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

Sponsor

Escient Pharmaceuticals, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06077773

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

11.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Spontaneous Urticaria	Drug: Oral EP262 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EP262 50 mg	Drug: Oral EP262 Once daily
Experimental: EP262 150 mg	Drug: Oral EP262 Once daily
Placebo Comparator: Placebo	Drug: Placebo Once daily

Arm

Intervention/Treatment

Experimental: EP262 50 mg

Drug: Oral EP262

Once daily

Experimental: EP262 150 mg

Drug: Oral EP262

Once daily

Placebo Comparator: Placebo

Drug: Placebo

Once daily

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AllerVie Clinical Research	Birmingham	Alabama	United States	35209
2	Antelope Valley Clinical Trials	Los Angeles	California	United States	90025
3	Advanced Clinical Research Institute	Tampa	Florida	United States	33607
4	Treasure Valley Medical Research	Boise	Idaho	United States	83706
5	Chesapeake Clinical Research, Inc.	White Marsh	Maryland	United States	21162
6	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma	United States	74136
7	National Allergy and Asthma Research, LLC.	North Charleston	South Carolina	United States	29420
8	Gordon Sussman Clinical Research	North York		Canada	M3B 3S6