m2.
- •5. Diagnosis of CD (colonic localization) confirmed (at least 12 weeks prior to Screening) by either radiological or endoscopic evidence and/or histological examination.
- •6. Colonoscopy performed prior to first IMP administration (Week 0) with evidence of active CD and presence of ulceration but with no clinical suspicion of dysplasia or malignancy (colonoscopy to be performed after informed consent has been received, and all other Screening assessments have been completed).
- •7. Active inflammation indicated by CRP level = 5mg/L at Screening.
- •8. Moderately to severely active CD (CDAI score: 220 to 450, inclusive) at Baseline.
- •9. Chest x-ray must have been performed within the last 6 months prior to Screening and must rule out active or old TB infection. Positive radiographic findings consistent with active or old TB infection may include apical lung fibrosis, pleural thickening, calcified lung nodules, calcified hilar lymph nodes, and pericardial calcification. Suspected radiographic findings must be documented with clinical interpretation by the treating physician or medical expert.
- •10. Subject must meet all concomitant medication criteria summarized in Table 6:1(page 24 in the protocol) before Baseline (Week 0).
- •a) If subjects discontinue the medication prior to Baseline a washout period of at least 2 weeks is required, or longer as detailed in the table.
- •b) Corticosteroid equivalent doses are summarized in Appendix 18.1.(see protocol page 65)
- •Notes: Nonsteroidal anti-inflammatory drugs and COX inhibitors are prohibited during the study. Low dose
- •aspirin (up to 100mg/day) for cardiovascular protection and acetaminophen (as required) are permitted.
- •11. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and
- •spermicide). Abstinence alone is not an acceptable method. Subjects must agree to use at least 2 forms of adequate contraception during the study and for 6 months (24 weeks) (or longer if required by local regulations) after the last dose of study treatment. Male
- •subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 12 weeks (or longer if required by local regulations) after the subject receives the last dose of IMP.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •General Criteria:
- •1. Subject has a history of chronic alcohol abuse or drug abuse within the last year.
- •2. Subject has any medical or psychiatric condition (according to the Diagnostic and Statistical Manual of Mental Disorders [DSM-IV-TR] criteria) that could jeopardize or would compromise the subject’s ability to participate in this study.
- •3. Subject has participated in another study of an IMP, or a medical device, within the last 3 months or 5 half-lives, which ever is longer, or is currently participating in another
- •study of an IMP or a medical device.
- •4. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 24 weeks following the last dose of the IMP.
- •Disease Specific Criteria:
- •5. Subject has a diagnosis of ulcerative colitis or indeterminant colitis as determined by the
- •Investigator.
- •6. Subject has obstructive strictures with clinical evidence of partial or completeobstruction.
- •7. Subject has an active fistula (fistula secreting spontaneously or by gentle pressure).
- •8. In subjects with non-secreting fistula, abscesses need to be ruled out according to local practice (eg, ultrasound, endoscopic ultrasound, or magnetic resonance imaging).
- •9. Subject has evidence of an intra-abdominal or peri-rectal infection or abscess.
- •10. Subject has a history of diverticulitis or symptomatic diverticulosis.
- •11. Subject has had more than one bowel resection, or has had a bowel resection within the 12 months prior to Screening.
- •12. Subject has current status or any history of bowel perforation prior to Screening.
- •13. Subject has ostomy or ileoanal pouch.
- •14. Subject has short bowel syndrome with clinical evidence of malabsorption.
- •Prior/Concomitant Medication Criteria:
- •15. Subject is currently receiving total parenteral nutrition.
- •16. Subject has any prior exposure to natalizumab (Tysabri®).
- •17. Subject has any prior exposure to anti-IL-6 agents (eg, TCZ).
- •18. Subject is receiving continuous dosing with narcotic analgesics or Vitamin K antagonists (eg, phenprocoumon, acenocoumarol, warfarin).
- •19. Subject has had previous exposure to OKZ in a clinical study.
- •20. Subject is receiving or has received any live (includes attenuated) vaccination within the 8 weeks prior to Baseline (Week 0) (eg, inactivated influenza and pneumococcal vaccines are allowed but nasal influenza vaccination is not permitted).
- •21. Subject has any condition that requires additional immunosuppressants during the study.
- •Laboratory Test Criteria:
- •22. Subject has positive stool cultures for enteric pathogens during Screening.
- •23. Subject has clinically significant laboratory abnormalities
- •Safety Criteria:
- •24. Currently known active TB or clinical signs and symptoms consistent with pulmonary or extra-pulmonary TB infection and active TB can not be ruled out at the time of randomization.
- •25. Subject has a positive PPD test result at Screening (induration of 5mm or greater), unless the subject has been adequately treated and that there are no residual findings.
- •26. Subject receiving concomitant treatment for latent TB during the study.
- •27. Subject has concurrent acute or chronic viral hepatitis B or C or known human immunodeficiency virus (HIV) infection.
- •28. Subject has a known history of, or current clinically active infection with, Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, or Aspergillus.
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