A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
UCB Biopharma SRL
Study ID
NCT04242446
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 during the Initial Treatment Period.

Study Details

The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

Key Dates

Start date
Feb 19, 2020
Status verified
May 2026
Primary completion
Apr 7, 2022
Completion
Feb 19, 2023

Study Design

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

Arms

  • Experimental: Bimekizumab dosing regimen 1
    Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the Treatment Period.
  • Experimental: Bimekizumab dosing regimen 2
    Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the Treatment Period.
  • Experimental: Bimekizumab dosing regimen 3
    Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the Treatment Period.
  • Placebo Comparator: Placebo Group
    Subjects randomized to this arm will receive placebo during the Initial Treatment Period and bimekizumab during the Maintenance Treatment Period.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at Week 16 [ Time Frame: Week 16 ]

Locations (28)

FacilityCityStateZIPSite coordinators
Hs0003 50140BirminghamAlabama35233-
Hs0003 50175PhoenixArizona85006-
Hs0003 50161Los AngelesCalifornia90045-
Hs0003 50220San DiegoCalifornia92123-
Hs0003 50205North Miami BeachFlorida33162-4708-
Hs0003 50153Ormond BeachFlorida32174-
Hs0003 50141TampaFlorida33613-
Hs0003 50210AtlantaGeorgia30309-
Hs0003 50280WatkinsvilleGeorgia30677-
Hs0003 50425MurrayKentucky42071-
Hs0003 50198BeverlyMassachusetts01915-
Hs0003 50146BostonMassachusetts02215-
Hs0003 50194OmahaNebraska68144-
Hs0003 50208Las VegasNevada89148-
Hs0003 50137East WindsorNew Jersey08520-
Hs0003 50235New YorkNew York10003-
Hs0003 50151Chapel HillNorth Carolina27516-
Hs0003 50177CincinnatiOhio45219-
Hs0003 50138ColumbusOhio43213-
Hs0003 50204TulsaOklahoma74135-
Hs0003 50147HersheyPennsylvania17033-
Hs0003 50008JohnstonRhode Island02919-
Hs0003 50180ProvidenceRhode Island02903-
Hs0003 50142NashvilleTennessee37215-
Hs0003 50201ArlingtonTexas76011-
Hs0003 50166DallasTexas75246-
Hs0003 50149San AntonioTexas78213-
Hs0003 50270SeattleWashington98101-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Hs0003 50140· Birmingham, ALHs0003 50175· Phoenix, AZHs0003 50161· Los Angeles, CAHs0003 50220· San Diego, CAHs0003 50205· North Miami Beach, FLHs0003 50153· Ormond Beach, FL

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