Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05267600 · ClinicalTrials.gov registry record · Phase 2
A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
A Phase 2 study, sponsored by argenx.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT05267600 is a Phase 2 study that has completed, run by argenx. The registered enrollment target is 98 participants.
The verdict
NCT05267600, a Phase 2 study, has completed, sponsored by argenx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Prednisone
- OTHER placebo
- BIOLOGICAL efgartigimod PH20 SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2024-09-13 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05267600
The ClinicalTrials.gov registry entry for NCT05267600 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 98 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 3 interventions - of which Prednisone is the first listed.
NCT05267600 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05267600 about?
NCT05267600 is a clinical study titled "A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid". 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), P...
What is the current status of trial NCT05267600?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2022-06-09. Estimated completion is 2024-09-13.
What interventions are being tested in trial NCT05267600?
The interventions under investigation include: Prednisone (DRUG), placebo (OTHER), efgartigimod PH20 SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT05267600?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.