Clinical Trial: Ilaris® Effects in Schnitzler Syndrome (ILESCH)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multi-center, Double-blind, Placebo-controlled Phase II Study of the Efficacy and Safety of Canakinumab in Subjects With Schnitzler Syndrome

Brief Summary:

This is a multi-center double-blind placebo-controlled study to assess the efficacy and safety of canakinumab (trade name Ilaris®), a high-affinity monoclonal antibody that neutralizes IL-1β, in patients with Schnitzler syndrome. Efficacy is assessed by physician's global assessment (a combined clinical symptom score) and inflammation markers. Following a baseline period of 1-4 weeks, patients will be randomized to receive single s.c. injections of either 150 mg canakinumab or placebo (day 0). Treatment response will be assessed on day 7. Patients will then be eligible to enter the 16-week open-label phase and receive canakinumab injections (150-300mg, dose depends on clinical response on day 7) upon relapse of symptoms. Visits for investigator's assessments will be scheduled at 4-weekly intervals following day 7. Overall a max. of 20 subjects with Schnitzler syndrome will be enrolled.

1. Amendment: After successful completion of the 16-week open-label phase patients will be eligible to enter a one-year open-label extension of the study. During this part of the study patients will be scheduled at bi-monthly intervals. Canakinumab dosing will be performed upon relapse of symptoms comparable to the 16-week open-label phase.
2. Amendment: After successful completion of the 1-year open-label study extension patients will be eligible to enter another 3-year open-label extension. Patients will be scheduled at 3-month-intervals and Canakinumab dosing will be performed on an individual basis with optimized dosing intervals to ensure a constant low disease activity.

Detailed Summary:
Sponsor: Charite University, Berlin, Germany

Current Primary Outcome: The effect of canakinumab on the clinical signs and symptoms of SchS measured by physician's global assessment [ Time Frame: 16 months ]

Original Primary Outcome: The effect of canakinumab on the clinical signs and symptoms of SchS measured by physician's global assessment [ Time Frame: 16 weeks ]

Current Secondary Outcome:

• The safety and tolerability of canakinumab in subjects with Schnitzler syndrome [ Time Frame: 16 months ]
• The change in biomarkers of inflammation during the treatment period with canakinumab [ Time Frame: 16 months ]
  Biomarkers of inflammation include C-reactive protein, serum amyloid A and erythrocyte sedimentation rate
• Changes in patients' quality of life during the treatment period with canakinumab [ Time Frame: 16 months ]
  Patient's quality of life assessment includes the Dermatology Life Quality Index and SF 36

Original Secondary Outcome:

• The safety of canakinumab in subjects with Schnitzler syndrome [ Time Frame: 16 weeks ]
  Safety of patients treated with canakinumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting
• The change in biomarkers of inflammation during the treatment period with canakinumab [ Time Frame: 16 weeks ]
  Biomarkers of inflammation include C-reactive protein, serum amyloid A and erythrocyte sedimentation rate
• Changes in patients' quality of life during the treatment period with canakinumab [ Time Frame: 16 weeks ]
  Patient's quality of life assessment includes the Dermatology Life Quality Index and SF 36

Information By: Charite University, Berlin, Germany

Dates:
Date Received: July 7, 2011
Date Started: July 2011
Date Completion: April 2018
Last Updated: February 6, 2017
Last Verified: February 2017