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NCT04598477 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by argenx.
- Terminated
- Registry status
- Phase 3
- Development phase
- 183
- Enrollment target
NCT04598477 is a Phase 3 study that was terminated before completion, run by argenx. The registered enrollment target is 183 participants.
The verdict
NCT04598477, a Phase 3 study, was terminated before completion, sponsored by argenx.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 183 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG prednisone
- BIOLOGICAL efgartigimod PH20 SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2021-07-15 |
| Est. Completion | 2024-03-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04598477
The ClinicalTrials.gov registry entry for NCT04598477 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 183 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.
NCT04598477 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04598477 about?
NCT04598477 is a clinical study titled "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)". 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 o...
What is the current status of trial NCT04598477?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 183 participants. The study started on 2021-07-15. Estimated completion is 2024-03-25.
What interventions are being tested in trial NCT04598477?
The interventions under investigation include: prednisone (DRUG), efgartigimod PH20 SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT04598477?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
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