Clincosm LogoSign in Get a demo

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)

Sponsor
UCB Biopharma S.P.R.L. (Industry)
Overall Status
Completed
CT.gov ID
NCT03766685
Collaborator
(none)
172
Enrollment
39
Locations
2
Arms
20.6
Actual Duration (Months)
4.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
172 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 :
Dec 20, 2018
Actual Primary Completion Date :
Jul 14, 2020
Actual Study Completion Date :
Sep 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bimekizumab-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

    		•

    Outcome Measures

    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 [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 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dv0002 946 Phoenix Arizona United States 85032
    2 Dv0002 910 Bakersfield California United States 93309
    3 Dv0002 955 San Diego California United States 92123
    4 Dv0002 943 San Luis Obispo California United States 93405
    5 Dv0002 967 Santa Monica California United States 90404
    6 Dv0002 906 Boca Raton Florida United States 33486
    7 Dv0002 907 Miami Florida United States 33144
    8 Dv0002 903 Ocala Florida United States 34471
    9 Dv0002 936 Tampa Florida United States 33624
    10 Dv0002 941 Alpharetta Georgia United States 30022
    11 Dv0002 954 Skokie Illinois United States 60077
    12 Dv0002 900 West Des Moines Iowa United States 50265
    13 Dv0002 905 Overland Park Kansas United States 66215
    14 Dv0002 962 Owensboro Kentucky United States 42301
    15 Dv0002 922 Baton Rouge Louisiana United States 70809
    16 Dv0002 925 Brighton Massachusetts United States 02135
    17 Dv0002 917 Troy Michigan United States 48084
    18 Dv0002 915 Saint Louis Missouri United States 63117
    19 Dv0002 901 Portsmouth New Hampshire United States 03801
    20 Dv0002 908 East Windsor New Jersey United States 08520
    21 Dv0002 913 New York New York United States 10029
    22 Dv0002 963 Rochester New York United States 14623
    23 Dv0002 920 Portland Oregon United States 97210
    24 Dv0002 929 Portland Oregon United States 97223
    25 Dv0002 937 Johnston Rhode Island United States 02919
    26 Dv0002 951 Houston Texas United States 77598
    27 Dv0002 914 San Antonio Texas United States 78213
    28 Dv0002 672 Edmonton Canada
    29 Dv0002 673 Halifax Canada
    30 Dv0002 671 Hamilton Canada
    31 Dv0002 675 Markham Canada
    32 Dv0002 663 Mississauga Canada
    33 Dv0002 660 Montréal Canada
    34 Dv0002 665 Québec City Canada
    35 Dv0002 651 Richmond Hill Canada
    36 Dv0002 653 Toronto Canada
    37 Dv0002 662 Toronto Canada
    38 Dv0002 657 Waterloo Canada
    39 Dv0002 670 Windsor Canada

    Sponsors and Collaborators

    • UCB Biopharma S.P.R.L.

    Investigators

    • Study Director: UCB Cares, 001 844 599 2273 (UCB)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UCB Biopharma S.P.R.L.
    ClinicalTrials.gov Identifier:
    NCT03766685
    Other Study ID Numbers:
    • DV0002
    First Posted:
    Dec 6, 2018
    Last Update Posted:
    Jan 10, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    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 Biopharma S.P.R.L.
    Bimekizumab
    PSO
    Psoriasis
    Auto-Injector
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Jan 10, 2022