Clinical trial NCT03766685: 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)
Official title: A Multicenter, Randomized, Open-Label 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Moderate to Severe Chronic Plaque Psoriasis
Keywords: Bimekizumab
PSO
Psoriasis
Auto-Injector
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-safety Syringe (SS)-1mL or the Bimekizumab-auto-injector (AI)-1mL at Week 8, After Training in Self-injection Technique
timeFrame: Week 8
measure: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Week 8, After Training in Self-injection Technique
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-1mL or the Bimekizumab-AI-1mL at Baseline, After Training in Self-injection Technique
timeFrame: Baseline (the first self-injection visit)
measure: Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab-SS-2mL or the Bimekizumab-AI-2mL at Baseline, After Training in Self-injection Technique
timeFrame: Baseline (the first self-injection visit)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dv0002 946
state: Arizona
city: Bakersfield
country: United States
facility: Dv0002 910
state: California
city: San Diego
country: United States
facility: Dv0002 955
state: California
city: San Luis Obispo
country: United States
facility: Dv0002 943
state: California
city: Santa Monica
country: United States
facility: Dv0002 967
state: California
city: Boca Raton
country: United States
facility: Dv0002 906
state: Florida
city: Miami
country: United States
facility: Dv0002 907
state: Florida
city: Ocala
country: United States
facility: Dv0002 903
state: Florida
city: Tampa
country: United States
facility: Dv0002 936
state: Florida
city: Alpharetta
country: United States
facility: Dv0002 941
state: Georgia
city: Skokie
country: United States
facility: Dv0002 954
state: Illinois
city: West Des Moines
country: United States
facility: Dv0002 900
state: Iowa
city: Overland Park
country: United States
facility: Dv0002 905
state: Kansas
city: Owensboro
country: United States
facility: Dv0002 962
state: Kentucky
city: Baton Rouge
country: United States
facility: Dv0002 922
state: Louisiana
city: Brighton
country: United States
facility: Dv0002 925
state: Massachusetts
city: Troy
country: United States
facility: Dv0002 917
state: Michigan
city: Saint Louis
country: United States
facility: Dv0002 915
state: Missouri
city: Portsmouth
country: United States
facility: Dv0002 901
state: New Hampshire
city: East Windsor
country: United States
facility: Dv0002 908
state: New Jersey
city: New York
country: United States
facility: Dv0002 913
state: New York
city: Rochester
country: United States
facility: Dv0002 963
state: New York
city: Portland
country: United States
facility: Dv0002 920
state: Oregon
city: Portland
country: United States
facility: Dv0002 929
state: Oregon
city: Johnston
country: United States
facility: Dv0002 937
state: Rhode Island
city: Houston
country: United States
facility: Dv0002 951
state: Texas
city: San Antonio
country: United States
facility: Dv0002 914
state: Texas
city: Edmonton
country: Canada
facility: Dv0002 672
city: Halifax
country: Canada
facility: Dv0002 673
city: Hamilton
country: Canada
facility: Dv0002 671
city: Markham
country: Canada
facility: Dv0002 675
city: Mississauga
country: Canada
facility: Dv0002 663
city: Montréal
country: Canada
facility: Dv0002 660
city: Québec City
country: Canada
facility: Dv0002 665
city: Richmond Hill
country: Canada
facility: Dv0002 651
city: Toronto
country: Canada
facility: Dv0002 653
city: Toronto
country: Canada
facility: Dv0002 662
city: Waterloo
country: Canada
facility: Dv0002 657
city: Windsor
country: Canada
facility: Dv0002 670
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Bagel J, Tatla D, Hellot S, Knapp B, Murphy C, Peterson L, Sebastian M. Bimekizumab Self-Injection Devices: Two Multicenter, Randomized, Open-Label Studies on Self-Administration by Patients With Psoriasis. J Drugs Dermatol. 2022 Feb 1;21(2):162-171. doi: 10.36849/jdd.6274.