AS0014 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 Brief 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). Medical Condition Axial Spondyloarthritis Min. Age 18 Years Max. Age - Who Can Join? All Status Active, not recruiting 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 Study Medication Description Study Medication: Bimzelx? Other Descriptive Name: bimekizumab Placebo No Comparator: No Share this study Refer to a friend Via email Study Dates June 2020 Actual Start Date of Enrollment August 2026 Planned Study Completion Date General Information Study ID: AS0014 EudraCT Number: CT.gov Number: Phase: Phase 3 Locations Interested in our clinical studies? Just contact us Austria 金禾娱乐城Cares.AT@ucb.com +43 (0) 1 291 80 08 0800-296176 (freephone) Belgium 金禾娱乐城Cares.BE@ucb.com +32 2 559 92 00 0800 38 008 (freephone) Bulgaria 金禾娱乐城Cares.BG@ucb.com +359 2 962 9933 Canada +1 866 709 8444 Czech Republic 金禾娱乐城Cares.CZ@ucb.com +420 221 773 442 800 144 395 (freephone) Denmark 金禾娱乐城Cares.DK@ucb.com +45 32462480 80 253827 (freephone) Finland 金禾娱乐城Cares.FI@ucb.com +358 942733300 0800 9 13353 (freephone) France 金禾娱乐城Cares.FR@ucb.com +33 1 47 29 45 55 0 805 222 949 (freephone) Germany 金禾娱乐城Cares.DE@ucb.com +49 2173 48 48 48 Greece 金禾娱乐城Cares.GR@ucb.com +30 21 0997 4200 0080 012 9910 (freephone) Hungary 金禾娱乐城Cares.HU@ucb.com +36 1 472 5060 06 80 021 486 (freephone) Ireland 金禾娱乐城Cares.IE@ucb.com +353 1 463 2371 1800 93 00 75 (freephone) Italy 金禾娱乐城Cares.IT@ucb.com +39 02 3007 9300 8009-86932 (freephone) Japan Luxemburg 金禾娱乐城Cares.LU@ucb.com +32 2 559 92 12 8002 3204 (freephone) Norway 金禾娱乐城Cares.NO@ucb.com +45 32462482 800-10101 (freephone) Poland 金禾娱乐城Cares.PL@ucb.com +48 22 596 97 97 00 800 121 68 25 (freephone) Portugal 金禾娱乐城Cares.PT@ucb.com +351 213 025 300 800-8-56033 (freephone) Romania +4021 300 19 07 Slovakia 金禾娱乐城Cares.SK@ucb.com +421 2 592 020 23 0800 002 566 (freephone) Spain 金禾娱乐城Cares.ES@ucb.com +34 915 70 06 49 8000-99684 (freephone) Sweden 金禾娱乐城Cares.SE@ucb.com +45 32462481 0200 898 671 (freephone) Switzerland +41 58 822 3180 The Netherlands 金禾娱乐城Cares.NL@ucb.com +31 76 573 1130 0800 3434335 (freephone) UK 金禾娱乐城Cares.UK@ucb.com +44 1753 777 100 0800 279 3177 (freephone) USA 金禾娱乐城Cares@ucb.com +1-844-599-2273 Email Print Back to results
