Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Afimetoran, a Toll-Like Receptor 7 and 8 Inhibitor, in Patients With Cutaneous Lupus Erythematosus: A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study.

ABSTRACT:

Objective

There is an unmet need for safe and effective oral treatments for cutaneous lupus erythematosus (CLE). Afimetoran is an investigational, first-in-class, orally bioavailable, selective small molecule inhibitor of Toll-like receptors (TLRs) 7 and 8. We investigated the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of afimetoran in patients with CLE.

Methods

In this Phase 1b, randomized, double-blind, placebo-controlled study (NCT04493541), patients with CLE received afimetoran (30 mg once daily) or a placebo, in addition to select background medications, over 16 weeks. Safety and tolerability were mainly reported through adverse events (AEs). Pharmacokinetics were determined using plasma concentration-time data. Pharmacodynamic biomarkers and

SUBMITTER: Hosein F 

PROVIDER: S-EPMC12198911 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature