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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 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.
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)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-10-26 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (91% lower). The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.