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NCT04109976 Clinical Trial

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

Psoriatic Arthritis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04109976
Other study ID # DV0004
Secondary ID 2018-004725-86
Status Completed
Phase Phase 3
First received
Last updated
Start date August 13, 2019
Est. completion date November 13, 2020

Study information
Verified date November 2023
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 214
Est. completion date November 13, 2020
Est. primary completion date November 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: -Subjects are not permitted to enroll in DV0004 if any of the PA0012 [NCT04009499] study exclusion criteria are met

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bimekizumab
Study participants will receive bimekizumab at pre-specified time points.

Locations
Country Name City State
Czechia Dv0004 40061 Brno
Czechia Dv0004 40009 Pardubice
Czechia Dv0004 40066 Praha 2
Czechia Dv0004 40063 Praha 5
Czechia Dv0004 40010 Uherské Hradište
Czechia Dv0004 40012 Zlín
Germany Dv0004 40029 Hamburg
Hungary Dv0004 40079 Szentes
Poland Dv0004 40038 Elblag
Poland Dv0004 40088 Elblag
Poland Dv0004 40096 Gdynia
Poland Dv0004 40042 Kraków
Poland Dv0004 40092 Kraków
Poland Dv0004 40037 Lublin
Poland Dv0004 40091 Nowa Sól
Poland Dv0004 40044 Poznan
Poland Dv0004 40118 Torun
Poland Dv0004 40041 Warsaw
Poland Dv0004 40097 Warsaw
Poland Dv0004 40098 Warszawa
Poland Dv0004 40039 Wroclaw
Poland Dv0004 40043 Wroclaw
Russian Federation Dv0004 20005 Moscow
Russian Federation Dv0004 20013 Petrozavodsk
Russian Federation Dv0004 20004 Saint Petersburg
Russian Federation Dv0004 20014 Ulyanovsk
Russian Federation Dv0004 20015 Yaroslavl
United States Dv0004 50029 Albuquerque New Mexico
United States Dv0004 50023 Baton Rouge Louisiana
United States Dv0004 50050 Beckley West Virginia
United States Dv0004 50024 Boise Idaho
United States Dv0004 50010 Brooklyn New York
United States Dv0004 50125 Charlotte North Carolina
United States Dv0004 50040 Dayton Ohio
United States Dv0004 50020 Duncansville Pennsylvania
United States Dv0004 50005 Freehold New Jersey
United States Dv0004 50015 Hagerstown Maryland
United States Dv0004 50001 Jackson Tennessee
United States Dv0004 50008 Johnston Rhode Island
United States Dv0004 50019 Lansing Michigan
United States Dv0004 50028 Lexington Kentucky
United States Dv0004 50036 Mesquite Texas
United States Dv0004 50016 Saint Louis Missouri
United States Dv0004 50031 Salisbury North Carolina
United States Dv0004 50009 Waco Texas
United States Dv0004 50026 Wheaton Maryland
United States Dv0004 50006 Wyomissing Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  Hungary,  Poland,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Week 4 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-injection (ie, no serious ADEs (SADEs) and/or ADEs leading to withdrawal). Week 4
Secondary Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Baseline 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-SS or the bimekizumab-AI which shows that the IMP is delivered completely (ie, container is empty), and - No ADEs that would preclude continued use of the device for self-injection (ie, no SADEs and/or ADEs leading to withdrawal). Baseline
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