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 Fountain Valley, California.

Sponsor
UCB Biopharma SRL
Study ID
NCT04242498
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
Mar 2, 2020
Status verified
May 2026
Primary completion
Nov 9, 2021
Completion
Sep 28, 2022

Study Design

Enrollment
509 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 (24)

FacilityCityStateZIPSite coordinators
Hs0004 50162Fountain ValleyCalifornia92708-
Hs0004 50196Thousand OaksCalifornia91320-
Hs0004 50199MiamiFlorida33125-
Hs0004 50152Orange ParkFlorida32073-
Hs0004 50144OrlandoFlorida38219-
Hs0004 50184Pembroke PinesFlorida33028-
Hs0004 50193Sandy SpringsGeorgia30328-
Hs0004 50223SavannahGeorgia31419-
Hs0004 50164SkokieIllinois60077-
Hs0004 50234PlainfieldIndiana46168-
Hs0004 50178ClarkstonMichigan48346-
Hs0004 50105St LouisMissouri63110-
Hs0004 50197HendersonNevada89052-
Hs0004 50159PortsmouthNew Hampshire03801-
Hs0004 50200VeronaNew Jersey07044-
Hs0004 50237AlbuquerqueNew Mexico87106-
Hs0004 50211DurhamNorth Carolina27710-
Hs0004 50179Winston-SalemNorth Carolina27104-
Hs0004 50145ColumbusOhio43230-
Hs0004 50202FairbornOhio45324-
Hs0004 50150PhiladelphiaPennsylvania19103-
Hs0004 50236GreenvilleSouth Carolina29615-
Hs0004 50084Johns IslandSouth Carolina29425-
Hs0004 50148PflugervilleTexas78660-

Related coverage on Hipa.ai

Find similar trials in Fountain Valley, CA

By condition
Hidradenitis suppurativa
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Hs0004 50162· Fountain Valley, CAHs0004 50196· Thousand Oaks, CAHs0004 50199· Miami, FLHs0004 50152· Orange Park, FLHs0004 50144· Orlando, FLHs0004 50184· Pembroke Pines, FL

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