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

NCT06077773 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: EP-262-201
• Study Type: interventional
• Target: 113
• Locations: 6 countries
• Sites: 48

Brief Summary

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

Conditions

Chronic Spontaneous Urticaria

Keywords

Chronic Spontaneous Urticaria; Chronic Urticaria; Urticaria; EP262; CALM-CSU; CALM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  up to 81 days

• Number of Participants With Any ≥Grade 3 TEAE

  up to 81 days

• Number of Participants With Any Clinically Meaningful Change From Baseline in Electrocardiogram Parameters

  up to 81 days

• Number of Participants With Any Clinically Meaningful Change From Baseline in Vital Sign Measurements

  up to 81 days

• Number of Participants With Any Clinically Meaningful Change From Baseline in Clinical Laboratory Test Results

  up to 81 days

Study Arms (4)

EP262 50 mg

EXPERIMENTAL

Drug: Oral EP262

EP262 150 mg

EXPERIMENTAL

Drug: Oral EP262

Placebo

PLACEBO COMPARATOR

Drug: Placebo

EP262 25 mg

EXPERIMENTAL

Drug: Oral EP262

Interventions

Oral EP262 DRUG

Once daily

EP262 150 mg; EP262 25 mg; EP262 50 mg

Placebo DRUG

Once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Escient Pharmaceuticals, Inc: lead

Study Sites (48)

AllerVie Clinical Research

Birmingham, Alabama, 35209, United States

Location

Scottsdale Clinical Trials

Scottsdale, Arizona, 85260, United States

Location

Little Rock Allergy & Asthma Clinical Research Center

Little Rock, Arkansas, 72205, United States

Location

First OC Dermatology Research, Inc.

Fountain Valley, California, 92708, United States

Location

Allergy and Asthma Specialists Medical Group

Huntington Beach, California, 92647, United States

Location

Antelope Valley Clinical Trials

Los Angeles, California, 90025, United States

Location

Allervie Clinical Research

Destin, Florida, 32541, United States

Location

University of Miami Itch Center

Miami, Florida, 33136, United States

Location

Florida Center for Allergy and Asthma Research

Miami, Florida, 33186, United States

Location

NuLine Clinical Trial Center

Pompano Beach, Florida, 33060, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Southern Indiana Clinical Trials

New Albany, Indiana, 47150, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Velocity Clinical Research, Overland Park, KC Asthma & Allergy

Overland Park, Kansas, 66210, United States

Location

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, 42301, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, 21162, United States

Location

The Clinical Research Center LLC

St Louis, Missouri, 63141, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

Corning Center for Clinical Research

Horseheads, New York, 14845, United States

Location

Bobby Buka MD, PC

New York, New York, 11211, United States

Location

Allergy Partners Clinical Research

Asheville, North Carolina, 28803, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45236, United States

Location

Toledo Institute of Clinical Research Inc.

Toledo, Ohio, 43617, United States

Location

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

Location

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina, 29420, United States

Location

Progressive Clinical Research, PA

San Antonio, Texas, 78213, United States

Location

Allergy Associates of Utah

Murray, Utah, 84107, United States

Location

Red Maple Trials Inc.

Ottawa, Ontario, K1H1E4, Canada

Location

Evidence Based Medical Educator Inc

Toronto, Ontario, M5G 1E2, Canada

Location

Centre de Recherche Saint-Louis

Québec, Quebec, Canada

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitatsmedizin Mainz der Johannes Gutenberg-Universitat

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Saxony, 01307, Germany

Location

Institut fur Allergieforschung Charite - Universitatsmedizin Berlin

Berlin, 12203, Germany

Location

Centre for Human Drug Research

Leiden, South Holland, 2333 CL, Netherlands

Location

Prywatna Praktyka Lekarska Ewa Ring

Warsaw, Masovian Voivodeship, 02-482, Poland

Location

Pim Mswia

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated following the completion of Part 1 due to business reasons; Part 2 was not enrolled.

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: September 25, 2023
• Primary Completion: December 18, 2024
• Study Completion: January 16, 2025
• Last Updated: December 19, 2025
• Results First Posted: December 5, 2025

Record last verified: 2025-11

Locations

CA (3); NL (1); US (34); DE (4); PL (3); ES (3)