Site for DV0004 A MULTICENTER RANDOMIZED OPEN-LABEL STUDY TO EVALUATE THE SAFE AND EFFECTIVE USE OF THE PREFILLED SAFETY SYRINGE OR AUTO-INJECTOR FOR THE SUBCUTANEOUS SELF-INJECTION OF BIMEKIZUMAB SOLUTION BY SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS

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Site for DV0004 A MULTICENTER RANDOMIZED OPEN-LABEL STUDY TO EVALUATE THE SAFE AND EFFECTIVE USE OF THE PREFILLED SAFETY SYRINGE OR AUTO-INJECTOR FOR THE SUBCUTANEOUS SELF-INJECTION OF BIMEKIZUMAB SOLUTION BY SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS

Brief description of study

Site for DV0004 is a Phase 3, multicenter, open-label, randomized, noncomparator, North America and Europe substudy to PA0012 in adult subjects with active psoriatic arthritis (PsA) to evaluate the safe and effective use of 2 single-use disposable self-injecting device presentations for the subcutaneous (sc) administration of bimekizumab solution (the investigational medicinal product [IMP]). To provide patients with PsA with options for the self-administration of bimekizumab, DV0004 will evaluate 2 investigational self-injecting device presentations, which are drug product (IMP) associated with a functional secondary packaging: the 1mL bimekizumab safety syringe (bimekizumab-SS-1mL) and the 1mL bimekizumab auto-injector (bimekizumab-AI-1mL).

Clinical Study Identifier: s19-00833

Principal Investigator: David H. Goddard.

Other Investigators: Jennifer Hill, Andres M. Piatti, Lauren E. Wong.

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