A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
← catalyst calendarNCT07630714 · readout in 1,476 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 2
Status
Not yet recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
24estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-28 | estimated | When the study began enrolling |
| Primary completion | 2030-09-03 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-09-05 | estimated | The whole study's end, after follow-up |
| First posted | 2026-06-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Systemic Lupus Erythematosus
Intervention
- Combination product: Anifrolumab + APFS — also filed as MEDI-546, SAPHNELO™
Primary outcomes
what the primary-completion date above is the date OFMaximum observed serum (peak) concentration (Cmax)
measured Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Area under the serum concentration-time curve (AUC)
measured Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Time to maximum plasma concentration (tmax)
measured Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Apparent total body clearance of drug from plasma (CL/F)
measured Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Trough drug concentration at steady state (Ctrough,ss)
measured At Week 12
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