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

Last updated: May 21, 2026
Sponsor: UCB Biopharma SRL
Overall Status: Active - Not Recruiting

Phase

3

Condition

Ankylosing Spondylitis

Arthritis And Arthritic Pain

Bone Diseases

Treatment

Bimekizumab

Clinical Study ID

NCT04436640
AS0014
U1111-1304-6865
2023-506527-28
2019-004163-47
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

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

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

Exclusion

Exclusion Criteria:

  • Female study participants who plan to become pregnant during the study or within 20weeks following final dose of Investigational Medicinal Product (IMP). Male studyparticipants who are planning a partner pregnancy during the study or within 20weeks following the final dose

  • Study participants who meet any withdrawal criteria in AS0010 or AS0011. For anystudy participant with an ongoing serious adverse event (SAE), or a history ofserious infections (including hospitalizations) in the feeder study, the MedicalMonitor 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

Study Design

Total Participants: 508
Treatment Group(s): 1
Primary Treatment: Bimekizumab
Phase: 3
Study Start date:
June 16, 2020
Estimated Completion Date:
August 07, 2026

Connect with a study center

  • As0014 40004

    Brussels,
    Belgium

    Site Not Available

  • As0014 40004

    Brussels 2800866,
    Belgium

    Site Not Available

  • As0014 40004

    Bruxelles,
    Belgium

    Site Not Available

  • As0014 40003

    Genk,
    Belgium

    Site Not Available

  • As0014 40003

    Genk 2797670,
    Belgium

    Site Not Available

  • As0014 40001

    Gent,
    Belgium

    Site Not Available

  • As0014 40001

    Ghent,
    Belgium

    Site Not Available

  • As0014 40001

    Ghent 2797656,
    Belgium

    Site Not Available

  • As0014 40006

    Plovdiv,
    Bulgaria

    Site Not Available

  • As0014 40007

    Plovdiv,
    Bulgaria

    Site Not Available

  • As0014 40006

    Plovdiv 728193,
    Bulgaria

    Site Not Available

  • As0014 40007

    Plovdiv 728193,
    Bulgaria

    Site Not Available

  • As0014 40005

    Sofia,
    Bulgaria

    Site Not Available

  • As0014 40008

    Sofia,
    Bulgaria

    Site Not Available

  • As0014 40005

    Sofia 727011,
    Bulgaria

    Site Not Available

  • As0014 40008

    Sofia 727011,
    Bulgaria

    Site Not Available

  • As0014 20040

    Beijing,
    China

    Site Not Available

  • As0014 20040

    Beijing 1816670,
    China

    Site Not Available

  • As0014 20021

    Chengdu,
    China

    Site Not Available

  • As0014 20021

    Chengdu 1815286,
    China

    Site Not Available

  • As0014 20019

    Guangzhou,
    China

    Site Not Available

  • As0014 20019

    Guangzhou 1809858,
    China

    Site Not Available

  • As0014 20034

    Hefei,
    China

    Site Not Available

  • As0014 20034

    Hefei 1808722,
    China

    Site Not Available

  • As0014 20024

    Nanjing,
    China

    Site Not Available

  • As0014 20024

    Nanjing 1799962,
    China

    Site Not Available

  • As0014 20018

    Shanghai,
    China

    Site Not Available

  • As0014 20020

    Shanghai,
    China

    Site Not Available

  • As0014 20026

    Shanghai,
    China

    Site Not Available

  • As0014 20018

    Shanghai 1796236,
    China

    Site Not Available

  • As0014 20020

    Shanghai 1796236,
    China

    Site Not Available

  • As0014 20026

    Shanghai 1796236,
    China

    Site Not Available

  • As0014 20025

    Wenzhou,
    China

    Site Not Available

  • As0014 20025

    Wenzhou 1791388,
    China

    Site Not Available

  • As0014 40011

    Brno,
    Czechia

    Site Not Available

  • As0014 40011

    Brno 3078610,
    Czechia

    Site Not Available

  • As0014 40009

    Pardubice,
    Czechia

    Site Not Available

  • As0014 40009

    Pardubice 3068582,
    Czechia

    Site Not Available

  • As0014 40013

    Prague,
    Czechia

    Site Not Available

  • As0014 40014

    Prague,
    Czechia

    Site Not Available

  • As0014 40015

    Prague,
    Czechia

    Site Not Available

  • As0014 40016

    Prague,
    Czechia

    Site Not Available

  • As0014 40013

    Prague 3067696,
    Czechia

    Site Not Available

  • As0014 40014

    Prague 3067696,
    Czechia

    Site Not Available

  • As0014 40015

    Prague 3067696,
    Czechia

    Site Not Available

  • As0014 40016

    Prague 3067696,
    Czechia

    Site Not Available

  • As0014 40015

    Praha,
    Czechia

    Site Not Available

  • As0014 40013

    Praha 11,
    Czechia

    Site Not Available

  • As0014 40016

    Praha 2,
    Czechia

    Site Not Available

  • As0014 40015

    Praha 3,
    Czechia

    Site Not Available

