Clinical trial NCT06077773: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Spontaneous Urticaria
Keywords: Chronic Spontaneous Urticaria
Chronic Urticaria
Urticaria
EP262
CALM-CSU
CALM
Lead sponsor: Escient Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2023-10-11
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7)
timeFrame: Measured from Baseline to Week 6
Secondary outcomes:
measure: Safety and tolerability of EP262
timeFrame: Measured from Day 1 to End of Study or Early Termination (up to 10 weeks)
measure: Change in Itch Severity Score (ISS) over a 7-day period (ISS7)
timeFrame: Measured from Baseline to Week 6
measure: Change in Hive Severity Score (HSS) over a 7-day period (HSS7)
timeFrame: Measured from Baseline to Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AllerVie Clinical Research
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma Clinical Research Center
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology Research, Inc.
state: California
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialists Medical Group
state: California
city: Los Angeles
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: Destin
country: United States
facility: Allervie Clinical Research
state: Florida
city: Miami
country: United States
facility: University of Miami Itch Center
state: Florida
city: Miami
country: United States
facility: Florida Center for Allergy and Asthma Research
state: Florida
city: Pompano Beach
country: United States
facility: NuLine Clinical Trial Center
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Overland Park
country: United States
facility: Velocity Clinical Research, Overland Park, KC Asthma & Allergy
state: Kansas
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists, P.S.C.
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Saint Louis
country: United States
facility: The Clinical Research Center LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Horseheads
country: United States
facility: Corning Center for Clinical Research
state: New York
city: New York
country: United States
facility: Bobby Buka MD, PC
state: New York
city: Asheville
country: United States
facility: Allergy Partners Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research Inc.
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: North Charleston
country: United States
facility: National Allergy and Asthma Research, LLC.
state: South Carolina
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Murray
country: United States
facility: Allergy Associates of Utah
state: Utah
city: Ottawa
country: Canada
facility: Red Maple Trials Inc.
state: Ontario
city: Toronto
country: Canada
facility: Evidence Based Medical Educator Inc
state: Ontario
city: Québec
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Mainz
country: Germany
facility: Universitatsmedizin Mainz der Johannes Gutenberg-Universitat
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
state: Sachsen
city: Berlin
country: Germany
facility: Institut fur Allergieforschung Charite - Universitatsmedizin Berlin
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
state: South Holland
city: Warsaw
country: Poland
facility: Pim Mswia
state: Masovian Voivodeship
city: Warszawa
country: Poland
facility: Prywatna Praktyka Lekarska Ewa Ring
state: Mazowieckie
city: Gdańsk
country: Poland
facility: Centrum Badan Klinicznych PI-House Sp. z o.o.
state: Pomorskie
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
References: