Recruiting

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

Sponsor:

argenx

Code:

NCT06299748

Conditions

Myasthenia Gravis

CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Efgartigimod

Study Details

Brief summary:

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.

Conditions

Myasthenia Gravis

CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Study ID

NCT06299748

Start date

Nov 30, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2033

Anticipated

Primary completion date

Jan, 2033

Anticipated

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days.
Written/verbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written/verbal informed assent or eConsent by the pregnant minor (where applicable) and written/verbal informed consent or eConsent by the parent/legal guardian).

Exclusion Criteria:

None

Study Design

Enrollment

279 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrospective Pregnancy

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

Prospective Pregnancy

woman is pregnant or breastfeeding at time of study enrollment.

Interventions

Efgartigimod

Efgartigimod IV or SC

Primary outcome measure

Pregnancy outcomes [ Time Frame: up to 10 years ]

Central Contacts and Locations

Central contacts

Sabine Coppieters, MD

857-350-4834 Clinicaltrials@argenx.com

Locations

United BioSource LLC

Recruiting

Morgantown, West Virginia, United States, 26508

Contacts

Sabine Coppieters, MD

857-350-4834 clinicaltrials@argenx.com

More Information

Sponsor

argenx

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by argenx on 2026-02-17.