A Study to Test the Long-term Treatment 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
NCT04901195
Phase
PHASE3
Status
Active Not Recruiting

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.

Study Details

The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

Key Dates

Start date
May 27, 2021
Status verified
Jun 2026
Primary completion
Jul 28, 2026
Completion
Jul 28, 2026

Study Design

Enrollment
658 participants (actual)
Allocation
NON_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 open-label extension period.
  • Experimental: Bimekizumab dosing regimen 2
    Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.

Primary Outcome Measure

Percentage of participants with treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196) ]

Locations (43)

FacilityCityStateZIPSite coordinators
Hs0005 50140BirminghamAlabama35249-
Hs0005 50175PhoenixArizona85006-
Hs0005 50162Fountain ValleyCalifornia92708-
Hs0005 50161Los AngelesCalifornia90045-
Hs0005 50220San DiegoCalifornia92123-
Hs0005 50196Thousand OaksCalifornia91320-
Hs0005 50199MiamiFlorida33136-
Hs0005 50205North Miami BeachFlorida33162-4708-
Hs0005 50152Orange ParkFlorida32073-
Hs0005 50184Pembroke PinesFlorida33028-
Hs0005 50193Sandy SpringsGeorgia30329-
Hs0005 50280WatkinsvilleGeorgia30677-
Hs0005 50234PlainfieldIndiana46168-
Hs0005 50425MurrayKentucky42071-
Hs0005 50198BeverlyMassachusetts01915-
Hs0005 50146BostonMassachusetts02215-
Hs0005 50178ClarkstonMichigan48346-
Hs0005 50105St LouisMissouri63110-
Hs0005 50194OmahaNebraska68144-
Hs0005 50208Las VegasNevada89148-
Hs0005 50159NewingtonNew Hampshire03801-
Hs0005 50137East WindsorNew Jersey08520-
Hs0005 50200VeronaNew Jersey07044-
Hs0005 50237AlbuquerqueNew Mexico87102-
Hs0005 50235New YorkNew York10003-
Hs0005 50151Chapel HillNorth Carolina27516-
Hs0005 50211DurhamNorth Carolina27710-
Hs0005 50179Winston-SalemNorth Carolina27157-
Hs0005 50177CincinnatiOhio45219-
Hs0005 50138ColumbusOhio43213-
Hs0005 50145ColumbusOhio43230-
Hs0005 50202FairbornOhio45324-
Hs0005 50204TulsaOklahoma74137-
Hs0005 50147HersheyPennsylvania17033-
Hs0005 50008JohnstonRhode Island02919-
Hs0005 50180ProvidenceRhode Island02903-
Hs0005 50084CharlestonSouth Carolina29425-
Hs0005 50236GreenvilleSouth Carolina29615-
Hs0005 50142NashvilleTennessee37215-
Hs0005 50201ArlingtonTexas76011-
Hs0005 50148PflugervilleTexas78660-
Hs0005 50141Salt Lake CityUtah84107-
Hs0005 50270SeattleWashington98101-

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