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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 is a Phase 3 study that was terminated before completion, run by argenx. The registered enrollment target is 64 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05681481
The ClinicalTrials.gov registry entry for NCT05681481 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prednisone is the first listed.
NCT05681481 reports 0 study locations.
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.
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