drugset / Trial / NCT00442182

The Efficacy and Safety of ITF2357 in AIS

NCT00442182

Phase 2 Unknown 20 enrolled Radboud University Medical Center
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Autoinflammatory syndromes (AIS) are a group of disorders characterized by recurrent episodes of inflammation.Although for the hereditary autoinflammatory diseases the genetic mutations are known it remains largely unclear how these mutations lead to recurrent inflammatory attacks. Treatment of the inflammatory symptoms remains a challenge. With beneficial responses reported during treatment with simvastatin, etanercept or anakinra in some but not all patients. ITF2357 is an orally active histon deacetylase inhibitor with a potent anti-inflammatory effect due to inhibition of pro-inflammatory cytokines (IL-1β, TNFα, IFNg, IL-6). We expect that ITF2357 is able to modify the clinical symptoms of AIS patients and induce clinical complete remission or a reduction in attack duration.

Timeline

Start
2006-09
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Givinostat Small molecule 50 mg Oral