06 Jun PA0011
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).
The overall study design consists of a Screening Period (≥14 days to ≤35 days), a 16-week placebo-controlled Double-Blind Treatment Period, and a Safety Follow-Up (SFU) Visit, 20 weeks after the final dose of investigational medicinal product (IMP) (for subjects not entering the open-label extension [OLE] study or who discontinue early, including those withdrawn from IMP).
The maximum study duration per subject will be up to 37 weeks.
Approximately 390 subjects will be randomly assigned in a 2:1 ratio to the following treatment groups: bimekizumab 160mg sc Q4W (260 subjects), and placebo (130 subjects).
Key Inclusion Criteria:
• Subject is male or female at least 18 years of age
• Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
• Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
• Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
• Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
• Subject has a history of inadequate response (lack of efficacy after at least 3 months of therapy at an approved dose) or intolerance to treatment with 1 or 2 tumor necrosis factor alpha (TNF(α)) inhibitors for either PsA or PSO
• Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
Key Exclusion Criteria:
• Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
• Subjects with current or prior exposure to any biologics except tumor necrosis factor (TNF) inhibitors for the treatment of PsA or PSO
• Subject has an active infection or a history of recent serious infectionsubject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
• Subject has a diagnosis of inflammatory conditions other than PSO or PsA. Subjects with a diagnosis of Crohn’s disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
• Subject had acute anterior uveitis within 6 weeks of Baseline
• Subject has 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
• Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
• Presence of active suicidal ideation, or moderately severe major depression or severe major depression
• Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
(425) 248-2635 x_____
Additional Study Details
Full Study Title
PA0011: A Multicenter, Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluation the Efficacy and Safety of Bimekizumab in the Treatment of Subjects with Active Psoriatic Arthritis
Jeff R. Peterson, MD
Richard A.H. Jimenez, MD
Accepts Healthy Volunteers?
Western Washington Arthritis Clinic
1909 214th St SE Suite 211
Bothell, Washington 98021