A Study to Test 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
NCT03895203
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.
  • Adalimumab — DRUG
    Adalimumab will be administered according to the labeling recommendations.
  • 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 subjects with active Psoriatic Arthritis (PsA).

Key Dates

Start date
Apr 3, 2019
Status verified
Jan 2026
Primary completion
Aug 17, 2021
Completion
Jul 11, 2022

Study Design

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

Arms

  • Experimental: Bimekzumab dosage regimen
    Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
  • Active Comparator: Adalimumab dosage regimen
    Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.
  • Placebo Comparator: Placebo
    Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16 [ Time Frame: Week 16 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Pa0010 50017PhoenixArizona85037-
Pa0010 50035San DiegoCalifornia92025-
Pa0010 50004TustinCalifornia92780-
Pa0010 50033Palm HarborFlorida34684-
Pa0010 50037TampaFlorida33613-
Pa0010 50039AtlantaGeorgia30342-
Pa0010 50028LexingtonKentucky40504-
Pa0010 50015HagerstownMaryland21742-
Pa0010 50016St LouisMissouri63141-
Pa0010 50029AlbuquerqueNew Mexico87102-
Pa0010 50010BrooklynNew York11201-
Pa0010 50125CharlotteNorth Carolina28210-
Pa0010 50040DaytonOhio45417-
Pa0010 50020DuncansvillePennsylvania16635-
Pa0010 50006WyomissingPennsylvania19610-
Pa0010 50008JohnstonRhode Island02919-
Pa0010 50007OrangeburgSouth Carolina29118-
Pa0010 50001JacksonTennessee38305-
Pa0010 50012MemphisTennessee38119-
Pa0010 50002AustinTexas78731-
Pa0010 50049Corpus ChristiTexas78404-
Pa0010 50051HoustonTexas77034-
Pa0010 50036MesquiteTexas75150-
Pa0010 50009WacoTexas76710-
Pa0010 50050BeckleyWest Virginia25801-

Find similar trials in Phoenix, AZ

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Pa0010 50017· Phoenix, AZPa0010 50035· San Diego, CAPa0010 50004· Tustin, CAPa0010 50033· Palm Harbor, FLPa0010 50037· Tampa, FLPa0010 50039· Atlanta, GA

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