Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
← catalyst calendarNCT06594068 · readout in 376 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With PPD Development, LP.
Phase
Phase 4
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
16estimated
Sites
1
Country
United States
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 | 2026-01-16 | actual | When the study began enrolling |
| Primary completion | 2027-08-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-08-31 | estimated | The whole study's end, after follow-up |
| First posted | 2024-09-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | 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
- Drug: Anifrolumab
Primary outcomes
what the primary-completion date above is the date OFArea under the milk concentration-time curve during a dosing interval
measured Approximately 30 days
Area under the milk concentration-time curve from time 0 to last quantifiable concentration
measured Approximately 30 days
Average milk concentration at steady state
measured Approximately 30 days
Observed milk concentration at end of dosing interval
measured Approximately 30 days
Maximum observed milk concentration
measured Approximately 30 days
Time of maximum concentration
measured Approximately 30 days
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