The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria

Product: Kineret (anakinra) Protocol title: The Use of Kineret (anakinra) in the Treatment of Familial Cold Urticaria (FCU) Target Disease: Familial Cold Urticaria Patients: 8 patients all previously diagnosed with FCU and living close to Moncton, N.B.

Study Objectives:

• To assess the efficacy of Kineret (anakinra) 100mg. given subcutaneously daily in subjects with FCU.
• To demonstrate the use of CRP and SAA as objective laboratory markers of the effectiveness of treatment.
• To determine the effect of Kineret (anakinra)on the quality of life of patients with FCU.

Study design: An open-labelled trial of Kineret (anakinra) induction therapy (100mg./day) over a four week period.

Treatment regimens: After initial clinical and laboratory assessment, the patients will receive Kineret (anakinra) 100mg. daily for four weeks. They will be observed for two further weeks without the medication.

Route of administration: Subcutaneous injection Interval between first and last dose of active study agent: 4 weeks Duration of study participation: 8 weeks Number of subjects: 8 Number of sites: 1 Interim analysis: Daily patient diary; weekly follow-up phone calls; CRP reports

Inclusion criteria

• Must be 18 years of age or older at the time of enrollment; may be male or female
• Must be previously diagnosed with Familial Cold Urticaria (FCU)
• Must react with at least one of the symptoms of FCU in the summer months at least four times per week sufficiently to interfere with ordinary daily activities or inhibit normal life enjoyment.
• Women must be willing to have a pregnancy test and if necessary, use contraceptive measures.

Exclusion criteria

• Receiving any systemic medications/treatments that could affect FCU.
• Pregnancy, nursing or planning pregnancy, or, have recently been pregnant to less than three months development and with a history of serious birth defect.
• Have had any previous treatment with Kineret (anakinra) or any therapeutic agent targeted at IL-1 blockade.
• Have used any investigational drug within the previous 1 month or five times the half life of the investigational agent, whichever is longer, or 3 months for any biologic of unknown half life.
• Have received any systemic medication or treatments that could affect the symptoms of FCU such as antihistamines, corticosteroid drugs, NSAIDS, anabolic medications or Ketotifen within 2 weeks of the baseline visit.
• Have any known malignancy or have a history of malignancy within the previous five years (with the exception of basal or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence).