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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: Completed Phase 3 study, sponsored by argenx.
NCT04598451 is a Phase 3 study that has completed, run by argenx. The registered enrollment target is 222 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Proportion of participants with pemphigus vulgaris who had CRmin within 30 weeks, defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
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 |
What the finished NCT04598451 record still lists
NCT04598451 is an interventional study that assigns participants to a tested intervention. The registered 222 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 (71% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04598451 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04598451's enrollment target sits among peer trials
222 1317th of 2000 higher than 683 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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