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

Completed · Phase 3

Conditions studied: Psoriatic Arthritis

In brief

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).

Key facts

Study ID

NCT04109976

Run by

UCB Biopharma SRL

People needed

214

Starts

2019-08-13

Expected to finish

2020-11-13

Last updated by the study team

2023-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject fulfills all inclusion criteria for the PA0012 [NCT04009499] study
• Subject is considered reliable and capable of adhering to the DV0004 protocol (eg, able to understand and complete questionnaires, able to use investigational self-injecting device presentations according to the instructions for use (IFU), and able to adhere to the visit schedule) according to the judgment of the Investigator
• Subject is willing to self-inject

You may not qualify if…

• Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study exclusion criteria are met

Where it is running

• Dv0004 50024 — Boise, Idaho, United States
• Dv0004 50028 — Lexington, Kentucky, United States
• Dv0004 50023 — Baton Rouge, Louisiana, United States
• Dv0004 50015 — Hagerstown, Maryland, United States
• Dv0004 50026 — Wheaton, Maryland, United States
• Dv0004 50019 — Lansing, Michigan, United States
• Dv0004 50016 — St Louis, Missouri, United States
• Dv0004 50005 — Freehold, New Jersey, United States
• Dv0004 50029 — Albuquerque, New Mexico, United States
• Dv0004 50010 — Brooklyn, New York, United States
• Dv0004 50125 — Charlotte, North Carolina, United States
• Dv0004 50031 — Salisbury, North Carolina, United States
• Dv0004 50040 — Dayton, Ohio, United States
• Dv0004 50020 — Duncansville, Pennsylvania, United States
• Dv0004 50006 — Wyomissing, Pennsylvania, United States
• Dv0004 50008 — Johnston, Rhode Island, United States
• Dv0004 50001 — Jackson, Tennessee, United States
• Dv0004 50036 — Mesquite, Texas, United States
• Dv0004 50009 — Waco, Texas, United States
• Dv0004 50050 — Beckley, West Virginia, United States
• Dv0004 40061 — Brno, Czechia
• Dv0004 40009 — Pardubice, Czechia
• Dv0004 40063 — Prague, Czechia
• Dv0004 40066 — Prague, Czechia
• Dv0004 40010 — Uherské Hradiště, Czechia

Full record on ClinicalTrials.gov

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