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

Chronic Spontaneous Urticaria Clinical Trial

— CALM-CSU  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077773
• Other study ID #: EP-262-201
• Status: Recruiting
• Phase: Phase 2
• Start date: September 25, 2023
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Escient Pharmaceuticals, Inc
• Contact: Escient Clinical Trials
• Phone: 858-617-8220
• Email: clinicaltrials[@]escientpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Drug:
• Oral EP262
Once daily
• Placebo
Once daily

Locations

Country	Name	City	State
Canada	Gordon Sussman Clinical Research	North York
Canada	Red Maple Trials Inc.	Ottawa	Ontario
Canada	Evidence Based Medical Educator Inc	Toronto	Ontario
Germany	Institut fur Allergieforschung Charite - Universitatsmedizin Berlin	Berlin
Germany	Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden	Dresden	Sachsen
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitatsmedizin Mainz der Johannes Gutenberg-Universitat	Mainz	Rheinland-Pfalz
Netherlands	Centre for Human Drug Research	Leiden	South Holland
Poland	Centrum Badan Klinicznych PI-House Sp. z o.o.	Gdansk	Pomorskie
Poland	Pim Mswia	Warsaw	Masovian Voivodeship
Poland	Prywatna Praktyka Lekarska Ewa Ring	Warszawa	Mazowieckie
Spain	Hospital del Mar	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Arnau de Vilanova	Valencia
United States	Allergy Partners Clinical Research	Asheville	North Carolina
United States	Johns Hopkins University	Baltimore	Maryland
United States	AllerVie Clinical Research	Birmingham	Alabama
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Bernstein Clinical Research Center, LLC	Cincinnati	Ohio
United States	First OC Dermatology Research, Inc.	Fountain Valley	California
United States	Allergy and Asthma Specialists Medical Group	Huntington Beach	California
United States	Little Rock Allergy & Asthma Clinical Research Center	Little Rock	Arkansas
United States	Antelope Valley Clinical Trials	Los Angeles	California
United States	University of Miami Itch Center	Miami	Florida
United States	Allergy Associates of Utah	Murray	Utah
United States	National Allergy and Asthma Research, LLC.	North Charleston	South Carolina
United States	Allergy & Asthma Specialists, P.S.C.	Owensboro	Kentucky
United States	Allergy and Clinical Immunology Associates	Pittsburgh	Pennsylvania
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Advanced Clinical Research Institute	Tampa	Florida
United States	Toledo Institute of Clinical Research Inc.	Toledo	Ohio
United States	Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma
United States	Chesapeake Clinical Research, Inc.	White Marsh	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Escient Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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