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Anifrolumab for Lupus (PRIMULA Lac Trial)

Phase 4

Waitlist Available

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

Be older than 18 years old

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

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.

Eligible Conditions

Lupus

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

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