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NCT04833894 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Generalized Myasthenia Gravis, sponsored by argenx.

Recruiting
Registry status
Phase 2
Development phase
12
Enrollment target
20
Study locations

NCT04833894: Recruiting Phase 2 study of Generalized Myasthenia Gravis, sponsored by argenx.

NCT04833894 is a Phase 2 study of Generalized Myasthenia Gravis that is actively recruiting participants, run by argenx. The registered enrollment target is 12 participants, below the 131-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04833894, a Phase 2 study of Generalized Myasthenia Gravis, is actively recruiting participants, sponsored by argenx.

RECRUITING
Registry status
Phase 2
Development phase
12 participants
Enrollment target
20
Study locations

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)

Primary Outcome

Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod

Conditions Studied

Generalized Myasthenia Gravis

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
argenx

49 total trials

What NCT04833894 shows while recruiting

NCT04833894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 131-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (91% lower).

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.

NCT04833894 names 20 study sites across 6 states, led by Other, Illinois, North Carolina.

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.

What interventions are being tested in trial NCT04833894?

The interventions under investigation include: Efgartigimod IV (BIOLOGICAL).

Who is sponsoring clinical trial NCT04833894?

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

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.

Learn More About Clinical Trials

Similar trials for Generalized Myasthenia Gravis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04833894's enrollment target sits among peer trials

12 22nd of 26 higher than 1 of 26 other Generalized Myasthenia Gravis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Generalized Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04833894

Source: ClinicalTrials.gov NCT04833894, the US trial registry maintained by the National Library of Medicine. NCT04833894 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.