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

NCT06299748 | Recruiting FDA Drug

• 1 other identifier: ARGX-113-PAC-2206
• Study Type: observational
• Target: 279
• Locations: 4 countries
• Sites: 4

Brief 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.

Conditions

Myasthenia Gravis; CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• Pregnancy outcomes

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

  up to 10 years

Secondary Outcomes (5)

• Congenital malformations

  up to 10 years

• The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness)

  up to 10 years

• Maternal complications of pregnancy

  up to 10 years

• Maternal infections

  up to 10 years

• The number of observed fetal growth deficiency

  up to 10 years

Study Arms (2)

Retrospective Pregnancy

woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy

Biological: Efgartigimod

Prospective Pregnancy

woman is pregnant or breastfeeding at time of study enrollment.

Biological: Efgartigimod

Interventions

Efgartigimod BIOLOGICAL

Efgartigimod IV or SC

Prospective Pregnancy; Retrospective Pregnancy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women or women no longer pregnant at the time of study enrollment but exposed to efgartigimod any time within 25 days prior to conception or any time during the pregnancy.

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• argenx: lead

Study Sites (4)

United BioSource LLC

Morgantown, West Virginia, 26508, United States

RECRUITING

Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1)

Bochum, 44791, Germany

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

efgartigimod alfa

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Polyradiculoneuropathy; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; Clinicaltrials@argenx.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 8, 2024
• Study Start: November 30, 2023
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

DE (1); US (1); ES (1); IT (1)