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NCT05681481 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
A Phase 3 study, sponsored by argenx.
- Terminated
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
NCT05681481: Clinical Trial Phase 3 study, sponsored by argenx.
NCT05681481 is a Phase 3 study that was terminated before completion, run by argenx. The registered enrollment target is 64 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05681481, a Phase 3 study, was terminated before completion, sponsored by argenx.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of efgartigimod PH20 SC over a longer period of time in adult participants with moderate-to-severe bullous pemphigoid (BP) who have completed ARGX-113-2009 study. The study will also evaluate the efficacy of efgartigimod PH20 SC. Eligible participants can roll over from the main study (ARGX-113-2009) to this open-label extension study (ARGX-113-2010). The study consists of a treatment period of up to 48 weeks in which participants could receive efgartigimod PH20 SC according to their clinical status. After the first 5 visits, the participants will visit the study centres at least once every 4 weeks. The participants who are not receiving efgartigimod PH20 SC (after the main study or currently on the study), will enter an observation period with study visits at least once every 8 weeks. If the participant relapses, they can re-enter the treatment period where they will receive efgartigimod PH20 SC. The treatment and observation period is followed by a follow-up period of 8 weeks. Oral or topical corticosteroids can be administered at the investigator's discretion.
Primary Outcome
Adverse events, Serious Adverse event and Adverse events of special interest. Adverse events in the 'Infections and infestations' SOC were defined as AESIs because efgartigimod causes a transient reduction in total IgG levels.
Interventions
- DRUG Prednisone
- BIOLOGICAL efgartigimod PH20 SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2025-03-20 |
| Phase | Phase 3 |
Why NCT05681481 stopped before completion
NCT05681481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Prednisone is the first listed.
NCT05681481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05681481 about?
NCT05681481 is a clinical study titled "A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid". The purpose of this study is to evaluate the safety of efgartigimod PH20 SC over a longer period of time in adult participants with moderate-to-severe bullous pemphigoid (BP) who have completed ARGX-113-2009 study. The study will also evaluate the efficacy of efgartigimod PH20 SC. Eligible particip...
What is the current status of trial NCT05681481?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 2023-03-22. Estimated completion is 2025-03-20.
What interventions are being tested in trial NCT05681481?
The interventions under investigation include: Prednisone (DRUG), efgartigimod PH20 SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT05681481?
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 NCT05681481's enrollment target sits among peer trials
64 1799th of 2000 higher than 201 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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