A Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-jRCT2080224070
- Lead Sponsor
- AbbVie GK
- Brief Summary
Achieved statistically significant improvements in efficacy primary endpoint in UPA vs PBO. The treatment was well tolerated; AEs were consistent with the known safety profile of UPA with no new safety signals identified.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 522
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.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method