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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: Completed Phase 2 study, sponsored by argenx.
NCT05267600 is a Phase 2 study that has completed, run by argenx. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
CRoff = complete remission while receiving efgartigimod PH20 SC or placebo and being off oral corticosteroid therapy for at least 8 weeks. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus.
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 |
What the finished NCT05267600 record still lists
NCT05267600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT05267600 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05267600's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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