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

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

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

Study Overview

• Status: Terminated
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: Placebo; Drug: Oral EP262

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H1E4
      • Red Maple Trials Inc.
    • Toronto, Ontario, Canada, M5G 1E2
      • Evidence Based Medical Educator Inc
  • Quebec
    • Québec, Quebec, Canada
      • Centre de Recherche Saint-Louis
• Germany
  • Berlin, Germany, 12203
    • Institut fur Allergieforschung Charite - Universitatsmedizin Berlin
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Universitatsmedizin Mainz der Johannes Gutenberg-Universitat
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
• Netherlands
  • South Holland
    • Leiden, South Holland, Netherlands, 2333 CL
      • Centre For Human Drug Research
• Poland
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-507
      • Pim Mswia
    • Warsaw, Masovian Voivodeship, Poland, 02-482
      • Prywatna Praktyka Lekarska Ewa Ring
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o.
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Valencia, Spain, 46015
    • Hospital Arnau De Vilanova
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Allervie Clinical Research
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Clinical Trials
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Allergy & Asthma Clinical Research Center
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology Research, Inc.
    • Huntington Beach, California, United States, 92647
      • Allergy and Asthma Specialists Medical Group
    • Los Angeles, California, United States, 90025
      • Antelope Valley Clinical Trials
  • Florida
    • Destin, Florida, United States, 32541
      • Allervie Clinical Research
    • Miami, Florida, United States, 33136
      • University of Miami Itch Center
    • Miami, Florida, United States, 33186
      • Florida Center for Allergy and Asthma Research
    • Pompano Beach, Florida, United States, 33060
      • NuLine Clinical Trial Center
    • Tampa, Florida, United States, 33612
      • University of South Florida
    • Tampa, Florida, United States, 33607
      • Advanced Clinical Research Institute
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • New Albany, Indiana, United States, 47150
      • Southern Indiana Clinical trials
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Velocity Clinical Research, Overland Park, KC Asthma & Allergy
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Allergy & Asthma Specialists, P.S.C.
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research, Inc.
  • Missouri
    • St Louis, Missouri, United States, 63141
      • The Clinical Research Center LLC
  • Montana
    • Missoula, Montana, United States, 59808
      • Montana Medical Research, Inc.
  • Nevada
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
  • New York
    • Horseheads, New York, United States, 14845
      • Corning Center for Clinical Research
    • New York, New York, United States, 11211
      • Bobby Buka MD, PC
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Allergy Partners Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center, LLC
    • Toledo, Ohio, United States, 43617
      • Toledo Institute of Clinical Research Inc.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, PC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC.
  • Texas
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research, PA
  • Utah
    • Murray, Utah, United States, 84107
      • Allergy Associates of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Once daily
Experimental: EP262 50 mg	Drug: Oral EP262; Once daily
Experimental: EP262 150 mg	Drug: Oral EP262; Once daily
Experimental: EP262 25 mg	Drug: Oral EP262; Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Visit 4 (Week 6) in the Urticaria Activity Score Over a 7-day Period (UAS7)	The UAS is a chronic spontaneous urticaria (CSU)-specific, 24-hour self-evaluation, patient-reported outcome measure based on the assessment of key CSU symptoms: intensity of itch (assessed as the Itch Severity Score [ISS]) and number of wheals (assessed as the Hive Severity Score [HSS]). The UAS scales for both itch and wheal assessment are recorded as a score from 0 to 3, with 0 representing no itch/hives to 3 representing intense itch/hives. ISS and HSS scores are summed over 7 consecutive days to create the ISS7 and HSS7 scores, which range from 0 to 21. Higher scores indicate greater disease severity. The UAS score is the sum of the ISS and HSS scores. Daily UAS scores are summed over 7 consecutive days to create the UAS7 score, which ranges from 0 to 42. Higher scores indicate greater disease severity. The 7 daily UAS/ISS/HSS scores prior to or on the nominal Visit 4 (Week 6) date (including the nominal Week 6 visit date UAS/ISS/HSS score) were summed.	Baseline; Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Medical conditions present at baseline that worsened in severity or frequency after exposure to study drug were considered TEAEs. A TEAE was any condition that was not present prior to treatment with the study drug but appeared following treatment, was present at treatment initiation but worsened during treatment, or was present at treatment initiation but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).	up to 81 days
Number of Participants With Any ≥Grade 3 TEAE	An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. Medical conditions present at baseline that worsened in severity or frequency after exposure to study drug were considered TEAEs. TEAEs were graded for severity (i.e., intensity) using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Grade 1: mild; asymptomatic or mild symptoms; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated. Grade 3: severe or medically significant, but not immediately life-threatening. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to TEAE.	up to 81 days
Number of Participants With Any Clinically Meaningful Change From Baseline in Electrocardiogram Parameters	Clinically meaningful changes were determined by the investigator.	up to 81 days
Number of Participants With Any Clinically Meaningful Change From Baseline in Vital Sign Measurements	Clinically meaningful changes were determined by the investigator.	up to 81 days
Number of Participants With Any Clinically Meaningful Change From Baseline in Clinical Laboratory Test Results	Clinically meaningful changes were determined by the investigator.	up to 81 days
Change From Baseline to Visit 4 (Week 6) in the Itch Severity Score Over a 7-day Period (ISS7)	The ISS is part of the UAS, a CSU-specific, 24-hour self-evaluation, patient-reported outcome measure based on the assessment of key CSU symptoms: intensity of itch (assessed as the ISS) and number of wheals (assessed as the HSS). The UAS scale for itch is recorded as a score from 0 to 3, with 0 representing no itch to 3 representing intense itch. ISS scores are summed over 7 consecutive days to create the ISS7 score, which ranges from 0 to 21. Higher scores indicate greater disease severity. The 7 daily ISS scores prior to or on the nominal Visit 4 (Week 6) date (including the nominal Week 6 visit date ISS score) were summed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	Baseline; Week 6
Change From Baseline to Visit 4 (Week 6) in the Hive Severity Score Over a 7-day Period (HSS7)	The HSS is part of the UAS, a CSU-specific, 24-hour self-evaluation, patient-reported outcome measure based on the assessment of key CSU symptoms: intensity of itch (assessed as the ISS) and number of wheals (assessed as the HSS). The UAS scale for wheal assessment is recorded as a score from 0 to 3, with 0 representing no hives to 3 representing intense hives. HSS scores are summed over 7 consecutive days to create the HSS7 score, which ranges from 0 to 21. Higher scores indicate greater disease severity. The 7 daily HSS scores prior to or on the nominal Visit 4 (Week 6) date (including the nominal Week 6 visit date HSS score) were summed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	Baseline; Week 6

Collaborators and Investigators

• Sponsor: Escient Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Actual): December 18, 2024
• Study Completion (Actual): January 16, 2025

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Urticaria; Chronic Urticaria; CALM; Chronic Spontaneous Urticaria; EP262; CALM-CSU
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria; Urticaria
• Other Study ID Numbers: EP-262-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No