A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis

Part of paid clinical trials in Anniston, Alabama.

Sponsor
UCB Biopharma S.P.R.L.
Study ID
NCT02963506
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — OTHER
  • Bimekizumab — DRUG
    Bimekizumab in different dosages.

Study Details

This is a study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).

Key Dates

Start date
Oct 31, 2016
Status verified
May 2023
Primary completion
Oct 31, 2017
Completion
Aug 31, 2018

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Subjects will receive for 12 Weeks Placebo and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
  • Experimental: Bimekizumab Dose 1
    Subjects will receive for 12 Weeks Bimekizumab Dose 1 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
  • Experimental: Bimekizumab Dose 2
    Subjects will receive for 12 Weeks Bimekizumab Dose 2 and will then be re-randomized to Bimekizumab Dose 3 or Bimekizumab Dose 4 for 36 Weeks.
  • Experimental: Bimekizumab Dose 3
    Subjects will receive for 48 Weeks Bimekizumab Dose 3.
  • Experimental: Bimekizumab Dose 4
    Subjects will receive for 48 Weeks Bimekizumab Dose 4.

Primary Outcome Measure

Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12 [ Time Frame: Week 12 ]

Locations (15)

FacilityCityStateZIPSite coordinators
As0008 019AnnistonAlabama36207-
As0008 007La JollaCalifornia92037-
As0008 009UplandCalifornia91786-
As0008 005AventuraFlorida33180-
As0008 022Ormond BeachFlorida32174-11-
As0008 030SarasotaFlorida34239-
As0008 027BostonMassachusetts02111-
As0008 021FreeholdNew Jersey07728-
As0008 015ClevelandOhio44109-19-
As0008 014PortlandOregon97239-
As0008 001DuncansvillePennsylvania16635-
As0008 020AustinTexas78731-
As0008 006DallasTexas75231-
As0008 018HoustonTexas77030-
As0008 002SeattleWashington98122-

Find similar trials in Anniston, AL

By research site
As0008 019· Anniston, ALAs0008 007· La Jolla, CAAs0008 009· Upland, CAAs0008 005· Aventura, FLAs0008 022· Ormond Beach, FLAs0008 030· Sarasota, FL

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