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

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 and Jean-François Zagury ()
Additional contact information
François Rannou: Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis
Lucille Desallais: Hôpital Cochin
Christelle Nguyen: Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis
Camille Daste: Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis
Quentin Kirren: Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis
Marie-Martine Lefevre-Colau: Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis
Odile Launay: CIC Cochin Pasteur; Inserm
Hadley Mouhsine: Hôpital Cochin
Barbara Ruiz: Hôpital Cochin
Gabriel Moreau: Hôpital Cochin
Florent Langenfeld: Hôpital Cochin
Edita Dolimier: Hôpital Cochin
Hervé Do: Hôpital Cochin
René Azoulai: Hôpital Cochin
Francis Berenbaum: AP-HP Hôpital Saint-Antoine
Marie-Christophe Boissier: Inserm UMR
Jean-Pierre Salles: Hôpital Cochin
Jean-François Zagury: Conservatoire National des Arts et Métiers (Cnam)

Nature Communications, 2025, vol. 16, issue 1, 1-9

Abstract: Abstract 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.

Date: 2025
References: Add references at CitEc
Citations:

Downloads: (external link)
https://www.nature.com/articles/s41467-025-64710-6 Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:16:y:2025:i:1:d:10.1038_s41467-025-64710-6

Ordering information: This journal article can be ordered from
https://www.nature.com/ncomms/

DOI: 10.1038/s41467-025-64710-6

Access Statistics for this article

Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie

More articles in Nature Communications from Nature
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().