A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Completed · Phase 3

Conditions studied: Psoriatic Arthritis

In brief

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

Key facts

Study ID

NCT04009499

Run by

UCB Biopharma SRL

People needed

1131

Starts

2019-08-13

Expected to finish

2026-05-26

Last updated by the study team

2026-07-06

Who can join

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

You may qualify if…

• In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
• Subject completed PA0010 [NCT03895203] or PA0011 [NCT03896581] without meeting any withdrawal criteria
• Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

You may not qualify if…

• Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
• Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
• Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated

Where it is running

• Pa0012 50017 — Phoenix, Arizona, United States
• Pa0012 50035 — San Diego, California, United States
• Pa0012 50033 — Palm Harbor, Florida, United States
• Pa0012 50037 — Tampa, Florida, United States
• Pa0012 50039 — Atlanta, Georgia, United States
• Pa0012 50024 — Boise, Idaho, United States
• Pa0012 50028 — Lexington, Kentucky, United States
• Pa0012 50023 — Baton Rouge, Louisiana, United States
• Pa0012 50015 — Hagerstown, Maryland, United States
• Pa0012 50047 — Boston, Massachusetts, United States
• Pa0012 50019 — Lansing, Michigan, United States
• Pa0012 50016 — St Louis, Missouri, United States
• Pa0012 50005 — Freehold, New Jersey, United States
• Pa0012 50029 — Albuquerque, New Mexico, United States
• Pa0012 50010 — Brooklyn, New York, United States
• Pa0012 50011 — New York, New York, United States
• Pa0012 50034 — Rochester, New York, United States
• Pa0012 50125 — Charlotte, North Carolina, United States
• Pa0012 50031 — Winston-Salem, North Carolina, United States
• Pa0012 50040 — Vandalia, Ohio, United States
• Pa0012 50020 — Duncansville, Pennsylvania, United States
• Pa0012 50006 — Wyomissing, Pennsylvania, United States
• Pa0012 50008 — Johnston, Rhode Island, United States
• Pa0012 50007 — Orangeburg, South Carolina, United States
• Pa0012 50001 — Jackson, Tennessee, United States

Full record on ClinicalTrials.gov

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