A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
Public ClinicalTrials.gov record NCT05267600. 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 Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity, participant-reported outcome measures (including those assessing participant QoL), PK, and PD of efgartigimod PH20 SC administered via subcutaneous (SC) injection in adult participants with moderate to severe BP. This study intends to demonstrate that efgartigimod is an effective and safe treatment for BP, providing participants with control of disease activity (CDA) and eventually remission while reducing their cumulative exposure to OCS. study will consist of 2 parts: * Part A of the study is a phase 2 evaluation that intends to provide proof of concept for the therapeutic activity of efgartigimod PH20 SC in participants with BP. * Part B of the study is a phase 3 evaluation that intends to confirm the results obtained from part A in a separate, larger group of participants with BP. An interim analysis will be performed during part A (on data obtained through week 26 for all Part A participants) to assess the primary endpoint and several secondary endpoints, confirm the appropriate sample size for part B of the study, and determine whether the efficacy results observed through week 26 of part A warrant continued study of efgartigimod PH20 SC for the treatment of participants with BP (futility analysis).
Study identification
- NCT ID
- NCT05267600
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 98 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
- Jun 8, 2022
- Primary completion
- Sep 12, 2024
- Completion
- Sep 12, 2024
- Last update posted
- Oct 22, 2025
2022 – 2024
United States locations
- U.S. sites
- 21
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator site 74 - US0010178 | Phoenix | Arizona | 85006 | — |
| Investigator site 6 - US0010138 | Fountain Valley | California | 92708 | — |
| Investigator site 121 - US0010092 | Redwood City | California | 94063 | — |
| Investigator site 72 - US0010186 | Santa Monica | California | 90404 | — |
| Investigator site 10 - US0010153 | Castle Rock | Colorado | 80109 | — |
| Investigator site 2 - US0010087 | Boca Raton | Florida | 33428 | — |
| Investigator site 21 - US0010152 | Clearwater | Florida | 33756 | — |
| Investigator site 1 - US0010017 | Miami | Florida | 33173 | — |
| Investigator site 13 - US0010155 | West Lafayette | Indiana | 47906 | — |
| Investigator site 35 - US0010156 | Louisville | Kentucky | 40217 | — |
| Investigator site 50 - US0010149 | Ann Arbor | Michigan | 48109 | — |
| Investigator site 115 - US0010157 | Jackson | Mississippi | 39216 | — |
| Investigator site 73 - US0010098 | St Louis | Missouri | 63110 | — |
| Investigator site 85 - US0010159 | Lebanon | New Hampshire | 03756 | — |
| Investigator site 5 - US0010088 | Buffalo | New York | 14203 | — |
| Investigator site 93 - US0010169 | New York | New York | 10016 | — |
| Investigator site 4 - US0010137 | Fairborn | Ohio | 45324 | — |
| Investigator site 25 - US0010158 | Pittsburgh | Pennsylvania | 15213 | — |
| Investigator site 34 - US0010182 | Houston | Texas | 77004 | — |
| Investigator site 92 - US0010150 | Murray | Utah | 84107 | — |
| Investigator site 3 - US0010151 | Morgantown | West Virginia | 26505 | — |
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 108 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05267600, 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 Oct 22, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05267600 live on ClinicalTrials.gov.