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)

UCB

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis

Treatments: Drug: Bimekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03766685

DV0002

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Bimekizumab-SS

Experimental group

Description:

Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).

Treatment:

Drug: Bimekizumab

Bimekizumab-AI

Experimental group

Description:

Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).

Treatment:

Drug: Bimekizumab