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Monoclonal Antibodies

Anifrolumab for Lupus (PRIMULA Lac Trial)

Phase 4

Recruiting

Led By Darin Brimhall, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infant: Weight > 10th percentile at the time of enrollment

Infant: Gestational age at delivery ≥32 weeks

Must not have

Infant: Any abnormality noted or clinically significant medical condition at the time of screening

Maternal: History of malignancy in the last 10 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up total duration of participation for each participant will be approximately 1 month; data collection is planned for approximately 3 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial, PRIMULA Lac, is a study to gather information on the effects of anifrolumab on breastfeeding mothers and their infants. It aims to understand how anifrolumab

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, generally speaking, participants may experience potential side effects related to anifrolumab which could include infusion reactions, infections due to immune system suppression, or other immune-related conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My infant's weight is in the top 90% for their age.

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My baby was born at or after 32 weeks of pregnancy.

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I am 18 years old or older.

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I have been diagnosed with moderate to severe lupus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant has a notable health issue or significant medical condition.

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I have had cancer within the last 10 years.

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I do not have mastitis or any serious infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ total duration of participation for each participant will be approximately 1 month; data collection is planned for approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~total duration of participation for each participant will be approximately 1 month; data collection is planned for approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and total duration of participation for each participant will be approximately 1 month; data collection is planned for approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the milk concentration-time curve during a dosing interval

Area under the milk concentration-time curve from time 0 to last quantifiable concentration

Average milk concentration at steady state

+3 more

Secondary study objectives

Estimates of infant exposure

Fraction of dose excreted in milk

Maternal and Infant adverse events (AEs)

+2 more

Side effects data

From 2018 Phase 3 trial • 373 Patients • NCT02446899

23%

Upper respiratory tract infection

16%

Nasopharyngitis

14%

Infusion related reaction

13%

Bronchitis

12%

Urinary tract infection

Herpes zoster

Sinusitis

Cough

Headache

Back pain

Arthralgia

Nausea

Pneumonia

Lip squamous cell carcinoma

Cervical dysplasia

Angioedema

Hypoaesthesia

Acute coronary syndrome

Chilaiditi's syndrome

Hypersensitivity

Appendicitis

Diverticulitis

Gastroenteritis viral

Fall

Nephrolithiasis

Traumatic fracture

Blood creatinine increased

Osteonecrosis

Systemic lupus erythematosus

100%

80%

60%

40%

20%

Study treatment Arm

Anifrolumab 300 mg

Placebo

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AnifrolumabExperimental Treatment1 Intervention

Lactating individuals 18 years of age or older receiving anifrolumab therapeutically who provide consent to participate will be included in the study. Milk collection will occur at a series of 14 timepoints, 1 pre-dose (spot) and 13 post-dose: Day 1 \[0-4 hours, 4-8 hours, 8-12 hours, 12-18 hours, 18-24 hours\], Day 3 \[48 hours, spot\], 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 will be collected Day 1 (pre-dose and 0-4 hours post-dose), Day 12, and approximately Day 29 (immediately preceding subsequent dose). Infant serum will be collected on approximately Day 30 following the next dose and after 24 hours of breast feeding.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anifrolumab

2015

Completed Phase 3

~1990

0 / 7Eligibility criteria met