Upadacitinib Achieved Primary and Key Secondary Endpoints in First Phase 3 Induction Study in Patients with Crohn’s Disease

The U-EXCEED study enrolled patients with Crohn’s disease who had an inadequate response or were intolerant to biologic therapy

AbbVie has announced positive top-line results from U-EXCEED, a Phase 3 induction study, showing upadacitinib (45 mg once daily) achieved both primary endpoints of clinical remission^a,b and endoscopic response^c at week 12.¹ The U-EXCEED study enrolled patients with moderate to severe Crohn’s disease who had an inadequate response or were intolerant to biologic therapy, with over 60 percent having previously failed two or more biologics.¹ U-EXCEED is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe Crohn’s disease.¹

“The data from this first Phase 3 induction study in Crohn’s disease suggest upadacitinib may help address the needs of patients suffering from this disease, as demonstrated in stringent endpoints such as endoscopic response,” said Michael Severino, M.D., vice chairman and president, AbbVie. “We continue to leverage our expertise in IBD by driving research and development that help shape the IBD landscape and elevate standards of care for patients.”