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

Part of paid clinical trials in Mesa, Arizona.

Sponsor
UCB Biopharma SRL
Study ID
NCT03928743
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 Double-Blind Treatment Period.

Study Details

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).

Key Dates

Start date
Apr 25, 2019
Status verified
Dec 2025
Primary completion
Sep 3, 2021
Completion
Aug 8, 2022

Study Design

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

Arms

  • Experimental: Bimekizumab
    Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.
  • Placebo Comparator: Placebo
    Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.

Primary Outcome Measure

Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 16 [ Time Frame: Week 16 ]

Locations (14)

FacilityCityStateZIPSite coordinators
As0011 50131MesaArizona85210-
As0011 50052PhoenixArizona85032-
As0011 50058PhoenixArizona85037-
As0011 50062Sun CityArizona85351-
As0011 50060UplandCalifornia91786-
As0011 50056SarasotaFlorida34239-
As0011 50015HagerstownMaryland21740-
As0011 50016St LouisMissouri63141-
As0011 50054Oklahoma CityOklahoma73103-
As0011 50020DuncansvillePennsylvania16635-
As0011 50001JacksonTennessee38305-
As0011 50012MemphisTennessee38119-
As0011 50057DallasTexas75231-
As0011 50036MesquiteTexas75150-

Find similar trials in Mesa, AZ

By research site
As0011 50131· Mesa, AZAs0011 50052· Phoenix, AZAs0011 50058· Phoenix, AZAs0011 50062· Sun City, AZAs0011 50060· Upland, CAAs0011 50056· Sarasota, FL

Related Studies