The Efficacy and Safety of ITF2357 in AIS

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Givinostat hydrochloride

Criteria

Inclusion Criteria:

• Autoinflammatory syndrome (hereditary or acquired)

• Age ³18 years

• Severe active disease (≥1 attack every eight weeks or continuous symptoms).

An attack will be defined as:

• Temperature of ≥38 ºC not otherwise explained.

• At least two other accompanying symptoms (e.g. joint pain, lymphadenopathy, skin lesions, abdominal symptoms)

• written informed consent obtained

Exclusion Criteria:

• Age < 18 years

• Pregnancy and lactation

• Increased risk for infection or current infection

• Renal failure (GFR<30ml/1.73m2/min)

• Pre-existing malignancy