Summary:
The purpose of this study is to provide 16 week safety, efficacy and tolerability data in adult biologic naïve PsA patients with active psoriatic arthritis after 16 weeks of treatment compared to placebo and to assess the safety, tolerability and efficacy up to 52 weeks.
Qualified Participants Must:
• Be able to understand and communicate with the investigator and comply with the requirements of the study
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Be male or non-pregnant, non-lactating female patients at least 18 years of age
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Have a diagnosis of PsA with symptoms for at least 6 months with moderate to severe PsA
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Patients who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization
• Patients taking corticosteroids should be on a stable dose of &le
• 10 mg/day prednisone or equivalent for at least 2 weeks before randomization
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Patients taking MTX (25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization, and must be on folic acid supplementation at randomization
MUST NOT:
•Have previous exposure to biologic drug directly targeting IL-17 or IL-17 receptor
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Be patients who ever received biologic immunomodulating agents
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Have pngoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, ultraviolet therapy) at randomization
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Have significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (160/95 mmHg)
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Have a history or evidence of ongoing alcohol or drug abuse, within the last six months before randomization
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Plans for administration of live vaccines during the study period or within 6 weeks preceding randomization
Qualified Participants May Receive:
Compensation for Time and Travel
Full Laboratory work up/ Physicals and Study Products
Access to medical staff 24 hours