A randomized, double-blind, placebo-controlled phase 2 study of eltrekibart, a novel septa-specific monoclonal antibody to CXCR1/2 ligands, in adults with hidradenitis suppurativa.

Abstract

Human CXC motif chemokine receptors 1 and 2 ligands are implicated in hidradenitis suppurativa (HS) pathogenesis. To evaluate the efficacy and safety of eltrekibart, a monoclonal antibody targeting the CXC motif chemokine receptors 1 and 2 pathway, in HS. In this phase 2 double-blind trial (NCT04493502), adults with moderate-to-severe HS were randomized 2:1 to receive eltrekibart 600 mg or placebo every 2 weeks. The primary endpoint was the proportion of participants achieving ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count relative to baseline (HS Clinical Response [HiSCR50]) at week 16. A prespecified Bayesian augmented control analysis was also implemented on the primary endpoint, which sourced historical placebo data from phase 3 HS trials. At week 16, 48.9% of 47 eltrekibart-treated participants and 31.8% of 20 placebo-treated participants achieved HiSCR50 (P = .19). For the augmented-control analysis, 65.6% of eltrekibart-treated participants and 32.3% of placebo-treated participants achieved HiSCR50 at week 16; posterior probability of eltrekibart superiority was 99.9%, with a 61.9% probability of ≥30% difference. Most treatment-emergent adverse events were mild or moderate. Short timeline, limited geography, and small sample size. Neutralizing CXC motif chemokine receptors 1 and 2 ligands offer a promising HS treatment strategy.