drugset / Trial / NCT00288704

Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

NCT00288704

Phase 3 Completed 104 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1). These mutations result in the body's overproduction of interleukin-1 (IL-1), a protein that stimulates the inflammatory process. IL-1 Trap (rilonacept) was designed to bind to the interleukin-1 cytokine and prevent it from binding to its receptors in the body.

Timeline

Start
2005-12
Primary completion
2008-06
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilonacept Protein / enzyme biologic 2.2 mg/kg Subcutaneous
Subject Rilonacept Protein / enzyme biologic 160 mg Subcutaneous