A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis - M14-675

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

Trial never started

•1. Male or female between 16 and 75 years of age at Baseline.
•- Adolescent subjects at the age of 16 and 17 years old will be enrolled if
•approved by the country or regulatory/health authority. If these approvals have
•not been granted, only subjects = 18 years old will be enrolled.
•- Adolescent subjects at the age of 16 and 17 years old must weigh = 40 kg and
•meet the definition of Tanner Stage 5 (refer to Appendix J) at the screening
•2. Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline,
•confirmed by colonoscopy
•3. Moderately to severely active ulcerative colitis
•4. Demonstrated an inadequate response to, loss of response to, or intolerance
•to immunosuppressants, corticosteroids or biologic therapies
•5. Negative pregnancy test for female subjects of childbearing potential

•1. Subject with current diagnosis of Crohn's disease (CD) or diagnosis of
•indeterminate colitis (IC).
•2. Current diagnosis of fulminant colitis and/or toxic megacolon.
•3. Subject with disease limited to the rectum (ulcerative proctitis) during the
•screening endoscopy.
•4. Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide
•within 30 days prior to Baseline.
•5. Subject who received azathioprine or 6-mercaptopurine within 10 days of
•6. Received intravenous corticosteroids within 14 days prior to Screening or
•during the Screening Period.
•7. Subject with previous exposure to JAK inhibitor.

发起方