A Multicenter, Open-Label, Phase II Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age with Systemic Lupus Erythematosus.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524578-41-00

Enrollment

Registered

2026-09-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-21

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

Conditions

Systemic Lupus Erythematosus

Brief summary

PK parameters of Cmax, AUC, tmax, and CL/F (all following the first dose), and Ctrough,ss (at Week 12), as data allow

Detailed description

Suppression of type I IFN 21-gene signature at Week 12 and 52. Change from baseline at Week 12 and 52 in: - Anti-dsDNA antibodies - C3, C4, and CH50 complement levels, Incidence of ADAs against anifrolumab

Interventions

DRUGSaphnelo 120 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
PK parameters of Cmax, AUC, tmax, and CL/F (all following the first dose), and Ctrough,ss (at Week 12), as data allow	—

Secondary

Measure	Time frame
Suppression of type I IFN 21-gene signature at Week 12 and 52. Change from baseline at Week 12 and 52 in: - Anti-dsDNA antibodies - C3, C4, and CH50 complement levels, Incidence of ADAs against anifrolumab	—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 22, 2026