Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
AstraZeneca
Study ID
NCT06594068
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

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 (Furie et al., 2017). Clinical trial evidence from TULIP 1, 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 (Furie et al., 2019; Morand et al., 2020). The phase II MUSE study showed that administration of anifrolumab resulted in substantially reduced disease activity, measured by the SLE Responder Index, compared to patients receiving placebo (Furie et al., 2017). These data resulted with applications to the FDA and the EMA, leading to approvals in July 2021 and February 2022, for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

Study Details

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 are receiving anifrolumab therapeutically via intravenous (IV) or subcutaneous (SC) administration and evaluate exposure and effects on the breastfed infant.

Key Dates

First listed
Sep 19, 2024
Start date
Jan 16, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anifrolumab (IV administration and SC administration)
    For participants with IV administration, milk will be collected at 14 timepoints: 1 pre-dose (spot) and 13 post-dose: Day 1 \[0-4, 4-8, 8-12, 12-18, 18-24 hours\], Day 3 \[48 hours\], Day 4 (spot), Day 6 (spot), Day 8 (spot), Day 12 (spot), Day 16 (spot), Day 22 (spot), and Day 29 (prior to next dose, spot). Maternal serum collection: Day 1 (pre-dose and 0-4 hours post-dose), Day 12, and Day 29. Infant serum collection: Day 30 after the next dose and after 24 hours of breastfeeding. Total duration of participation will be 1 month. For participants with SC administration, the total duration of participation will be 9 days. Milk will be collected at 10 timepoints: 1 pre-dose (spot) and 9 post-dose: Day 1 \[0-4, 4-8, 8-12, 12-18, 18-24 hours\], Day 3 \[48 hours\], Day 4 (spot), Day 6 (spot), Day 8 (prior to next dose, spot). Maternal serum collection: Day 1 (pre-dose and 0-4 hours postdose), and Day 8. Infant serum collection: Day 9 after the next dose and after 24 hours of breastfeeding.

Primary Outcome Measure

Area under the milk concentration-time curve during a dosing interval [ Time Frame: Approximately 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteLas VegasNevada89113-

Find similar trials in Las Vegas, NV

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Research Site· Las Vegas, NV

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