The Anifrolumab PRIM Program

NCT06795893 | Recruiting FDA Drug

• 1 other identifier: D3461R00090
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

chronic autoimmune disease; immunosuppressants; corticosteroids; human monoclonal antibody (IgG1ƙ mAb); post Marketing Requirements (PMR) study; pregnancy; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Major congenital malfunctions

  The primary objective of the PRIM program is to estimate the proportion of anifrolumab-exposed pregnancies with major congenital malformations (MCMs) associated with exposure to anifrolumab during pregnancy.

  From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

Secondary Outcomes (3)

• Minor congenital malformations

  From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

• Adverse pregnancy outcomes

  From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

• Frequency of adverse pregnancy and birth outcomes

  From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

Study Arms (1)

Anifrolumab exposed pregnancies

The primary analysis cohort will be prospectively reported pregnancies with anifrolumab exposure anytime from 16 weeks prior to date of conception (DOC) until pregnancy outcome.

Drug: Anifrolumab

Interventions

Anifrolumab DRUG

Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor,which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving placebo. Moreover, the phase II MUSE study showed that administration of anifrolumab resulted in substantially reduce disease activity, as measured by the SLE Responder Index,compared to patients receiving placebo. Anifrolumab was approved by the FDA and EMA in July 2021 and February 2022,respectively, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

Also known as: Saphnelo

Anifrolumab exposed pregnancies

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All pregnancies exposed to anifrolumab and reported to the AstraZeneca pharmacovigilance database on or after the initiation of the PRIM program, regardless of when the pregnancy outcome was ascertained.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• PPD Development, LP: collaborator

Study Sites (1)

Reseach Facility

Södertälje, Sweden

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Syd Philips

  PPD Miami, US

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): April 15, 2031
• Study Completion (Estimated): April 15, 2031
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

SE (1)