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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04436640
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UCB Biopharma SRL
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

UCB Cares
Principal Investigator Affiliation 001 844 599 2273 (UCB)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries Belgium, Bulgaria, Czechia, France, Germany, Hungary, Japan, Netherlands, Poland, Spain, Turkey, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Axial Spondyloarthritis, Ankylosing Spondylitis, r-axSpa
Arms & Interventions

Arms

Experimental: Bimekizumab

Subjects will receive bimekizumab throughout the Treatment Period.

Interventions

Drug: - Bimekizumab

Subjects will receive bimekizumab at prespecified time-points.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

As0014 50052, Phoenix, Arizona

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Address

As0014 50052

Phoenix, Arizona, 85032

As0014 50060, Upland, California

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As0014 50060

Upland, California, 91786

As0014 50059, Ormond Beach, Florida

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As0014 50059

Ormond Beach, Florida, 32174

As0014 50056, Sarasota, Florida

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As0014 50056

Sarasota, Florida, 34239

As0014 50016, Saint Louis, Missouri

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As0014 50016

Saint Louis, Missouri, 63141

As0014 50020, Duncansville, Pennsylvania

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As0014 50020

Duncansville, Pennsylvania, 16635

As0014 50061, Spokane, Washington

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As0014 50061

Spokane, Washington, 99204

International Sites

As0014 40004, Brussels, Belgium

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As0014 40004

Brussels, ,

As0014 40003, Genk, Belgium

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As0014 40003

Genk, ,

As0014 40001, Gent, Belgium

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As0014 40001

Gent, ,

As0014 40006, Plovdiv, Bulgaria

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As0014 40006

Plovdiv, ,

As0014 40007, Plovdiv, Bulgaria

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As0014 40007

Plovdiv, ,

As0014 40005, Sofia, Bulgaria

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As0014 40005

Sofia, ,

As0014 40008, Sofia, Bulgaria

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As0014 40008

Sofia, ,

As0014 40011, Brno, Czechia

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As0014 40011

Brno, ,

As0014 40009, Pardubice, Czechia

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As0014 40009

Pardubice, ,

As0014 40013, Praha 11, Czechia

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As0014 40013

Praha 11, ,

As0014 40016, Praha 2, Czechia

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As0014 40016

Praha 2, ,

As0014 40014, Praha 4, Czechia

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As0014 40014

Praha 4, ,

AS0014, Praha 4, Czechia

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AS0014

Praha 4, ,

As0014 40015, Praha, Czechia

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As0014 40015

Praha, ,

As0014 40010, Uherské Hradiště, Czechia

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As0014 40010

Uherské Hradiště, ,

As0014 40012, Zlín, Czechia

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As0014 40012

Zlín, ,

As0014 40018, Boulogne-Billancourt, France

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As0014 40018

Boulogne-Billancourt, ,

As0014 40025, Berlin, Germany

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As0014 40025

Berlin, ,

As0014 40029, Hamburg, Germany

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As0014 40029

Hamburg, ,

As0014 40024, Hannover, Germany

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As0014 40024

Hannover, ,

As0014 40027, Herne, Germany

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As0014 40027

Herne, ,

As0014 40026, Ratingen, Germany

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As0014 40026

Ratingen, ,

As0014 40032, Debrecen, Hungary

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As0014 40032

Debrecen, ,

As0014 40031, Szeged, Hungary

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As0014 40031

Szeged, ,

As0014 40033, Székesfehérvár, Hungary

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As0014 40033

Székesfehérvár, ,

As0014 20030, Chuo Ku, Japan

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As0014 20030

Chuo Ku, ,

As0014 20036, Kawachi-Nagano, Japan

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As0014 20036

Kawachi-Nagano, ,

As0014 20045, Kita-Gun, Japan

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As0014 20045

Kita-Gun, ,

As0014 20084, Saga, Japan

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As0014 20084

Saga, ,

As0014 40034, Amsterdam, Netherlands

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As0014 40034

Amsterdam, ,

As0014 40038, Elbląg, Poland

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As0014 40038

Elbląg, ,

As0014 40042, Kraków, Poland

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As0014 40042

Kraków, ,

As0014 40037, Lublin, Poland

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As0014 40037

Lublin, ,

As0014 40044, Poznań, Poland

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As0014 40044

Poznań, ,

As0014 40040, Toruń, Poland

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As0014 40040

Toruń, ,

As0014 40041, Warsaw, Poland

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As0014 40041

Warsaw, ,

As0014 40043, Wroclaw, Poland

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As0014 40043

Wroclaw, ,

As0014 40039, Wrocław, Poland

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As0014 40039

Wrocław, ,

S0014 40045, Coruña, Spain

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S0014 40045

Coruña, ,

As0014 40046, Córdoba, Spain

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As0014 40046

Córdoba, ,

As0014 40048, Santiago De Compostela, Spain

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As0014 40048

Santiago De Compostela, ,

As0014 40049, Sevilla, Spain

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As0014 40049

Sevilla, ,

As0014 40053, Ankara, Turkey

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As0014 40053

Ankara, ,

As0014 40050, Istanbul, Turkey

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As0014 40050

Istanbul, ,

As0014 40057, Edinburgh, United Kingdom

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As0014 40057

Edinburgh, ,

As0014 40056, Leeds, United Kingdom

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As0014 40056

Leeds, ,

As0014 40055, Norwich, United Kingdom

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As0014 40055

Norwich, ,