A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Part of paid clinical trials in Glendale, Arizona.

Sponsor
UCB Biopharma SRL
Study ID
NCT03412747
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Plaque Psoriasis
  • Moderate to Severe Plaque Psoriasis

Eligibility Criteria

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

Interventions

  • Bimekizumab — DRUG
    Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
  • Adalimumab — DRUG
    Adalimumab will be administered according to the labeling recommendations.
  • Placebo — OTHER
    Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).

Study Details

This is a study to compare the efficacy of bimekizumab versus adalimumab in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).

Key Dates

Start date
Jan 26, 2018
Status verified
Apr 2026
Primary completion
Feb 7, 2019
Completion
Feb 26, 2020

Study Design

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

Arms

  • Experimental: Bimekizumab Arm 1
    Subjects will receive bimekizumab dose regimen 1 for 56 weeks. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
  • Experimental: Bimekizumab Arm 2
    Subjects will receive bimekizumab dose regimen 1 for 16 weeks and will proceed with bimekizumab dose regimen 2 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.
  • Active Comparator: Adalimumab Arm
    Subjects will receive adalimumab for 24 weeks and will then receive bimekizumab dose regimen 1 until week 56. Subjects will receive placebo at pre-specified time-points to maintain the blinding.

Primary Outcome Measure

Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16 [ Time Frame: Week 16 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Ps0008 957GlendaleArizona85308-
Ps0008 927Los AngelesCalifornia90033-
Ps0008 955San DiegoCalifornia92123-
Ps0008 943San Luis ObispoCalifornia93405-
Ps0008 967Santa MonicaCalifornia90404-
Ps0008 939DanburyConnecticut06810-
Ps0008 934Washington D.C.District of Columbia20037-
Ps0008 906Boca RatonFlorida33486-
Ps0008 936TampaFlorida33624-
Ps0008 900West Des MoinesIowa50265-
Ps0008 905Overland ParkKansas66215-
Ps0008 940BeverlyMassachusetts01844-
Ps0008 925BrightonMassachusetts02135-
Ps0008 917TroyMichigan48084-
Ps0008 908East WindsorNew Jersey08520-
Ps0008 961Rocky MountNorth Carolina27804-
Ps0008 935Winston-SalemNorth Carolina27104-35 20-
Ps0008 932Oklahoma CityOklahoma73112-
Ps0008 929PortlandOregon97223-
Ps0008 945GreerSouth Carolina29650-
Ps0008 931DallasTexas75231-
Ps0008 924HoustonTexas77004-
Ps0008 951HoustonTexas77004-

Find similar trials in Glendale, AZ

By research site
Ps0008 957· Glendale, AZPs0008 927· Los Angeles, CAPs0008 955· San Diego, CAPs0008 943· San Luis Obispo, CAPs0008 967· Santa Monica, CAPs0008 939· Danbury, CT

Related Studies