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)

Conditions

• Chronic Plaque Psoriasis
• Moderate to Severe Chronic Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bimekizumab — DRUG
  Subjects will receive bimekizumab at pre-specified time-points.

Study Details

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.

Key Dates

Start date

Dec 20, 2018

Status verified

Jul 2025

Primary completion

Jul 14, 2020

Completion

Sep 8, 2020

Study Design

Enrollment

172 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bimekizumab-SS
  Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).
• Experimental: Bimekizumab-AI
  Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).

Primary Outcome 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 [ Time Frame: Week 8 ]

Locations (27)

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