AbbVie, a global biopharmaceutical company, has announced promising results from CELEST, a phase 2, randomized, double-blind, placebo-controlled study evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in adult patients with moderately to severely active Crohn's disease. These data are being presented during the Clinical Science: Late-Breaking Abstract Plenary Session (Presentation #874h) at Digestive Disease Week 2017.

"Crohn's disease is a serious, chronic disease with symptoms and complications that can have a major impact on patients' daily lives, and additional treatments are needed to improve the prognosis for many living with the disease," said William Sandborn, M.D., study investigator and director, Inflammatory Bowel Disease Center chief, Division of Gastroenterology and professor of Medicine at the University of California, San Diego. "The CELEST study included patients with difficult-to-treat Crohn's disease who failed two or more biologics. These positive results support advancement into Phase 3 to further explore a potential new treatment option that may address the unmet needs of patients living with this challenging disease."

The phase 2 study evaluated the safety and efficacy of multiple dosing regimens of upadacitinib after 16 weeks of treatment. The positive results support advancement of the program into phase 3. Results showed that more patients achieved endoscopic remission with upadacitinib compared to placebo, specifically within the 24 mg twice daily treatment group 22 percent of patients (n=8/36) achieved endoscopic remission with upadacitinib compared to 0 percent of patients (n=0/37, P?0.01) taking placebo. Additionally, significantly more patients receiving upadacitinib 6 mg twice daily achieved clinical remission (27 per cent, n=10/37) compared to placebo (11 percent, n=4/37, P?0.1). Secondary endpoint results included the finding that nearly twice as many patients achieved clinical response with upadacitinib (61 percent, n=22/36 and 57 percent, n=21/37 in the 24 mg and 6 mg twice daily groups, respectively) compared with the placebo group (32 percent, n=12/37, P?0.05 for both comparisons). Significantly more patients receiving upadacitinib doses greater than or equal to 6 mg twice daily achieved endoscopic response compared to placebo (P?0.01 for all comparisons).

"Results from CELEST are encouraging and provide new information to the gastroenterology community on the potential for upadacitinib as an oral treatment option for patients with Crohn's disease," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "For nearly two decades, AbbVie has pioneered research in immune-mediated diseases, and these findings demonstrate our commitment to meaningful scientific innovation with the potential to improve patient lives."

In this study, the safety profile was consistent with that observed in the upadacitinib investigational rheumatoid arthritis clinical trials. While overall adverse events (AEs) and infections were numerically higher with upadacitinib than placebo, these events did not appear to be dose-related in this phase 2 study. Serious AEs and discontinuations were similar in all groups, except for numerically greater events in the 12 mg twice daily group. One case of non-melanoma skin cancer was reported in the 24 mg twice daily group.1 One death was reported during screening, but the patient did not receive study drug.

CELEST is a phase 2, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of multiple dosing regimens of upadacitinib in adult patients with moderately to severely active Crohn's disease.