Lupus & antiphospholipid syndrome
Efficacy and safety of the CD40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (PHOENYCS GO): a randomised, double-blind, placebo-controlled, phase 3 trial
Primary result · BICLA responseResult — go to the resultDifference 14.6 95% CI 3.3–25.8Authors' conclusion
Dapirolizumab pegol was associated with significant improvement in disease activity in patients with SLE.
Study context
- Population
- Patients aged 16 years or older with moderate-to-severe, active systemic lupus erythematosus (SLE) despite standard-of-care medication315 in full-analysis set
- Participants
- 321 patients
- Comparison
- Intravenous dapirolizumab pegol 24 mg/kg every 4 weeks vs placebo, both plus standard of care
- Dapirolizumab pegoln = 213
- Placebon = 108reference
- Primary endpoint
- BICLA response
- Follow-up
- Week 48
Methodological detailsphase 3, double-blind, placebo-controlled, multicentre (177 centres, 25 countries), 2:1 randomisation, Six patients excluded due to non-compliance of one site with Good Clinical Practice guidelines
- Phase 3
- Double-blind
- Placebo-controlled
- Multicentre (177 centres, 25 countries)
- 2:1 randomisation
- Six patients excluded due to non-compliance of one site with Good Clinical Practice guidelines
Primary result
As reported in the abstract
Difference
14.6
95% CI 3.3–25.8
P = 0.011
Events by treatment group
Dapirolizumab pegolvs Placebo
difference 14.6 (95% CI 3.3–25.8); P = 0.011
Safety
Treatment-emergent adverse events
Serious treatment-emergent adverse events
Serious infections
| Outcome | Dapirolizumab pegol | Placebo |
|---|---|---|
| Hypersensitivity reactions during infusion | 3% | — not stated in the abstract |
— not stated in the abstract
Thromboembolic event (MI) and death (gangrene-related sepsis)
- One thromboembolic event (MI) in the dapirolizumab pegol group
- 1
- One death (gangrene-related sepsis) in the dapirolizumab pegol group
- 1
Original publication
Efficacy and safety of the CD40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (PHOENYCS GO): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. Published 29 May 2026. doi:10.
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