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NCT04735432 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
A Phase 3 study, sponsored by argenx.
- Completed
- Registry status
- Phase 3
- Development phase
- 110
- Enrollment target
NCT04735432 is a Phase 3 study that has completed, run by argenx. The registered enrollment target is 110 participants.
The verdict
NCT04735432, a Phase 3 study, has completed, sponsored by argenx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 110 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)
Interventions
- BIOLOGICAL efgartigimod PH20 SC
- BIOLOGICAL efgartigimod IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2021-02-05 |
| Est. Completion | 2021-12-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04735432
The ClinicalTrials.gov registry entry for NCT04735432 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which efgartigimod PH20 SC is the first listed.
NCT04735432 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04735432 about?
NCT04735432 is a clinical study titled "Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis". The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generaliz...
What is the current status of trial NCT04735432?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2021-02-05. Estimated completion is 2021-12-13.
What interventions are being tested in trial NCT04735432?
The interventions under investigation include: efgartigimod PH20 SC (BIOLOGICAL), efgartigimod IV (BIOLOGICAL).
Who is sponsoring clinical trial NCT04735432?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
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