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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)

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ClinicalTrials.gov Identifier: NCT03766685
Recruitment Status : Enrolling by invitation
First Posted : December 6, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis Drug: Bimekizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Bimekzumab-SS
Subjects will receive assigned bimekizumab dose regimen using a prefilled safety syringe (SS).
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • UCB4940
  • BKZ

Experimental: Bimekizumab-AI
Subjects will receive assigned bimekizumab dose regimen using an auto-injector (AI).
Drug: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
Other Names:
  • UCB4940
  • BKZ




Primary Outcome Measures :
  1. Percentage of subjects able to self-administer safe and effective injections using the bimekizumab-safety syringe (SS) or the bimekizumab-auto-injector (AI) respectively at Week 8 [ Time Frame: Week 8 ]

    Safe and effective self-injection will be evaluated by the study personnel and is defined as:

    • Complete dose delivery: Subject self-injects 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) is 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)


Secondary Outcome Measures :
  1. Percentage of subjects able to self-administer safe and effective injections using the bimekizumab-SS or the bimekizumab-AI at Baseline [ Time Frame: Baseline (the first self-injection visit) ]

    Safe and effective self-injection will be evaluated by the study personnel and is defined as:

    • Complete dose delivery: Subject self-injects 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766685


Locations
United States, Iowa
Dv0002 900
West Des Moines, Iowa, United States, 50265
United States, Kansas
Dv0002 905
Overland Park, Kansas, United States, 66215
United States, New Hampshire
Dv0002 901
Portsmouth, New Hampshire, United States, 03801
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Study Director: UCB Cares 001 844 599 2273 (UCB)

Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03766685     History of Changes
Other Study ID Numbers: DV0002
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Bimekizumab
PSO
Psoriasis
Auto-Injector

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases