A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
Public ClinicalTrials.gov record NCT04598477. 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
An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Pemphigus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a prospective, multicenter, open label extension (OLE) trial on the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK and PD of efgartigimod PH20 SC in adult PV or PF participants, who participated in antecedent trial ARGX-113-1904. This trial provided extension of efgartigimod PH20 SC treatment and retreatment options for participants who had been randomized to efgartigimod PH20 SC treatment arm in the trial ARGX-113-1904, and first treatment of efgartigimod PH20 SC and retreatment options for participants who had been randomized to the placebo arm in trial ARGX-113-1904. The participants could also receive concomitant prednisone therapy. Investigators could increase or decrease the prednisone dose based on protocol-specified criteria. Trial ARGX-113-1905 evaluated the ability to (further) taper prednisone therapy and achieve Clinical Remission (CR) off therapy (CRoff), the ability to achieve CR and CR on minimal therapy (CRmin) for participants who had not yet achieved CR or CRmin, and the ability to treat flare; it also assessed patient outcome measures and the safety, PD, PK and immunogenicity of efgartigimod PH20 SC over the duration of trial. Study duration: Up to 60 weeks for participants who receive IMP administration up to 52 weeks and with a follow-up period of 8 weeks after the last IMP administration
Study identification
- NCT ID
- NCT04598477
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 183 participants
Conditions and interventions
Conditions
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
- Jul 14, 2021
- Primary completion
- Mar 24, 2024
- Completion
- Mar 24, 2024
- Last update posted
- Mar 29, 2025
2021 – 2024
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator site 115 - US0010086 | Birmingham | Alabama | 35233 | — |
| Investigator site 89 - US0010091 | Scottsdale | Arizona | 85259 | — |
| Investigator site 124 - US0010092 | Redwood City | California | 94063 | — |
| Investigator site 1 - US0010087 | Boca Raton | Florida | 33428 | — |
| Investigator site 90 - US0010117 | Miami | Florida | 33173 | — |
| Investigator site 91 - US0010109 | Orlando | Florida | 32827 | — |
| Investigator site 126 - US0010090 | Minneapolis | Minnesota | 55455 | — |
| Investigator site 111 - US0010098 | St Louis | Missouri | 63110 | — |
| Investigator site 10 - US0010088 | Buffalo | New York | 14203-1070 | — |
| Investigator site 76 - US0010096 | Durham | North Carolina | 27710 | — |
| Investigator site 30 - US0010094 | Cleveland | Ohio | 44106-1716 | — |
| Investigator site 84 - US0010089 | Philadelphia | Pennsylvania | 19104 | — |
| Investigator site 103 - US0010097 | Philadelphia | Pennsylvania | 19140 | — |
| Investigator site 125 - US0010107 | Dallas | Texas | 75246 | — |
| Investigator site 87 - US0010084 | Dripping Springs | Texas | 78620 | — |
| Investigator site 88 - US0010114 | Houston | Texas | 77008 | — |
| Investigator site 44 - 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 110 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04598477, 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 Mar 29, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04598477 live on ClinicalTrials.gov.