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NCT06299748 · ClinicalTrials.gov registry record

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

A clinical trial of Myasthenia Gravis and CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by argenx.

Recruiting
Registry status
279
Enrollment target
4
Study locations

NCT06299748 is a study of Myasthenia Gravis and CIDP - Chronic Inflammatory Demyelinating Polyneuropathy that is actively recruiting participants, run by argenx. The registered enrollment target is 279 participants, above the 182-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (53% higher). The trial reports 4 study locations across 2 states.

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The verdict

NCT06299748, a study of Myasthenia Gravis and CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, is actively recruiting participants, sponsored by argenx.

RECRUITING
Registry status
279 participants
Enrollment target
4
Study locations

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.

Conditions Studied

Myasthenia Gravis CIDP - Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

  • BIOLOGICAL Efgartigimod

Study Locations (4)

Other

  • Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1) - Bochum
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma
  • Hospital Universitari Vall d'Hebron - Barcelona

West Virginia

  • United BioSource LLC - Morgantown

Trial Details

FieldValue
Enrollment Target 279 participants
Start Date 2023-11-30
Est. Completion 2033-12

Sponsor

argenx

49 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06299748

The ClinicalTrials.gov registry entry for NCT06299748 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 279 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 182-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (53% higher). The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Myasthenia Gravis appearing as the primary indexed condition, and to 1 intervention - of which Efgartigimod is the first listed.

NCT06299748 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Other, West Virginia.

Frequently Asked Questions

What is clinical trial NCT06299748 about?

NCT06299748 is a clinical study titled "A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.". 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 enrol...

What is the current status of trial NCT06299748?

This trial is currently recruiting. The enrollment target is 279 participants. The study started on 2023-11-30. Estimated completion is 2033-12.

What conditions does trial NCT06299748 study?

This clinical trial studies the following conditions: Myasthenia Gravis, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy.

What interventions are being tested in trial NCT06299748?

The interventions under investigation include: Efgartigimod (BIOLOGICAL).

Who is sponsoring clinical trial NCT06299748?

This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06299748 being conducted?

This trial has 4 study locations across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.