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NCT04436640CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
508 (actual)
First submitted
15 Jun 2020
Start date
16 Jun 2020
Primary completion date
9 Aug 2026
Lead sponsor
UCB Biopharma SRL
NCT number
NCT04436640
EU CT number
2023-506527-28-00
EudraCT number
2019-004163-47

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 508
  • From 16 Jun 2020 to the primary completion date, 9 Aug 2026
  • 71 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • 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 participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (71)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ReumaClinic
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GenkBelgiumCompleted
As0014 40006
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PlovdivBulgariaUnknown status
As0014 40007
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PlovdivBulgariaUnknown status
As0014 40008
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SofiaBulgariaUnknown status
As0014 40005
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SofiaBulgariaUnknown status
As0014 20040
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BeijingChinaUnknown status
As0014 20021
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ChengduChinaUnknown status
As0014 20019
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GuangzhouChinaUnknown status
As0014 20034
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HefeiChinaUnknown status
As0014 20024
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NanjingChinaUnknown status
As0014 20018
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ShanghaiChinaUnknown status
As0014 20026
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ShanghaiChinaUnknown status
As0014 20020
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ShanghaiChinaUnknown status
As0014 20025
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WenzhouChinaUnknown status
Revmatologie s.r.o.
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Brno-SeverCzechiaCompleted
Pratia Pardubice a.s.
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Pardubice ICzechiaCompleted
Affidea Praha s.r.o.
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Prague 11CzechiaCompleted
Revmatologicky Ustav
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Prague 2CzechiaCompleted
Pratia Prague s.r.o.
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Prague 3CzechiaCompleted
MUDR. Zuzana URBANOVA
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Prague 4CzechiaCompleted
MEDICAL PLUS s.r.o.
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Uherské HradištěCzechiaCompleted
PV Medical S R O
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ZlínCzechiaCompleted
Rheumatologische Schwerpunktpraxis
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BerlinGermanyCompleted
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
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HamburgGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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HerneGermanyCompleted
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyCompleted
Rheumazentrum Ratingen
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RatingenGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital General Universitario Reina Sofia
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CórdobaSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Hôpital Ambroise-Paré
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Boulogne-BillancourtFranceCompleted
Polyclinique De Limoges
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Limoges Cedex IFranceCompleted
As0014 40057
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EdinburghUnited KingdomUnknown status
As0014 40056
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LeedsUnited KingdomUnknown status
As0014 40055
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NorwichUnited KingdomUnknown status
University of Debrecen
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DebrecenHungaryCompleted
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
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SzekesfehervarHungaryCompleted
As0014 20035
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Bunkyō CityJapanUnknown status
As0014 20030
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ChūōkuJapanUnknown status
As0014 20039
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Iruma-gunJapanUnknown status
As0014 20036
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Kawachi-NaganoJapanUnknown status
As0014 20045
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Kita-gunJapanUnknown status
As0014 20065
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KitakyushuJapanUnknown status
As0014 20037
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OsakaJapanUnknown status
As0014 20084
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SagaJapanUnknown status
As0014 20048
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SaitamaJapanUnknown status
As0014 20031
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SapporoJapanUnknown status
As0014 20032
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SuitaJapanUnknown status
As0014 40034
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AmsterdamNetherlandsUnknown status
Pratia S.A.
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CracowPolandCompleted
Reumed Sp. z o.o.
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LublinPolandCompleted
Medyczne Centrum Hetmańska Piotr Leszczyński
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PoznanPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandCompleted
Futuremeds Sp. z o.o.
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WarsawPolandCompleted
Centrum Medyczne Oporow
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WroclawPolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o
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WroclawPolandCompleted
As0014 50057
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DallasUnited StatesUnknown status
As0014 50020
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DuncansvilleUnited StatesUnknown status
As0014 50062
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GlendaleUnited StatesUnknown status
As0014 50015
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HagerstownUnited StatesUnknown status
As0014 50059
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Ormond BeachUnited StatesUnknown status
As0014 50052
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PhoenixUnited StatesUnknown status
As0014 50055
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PortlandUnited StatesUnknown status
As0014 50056
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SarasotaUnited StatesUnknown status
As0014 50016
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St LouisUnited StatesUnknown status
As0014 50060
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UplandUnited StatesUnknown status
As0014 40053
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AnkaraTurkey (Türkiye)Unknown status
As0014 40052
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AnkaraTurkey (Türkiye)Unknown status
As0014 40050
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IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.