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NCT04598451 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
A Phase 3 study, sponsored by argenx.
- Completed
- Registry status
- Phase 3
- Development phase
- 222
- Enrollment target
NCT04598451 is a Phase 3 study that has completed, run by argenx. The registered enrollment target is 222 participants.
The verdict
NCT04598451, a Phase 3 study, has completed, sponsored by argenx.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 222 participants
- Enrollment target
Study Summary
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult participants aged from 18 years with PV or PF. The trial comprises a screening period of up to 3 weeks, a treatment period of up to 30 weeks, and an 8-week follow-up period for participants who do not enroll into the open-label extension (OLE) trial ARGX-113-1905. The primary objective of the ARGX-113-1904 trial is to demonstrate the efficacy of subcutaneous administration of efgartigimod co-formulated with recombinant human hyaluronidase PH20 (Efgartigimod PH20 SC) compared to placebo in the treatment of participants with Pemphigus Vulgaris (PV). Secondary objectives are to also demonstrate the efficacy of efgartigimod PH20 SC in the treatment of participants with Pemphigus Foliaceus (PF), and to demonstrate early onset of action and a prednisone-sparing effect. After confirmation of eligibility, participants will be randomized in a 2: 1 ratio to receive efgartigimod PH20 SC or placebo
Interventions
- OTHER Placebo
- DRUG prednisone
- BIOLOGICAL efgartigimod PH20 SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2023-08-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04598451
The ClinicalTrials.gov registry entry for NCT04598451 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 222 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 3 interventions - of which Placebo is the first listed.
NCT04598451 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04598451 about?
NCT04598451 is a clinical study titled "A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)". This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult participants aged from 18 years with PV or PF. The trial comprises a scree...
What is the current status of trial NCT04598451?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 222 participants. The study started on 2020-12-01. Estimated completion is 2023-08-22.
What interventions are being tested in trial NCT04598451?
The interventions under investigation include: Placebo (OTHER), prednisone (DRUG), efgartigimod PH20 SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT04598451?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
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