A multicenter phase 3 randomized double-blind placebo-controlled study evaluating the efficacy and safety of bimekizumab in the treatment of subjects with active psoriatic arthritis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Psoriatic Arthritis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects able to provide written consent form and adhere to the procedures of the protocol
    2. Female subjects who are postmenopausal, permanently sterilized or if of childbearing potential, must be willing to use a highly effective method of contraception throughout the duration of the study.
    3. Subjects who have documented diagnosis of adult-onset PsA classified and meets the CASPAR classification criteria
    4. Subjects must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies.
    5. Subjects must have at least 1 active psoriatic lesion(s) and/or a documented history of PSO
    6. Subjects who have history of inadequate response or intolerance to prior bDMARDs
    7. Subjects who are regularly taking NSAIDs/COX-2 inhibitors/mild opioid analgesics as part of their PsA therapy are required to be on a stable dose/dose regimen for at least 14 days
    8. Subjects taking corticosteroids must be on an average daily dose of =10mg/day prednisone or equivalent for at least 14 days
    9. Subjects taking MTX (=25mg /week) are allowed to continue their medication if started at least 12 weeks prior to Baseline
    10. Subjects taking LEF, SSZ, HCQ or apremilast are allowed to continue as per the protocol before randomization

You may not be eligible for this study if the following are true:

    1. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 20 weeks following final dose of IMP
    2. Subjects who had previously participated in a bimekizumab clinical study and received at least 1 dose of IMP (including placebo).
    3. Subjects previously participated in another study of a medication (systemic) under investigation
    4. Subjects previously participated in another study of a medical device under investigation
    5. Subjects known hypersensitivity to any excipients of bimekizumab
    6. Subjects who are taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit
    7. Subjects who have an active infection or history of infections
    8. Subjects with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
    9. Subjects received any live (includes attenuated) vaccination within the 8 weeks prior to the Baseline
    10. Subjects received Bacillus Calmette-Guerin (BCG) vaccinations within 1 year prior to the Baseline Visit.
    11. Subjects with known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
    12. Subjects with history of a lymphoproliferative disorder including lymphoma and/or current signs and symptoms suggestive of lymphoproliferative disease
    13. Subjects with diagnosis of inflammatory conditions other than PSO or PsA including but not limited to RA, sarcoidosis, systemic lupus erythematosus, and reactive arthritis
    14. Subjects with acute anterior uveitis within 6 weeks of Baseline
    15. Subjects who have fibromyalgia or osteoarthritis symptoms that, in the Investigator’s opinion, would have potential to interfere with efficacy assessments
    16. Subjects have any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer.
    17. Subjects with form of PSO other than chronic plaque-type
    18. Subjects have had major surgery (including joint surgery) within the 3 months prior to Baseline, or planned surgery within 6 months after entering the study.
    19. Subjects with any systemic disease (cardiovascular, neurological, renal, liver, metabolic, GI, hematological, immunological, etc) considered by the Investigator to be uncontrolled, unstable or likely to progress to a clinically significant degree during the course of the study
    20. Subjects have had myocardial infarction or stroke within the 6 months prior
    21. Subjects with laboratory abnormalities at Screening
    22. Subjects with presence of moderately severe major depression, or severe major depression,
    23. Subjects who have history of chronic alcohol or drug abuse



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