Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)
Chronic Spontaneous Urticaria
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring Chronic Spontaneous Urticaria, Chronic Urticaria, Urticaria, EP262, CALM-CSU, CALM
Eligibility Criteria
Inclusion Criteria: Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with standard of care Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines Exclusion Criteria: Urticaria with a clear underlying etiology other than CSU Urticaria with a clearly defined or sole trigger (chronic inducible urticaria) Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
Sites / Locations
- AllerVie Clinical ResearchRecruiting
- Antelope Valley Clinical TrialsRecruiting
- Advanced Clinical Research InstituteRecruiting
- Treasure Valley Medical ResearchRecruiting
- Chesapeake Clinical Research, Inc.Recruiting
- Vital Prospects Clinical Research Institute, PCRecruiting
- National Allergy and Asthma Research, LLC.Recruiting
- Gordon Sussman Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
EP262 50 mg
EP262 150 mg
Placebo