A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis

Part of paid clinical trials in Ormond Beach, Florida.

Sponsor
UCB Biopharma SRL
Study ID
NCT03215277
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bimekizumab — DRUG
    One bimekizumab dose will be administered.
  • Certolizumab pegol — DRUG
    Two certolizumab pegol doses will be administered. One of these doses is a loading dose.
  • Placebo — OTHER
    Placebo will be provided to maintain the blinding.

Study Details

The purpose of the study is to evaluate the efficacy and safety of bimekizumab compared to certolizumab pegol in the treatment of subjects with active ankylosing spondylitis (AS).

Key Dates

Start date
Oct 4, 2017
Status verified
Jul 2023
Primary completion
May 25, 2020
Completion
May 25, 2020

Study Design

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

Arms

  • Experimental: Bimekizumab
    Subjects will receive several bimekizumab administrations on pre-defined time points. Placebo will be provided in this arm to mask the certolizumab pegol loading dose.
  • Experimental: Certolizumab pegol
    Subjects will receive several certolizumab pegol administrations on pre-defined time points.

Primary Outcome Measure

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 [ Time Frame: From Baseline to Week 12 ]

Locations (4)

FacilityCityStateZIPSite coordinators
As0013 908Ormond BeachFlorida32174-
As0013 903LincolnNebraska68516-
As0013 902Oklahoma CityOklahoma73103-
As0013 906MemphisTennessee38119-

Find similar trials in Ormond Beach, FL

By research site
As0013 908· Ormond Beach, FLAs0013 903· Lincoln, NEAs0013 902· Oklahoma City, OKAs0013 906· Memphis, TN

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