Dose-ranging study evaluating the efficacy and safety of EVO756 in adults with Chronic Spontaneous Urticaria.

Ki vehet részt

• Male or female, ages ≥ 18 at Screening
• Capable of providing written informed consent and willing and able to comply with study requirements
• Confirmed CSU diagnosis for ≥ 3 months with an inadequate response to H1 antihistamines
• Urticaria Activity Score (UAS7) ≥ 16 at Day 1, with completed UAS entries for a minimum of 4 out of the 7 days prior to Day 1
• Subjects taking H1 antihistamines must be on a stable regimen 4 weeks prior to Day 1 and while on study

Ki nem vehet részt

• Use of the following medications for the timeframes specified below and while on study: o Biologics (e.g., omalizumab, dupilumab, tezepelumab, ligelizumab) for 120 days or 5 half-lives (whichever is longer) prior to Day 1, o Cyclosporine, methotrexate, sulfonamides, systemic glucocorticoids (e.g., prednisone), or mycophenolate for 28 days prior to Day 1, o Leukotriene inhibitors (e.g., montelukast, zafirlukast) for 14 days prior to Day 1 (if taken for CSU), o H2-receptor antagonists (e.g., ranitidine, famotidine) for 14 days prior to Day 1 (if taken for CSU)
• History of diseases with urticaria or angioedema symptoms, other than CSU and symptomatic dermographism, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema
• Any other skin disease that might confound the assessment of CSU in the Investigator's opinion
• AST, ALT, alkaline phosphatase, or total bilirubin above the ULN at Screening