EUCTR2019-000886-19-AT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence
Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)0 个研究点目标入组 96 人开始时间: 2019年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
- •2. Subject signs and dates a written informed consent form (ICF), and any required privacy authorization before performance of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- •3. Male or female subject aged =18 years or local legal age at signing of ICF.
- •4. Subject must have a documented diagnosis of CD confirmed by endoscopic biopsy before resection or by tissue obtained at resection.
- •5. Subject is planned to undergo a laparoscopic ileocecal resection with primary anastomosis within 72 hours before randomization (D1). Confirmation that no active disease has been left behind after resection will be based on surgeon’s documentation in the operative report.
- •6. Subject with postoperative discontinuation of all concomitant medications specifically related to the treatment of CD. This includes anti-TNF-alpha and anti-integrin therapy, anti-IL 12/23, thiopurines and other
- •immunomodulators, steroids, 5-aminosalicylates, and prophylactic use of antibiotics for the prevention of postoperative recurrence such as metronidazole.
- •7. Subject has resumed oral intake and is capable of swallowing tablets within 72 hours after surgery.
- •8. Female subject who is:
- •- Postmenopausal for at least 1 year before signing of the informed consent, OR
- •- Surgically sterile, OR
- •- If she is of childbearing potential, agrees to practice 1 highly effective method of contraception (specified in protocol Section 9.3.17) and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 40 days after the last dose of study drug, OR
- •- Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
- •Male subject, even if surgically sterilized (ie, status postvasectomy), who:
- •- Agrees to practice effective barrier contraception (specified in Section 9.3.17) during the entire study treatment period and through 100 days after the last dose of study drug, OR
- •- Agrees to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
- •9. Subject with suitable venous access for the study-required blood sampling, including PK sampling.
- •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 81
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Subject has active perianal CD.
- •2. Subject has had >3 previous surgical procedures for CD.
- •3. Subject has macroscopically active CD that was not resected at the time of surgery as documented in the surgeon´s operative report.
- •4. The length of small bowel resected exceeds 100 cm or the subject is considered at risk of short bowel syndrome by surgeon or investigator.
- •5. Subject has any significant intraoperative or postoperative complications such as anastomotic leak, surgical site infection, or inability to tolerate oral intake.
- •6. Subject is unable or unwilling to undergo or has contraindications to ileocolonoscopic procedures as assessed by the investigator.
- •7. Subject has inadequate renal or hepatic function postsurgery and before randomization based on the following laboratory parameters:
- •? Total bilirubin >1.5× the institutional upper limit of normal (ULN) unless subject has known Gilbert’s syndrome that can explain the elevation of bilirubin, OR
- •? Serum alanine aminotransferase (ALT) >3× the institutional ULN, OR
- •? Creatinine >1.5× the institutional or central laboratory ULN or estimated creatinine clearance <50 mL/minute/1/73 m2 for subjects with serum creatinine concentrations above the institutional or central laboratory limits.
- •8. Subject has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, genitourinary, coagulation, immunological, endocrine/metabolic, neurologic, active substance abuse, psychiatric or other medical disorder not related to the subject’s primary disease that, in the opinion of the investigator, would confound the study results, compromise subject safety, or interfere with completion of the study.
- •9. Subject has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following: history of tuberculosis, OR positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR a tuberculin skin test reaction =10 mm (=5 mm in subjects receiving the equivalent of >15 mg/day prednisone).
- •10. Subject has chronic hepatitis B (hepatitis B surface antigen positive, or positive for both hepatitis B surface antibody and hepatitis B core antibody but negative for hepatitis B surface antigen) or hepatitis C infection (evident by viral replication by polymerase chain reaction) within 30 days of randomization.
- •11. Subject has a history of HIV or tests positive for HIV at screening.
- •12. If female, the subject is pregnant, lactating or breastfeeding, or intending to become pregnant before, during, or within 40 days after last dose of the study drug; or intending to donate ova during such time period.
- •13. If male, the subject intends to donate sperm during this study or for 100 days thereafter.
- •14. Subject has a current diagnosis of biliary obstruction.
- •15. Subject demonstrates significant undernutrition at the time of screening (body mass index <18.5 kg/m2, and weight loss >15% within 6 months, and serum albumin <3 g/dL)
- •16. A subject who, in the opinion of the investigator, is unwilling or unlikely to comply with the
- •requirements of the study.
- •17. Subject has participated in another clinical study within the past 30 days before completing informed consent or has received any investigational compound within 30 days before screening.
- •18. Subject has received TAK-018 (previously known as EB8018) in a previous clinical study.
- •19. Subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved
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