AbbVie asserted results from the double-blinded extension phase of the Phase 2 CELEST Study, exhibiting that many patients treated with upadacitinib who attained clinical response after the 16-week induction phase maintained their response to treatment after the 36-week extension phase, results marked for the higher doses (6 mg and 12 mg twice- daily) were numerically greater compared to 3 mg twice-daily at 52 weeks.
The CELEST study evaluated upadacitinib, an investigational oral JAK1-selective inhibitor, in adult patients with moderately to severely active Crohn’s disease and inadequate response/intolerance to an immunomodulator or tumor necrosis factor alpha antagonist.
Marek Honczarenko, vice president, immunology development, AbbVie said “We will continue to develop therapies that extend beyond symptoms and include endoscopic outcomes with a long-term aim to limit disease progression.”
CELEST is a 52-week, Phase 2, randomized, double-blind study consisting of a 16-week dose-ranging induction and 36-week extension phase. Patients who responded to treatment in the 16-week induction phase entered the extension phase of the study, which evaluated multiple dosing regimens of upadacitinib through week 52.