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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: Recruiting Phase 4 study of Systemic Lupus Erythematosus, sponsored by AstraZeneca.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the milk concentration-time curve during a dosing interval is a component used to assess pharmacokinetic (PK) of anifrolumab in milk of lactating individuals. Milk PK parameters of anifrolumab will be derived using non-compartmental analysis methods and will be determined using the concentration-time data for all evaluable participants included in the PK population
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 |
What NCT06594068 shows while recruiting
NCT06594068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06594068's enrollment target sits among peer trials
16 93rd of 99 higher than 7 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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