SAR445399 / Sanofi, MAB Discovery - LARVOL DELTA

CLAROS: A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=144 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

The novel, first-in-class IL-1R3 Antagonist SAR445399 Reduces Skin Inflammation in an Innovative Proof-of-Mechanism Study with Dual Immune Challenge Models and Comparator Drugs (EADV 2025) - "This study was designed to evaluate the effect of SAR445399 on dermal inflammation induced by imiquimod (IMQ) and lipopolysaccharide (LPS) which trigger a local skin reaction via IL-36 and IL-1 pathways. In this innovative study SAR445399 demonstrated significant inhibition of skin inflammation after LPS and IMQ challenges via the IL-1 and IL-36 pathways. Canakinumab also inhibited LPS and IMQ induced skin inflammation while spesolimab was effective in the IMQ model only. Results are in line with scientific literature describing IL-1 contribution to the LPS and IL-1/ IL-36 contribution to the IMQ driven skin inflammation."

Dermatitis • Dermatology • Inflammation • IFNG • IL12A • IL17C • IL1B • IL1RAP • IL33 • IL6

SAR445399 – an anti-IL-1R3 monoclonal antibody that blocks IL-1, IL-33 and IL-36 cytokine pathways for dermatologic diseases (ISDS 2023) - "Multiple therapies targeting individual members of the IL-1 family have only shown low to moderate efficacy in dermatologic disorders such as: αIL-36γ (Spesolimab) in AD, HS and PPP, αIL-33 (Itepekimab) in AD and IL-1R antagonist (Anakinra) or αIL-1R (MEDI-8968) in HS. Furthermore, an anti-murine surrogate of SAR445399 alleviates disease and inflammation in an Imiquimod-induced skin inflammation model with superior efficacy than IL-1 blockade alone. In summary, SAR445399 is a broad IL-1 pathway drug hitting 3 birds with 1 stone and is uniquely positioned to potentially raising the efficacy ceiling where a single agent therapy may not be fully efficacious in dermatology or other immunology areas."

Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Psoriasis • IL1B • IL1RAP • IL33