Back to search results

Pregnancy Safety Study for Efgartigimod in Myasthenia Gravis and CIDP

This study is looking at the safety of efgartigimod (given intravenously or under the skin) for women who are pregnant or breastfeeding. It's for women with conditions like Myasthenia Gravis or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who have been exposed to efgartigimod. Researchers want to understand how efgartigimod affects mothers, babies, and children after birth. They will compare outcomes in women who took efgartigimod to general population rates. The study aims to enroll 279 women and will track pregnancy outcomes for up to 10 years. You can join if you were exposed to efgartigimod within 25 days before conception, during pregnancy, or while breastfeeding.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 279 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pregnancy outcomes will be measured for up to 10 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06299748

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

Recruiting
Not specifiedAll AgesObservational
argenx
~279 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Efgartigimod

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pregnancy outcomes
Measured over up to 10 years

Conditions

Myasthenia Gravis
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Explore related trials

Chronic Inflammatory Demyelinating PolyneuropathyMyasthenia Gravis

Where it's being run

4 sites across 4 states
West Virginia1
Germany1
Italy1
Spain1

Who to contact

Sabine Coppieters, MD
[email protected]
857-350-4834
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

None

What this trial measures

  • Pregnancy outcomesup to 10 years

    Pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth ; Molar or ectopic pregnancy; Live birth (Preterm delivery; Fullterm delivery)