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Recruiting NCT06795893

NCT06795893 The Anifrolumab PRIM Program

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Clinical Trial Summary
NCT ID NCT06795893
Status Recruiting
Phase
Sponsor AstraZeneca
Condition Systemic Lupus Erythematosus
Study Type OBSERVATIONAL
Enrollment 240 participants
Start Date 2025-11-07
Primary Completion 2031-04-15

Eligibility & Interventions

Sex Female only
Min Age N/A
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Anifrolumab

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 240 participants in total. It began in 2025-11-07 with a primary completion date of 2031-04-15.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

Eligibility Criteria

Inclusion Criteria: * Currently or recently (within 1 year of pregnancy outcome) pregnant * Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception Exclusion Criteria: * Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.

Contact & Investigator

Central Contact

AstraZeneca Clinical Study Information Center

✉ information.center@astrazeneca.com

📞 1-877-240-9479

Principal Investigator

Syd Philips

PRINCIPAL INVESTIGATOR

PPD Miami, US

Frequently Asked Questions

Who can join the NCT06795893 clinical trial?

This trial is open to female participants only, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06795893 currently recruiting?

Yes, NCT06795893 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.

Where is the NCT06795893 trial being conducted?

This trial is being conducted at Södertälje, Sweden.

Who is sponsoring the NCT06795893 clinical trial?

NCT06795893 is sponsored by AstraZeneca. The principal investigator is Syd Philips at PPD Miami, US. The trial plans to enroll 240 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology