A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
UCB Biopharma SRL
Study ID
NCT03370133
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bimekizumab — DRUG
    Bimekizumab will be provided at pre-specified time intervals.
  • Ustekinumab — DRUG
    Ustekinumab will be provided as dose 1 for subjects weighing \<=100 kg and as dose 2 for subjects weighing \>100 kg at pre-specified time intervals.
  • Placebo — OTHER
    Subjects will receive Placebo at pre-specified time points.

Study Details

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

Key Dates

Start date
Dec 6, 2017
Status verified
Apr 2026
Primary completion
Jan 8, 2019
Completion
Dec 13, 2019

Study Design

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

Arms

  • Experimental: Bimekizumab cohort
    Subjects will receive bimekizumab for 52 weeks.
  • Active Comparator: Ustekinumab cohort
    Subjects will receive ustekinumab (dose 1 or dose 2 depending on subjects weight) for 52 weeks. Placebo will be administered at pre-specified time points to maintain the blinding.
  • Placebo Comparator: Placebo
    Subjects will receive placebo up to week 16 and bimekizumab starting at week 16 through week 52.

Primary Outcome Measure

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

Locations (25)

FacilityCityStateZIPSite coordinators
Ps0009 946PhoenixArizona85032-
Ps0009 910BakersfieldCalifornia93309-
Ps0009 919San DiegoCalifornia92103-
Ps0009 906Boca RatonFlorida33486-
Ps0009 909Boynton BeachFlorida33437-
Ps0009 912Coral GablesFlorida33134-
Ps0009 907MiamiFlorida33144-
Ps0009 903OcalaFlorida34471-
Ps0009 921Ormond BeachFlorida32174-
Ps0009 918TampaFlorida33612-
Ps0009 941AlpharettaGeorgia30022-
Ps0009 911PlainfieldIndiana46168-
Ps0009 900West Des MoinesIowa50265-
Ps0009 905Overland ParkKansas66215-
Ps0009 922Baton RougeLouisiana70809-
Ps0009 917TroyMichigan48084-
Ps0009 915St LouisMissouri63117-
Ps0009 958OmahaNebraska68144-
Ps0009 901PortsmouthNew Hampshire03801-
Ps0009 908East WindsorNew Jersey08520-
Ps0009 923AlbuquerqueNew Mexico87106-
Ps0009 913New YorkNew York10029-65-
Ps0009 920PortlandOregon97210-
Ps0009 924HoustonTexas77004-
Ps0009 914San AntonioTexas78213-

Find similar trials in Phoenix, AZ

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Ps0009 946· Phoenix, AZPs0009 910· Bakersfield, CAPs0009 919· San Diego, CAPs0009 906· Boca Raton, FLPs0009 909· Boynton Beach, FLPs0009 912· Coral Gables, FL

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