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

UCB

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Bimekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04109976

DV0004

2018-004725-86 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Bimekizumab-SS

Experimental group

Description:

Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS).

Treatment:

Drug: Bimekizumab

Bimekizumab-AI

Experimental group

Description:

Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI).

Treatment:

Drug: Bimekizumab