Urticarial vasculitis MedDRA version: 12.1 Level: LLT Classification code 10048820 Term: Urticarial vasculitis
Conditions
Sponsors
Charité-Universitätsmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults (18 years or older) • UV diagnosis based on diagnostic criteria defined in Appendix 2 • Active UV, refractory to treatment with antihistamines, NSAIDS or colchicine, hydroxychloroquine or dapsone. • If necessary, concurrent/ongoing treatment with a stable dose of systemic corticosteroids not greater than 10mg/d for 14 days prior to screening • If necessary, concurrent/ongoing treatment with a stable dose of antihistamines and NSAIDs for 7 days prior to screening • Able to read, understand and willing to sign the informed consent form and abide with study procedures • Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have SC injections administered by a qualified person • In females of childbearing potential: Negative pregnancy test; males and females willing to use highly effective contraception (Pearl-Index =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Concurrent/ongoing treatment with Anakinra (Kineret®) or recent treatment within 3 days prior to screening • Concurrent/ongoing treatment with other biologics or recent treatment (less than 5 half lives) • with oral Corticosteriods greater than 10 mg/d within 2 weeks prior to screening • with parenteral Corticosteriods within 4 weeks prior to screening • with Cyclosporin A Methotrexate, Dapsone, Chloroquine, Hydroxychloroquine, Azathioprine, Cyclophosphamide within 4 weeks prior to screening • other immunosuppressives within 4 weeks or 5 half lives prior to screening, whichever is longer • Evidence of recurrent or latent systemic infection such as tuberculosis • Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial • Treatment with a live (attenuated) virus vaccine during three months prior to Baseline visit (Visit 2) • An abnormal chest radiograph consistent with clinical signs of prior or present tuberculosis infection whether or not previously treated with anti-tuberculosis agents • A history of listeriosis, active tuberculosis, persistent chronic or active infection(s) requiring treatment with parenteral antibiotics, parenteral antivirals, or parenteral antifungals within four weeks prior to screening • Significant concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, or lymphatic disease that would adversely affect the subject’s participation or evaluation in this study • Active systemic inflammatory condition other than UV including, but not limited to, rheumatoid arthritis, systemic lupus erythematosus or Sjögren’s Syndrome • 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 within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cervical cancer • History of a demyelinating disease or multiple sclerosis • 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 3.0 x ULN • Lactating females or pregnant females • Males not willing to use highly effective contraception • Enrollment in another investigational treatment or device study or use of an investigational agent, or 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 • Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of a single dose of Ilaris® on the clinical signs and symptoms of urticarial vasculitis (UV);Secondary Objective: To assess the safety, tolerability and immunogenicity following administration of ACZ885 to patients with active UV To assess the effect of Ilaris® on the systemic manifestations of UV (including arthralgias and arthritis, pulmonary, gastrointestinal and renal involvement, cardiac, ocular, neurologic and general symptoms such as fever and hepatosplenomegaly) To assess the effect of Ilaris® on laboratory parameters such as inflammation markers, complement levels, circulating immune complexes and autoantibodies To assess the effect of Ilaris® on the patient’s quality of life ;Primary end point(s): Change in the mean UV activity score (UVAS) from the last 2 weeks of the baseline phase (day -14 to day 0) to the last 2 weeks of the first 4 weeks treatment phase (day 15 to 28) of the study (The UVAS combines the key symptoms of UV). Daily UVAS values will be documented using DHAFs (Daily Health Assessment Forms). Values for the Sum UVAS can range from 0 to 50 per day (5 symptoms, 0-10 each). Mean Daily UVAS will be calculated by dividing the sum of the daily activity scores by 5. | — |
Countries
Germany
Outcome results
None listed