Overview

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 Moderate to Severe Chronic Plaque Psoriasis (PSO)

Status:
Completed
Trial end date:
2020-09-08
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to evaluate the ability of subjects with moderate to severe chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study start and 8 weeks after training in self-injection technique using a prefilled safety syringe or an auto-injector.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB Biopharma S.P.R.L.
Criteria
Inclusion Criteria:

- Subject fulfills all inclusion criteria for the PS0014 [NCT03598790] study

- Subject is considered reliable and capable of adhering to the DV0002 protocol (eg,
able to understand and complete questionnaires, willing to self-inject, able to use
investigational device according to the instructions for use (IFU), and able to adhere
to the visit schedule) according to the judgment of the Investigator

Exclusion Criteria:

- Subjects are not permitted to enroll in DV0002 if any of the PS0014 [NCT03598790]
study exclusion criteria are met