A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy And/or Breastfeeding.

Overseen By Sabine s Coppieters, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: argenx

Must be taking: Efgartigimod

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

279 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have not been exposed to efgartigimod before conception or during pregnancy/breastfeeding.

I have given my written consent, or if I'm a minor, my guardian has consented.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exposure Monitoring

Monitoring of pregnant women exposed to efgartigimod or efgartigimod PH20 SC during pregnancy or breastfeeding

up to 10 years

Follow-up

Participants are monitored for maternal, fetal, and infant outcomes, including congenital malformations and other health events

up to 10 years

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Retrospective Pregnancy Experimental Treatment 1 Intervention

woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy

Group II: Prospective Pregnancy Experimental Treatment 1 Intervention

woman is pregnant or breastfeeding at time of study enrollment.

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University