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A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

NCT03896581

CompletedPhase 3

Sponsor: UCB Biopharma SRL

Conditions: Psoriatic Arthritis

Interventions: Bimekizumab, Placebo

Countries: United States, Australia, Canada, Czechia, Germany, Hungary, Italy, Japan

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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

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 infections
* Subject 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
Locations (92)
  • Phoenix, Arizona, United States
  • San Diego, California, United States
  • Tustin, California, United States
  • Palm Harbor, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Boise, Idaho, United States
  • Lexington, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • Hagerstown, Maryland, United States
  • Wheaton, Maryland, United States
  • Boston, Massachusetts, United States
  • Lansing, Michigan, United States
  • St Louis, Missouri, United States
  • Freehold, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Brooklyn, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Charlotte, North Carolina, United States
  • Salisbury, North Carolina, United States
  • Vandalia, Ohio, United States
  • Duncansville, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Wyomissing, Pennsylvania, United States
  • Johnston, Rhode Island, United States
  • Summerville, South Carolina, United States
  • Jackson, Tennessee, United States
  • Memphis, Tennessee, United States
  • Austin, Texas, United States
  • + 62 more on CT.gov