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Clinical Trials in the USA / NCT06299748
Recruiting Observational

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
No
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)

FacilityCityRegionStatus
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 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
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP Recruiting
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis Enrolling by invitation
A Natural History Study in Participants With Congenital Myasthenic Syndromes (CMS) Due to Mutations in DOK7, MUSK, AGRN, or LRP4 Recruiting
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis Active, not recruiting

Other trials for the same condition

Myasthenia Gravis Inebilizumab Trial Active, not recruiting
A Phase 1b/2 Study of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis Recruiting
ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod Recruiting
SP Thoracic IDE Study Active, not recruiting
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis Recruiting
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