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 - 20110166-AMG 181 in Ulcerative Colitis

Amgen0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月29日

研究概览

暂无简介。

•-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, anti-TNF agents or to corticosteroids (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

•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
•-Planned bowel surgery within 24 weeks from baseline
•-Stool positive for C. Difficile toxin at screening
•-History of gastrointestinal surgery within 8 weeks of baseline
•-Primary Sclerosing Cholangitis ;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 corticosteroids within 2 weeks prior to screening and during screening
•-Subject previously treated with AMG 181
•-Subject who has received any type of live attenuated vaccine < 1 month prior to baseline or is planning to receive any such live attenuated vaccine over the course of the study
•-Treatment of infection with intravenous (within 30 days of baseline) or oral (within 14 days prior to baseline) antibiotics, antivirals, or antifungals

发起方