Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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

NCT04833894 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: * The maximum trial duration for each individual participant will be approximately 28 weeks * The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)

Interventions

  • BIOLOGICAL Efgartigimod IV

Study Locations (20)

Other

  • Medizinische Universitat Wien — Vienna
  • Universitair Ziekenhuis Antwerpen — Antwerp
  • Alberta Childrens Hospital — Calgary
  • British Columbia Children's Hospital — Vancouver
  • AP-HM - Hopital de la Timone — Marseille
  • Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades — Paris
  • Vian - M. Iashvili Children's Central Hospital — Tbilisi
  • Tbilisi State Medical University - Givi Zhvania Pediatric Academic Clinic — Tbilisi
  • Charite Universitaetsmedizin Berlin - Campus Virchow-Klinikum - Sozialpadiatrisches Zentrum — Berlin
  • Universitätsklinikum Essen — Essen
  • Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari — Bari
  • Azienda Ospedaliero Universitaria A. Meyer — Florence
  • Ospedale Giannina Gaslini — Genova
  • Leids Universitair Medisch Centrum — Leiden
  • Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM — Warsaw

Illinois

  • Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital — Chicago

North Carolina

  • University of North Carolina at Chapel Hill — Chapel Hill

Virginia

  • University of Virginia (UVA) Health - Developmental Pediatrics Clinic — Charlottesville

Woj. Pomorskie

  • Uniwersyteckie Centrum Kliniczne — Gdansk

Woj. Slaskie

  • Wielospecjalistyczna Poradnia Lekarska Synapsis — Katowice

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2021-10-26
Est. Completion 2027-03
Phase Phase 2

Sponsor

argenx

96 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04833894

The ClinicalTrials.gov registry entry for NCT04833894 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 1 intervention — of which Efgartigimod IV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04833894 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Illinois, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04833894 about?

NCT04833894 is a clinical study titled "Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis". The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: * The maximum trial duration for each individual participant will be approximately 28 weeks * The tr...

What is the current status of trial NCT04833894?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2021-10-26. Estimated completion is 2027-03.

What conditions does trial NCT04833894 study?

This clinical trial studies the following conditions: Generalized Myasthenia Gravis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04833894?

The interventions under investigation include: Efgartigimod IV (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04833894?

This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04833894 being conducted?

This trial has 20 study locations across Illinois, North Carolina, Virginia, Woj. Pomorskie, Woj. Slaskie. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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