Abbvie UC with ABT-494 (JAK 1 inhibitor)

Placebo-controlled study to evaluate the safety and efficacy of ABT-494 for induction and maintenance therapy in subjects with moderately to severely active Ulcerative Colitis

  • Males and females between 18 and 75 years of age with a diagnosis of moderately to severely active Ulcerative Colitis
  • All subjects with a history of inadequate response or intolerance to immunosuppressants, corticosteroids or biologic therapies, and moderately to severely active Ulcerative Colitis defined as an adapted mayo score of 5 to 9 (consisting of stool frequency subscore, rectal bleeding subscore and endoscopy subscore) with endoscopy subscore of 2 or 3
  • 8-Week induction phase followed by 44-week maintenance phase
  • Patients who do not meet clinical response criteria at week 8 or complete the 44-week maintenance phase will be eligible for the open label extension study