Efficacy and safety of ABBV-154 in patients with moderately to severely active Crohn's disease: a phase 2b, randomized, double-blind, placebo-controlled trial.

内容摘要

ABBV-154 is an antibody-drug conjugate of adalimumab and a proprietary glucocorticoid receptor modulator. This phase 2b randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of ABBV-154 versus placebo in patients with moderately to severely active Crohn's disease who had inadequate response to or were intolerant of prior biologic therapy. Patients were randomized 1:1:1:1:1 to ABBV-154 induction groups: 150 mg IV at week 0, then 80 mg SC at week 2 and every other week (EOW); 300 mg IV at week 0, then 230 mg SC at week 2 and EOW; 600 mg IV at week 0, then 530 mg SC at week 2 and EOW; 600 mg IV at week 0, then 530 mg SC at weeks 4 and 8, and placebo at weeks 2, 6, and 10; or placebo. The primary endpoint was achievement of endoscopic response per SES-CD by central review at week 12. Adverse events were monitored throughout. Of 265 planned patients, 106 were randomized and treated until completion, discontinuation, or early study termination by the sponsor. At week 12, greater proportions of patients treated with ABBV-154 achieved endoscopic response versus placebo (7.1%, 33.3%, 28.6%, and 27.3% across the induction groups vs. 0%; data reported as observed). Adverse events were comparable across all ABBV-154 groups and slightly higher than placebo through week 12. ABBV-154 was well tolerated and demonstrated proof-of-concept for efficacy in patients with moderately to severely active Crohn's disease. Results should be interpreted with caution due to early study termination.