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<p>Osteoarthritis, a debilitating joint disorder, remains a major unmet medical need requiring new treatment options. Here, we evaluate the safety (primary endpoint) and immunogenicity (secondary endpoint) of PPV-06, an active anti-IL-6 immunotherapy designed to mitigate the impact of low-grade inflammation on disease progression. Twenty-four participants affected by inflammatory knee osteoarthritis (KOA) are enrolled in a randomized, placebo-controlled phase 1 clinical trial (NCT04447898) and divided into three groups, receiving low (10 µg, n = 9), high (50 µg, n = 9) dose&#xa0;of PPV-06, or placebo (n = 6). We observe a good safety profile with no dose-limiting toxicities in either the PPV-06 or the placebo groups. The incidence of adverse events is similar across the three groups, with mild to moderate drug-related adverse events typically associated with vaccines, including injection-site induration, pruritus, erythema, and headache. All participants receiving PPV-06 exhibit anti-IL-6 antibodies, and interestingly, participants with higher IL-6 neutralizing capacity exhibit an improved clinical outcome, as determined by changes in KOOS scores. These findings support further development of PPV-06 as a promising therapeutic strategy for knee osteoarthritis.</p>

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Safety and immunogenicity of PPV-06, an active anti-IL-6 immunotherapy targeting low-grade inflammation against knee osteoarthritis: a randomized, double-blind, placebo-controlled, clinical phase 1 study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月5日

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  • François Rannou,
  • Lucille Desallais,
  • Christelle Nguyen,
  • Camille Daste,
  • Quentin Kirren,
  • Marie-Martine Lefevre-Colau,
  • Odile Launay,
  • Hadley Mouhsine,
  • Barbara Ruiz,
  • Gabriel Moreau,
  • Florent Langenfeld,
  • Edita Dolimier,
  • Hervé Do,
  • René Azoulai,
  • Francis Berenbaum,
  • Marie-Christophe Boissier,
  • Jean-Pierre Salles,
  • Jean-François Zagury

摘要

Osteoarthritis, a debilitating joint disorder, remains a major unmet medical need requiring new treatment options. Here, we evaluate the safety (primary endpoint) and immunogenicity (secondary endpoint) of PPV-06, an active anti-IL-6 immunotherapy designed to mitigate the impact of low-grade inflammation on disease progression. Twenty-four participants affected by inflammatory knee osteoarthritis (KOA) are enrolled in a randomized, placebo-controlled phase 1 clinical trial (NCT04447898) and divided into three groups, receiving low (10 µg, n = 9), high (50 µg, n = 9) dose of PPV-06, or placebo (n = 6). We observe a good safety profile with no dose-limiting toxicities in either the PPV-06 or the placebo groups. The incidence of adverse events is similar across the three groups, with mild to moderate drug-related adverse events typically associated with vaccines, including injection-site induration, pruritus, erythema, and headache. All participants receiving PPV-06 exhibit anti-IL-6 antibodies, and interestingly, participants with higher IL-6 neutralizing capacity exhibit an improved clinical outcome, as determined by changes in KOOS scores. These findings support further development of PPV-06 as a promising therapeutic strategy for knee osteoarthritis.