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A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
CompletedPhase 3
Sponsor: UCB Biopharma SRL
Conditions: Psoriatic Arthritis
Interventions: Bimekizumab, Adalimumab, Placebo
Countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject * Subject is male or female at least 18 years of age * Female subject 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 must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator * 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 for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (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 (136)
- 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
- Lexington, Kentucky, United States
- Hagerstown, Maryland, United States
- St Louis, Missouri, United States
- Albuquerque, New Mexico, United States
- Brooklyn, New York, United States
- Charlotte, North Carolina, United States
- Dayton, Ohio, United States
- Duncansville, Pennsylvania, United States
- Wyomissing, Pennsylvania, United States
- Johnston, Rhode Island, United States
- Orangeburg, South Carolina, United States
- Jackson, Tennessee, United States
- Memphis, Tennessee, United States
- Austin, Texas, United States
- Corpus Christi, Texas, United States
- Houston, Texas, United States
- Mesquite, Texas, United States
- Waco, Texas, United States
- Beckley, West Virginia, United States
- Camberwell, Australia
- Clayton, Australia
- Hobart, Australia
- Maroochydore, Australia
- Victoria Park, Australia
- + 106 more on CT.gov