Chronic Hives Study

The focus of this study is to evaluate the efficacy of an investigational drug, EVO756, in adults with moderate to severe CSU, and how safely it interacts with the body.

Participants will receive either the study drug or placebo in tablet form to take for 12 weeks and be evaluated on an outpatient basis.

The total duration of participation for each subject is expected to be approximately 18 weeks, including up to 30 days for screening, the 12-week treatment window, and one follow-up visit.

Qualified participants may receive:
•All study-related medication(s) at no charge
•Study-related examinations & screenings at no cost 
•All study-related lab work or procedures at no cost
•Reimbursement for study-related time and travel 

Who may be a good candidate for this chronic spontaneous urticaria (CSU) study?

You may consider applying to be a participant if you meet the following criteria for qualification: 

• Be 18 years of age or older
• Have had a confirmed diagnosis of CSU for at least three months
• Do not have a history of diseases with hives or swelling symptoms other than CSU, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), hereditary or acquired angioedema, or any other skin disease that may impede the study team’s ability to assess efficacy
• If taking antihistamines, you have been on a stable regimen for at least four weeks prior to Day 1 (and will remain so throughout the study)
• You do not have HIV, hepatitis B, nor hepatitis C
• No history of liver disease, kidney disease, or uncontrolled cardiovascular disease
• No history of cancer (other than skin cancer or cervical cancer) within the past 5 years
• Not have undergone a major surgery within the past eight weeks, nor have major surgery planned during the study
• Not currently pregnant or breastfeeding, nor planning a pregnancy within the study period and up to three months post treatment completion

Use of the following medications for the timeframes specified below (or the necessity to be on one during the study) would disqualify one from potential participation:

• Biologics (e.g., omalizumab, dupilumab, tezepelumab, ligelizumab) for 120 days prior to Day 1
• Cyclosporine, methotrexate, sulfonamides, systemic glucocorticoids (e.g., prednisone), or mycophenolate mofetil 28 days prior to Day 1
• Leukotriene inhibitors (e.g., montelukast, zafirlukast) 14 days prior to Day 1 (if taken for CSU)
• H2-receptor antagonists (e.g., ranitidine, famotidine) 14 days prior to Day 1 (if taken for CSU)