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Study identifier: NCT06299748 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Myasthenia Gravis · CIDP - Chronic Inflammatory Demyelinating Polyneuropathy  ·  Sponsor: argenx

PhaseN/A
Planned participants279
Who can joinFemale, N/A to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sabine Coppieters, MD  ·  857-350-4834  ·  Clinicaltrials@argenx.com

Always discuss trial participation with your own doctor first.

Locations (4)

United BioSource LLCMorgantown, West Virginia, United StatesRecruiting
Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1)Bochum, GermanyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyRecruiting
Hospital Universitari Vall d'HebronBarcelona, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT06299748