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]

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2018
INTERVENTION: Intervention name : ABT‐494 INN of the intervention : upadacitinib Dosage And administration of the intervention : Will be orally administered Control intervention name : Placebo Dosage And administration of the control intervention : Will be orally administered CONDITION: Ulcerative Colitis INCLUSION CRITERIA: ‐ Diagnosis of Ulcerative Colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available. ‐ Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3. ‐ Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies. ‐ Female Participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit. ‐ If female, participant must meet the contraception recommendation criteria.
Epistemonikos ID: 0345cd4f988f119fc8a40930c659f882be5089d9
First added on: Aug 24, 2024