Lupus & antiphospholipid syndrome
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
Authors' conclusion
Enpatoran was well tolerated and demonstrated favourable safety and PK profiles in patients with SLE and CLE.
Study context
- Population
- Patients with active SLE/CLE80% female
- Participants
- 25 patients
- Comparison
- Enpatoran vs placebo
- Enpatorann = 19
- Placebon = 6reference
- Primary endpoint
- Safety and tolerability
Methodological detailsphase Ib, double-blind, placebo-controlled, multiple-ascending doses, 3:1 randomisation, four cohorts
- Phase Ib
- Double-blind
- Placebo-controlled
- Multiple-ascending doses
- 3:1 randomisation
- Four cohorts
Primary result
As reported in the abstract
TEAEs · week 12
- Most treatment-emergent adverse events (TEAEs) mild or moderate
- 96%
Secondary outcomes
Enpatoran pharmacokinetics (PK)
- Peak concentration reached postdose (hours)
- 1-2
- Apparent half-life across doses (hours)
- 6-10
- PK dose proportional
Clinical response (SLEDAI-2K, PGA, 28-joint count) · week 24
- Greater reductions in SLEDAI-2K, PGA and 28-joint count with enpatoran vs placebo
Interferon gene signature (IFN-GS) (exploratory)
- Rapid, dose-dependent and reversible suppression of IFN-GS
Safety
TEAEs · week 12 · across the four enpatoran dose groups
- TEAEs — Most TEAEs mild or moderate in severity
- 96%
Serious TEAEs
- There were no serious TEAEs
Original publication
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. Lupus Sci Med. Published 23 October 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →