Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria

Study Overview
=================
Brief Summary
-----------------
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria

Official Title
-----------------
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)

Conditions
-----------------
Chronic Spontaneous Urticaria

Intervention / Treatment
-----------------
* Drug: Oral EP262
* Drug: Placebo


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EP262 50 mg<br> | Drug: Oral EP262<br>* Once daily<br>|
| Experimental: EP262 150 mg<br> | Drug: Oral EP262<br>* Once daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7) | Assessed using the UAS7 measuring the intensity of itch and number of hives over the past 7 days | Measured from Baseline to Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of EP262 | Assessed by the incidence of treatment-emergent adverse events | Measured from Day 1 to End of Study or Early Termination (up to 10 weeks) | 
| Change in Itch Severity Score (ISS) over a 7-day period (ISS7) | Assessed using the ISS7 measuring the intensity of itch over the past 7 days | Measured from Baseline to Week 6 | 
| Change in Hive Severity Score (HSS) over a 7-day period (HSS7) | Assessed using the HSS7 measuring the number of hives over the past 7 days | Measured from Baseline to Week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Spontaneous Urticaria, Chronic Urticaria, Urticaria, EP262, CALM-CSU, CALM