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Active (not recruiting) Phase 3 NCT04436640

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis

Phase 3 – large-scale trial before approval
Conditions: Axial Spondyloarthritis Ankylosing Spondylitis r-axSpa Nr-axSpa

Sponsor: UCB Biopharma SRL

trial.available_in: БГ
Overview
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).
Who can participate
Inclusion Criteria: * 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) Exclusion Criteria: * Female study participants who plan to become pregnant during the study or within 20 weeks following final dose of Investigational Medicinal Product (IMP). Male study participants who are planning a partner pregnancy during the study or within 20 weeks following the final dose * Study participants who meet any withdrawal criteria in AS0010 or AS0011. For any study participant with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder study, the Medical Monitor must be consulted prior to the study participant's entry into AS0014 * Study participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated
Interventions
Bimekizumab
DRUG
Locations 75
Belgium (3)
As0014 40004
Brussels
As0014 40003
Genk
As0014 40001
Ghent
Bulgaria (4)
As0014 40006
Plovdiv
As0014 40007
Plovdiv
As0014 40005
Sofia
As0014 40008
Sofia
China (9)
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
Czech Republic (8)
As0014 40011
Brno
As0014 40009
Pardubice
As0014 40013
Prague
As0014 40014
Prague
As0014 40015
Prague
As0014 40016
Prague
As0014 40010
Uherské Hradiště
As0014 40012
Zlín
France (2)
As0014 40018
Boulogne-Billancourt
As0014 40022
Limoges
Germany (6)
As0014 40025
Berlin
As0014 40029
Hamburg
As0014 40024
Hanover
As0014 40027
Herne
As0014 40078
Leipzig
As0014 40026
Ratingen
Hungary (3)
As0014 40032
Debrecen
As0014 40031
Szeged
As0014 40033
Székesfehérvár
Japan (11)
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 (1)
As0014 40034
Amsterdam
Poland (8)
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 (4)
As0014 40045
A Coruña
As0014 40046
Córdoba
As0014 40048
Santiago de Compostela
As0014 40049
Seville
Turkey (3)
As0014 40052
Ankara
As0014 40053
Ankara
As0014 40050
Istanbul
United Kingdom (3)
As0014 40057
Edinburgh
As0014 40056
Leeds
As0014 40055
Norwich
United States (10)
As0014 50057
Dallas , Texas
As0014 50020
Duncansville , Pennsylvania
As0014 50062
Glendale , Arizona
As0014 50015
Hagerstown , Maryland
As0014 50059
Ormond Beach , Florida
As0014 50052
Phoenix , Arizona
As0014 50055
Portland , Oregon
As0014 50056
Sarasota , Florida
As0014 50016
St Louis , Missouri
As0014 50060
Upland , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.06.2020
Completion date
07.08.2026
Registry ID
NCT04436640
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.