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NCT06594068 · ClinicalTrials.gov registry record · Phase 4
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
A Phase 4 study of Systemic Lupus Erythematosus, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06594068 is a Phase 4 study of Systemic Lupus Erythematosus that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 16 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06594068, a Phase 4 study of Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who receive anifrolumab therapeutically.
Conditions Studied
Interventions
- DRUG Anifrolumab
Study Locations (1)
Nevada
- Research Site - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2026-01-16 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06594068
The ClinicalTrials.gov registry entry for NCT06594068 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (96% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which Anifrolumab is the first listed.
NCT06594068 reports 1 study location spanning 1 distinct geographic area - top geographies include Nevada.
Frequently Asked Questions
What is clinical trial NCT06594068 about?
NCT06594068 is a clinical study titled "Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users". Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and ...
What is the current status of trial NCT06594068?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2026-01-16. Estimated completion is 2027-08-31.
What conditions does trial NCT06594068 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT06594068?
The interventions under investigation include: Anifrolumab (DRUG).
Who is sponsoring clinical trial NCT06594068?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06594068 being conducted?
This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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