EUCTR2011-005251-13-LV进行中（未招募）1 期
A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 360
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
- •¦ Age 18 to 65 at screening (inclusive)
- •¦ Diagnosis of UC established = 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report
- •¦ Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy score = 2 prior to baseline
- •¦ Demonstrated an inadequate response to, loss of response to, or intolerance to immunomodulators or anti-TNF agents or to corticosteroids (non-US sites only)
- •¦ Subjects can be receiving the following treatments:
- •Azathioprine or 6 mercaptopurine if treatment initiated at least 12 weeks prior to baseline and if stable dosage for = 8 weeks prior to baseline
- •Methotrexate up to 25 mg/week if stable dosage for = 8 weeks prior to baseline
- •5 aminosalicylates and/or oral prednisone or equivalent up to 20 mg/day, if stable dosage for = 2 weeks prior to baseline
- •¦ Neurological exam, free of clinically significant, unexplained signs or symptoms in the opinion of the investigator during screening and no clinically significant change prior to randomization
- •¦ Subject has no known history of active tuberculosis
- •¦ Subject has a negative test for tuberculosis during screening
- •¦ Subject has provided informed consent
- •For full list of inclusion criteria, please refer to section 4.1 of the protocol
- •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 340
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Disease specific:
- •¦ Disease limited to the rectum (ie, within 10 cm of the anal verge)
- •¦ Toxic megacolon
- •¦ Crohn’s Disease
- •¦ History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC
- •¦ Stool positive for C. Difficile toxin at screening
- •Excluded Medications:
- •¦ Immunosuppressive therapy with either cyclosporine A, tacrolimus, or mycophenolate mofetil, within 1 month prior to baseline
- •¦ Prior exposure to anti TNF agents, within 2 months, or 5 times the respective elimination half life (whichever is longer) prior to baseline
- •¦ Any prior exposure to vedolizumab, rituximab, efalizumab, natalizumab
- •¦ Use of topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to baseline
- •¦ Use of intravenous or intramuscular corticosteroids within 2 weeks prior to screening and during screening
- •Laboratory Abnormalities:
- •¦ Abnormal laboratory results at screening:
- •Liver tests: either aspartate aminotransferase (AST), alanine transaminase (ALT) or alkaline phosphatase (ALP) > 2.0 Upper Limit of Normal (ULN) OR total bilirubin (TBL) > 1.5 ULN (except for subjects with Gilbert Syndrome)
- •White blood cell count < 3,000 cells/mm³(< 3 x 10^9/L in SI units)
- •Hemoglobin < 10 g/dL
- •¦ Female subject is not willing to prevent pregnancy from occurring during treatment and for 7 months after the last dose of investigational product (except if = 2 years postmenopausal or surgically sterile). Prevention of pregnancy involves a female subject not having intercourse during treatment and for 7 months after the last dose of investigational product, or the use of two methods of birth control. This means the simultaneous use of: Two highly effective methods of birth control, or one highly effective method of birth control and one effective method of birth control.
- •Highly effective methods (= 99% effective when used correctly) of birth control include: hormonal birth control methods (pills, shots, implants or patches), intrauterine devices, sexual activity with a male partner who has had a vasectomy, tubal sterilization (tie, clip, band, burn), or tubal occlusion (insert placed in tube after confirmed occlusion).
- •Effective methods (< 99% effective) of birth control include: barrier method of condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide.
- •¦ Subject is pregnant or breast feeding, or might become pregnant within 7 months after the last dose of investigational product
- •For full list of exclusion criteria, please refer to section 4.2 of the protocol
研究者
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