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

Running, not enrolling · Phase 3

Conditions studied: Axial Spondyloarthritis, Ankylosing Spondylitis, r-axSpa, Nr-axSpa

In brief

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).

Key facts

Study ID

NCT04436640

Run by

UCB Biopharma SRL

People needed

508

Starts

2020-06-16

Expected to finish

2026-08-07

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• As0014 50052 — Phoenix, Arizona, United States
• As0014 50060 — Upland, California, United States
• As0014 50059 — Ormond Beach, Florida, United States
• As0014 50056 — Sarasota, Florida, United States
• As0014 50015 — Hagerstown, Maryland, United States
• As0014 50016 — St Louis, Missouri, United States
• As0014 50055 — Portland, Oregon, United States
• As0014 50020 — Duncansville, Pennsylvania, United States
• As0014 50057 — Dallas, Texas, United States
• As0014 40004 — Brussels, Belgium
• As0014 40003 — Genk, Belgium
• As0014 40001 — Ghent, Belgium
• As0014 40006 — Plovdiv, Bulgaria
• As0014 40007 — Plovdiv, Bulgaria
• As0014 40005 — Sofia, Bulgaria
• As0014 40008 — Sofia, Bulgaria
• As0014 20040 — Beijing, China
• As0014 20021 — Chengdu, China
• As0014 20019 — Guangzhou, China
• As0014 20034 — Hefei, China
• As0014 20024 — Nanjing, China
• As0014 20018 — Shanghai, China
• As0014 20020 — Shanghai, China
• As0014 20026 — Shanghai, China
• As0014 50062 — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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