Safety assessment of efgartigimod exposure during pregnancy and breastfeeding
Official title: A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding
Run by argenx · NCT06299748 · Data updated 2026-11-12
This study is trying to see if efgartigimod is safe for pregnant women and breastfeeding mothers, and how it affects their babies.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 279 (estimated) |
| Sponsor | argenx Industry-sponsored |
| Locations | 4 sites (Morgantown, West Virginia and 3 other locations) |
| Status | Recruiting |
| Started | November 30, 2023 |
| Main results expected | January 2033 |
| Study ends | December 2033 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT06299748 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women or breastfeeding mothers who have been exposed to efgartigimod or efgartigimod PH20 SC.
✕Probably not a fit
Patients who have not been exposed to efgartigimod or efgartigimod PH20 SC during the specified timeframes will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multi-country, observational safety study focusing on pregnant women who have been exposed to efgartigimod or efgartigimod PH20 SC within 25 days prior to conception or during pregnancy. The study will also include women who were exposed during breastfeeding. The aim is to assess maternal, fetal, and infant outcomes and to compare these outcomes with background rates of major congenital malformations from the same regions. The study will gather data to better understand the safety profile of efgartigimod in these populations.
Why it matters
Potential benefit: If successful, this study could provide critical safety information regarding the use of efgartigimod during pregnancy and breastfeeding, potentially guiding treatment decisions for women with myasthenia gravis and CIDP.
How similar studies have gone: While this study is observational and focuses on a specific drug exposure, similar studies assessing drug safety during pregnancy have shown success in providing valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
United BioSource LLC
Morgantown, West Virginia, United States Recruiting -
Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1)
Bochum, Germany Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy Recruiting -
Hospital Universitari Vall d'Hebron
Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: Clinicaltrials@argenx.com
- Phone: 857-350-4834
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.