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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)

NCT ID: NCT03766685

Last Updated: 2025-07-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2020-09-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Plaque Psoriasis Moderate to Severe Chronic Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bimekizumab-SS

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

Group Type EXPERIMENTAL

Bimekizumab

Intervention Type DRUG

Subjects will receive bimekizumab at pre-specified time-points.

Bimekizumab-AI

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

Group Type EXPERIMENTAL

Bimekizumab

Intervention Type DRUG

Subjects will receive bimekizumab at pre-specified time-points.

Interventions

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Bimekizumab

Subjects will receive bimekizumab at pre-specified time-points.

Intervention Type DRUG

Other Intervention Names

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UCB4940 BKZ

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273

Locations

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Dv0002 946

Phoenix, Arizona, United States

Site Status

Dv0002 910

Bakersfield, California, United States

Site Status

Dv0002 955

San Diego, California, United States

Site Status

Dv0002 943

San Luis Obispo, California, United States

Site Status

Dv0002 967

Santa Monica, California, United States

Site Status

Dv0002 906

Boca Raton, Florida, United States

Site Status

Dv0002 907

Miami, Florida, United States

Site Status

Dv0002 903

Ocala, Florida, United States

Site Status

Dv0002 936

Tampa, Florida, United States

Site Status

Dv0002 941

Alpharetta, Georgia, United States

Site Status

Dv0002 954

Skokie, Illinois, United States

Site Status

Dv0002 900

West Des Moines, Iowa, United States

Site Status

Dv0002 905

Overland Park, Kansas, United States

Site Status

Dv0002 962

Owensboro, Kentucky, United States

Site Status

Dv0002 922

Baton Rouge, Louisiana, United States

Site Status

Dv0002 925

Brighton, Massachusetts, United States

Site Status

Dv0002 917

Troy, Michigan, United States

Site Status

Dv0002 915

St Louis, Missouri, United States

Site Status

Dv0002 901

Portsmouth, New Hampshire, United States

Site Status

Dv0002 908

East Windsor, New Jersey, United States

Site Status

Dv0002 913

New York, New York, United States

Site Status

Dv0002 963

Rochester, New York, United States

Site Status

Dv0002 920

Portland, Oregon, United States

Site Status

Dv0002 929

Portland, Oregon, United States

Site Status

Dv0002 937

Johnston, Rhode Island, United States

Site Status

Dv0002 951

Houston, Texas, United States

Site Status

Dv0002 914

San Antonio, Texas, United States

Site Status

Dv0002 672

Edmonton, , Canada

Site Status

Dv0002 673

Halifax, , Canada

Site Status

Dv0002 671

Hamilton, , Canada

Site Status

Dv0002 675

Markham, , Canada

Site Status

Dv0002 663

Mississauga, , Canada

Site Status

Dv0002 660

Montreal, , Canada

Site Status

Dv0002 665

Québec, , Canada

Site Status

Dv0002 651

Richmond Hill, , Canada

Site Status

Dv0002 653

Toronto, , Canada

Site Status

Dv0002 662

Toronto, , Canada

Site Status

Dv0002 657

Waterloo, , Canada

Site Status

Dv0002 670

Windsor, , Canada

Site Status

Countries

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United States Canada

References

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Sebastian M, Bagel J, Hoepken B, Knapp B, Bicer C, MacPherson M, Langley RG. Single-Injection Options for Administering a 320 mg Dose of Bimekizumab: 2 mL Safety Syringe and Auto-injector. Dermatol Ther (Heidelb). 2025 May;15(5):1113-1134. doi: 10.1007/s13555-025-01366-6. Epub 2025 Mar 29.

Reference Type RESULT
PMID: 40156698 (View on PubMed)

Bagel J, Tatla D, Hellot S, Knapp B, Murphy C, Peterson L, Sebastian M. Bimekizumab Self-Injection Devices: Two Multicenter, Randomized, Open-Label Studies on Self-Administration by Patients With Psoriasis. J Drugs Dermatol. 2022 Feb 1;21(2):162-171. doi: 10.36849/jdd.6274.

Reference Type DERIVED
PMID: 35133113 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf

Product Information

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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DV0002

Identifier Type: -

Identifier Source: org_study_id

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