A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
UCB Biopharma SRL
Study ID
NCT03896581
Phase
PHASE3
Status
Completed

Conditions

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.
  • Placebo — OTHER
    Subjects will receive placebo at pre-specified time-points.

Study Details

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).

Key Dates

Start date
Mar 28, 2019
Status verified
Jan 2026
Primary completion
Dec 8, 2021
Completion
Feb 14, 2022

Study Design

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

Arms

  • Experimental: Bimekizumab dosage regimen
    Subjects randomized to this arm will receive assigned bimekizumab dosage regimen.
  • Placebo Comparator: Placebo
    Subjects randomized to this arm will receive placebo.

Primary Outcome Measure

Percentage of Participants With American College of Rheumatology 50 (ACR50) Response [ Time Frame: From Baseline to Week 16 ]

Locations (33)

FacilityCityStateZIPSite coordinators
Pa0011 50017PhoenixArizona85037-
Pa0011 50035San DiegoCalifornia92128-
Pa0011 50004TustinCalifornia92780-
Pa0011 50033Palm HarborFlorida34684-
Pa0011 50037TampaFlorida33613-
Pa0011 50039AtlantaGeorgia30342-
Pa0011 50024BoiseIdaho83702-
Pa0011 50028LexingtonKentucky40504-
Pa0011 50023Baton RougeLouisiana70836-
Pa0011 50015HagerstownMaryland21740-
Pa0011 50026WheatonMaryland20902-
Pa0011 50047BostonMassachusetts02115-5817-
Pa0011 50019LansingMichigan48911-
Pa0011 50016St LouisMissouri63141-
Pa0011 50005FreeholdNew Jersey07728-
Pa0011 50029AlbuquerqueNew Mexico87102-
Pa0011 50010BrooklynNew York11201-
Pa0011 50011New YorkNew York10003-
Pa0011 50034RochesterNew York14642-
Pa0011 50125CharlotteNorth Carolina28210-
Pa0011 50031SalisburyNorth Carolina28144-
Pa0011 50040VandaliaOhio45377-
Pa0011 50020DuncansvillePennsylvania16635-
Pa0011 50064PhiladelphiaPennsylvania19104-
Pa0011 50006WyomissingPennsylvania19610-
Pa0011 50008JohnstonRhode Island02919-
Pa0011 50021SummervilleSouth Carolina29486-
Pa0011 50001JacksonTennessee38305-
Pa0011 50012MemphisTennessee38119-5214-
Pa0011 50002AustinTexas78731-
Pa0011 50036MesquiteTexas75150-
Pa0011 50009WacoTexas76710-
Pa0011 50050BeckleyWest Virginia25801-

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