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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: Completed Phase 3 study, sponsored by argenx.
NCT04735432 is a Phase 3 study that has completed, run by argenx. The registered enrollment target is 110 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
ANCOVA Analysis of Percent Change From Baseline in Total IgG Level at Day 29 (ie, 7 days after the fourth IV or SC administration).
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 |
What the finished NCT04735432 record still lists
NCT04735432 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which efgartigimod PH20 SC is the first listed.
NCT04735432 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04735432's enrollment target sits among peer trials
110 1657th of 2000 higher than 337 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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