Enpatoran, a first-in-class, selective, orally administered toll-like receptor 7/8 inhibitor, in systemic and cutaneous lupus erythematosus: results from a randomised, placebo-controlled phase Ib study.

ABSTRACT:

Objective

To evaluate multiple-ascending doses of enpatoran, a selective toll-like receptor 7/8 (TLR7/8) inhibitor with the potential to modulate processes central to lupus pathophysiology, in patients with systemic and cutaneous lupus erythematosus (SLE/CLE).

Methods

In this randomised, double-blind, placebo-controlled phase Ib trial (NCT04647708), patients with active SLE/CLE were randomised 3:1 to enpatoran or placebo across four cohorts. Treatment duration was 12/24 weeks. All patients had a 2-week safety follow-up. The primary endpoint was safety and tolerability. Secondary endpoints included pharmacokinetics (PK) and clinical response. Change in lupus biomarkers, including interferon gene signature (IFN-GS), was an exploratory endpoint.

Results

25 patients recei

SUBMITTER: Witte T 

PROVIDER: S-EPMC12557744 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature