Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available. Diagnosis of Ulcerative Colitis (UC) 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.Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit. Male or female participants ≥ 16 and ≤ 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.
Participants who achieve clinical response defined by Adapted Mayo Score at Week 8 or Week 16 and do not meet any study discontinuation criteria are eligible to enroll into Study M14-234 Substudy 3 (NCT02819635 52-week maintenance study) or Study M14-533 Cohort 1 (NCT03006068 long-term follow-up study). Within non-bio-IR, the randomization is further stratified by previous biologic use (yes or no). Within bio-IR, the randomization is further stratified by number of prior biologic treatments (≤ 1 or > 1). The randomization is stratified by biologic inadequate responder (bio-IR) status (bio-IR vs non-bio-IR), corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Part 2 is an open-label, 8-week extended treatment period for participants who did not achieve clinical response at Week 8 in Part 1.Įligible participants are randomized in a 2:1 ratio to one of the two treatment groups (upadacitinib 45 mg or matching placebo) for 8 weeks. Part 1 is a randomized, double-blind, placebo-controlled 8-week induction period.
Study M14-675 consists of 2 parts, Part 1 and Part 2.
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