Trials / Completed
CompletedNCT04109976
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 Multicenter, Randomized, Open-Label Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or Auto-Injector for the Subcutaneous Self-Injection of Bimekizumab Solution by Subjects With Active Psoriatic Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 214 (actual)
- Sponsor
- UCB Biopharma SRL · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bimekizumab | Study participants will receive bimekizumab at pre-specified time points. |
Timeline
- Start date
- 2019-08-13
- Primary completion
- 2020-11-05
- Completion
- 2020-11-13
- First posted
- 2019-10-01
- Last updated
- 2023-11-30
- Results posted
- 2023-11-30
Locations
47 sites across 6 countries: United States, Czechia, Germany, Hungary, Poland, Russia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04109976. Inclusion in this directory is not an endorsement.