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A prospective, open-label, single-arm, multicenter pharmacokinetic study evaluating the placental transfer of dapirolizumab pegol to the infant(s) from pregnant study participants with active systemic lupus erythematosus who are administered dapirolizumab pegol

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524595-37-00
Enrollment
5
Registered
2026-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus (SLE)

Brief summary

1. Plasma concentration of DZP in the infants at birth, 2. Plasma concentration of DZP in mothers at delivery, 3. Ratio between plasma concentration of DZP between the infants and mother at birth/delivery

Detailed description

1. Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum, 2. Predose and postdose plasma concentrations of DZP in mothers during pregnancy, 3. DZP plasma concentrations at 12 and 14 Weeks postpartum in mothers continuing DZP treatment postpartum, 4. DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum, 5. Treatment-emergent adverse events (TEAEs) of mothers, 6. Serious TEAEs of mothers, 7. TEAEs of special interest of mothers, 8. TEAEs of special monitoring of mothers, 9. AEs of infants, 10. Serious AEs of infants, 11. AEs of special interest of infants, 12. AEs of special monitoring of infants, 13. Pregnancy outcome, 14. Predicted area under the curve (AUC) over the dosing interval at steady state across the second and third trimesters of pregnancy, 15. Predicted trough plasma concentration (Ctrough) over the dosing interval at steady state across the second and third trimesters of pregnancy, 16. Predicted maximum plasma concentration (Cmax) over the dosing interval at steady state across the second and third trimesters of pregnancy, 17. Predicted AUC over the dosing interval at steady state across the postpartum, 18. Predicted Ctrough over the dosing interval at steady state across the postpartum, 19. Predicted Cmax over the dosing interval at steady state across the postpartum

Interventions

DRUGEPINEPHRINE
DRUGPARACETAMOL
DRUG-
DRUGDIPHENHYDRAMINE

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
1. Plasma concentration of DZP in the infants at birth, 2. Plasma concentration of DZP in mothers at delivery, 3. Ratio between plasma concentration of DZP between the infants and mother at birth/delivery—

Secondary

MeasureTime frame
1. Plasma concentration of DZP after birth in the infants from mothers continuing DZP treatment postpartum, 2. Predose and postdose plasma concentrations of DZP in mothers during pregnancy, 3. DZP plasma concentrations at 12 and 14 Weeks postpartum in mothers continuing DZP treatment postpartum, 4. DZP plasma concentrations at 12 weeks postpartum in mothers stopping DZP treatment postpartum, 5. Treatment-emergent adverse events (TEAEs) of mothers, 6. Serious TEAEs of mothers, 7. TEAEs of special interest of mothers, 8. TEAEs of special monitoring of mothers, 9. AEs of infants, 10. Serious AEs of infants, 11. AEs of special interest of infants, 12. AEs of special monitoring of infants, 13. Pregnancy outcome, 14. Predicted area under the curve (AUC) over the dosing interval at steady state across the second and third trimesters of pregnancy, 15. Predicted trough plasma concentration (Ctrough) over the dosing interval at steady state across the second and third trimesters of pregnancy, 16—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 30, 2026