AbbVie Reports Novel Antibody Drug Conjugate ABBV-3373 Meets Endpoints in Phase 2 Study for Rheumatoid Arthritis

AbbVie Reports Novel Antibody Drug Conjugate ABBV-3373 Meets Endpoints in Phase 2 Study for Rheumatoid Arthritis

AbbVie announced positive data from a Phase 2 study of ABBV-3373, an investigational anti-tumor necrosis factor (TNF) Glucocorticoid Receptor Modulator (GRM) steroid antibody drug conjugate (ADC), in adult patients with moderate to severe rheumatoid arthritis. Data confirmed the clinical activity of ABBV-3373 and support advancing the development of the platform in rheumatoid arthritis and initiating clinical studies in other immune-mediated diseases.

The phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of ABBV-3373 in adult patients with moderate to severe rheumatoid arthritis with an inadequate response to MTX. Patients were randomized in a 2:1 ratio to ABBV-3373 (n=31) at 100 mg, every other week (EOW) or adalimumab (n=17) at 80 mg, EOW for 12 weeks. The primary endpoint was the change in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) from baseline to week 12 and two statistical comparisons were pre-specified. The first compared ABBV-3373 and mean outcome from historical adalimumab data. The second compared ABBV-3373 and combined in-trial and ...

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