drugset / Trial / NCT01058343

Safety of IFNa Kinoid in Systemic Lupus Erythematosus

NCT01058343 ↗

Phase 1/2 Completed 28 enrolled Neovacs
RandomizedParallel-groupTriple-blindTreatment

Summary

Interferon alpha (IFNa) is involved in the pathogenesis of systemic lupus erythematosus (SLE)and IFNa levels are associated with the severity of the disease. Blocking IFNa could be an attractive therapeutic strategy. Active immunization with IFNa kinoid (IFN-K) induces a polyclonal antibody response. This study will evaluate the safety of IFN-K in patients with mild to moderate SLE. It will also measure the induction of anti-IFNa antibodies and evaluate the clinical impact on SLE disease.

Timeline

Start
2010-03
Primary completion
2011-04
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject IFN α Kinoid Vaccine 30 ug Intramuscular
Subject IFN α Kinoid Vaccine 60 ug Intramuscular
Subject IFN α Kinoid Vaccine 120 ug Intramuscular
Subject IFN α Kinoid Vaccine 240 ug Intramuscular