Lupus & antiphospholipid syndrome
Enpatoran, a Toll-like receptor 7/8 inhibitor, in moderate-to-severe systemic lupus erythematosus: findings from Cohort B of a multicentre, international, double-blind, placebo-controlled dose-finding phase 2 trial
Authors' conclusion
In this study of participants with moderate-to-severe SLE, enpatoran improved BICLA response rates versus placebo; however, the primary objective of a statistically significant dose-dependent effect on disease activity based on BICLA response was not met. Enpatoran was well tolerated across all dose groups.
Study context
- Population
- Adults aged 18–75 years with moderate-to-severe systemic lupus erythematosus (SLE) (with or without cutaneous manifestations), disease duration ≥6 months, stable medication; 132 centres in 22 countries353 in full analysis set
- Participants
- 354 adults
- Comparison
- Enpatoran 25 mg, 50 mg or 100 mg twice daily vs placebo for 24 weeks
- Enpatoran 25 mgn = 71
- Enpatoran 50 mgn = 74
- Enpatoran 100 mgn = 114
- Placebon = 95reference
- Primary endpoint
- Dose-response relationship of enpatoran on BICLA response rate (multiple comparison procedure-modelling analysis)
- Follow-up
- Week 24
Methodological detailsphase 2, double-blind, placebo-controlled, basket, dose-finding, multicentre, international, GC tapered to ≤5 mg/day prednisone-equivalent from weeks 2 to 12, as clinically tolerated
- Phase 2
- Double-blind
- Placebo-controlled
- Basket
- Dose-finding
- Multicentre
- International
- GC tapered to ≤5 mg/day prednisone-equivalent from weeks 2 to 12, as clinically tolerated
Primary result
As reported in the abstract
BICLA response rate
Each group vs placeboOdds ratio (95% CI)
Enpatoran 25 mg
2.2(1.1–4.0)
Enpatoran 50 mg
1.5(0.8–2.8)
Enpatoran 100 mg
1.6(0.9–2.8)
- No statistically significant dose-response relationship (primary objective not met)
- P = 0.14
Safety
Diarrhoea (most common treatment-emergent AE)
Serious adverse events
Original publication
Enpatoran, a Toll-like receptor 7/8 inhibitor, in moderate-to-severe systemic lupus erythematosus: findings from Cohort B of a multicentre, international, double-blind, placebo-controlled dose-finding phase 2 trial. Lancet. Published 9 May 2026. doi:10.
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