Cold Contact Urticaria Treatment With Rilonacept

Inclusion criteria

• Adult ( > 18 years of age)
• Outpatients with CCU for more than six weeks. Urticaria symptoms must comprise wheal and itch and be resistant to conventional antihistamine treatment in standard doses
• Patients with a positive cold stimulation test at 4°C (assessed by TEMPtest 3.0)
• Informed consent signed and dated. Able to read, understand and willing to sign the informed consent form
• Able to read, understand and complete study-related questionnaires
• Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to self-administer SC injections or to have SC injections administered by a qualified person
• In women, negative pregnancy test
• Reliable method of contraception for both women of childbearing potential as well as men, during the course of the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
• Subjects are considered eligible according to the following tuberculosis (TB) screening criteria:
• No history of latent or active TB prior to screening
• No signs or symptoms suggestive of active TB
• No recent close contacts with a person with active TB
• A negative QuantiFERON-TB test on day -14 (screening visit).

Exclusion criteria

• Treatment with a live (attenuated) virus vaccine during the month prior to day 0 (Randomization).
• A history of serious chronic or active infection(s) eg. listeriosis within six weeks prior to the screening visit.
• Evidence of acute or latent Tuberculosis as defined by the local guidelines/local medical practice
• A history of acute tuberculosis despite the proper treatment.
• Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, lymphatic or hematological disease that would adversely affect the subject's participation or evaluation in this study.
• Active systemic inflammatory condition including, but not limited to, rheumatoid arthritis, systemic lupus erythematosis, polymyalgia rheumatica, vasculitis, or myositis.
• History of fibromyalgia or chronic fatigue syndrome.
• Evidence of current HIV, Hepatitis B, or Hepatitis C infection by clinical or serological history.
• History of malignancies including malignant hematological disorders other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cervical cancer within five years of the Screening visit.
• Severe respiratory disease, including, but not limited to severe bronchiectasis, chronic obstructive pulmonary disease, bullous lung disease, uncontrolled asthma, or pulmonary fibrosis.
• Presence of any of the following laboratory abnormalities at enrollment visit: creatinine >1.5 x Upper Limit of Normal (ULN), WBC <3.6 x 103/mm3; platelet count <150,000 mm3; ALT or AST >2.0 x ULN.
• Previous ineffective treatment with IL1 inhibitor or other biologic agent.
• Known hypersensitivity to CHO cell derived therapeutics or proteins or any components of rilonacept.
• Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk.
• Present History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject's ability to comply with study procedures.
• Lactating females or pregnant females.
• Enrollment in another investigational treatment or device study or use of an investigational agent, or no completion of less than 4 weeks or 5 half-lives, whichever is longer, since end of another investigational device or drug trial.
• Subjects for whom there is concern about compliance with the protocol procedures.
• Subjects who are detained officially or legally to an official institute.