16 Participants Needed

Anifrolumab for Lupus

(PRIMULA Lac Trial)

AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: AstraZeneca
Must be taking: Anifrolumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires ongoing treatment with anifrolumab. It is best to discuss your current medications with the trial team to ensure they are compatible with the study requirements.

Is anifrolumab safe for humans?

Anifrolumab has been studied for safety in people with systemic lupus erythematosus (SLE), and the safety profile is generally similar to placebo, though there is a higher risk of certain viral infections like herpes zoster (shingles). Serious side effects occurred in 8-16% of patients taking anifrolumab compared to 16-19% with placebo.12345

How is the drug anifrolumab different from other lupus treatments?

Anifrolumab is unique because it specifically targets and blocks the type 1 interferon receptor, which plays a key role in lupus, unlike other treatments that generally suppress the immune system. This targeted approach may lead to different effects on the body, such as a higher risk of certain viral infections.12356

What data supports the effectiveness of the drug Anifrolumab for treating lupus?

Anifrolumab has been shown to be effective in treating moderate to severe systemic lupus erythematosus (SLE), as it targets the type 1 interferon receptor involved in the disease's underlying causes. It was approved in the USA for this use in 2021, and studies have demonstrated its safety and efficacy in reducing disease activity.13467

Who Is on the Research Team?

DB

Darin Brimhall, MD

Principal Investigator

PPD, Las Vegas, US

Are You a Good Fit for This Trial?

This study is for breastfeeding individuals at least 18 years old with moderate/severe Systemic Lupus Erythematosus (SLE), who are on anifrolumab treatment and have been pumping or breastfeeding for at least 4 weeks. Participants must be willing to exclusively breastfeed/pump, use only lanolin nipple cream during sampling, and continue milk feeding throughout the study.

Inclusion Criteria

Maternal: Has reached or will reach steady state with anifrolumab by the time of study Day 1
Maternal: Ongoing treatment with anifrolumab
Infant: Birthweight > 10th percentile
See 9 more

Exclusion Criteria

My infant has a notable health issue or significant medical condition.
Maternal: Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives prior to enrollment
I was diagnosed with lupus nephritis in the past year.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive anifrolumab and undergo milk and serum collection at specified timepoints

4 weeks
14 milk collection visits, 3 maternal serum collection visits, 1 infant serum collection visit

Follow-up

Participants are monitored for maternal and infant adverse events and pharmacokinetic analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Anifrolumab
Trial Overview The PRIMULA Lac trial is examining if the lupus medication anifrolumab can be found in human breast milk and blood serum of both mother and infant. It's a post-marketing study required by the FDA to gather more information after the drug has been approved.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: AnifrolumabExperimental Treatment1 Intervention

Anifrolumab is already approved in United States, European Union for the following indications:

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Approved in United States as Saphnelo for:
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Approved in European Union as Saphnelo for:

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Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from ร‰cole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from ร‰cole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

PPD DEVELOPMENT, LP

Industry Sponsor

Trials
167
Recruited
38,000+
David Simmons profile image

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer profile image

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

Published Research Related to This Trial

In a 3-year study involving 218 patients with moderate-to-severe systemic lupus erythematosus (SLE), long-term treatment with anifrolumab showed an acceptable safety profile, with only 6.9% of patients discontinuing due to adverse events.
Patients experienced sustained improvements in SLE disease activity and health-related quality of life, with no new safety concerns identified, indicating that anifrolumab effectively manages SLE over an extended period.
Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study.Chatham, WW., Furie, R., Saxena, A., et al.[2021]
Anifrolumab is a monoclonal antibody that targets the type 1 interferon receptor and has been approved in the USA for treating moderate to severe systemic lupus erythematosus (SLE) in adults, marking a significant advancement in autoimmune disorder therapies.
The drug is currently being evaluated in ongoing clinical studies and is under regulatory review in the EU and Japan, indicating its potential for broader use in managing SLE and related conditions.
Anifrolumab: First Approval.Deeks, ED.[2022]
In the TULIP-LN trial involving 147 patients with active lupus nephritis, the intensified regimen of anifrolumab (900 mg followed by 300 mg) showed a higher rate of complete renal response at Week 104 compared to the basic regimen and placebo (27.3% vs 18.6% and 17.8%).
The safety profile of anifrolumab remained consistent over two years, with 72% of patients reporting at least one adverse event, but serious adverse events were relatively low, suggesting that anifrolumab is a tolerable treatment option for lupus nephritis.
Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial.Jayne, D., Rovin, B., Mysler, E., et al.[2023]

Citations

Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. [2021]
Anifrolumab: First Approval. [2022]
Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. [2023]
Belimumab or anifrolumab for systemic lupus erythematosus? A risk-benefit assessment. [2022]
Interferon Inhibition for Lupus with Anifrolumab: Critical Appraisal of the Evidence Leading to FDA Approval. [2022]
Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials. [2021]
Evaluation of anifrolumab safety in systemic lupus erythematosus: A meta-analysis and systematic review. [2022]
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