Journal of the American Academy of Dermatology · 2025
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.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеМногоцентровое исследованиеПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Forman Seth, Patel Dipak R, Kimball Alexa B, Jaleel Tarannum, Laquer Vivian, Wang Tongrong, Zhang Ying, Shen Lei, Nirula Ajay, Klekotka Paul
Аннотация
BACKGROUND: Human CXC motif chemokine receptors 1 and 2 ligands are implicated in hidradenitis suppurativa (HS) pathogenesis.
OBJECTIVE: To evaluate the efficacy and safety of eltrekibart, a monoclonal antibody targeting the CXC motif chemokine receptors 1 and 2 pathway, in HS.
METHODS: 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.
RESULTS: 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.
LIMITATIONS: Short timeline, limited geography, and small sample size.
CONCLUSION: Neutralizing CXC motif chemokine receptors 1 and 2 ligands offer a promising HS treatment strategy.
OBJECTIVE: To evaluate the efficacy and safety of eltrekibart, a monoclonal antibody targeting the CXC motif chemokine receptors 1 and 2 pathway, in HS.
METHODS: 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.
RESULTS: 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.
LIMITATIONS: Short timeline, limited geography, and small sample size.
CONCLUSION: Neutralizing CXC motif chemokine receptors 1 and 2 ligands offer a promising HS treatment strategy.