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

NCT06299748 · tracked via the Priya Life Science USA tracker

Sponsor

argenx

Phase

Observational

Started

2023-11-30

Last updated

2026-02-17

Condition(s) studied

Myasthenia GravisCIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Investigational drug(s) / intervention(s)

Efgartigimod

Efgartigimod: Efgartigimod IV or SC

Study 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.

Eligibility

Sex

FEMALE

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Pregnancy outcomes — up to 10 years
Pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth ; Molar or ectopic pregnancy; Live birth (Preterm delivery; Fullterm delivery)

Trial sites (4)

Facility	City	Region	Status
United BioSource LLC	Morgantown	West Virginia	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

More argenx trials in the USA

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia Active, not recruiting

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis Recruiting

A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS) Active, not recruiting

ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis Recruiting

A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06299748 on ClinicalTrials.gov ↗ ← All trials in the USA