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 Active Psoriatic Arthritis

Part of paid clinical trials in Boise, Idaho.

Sponsor
UCB Biopharma SRL
Study ID
NCT04109976
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (PsA) to safely and effectively self-inject bimekizumab at study start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (SS) or the bimekizumab auto-injector (AI).

Key Dates

Start date
Aug 13, 2019
Status verified
Nov 2023
Primary completion
Nov 5, 2020
Completion
Nov 13, 2020

Study Design

Enrollment
214 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bimekizumab-SS
    Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the prefilled safety syringe (SS).
  • Experimental: Bimekizumab-AI
    Study participants randomized to this arm will receive assigned bimekizumab dose regimen using the auto-injector (AI).

Primary Outcome Measure

Percentage of Participants Able to Self-administer Safe and Effective Injections Using the Bimekizumab Safety Syringe (BKZ-SS) or the Bimekizumab Auto-injector (BKZ-AI) at Week 4 [ Time Frame: Week 4 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Dv0004 50024BoiseIdaho83702-
Dv0004 50028LexingtonKentucky40504-
Dv0004 50023Baton RougeLouisiana70836-
Dv0004 50015HagerstownMaryland21742-
Dv0004 50026WheatonMaryland20902-
Dv0004 50019LansingMichigan48910-
Dv0004 50016St LouisMissouri63141-
Dv0004 50005FreeholdNew Jersey07728-
Dv0004 50029AlbuquerqueNew Mexico87102-
Dv0004 50010BrooklynNew York11201-
Dv0004 50125CharlotteNorth Carolina28210-
Dv0004 50031SalisburyNorth Carolina28144-
Dv0004 50040DaytonOhio45417-
Dv0004 50020DuncansvillePennsylvania16635-
Dv0004 50006WyomissingPennsylvania19610-
Dv0004 50008JohnstonRhode Island02919-
Dv0004 50001JacksonTennessee38305-
Dv0004 50036MesquiteTexas75150-
Dv0004 50009WacoTexas76710-
Dv0004 50050BeckleyWest Virginia25801-

Find similar trials in Boise, ID

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Dv0004 50024· Boise, IDDv0004 50028· Lexington, KYDv0004 50023· Baton Rouge, LADv0004 50015· Hagerstown, MDDv0004 50026· Wheaton, MDDv0004 50019· Lansing, MI

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