Clinical Trials

Inclusion Criteria:

• Signed informed consent form

• Diagnosis of CSU (recurrent urticaria for ≥6 weeks without identifiable trigger) under the treatment of a clinician within the Division of Allergic Diseases at Mayo Clinic in Rochester, MN or in select Allergy Clinics within Mayo Clinic Health System (MCHS) in Austin, MN or Owatonna, MN

• Initiation, escalation, or modification of CSU pharmacotherapy at the enrollment visit

• Age ≥ 18 years

• Willing and able to provide urine samples at baseline, 4 weeks, and 8 weeks

Exclusion Criteria:

• Age < 18 years old

• Physical, cognitive, or language limitations that preclude reliable completion of study questionnaires (UAS-7 and UCT), as determined by the investigator

• Change in medications that impact urinary mast cell mediators outside of what is prescribed by the Allergy/Immunology clinician during the study period (at the discretion of the study team)

• Any condition that, in the investigator’s judgment, would interfere with study participation or interpretation of results

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/10/2026. Questions regarding updates should be directed to the study team contact.