A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.

Part of paid clinical trials in Los Angeles, California.

Sponsor
UCB Biopharma SRL
Study ID
NCT03248531
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bimekizumab — DRUG
    Bimekizumab in different dosages (dose 1 and 2).
  • Adalimumab — DRUG
    Adalimumab in different dosages (dose 1, 2 and 3).
  • Placebo — OTHER
    Placebo will be provided matching Bimekizumab.

Study Details

Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.

Key Dates

Start date
Sep 22, 2017
Status verified
Jan 2022
Primary completion
Nov 23, 2018
Completion
Feb 21, 2019

Study Design

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

Arms

  • Experimental: Bimekizumab
    Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
  • Active Comparator: Adalimumab
    Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
  • Placebo Comparator: Placebo
    Subjects will receive several placebo applications to keep the blinding.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: Week 12 ]

Locations (11)

FacilityCityStateZIPSite coordinators
Hs0001 121Los AngelesCalifornia90033-
Hs0001 119Coral GablesFlorida33134-
Hs0001 111OrangeFlorida32073-
Hs0001 117TampaFlorida33624-
Hs0001 112Sandy SpringsGeorgia30328-
Hs0001 113BostonMassachusetts02215-
Hs0001 115Las VegasNevada89074-
Hs0001 126ManhassetNew York11030-
Hs0001 125Chapel HillNorth Carolina27599-
Hs0001 123HersheyPennsylvania17033-
Hs0001 120NashvilleTennessee37215-

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