A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis

Who is this study for? Patients with Radiographic or Non-Radiographic Ankylosing Spondylitis or Axial Spondyloarthritis
What treatments are being studied? Bimekizumab
Status: Active_not_recruiting
Location: See all (67) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator

• In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study

• Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743)

Locations
United States
Arizona
As0014 50062
Glendale
As0014 50052
Phoenix
California
As0014 50060
Upland
Florida
As0014 50059
Ormond Beach
As0014 50056
Sarasota
Maryland
As0014 50015
Hagerstown
Missouri
As0014 50016
St Louis
Oregon
As0014 50055
Portland
Pennsylvania
As0014 50020
Duncansville
Texas
As0014 50057
Dallas
Other Locations
Belgium
As0014 40004
Brussels
As0014 40003
Genk
As0014 40001
Ghent
Bulgaria
As0014 40006
Plovdiv
As0014 40007
Plovdiv
As0014 40005
Sofia
As0014 40008
Sofia
China
As0014 20040
Beijing
As0014 20021
Chengdu
As0014 20019
Guangzhou
As0014 20034
Hefei
As0014 20024
Nanjing
As0014 20018
Shanghai
As0014 20020
Shanghai
As0014 20026
Shanghai
As0014 20025
Wenzhou
France
As0014 40018
Boulogne-billancourt
As0014 40022
Limoges
Germany
As0014 40025
Berlin
As0014 40029
Hamburg
As0014 40024
Hanover
As0014 40027
Herne
As0014 40078
Leipzig
As0014 40026
Ratingen
Hungary
As0014 40032
Debrecen
As0014 40031
Szeged
As0014 40033
Székesfehérvár
Japan
As0014 20035
Bunkyō City
As0014 20030
Chūōku
As0014 20039
Iruma-gun
As0014 20036
Kawachi-nagano
As0014 20045
Kita-gun
As0014 20065
Kitakyushu
As0014 20037
Osaka
As0014 20084
Saga
As0014 20048
Saitama
As0014 20031
Sapporo
As0014 20032
Suita
Netherlands
As0014 40034
Amsterdam
Poland
As0014 40038
Elblag
As0014 40042
Krakow
As0014 40037
Lublin
As0014 40044
Poznan
As0014 40040
Torun
As0014 40041
Warsaw
As0014 40039
Wroclaw
As0014 40043
Wroclaw
Spain
As0014 40045
A Coruña
As0014 40046
Córdoba
As0014 40048
Santiago De Compostela
As0014 40049
Seville
Turkey
As0014 40052
Ankara
As0014 40053
Ankara
As0014 40050
Istanbul
United Kingdom
As0014 40057
Edinburgh
As0014 40056
Leeds
As0014 40055
Norwich
Time Frame
Start Date: 2020-06-16
Completion Date: 2026-08-07
Participants
Target number of participants: 508
Treatments
Experimental: Bimekizumab
Subjects will receive bimekizumab throughout the Treatment Period.
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov