Anakinra in Hidradenitis Suppurativa

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim of this double-blind, randomized, controlled clinical trial is to compare the safety and the efficacy of anakinra over placebo for the management of patients with hidradenitis suppurativa (HS) of Hurley II and Hurley III disease stage. Patients will be evaluated on subsequent follow-up visits. Two scores will be applied: disease activity as assessed in the protocol by the investigator; and Sartorius score. Primary efficacy endpoint will be the comparisons of visual analogue scores, of disease activity, of Sartorius score and of dermatology life quality index between the two groups of treatment over follow-up.

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

Details

• Lead Sponsor: University of Athens
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• written informed consent provided by the patient;

• age above 18 years;

• diagnosis of hidradenitis suppurativa; and

• disease of Hurley II or III severity stage

Exclusion Criteria:

• history of systemic lupus erythematosus, of rheumatoid arthritis of of seronegative inflammatory arthritis;

• any prior administration of any type of anti-TNF therapy over the last six months;

• administration of any live (attenuated) vaccine over the last 4 weeks;

• history of recurrent vein thrombosis or embolism compatible with anti-cardiolipin syndrome;

• any present or smoldering infection;

• hepatic dysfunction defined as any value of transaminases, of γ-glutamyl transpeptidase or of bilirubin> 2 x upper normal limit;

• history of haematological or solid tumor malignancy, arterial hypertension, liver cirrhosis, HIV infection, and hepatitis virus B or C infection

• history of episodes mimicking demyelinating disorders or a definite diagnosis of multiple sclerosis

• any creatinine value above 1.5 mg/dl

• intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1mg/kg for the last three weeks;

• neutropenia defined as <1000 neutrophils/mm3; and

• pregnancy or lactation