A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
Public ClinicalTrials.gov record NCT04598451. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04598451
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 222 participants
Conditions and interventions
Conditions
Interventions
- efgartigimod PH20 SC Biological
- Placebo Other
- prednisone Drug
Biological · Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2020
- Primary completion
- Aug 21, 2023
- Completion
- Aug 21, 2023
- Last update posted
- Sep 30, 2024
2020 – 2023
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator site 77 - US0010086 | Birmingham | Alabama | 35233 | — |
| Investigator site 97 - US0010091 | Scottsdale | Arizona | 85259 | — |
| Investigator site 121 - US0010092 | Redwood City | California | 94063 | — |
| Investigator site 125 - US0010153 | Castle Rock | Colorado | 80109 | — |
| Investigator site 2 - US0010087 | Boca Raton | Florida | 33428 | — |
| Investigator site 99 - US0010117 | Miami | Florida | 33173 | — |
| Investigator site 78 - US0010109 | Orlando | Florida | 32827 | — |
| Investigator site 127 - US0010155 | West Lafayette | Indiana | 47906 | — |
| Investigator site 61 - US0010090 | Minneapolis | Minnesota | 55455 | — |
| Investigator site 102 - US0010098 | St Louis | Missouri | 63110 | — |
| Investigator site 19 - US0010088 | Buffalo | New York | 14203-1070 | — |
| Investigator site 136 - US0010196 | New York | New York | 10128 | — |
| Investigator site 60 - US0010096 | Durham | North Carolina | 27710 | — |
| Investigator site 20 - US0010094 | Cleveland | Ohio | 44106-1716 | — |
| Investigator site 73 - US00100 | Philadelphia | Pennsylvania | 19104 | — |
| Investigator site 101 - US0010097 | Philadelphia | Pennsylvania | 19140 | — |
| Investigator site 98 - US0010107 | Dallas | Texas | 75246 | — |
| Investigator site 1 - US0010084 | Dripping Springs | Texas | 78620 | — |
| Investigator site 126 - US0010182 | Houston | Texas | 77004 | — |
| Investigator site 88 - US0010114 | Houston | Texas | 77008 | — |
| Investigator site 59 - US0010106 | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 113 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04598451, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 30, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04598451 live on ClinicalTrials.gov.