  • As0014 40014

    Praha 4,
    Czechia

    Site Not Available

  • As0014 40010

    Uherske Hradiste,
    Czechia

    Site Not Available

  • As0014 40010

    Uherské Hradiště,
    Czechia

    Site Not Available

  • As0014 40010

    Uherské Hradiště 3063739,
    Czechia

    Site Not Available

  • As0014 40012

    Zlin,
    Czechia

    Site Not Available

  • As0014 40012

    Zlín,
    Czechia

    Site Not Available

  • As0014 40012

    Zlín 3061370,
    Czechia

    Site Not Available

  • As0014 40018

    Boulogne Billancourt,
    France

    Site Not Available

  • As0014 40018

    Boulogne-Billancourt,
    France

    Site Not Available

  • As0014 40018

    Boulogne-Billancourt 3031137,
    France

    Site Not Available

  • As0014 40022

    Limoges,
    France

    Site Not Available

  • As0014 40022

    Limoges 2998286,
    France

    Site Not Available

  • As0014 40025

    Berlin,
    Germany

    Site Not Available

  • As0014 40025

    Berlin 2950159,
    Germany

    Site Not Available

  • As0014 40029

    Hamburg,
    Germany

    Site Not Available

  • As0014 40029

    Hamburg 2911298,
    Germany

    Site Not Available

  • As0014 40024

    Hannover,
    Germany

    Site Not Available

  • As0014 40024

    Hanover,
    Germany

    Site Not Available

  • As0014 40024

    Hanover 2910831,
    Germany

    Site Not Available

  • As0014 40027

    Herne,
    Germany

    Site Not Available

  • As0014 40027

    Herne 2905891,
    Germany

    Site Not Available

  • As0014 40078

    Leipzig,
    Germany

    Site Not Available

  • As0014 40078

    Leipzig 2879139,
    Germany

    Site Not Available

  • As0014 40026

    Ratingen,
    Germany

    Site Not Available

  • As0014 40026

    Ratingen 2850174,
    Germany

    Site Not Available

  • As0014 40032

    Debrecen,
    Hungary

    Site Not Available

  • As0014 40032

    Debrecen 721472,
    Hungary

    Site Not Available

  • As0014 40031

    Szeged,
    Hungary

    Site Not Available

  • As0014 40031

    Szeged 715429,
    Hungary

    Site Not Available

  • As0014 40033

    Székesfehérvár,
    Hungary

    Site Not Available

  • As0014 40033

    Székesfehérvár 3044774,
    Hungary

    Site Not Available

  • As0014 20035

    Bunkyo-ku,
    Japan

    Site Not Available

  • As0014 20035

    Bunkyō City,
    Japan

    Site Not Available

  • As0014 20035

    Bunkyō City 11790632,
    Japan

    Site Not Available

  • As0014 20035

    Bunkyō-Ku,
    Japan

    Site Not Available

  • As0014 20030

    Chuo Ku,
    Japan

    Site Not Available

  • As0014 20030

    Chuo-ku,
    Japan

    Site Not Available

  • As0014 20030

    Chūōku,
    Japan

    Site Not Available

  • As0014 20030

    Chūōku 10262791,
    Japan

    Site Not Available

  • As0014 20039

    Iruma-gun,
    Japan

    Site Not Available

  • As0014 20036

    Kawachi-Nagano,
    Japan

    Site Not Available

  • As0014 20036

    Kawachi-Nagano 6825498,
    Japan

    Site Not Available

  • As0014 20036

    Kawachinagano,
    Japan

    Site Not Available

  • As0014 20045

    Kita-gun,
    Japan

    Site Not Available

  • As0014 20065

    Kitakyushu,
    Japan

    Site Not Available

  • As0014 20065

    Kitakyushu 1859307,
    Japan

    Site Not Available

  • As0014 20037

    Osaka,
    Japan

    Site Not Available

  • As0014 20037

    Osaka 1853909,
    Japan

    Site Not Available

  • As0014 20084

    Saga,
    Japan

    Site Not Available

  • As0014 20084

    Saga 1853303,
    Japan

    Site Not Available

  • As0014 20048

    Saitama,
    Japan

    Site Not Available

  • As0014 20048

    Saitama 6940394,
    Japan

    Site Not Available

  • As0014 20031

    Sapporo,
    Japan

    Site Not Available

  • As0014 20031

    Sapporo 2128295,
    Japan

    Site Not Available

  • As0014 20032

    Suita,
    Japan

    Site Not Available

  • As0014 20032

    Suita 1851483,
    Japan

    Site Not Available

  • As0014 40034

    Amsterdam,
    Netherlands

    Site Not Available

  • As0014 40034

    Amsterdam 2759794,
    Netherlands

    Site Not Available

  • As0014 40038

    Elblag,
    Poland

    Site Not Available

  • As0014 40038

    Elblag 3099759,
    Poland

    Site Not Available

  • As0014 40038

    Elbląg,
    Poland

    Site Not Available

  • As0014 40042

    Krakow,
    Poland

    Site Not Available

  • As0014 40042

    Krakow 3094802,
    Poland

    Site Not Available

  • As0014 40042

    Kraków,
    Poland

    Site Not Available

  • As0014 40037

    Lublin,
    Poland

    Site Not Available

  • As0014 40037

    Lublin 765876,
    Poland

    Site Not Available

  • As0014 40044

    Poznan,
    Poland

    Site Not Available

  • As0014 40044

    Poznan 3088171,
