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NCT04109976 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis
A Phase 3 study, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
NCT04109976: Completed Phase 3 study, sponsored by UCB Biopharma SRL.
NCT04109976 is a Phase 3 study that has completed, run by UCB Biopharma SRL. The registered enrollment target is 214 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04109976, a Phase 3 study, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject bimekizumab at study start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).
Primary Outcome
Safe and effective self-injection was evaluated by the study personnel and was defined as: - Complete dose delivery: Participant self-injected the complete dose of bimekizumab as confirmed by a visual inspection of the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) which shows that the investigational medicinal product (IMP) was delivered completely (ie, container is empty), and - No Adverse Device Effects (ADEs) that would preclude continued use of the device for self-inj
Interventions
- DRUG Bimekizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2020-11-13 |
| Phase | Phase 3 |
What the finished NCT04109976 record still lists
NCT04109976 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Bimekizumab is the first listed.
NCT04109976 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04109976 about?
NCT04109976 is a clinical study titled "A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis". The purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject bimekizumab at study start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS)...
What is the current status of trial NCT04109976?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2019-08-13. Estimated completion is 2020-11-13.
What interventions are being tested in trial NCT04109976?
The interventions under investigation include: Bimekizumab (DRUG).
Who is sponsoring clinical trial NCT04109976?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04109976's enrollment target sits among peer trials
214 1335th of 2000 higher than 666 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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