    Poland

    Site Not Available

  • As0014 40044

    Poznań,
    Poland

    Site Not Available

  • As0014 40040

    Torun,
    Poland

    Site Not Available

  • As0014 40040

    Torun 3083271,
    Poland

    Site Not Available

  • As0014 40040

    Toruń,
    Poland

    Site Not Available

  • As0014 40041

    Warsaw,
    Poland

    Site Not Available

  • As0014 40041

    Warsaw 756135,
    Poland

    Site Not Available

  • As0014 40041

    Warszawa,
    Poland

    Site Not Available

  • As0014 40039

    Wroclaw,
    Poland

    Site Not Available

  • As0014 40043

    Wroclaw,
    Poland

    Site Not Available

  • As0014 40039

    Wroclaw 3081368,
    Poland

    Site Not Available

  • As0014 40043

    Wroclaw 3081368,
    Poland

    Site Not Available

  • As0014 40039

    Wrocław,
    Poland

    Site Not Available

  • As0014 40045

    A Coruna,
    Spain

    Site Not Available

  • As0014 40045

    A Coruña,
    Spain

    Site Not Available

  • As0014 40045

    A Coruña 3119841,
    Spain

    Site Not Available

  • As0014 40046

    Cordoba,
    Spain

    Site Not Available

  • S0014 40045

    Coruña,
    Spain

    Site Not Available

  • As0014 40046

    Córdoba,
    Spain

    Site Not Available

  • As0014 40046

    Córdoba 2519240,
    Spain

    Site Not Available

  • As0014 40048

    Santiago de Compostela,
    Spain

    Site Not Available

  • As0014 40048

    Santiago de Compostela 3109642,
    Spain

    Site Not Available

  • As0014 40049

    Sevilla,
    Spain

    Site Not Available

  • As0014 40049

    Seville,
    Spain

    Site Not Available

  • As0014 40049

    Seville 2510911,
    Spain

    Site Not Available

  • As0014 40052

    Ankara,
    Turkey

    Site Not Available

  • As0014 40053

    Ankara,
    Turkey

    Site Not Available

  • As0014 40050

    Istanbul,
    Turkey

    Site Not Available

  • As0014 40052

    Ankara,
    Turkey (Türkiye)

    Site Not Available

  • As0014 40053

    Ankara,
    Turkey (Türkiye)

    Site Not Available

  • As0014 40052

    Ankara 323786,
    Turkey (Türkiye)

    Site Not Available

  • As0014 40053

    Ankara 323786,
    Turkey (Türkiye)

    Site Not Available

  • As0014 40050

    Istanbul,
    Turkey (Türkiye)

    Site Not Available

  • As0014 40050

    Istanbul 745044,
    Turkey (Türkiye)

    Site Not Available

  • As0014 40057

    Edinburgh,
    United Kingdom

    Site Not Available

  • As0014 40057

    Edinburgh 2650225,
    United Kingdom

    Site Not Available

  • As0014 40056

    Leeds,
    United Kingdom

    Site Not Available

  • As0014 40056

    Leeds 2644688,
    United Kingdom

    Site Not Available

  • As0014 40055

    Norwich,
    United Kingdom

    Site Not Available

  • As0014 40055

    Norwich 2641181,
    United Kingdom

    Site Not Available

  • As0014 50062

    Glendale, Arizona 85306
    United States

    Site Not Available

  • As0014 50052

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • As0014 50062

    Glendale 5295985, Arizona 5551752 85306
    United States

    Site Not Available

  • As0014 50052

    Phoenix 5308655, Arizona 5551752 85032
    United States

    Site Not Available

  • As0014 50060

    Upland, California 91786
    United States

    Site Not Available

  • As0014 50060

    Upland 5404915, California 5332921 91786
    United States

    Site Not Available

  • As0014 50059

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • As0014 50056

    Sarasota, Florida 34239
    United States

    Site Not Available

  • As0014 50059

    Ormond Beach 4167178, Florida 4155751 32174
    United States

    Site Not Available

  • As0014 50056

    Sarasota 4172131, Florida 4155751 34239
    United States

    Site Not Available

  • As0014 50015

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • As0014 50015

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Site Not Available

  • As0014 50016

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • As0014 50016

    St Louis, Missouri 63141
    United States

    Site Not Available

  • As0014 50016

    St Louis 4407066, Missouri 4398678 63141
    United States

    Site Not Available

  • As0014 50055

    Portland, Oregon 97239
    United States

    Site Not Available

  • As0014 50055

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • As0014 50020

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • As0014 50020

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Site Not Available

  • As0014 50057

    Dallas, Texas 75231
    United States

    Site Not Available

  • As0014 50057

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • As0014 50061

    Spokane, Washington 99204
    United States

    Site Not Available

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