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New pill for stubborn hives shows promise, but trial halted early

NCT ID NCT06077773

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested an experimental drug called EP262 in 113 people with chronic spontaneous urticaria (long-lasting hives with no clear cause). Participants took either EP262 or a placebo daily for 6 weeks, while continuing their usual antihistamines. The study aimed to see if EP262 could reduce itch and hive severity. However, the trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EP262 (oral drug)
What this could lead to
If it works, this could point toward a new treatment option for people with chronic hives that are not well controlled by antihistamines.
What could go wrong
The trial was terminated early, so results are limited. It is still in Phase 2, meaning it is early-stage and may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

113 people

The number who actually took part.

Started

Sep 2023

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Advanced Clinical Research Institute

    Tampa, Florida, 33607, United States

  • AllerVie Clinical Research

    Birmingham, Alabama, 35209, United States

  • Allergy & Asthma Specialists, P.S.C.

    Owensboro, Kentucky, 42301, United States

  • Allergy Associates of Utah

    Murray, Utah, 84107, United States

  • Allergy Partners Clinical Research

    Asheville, North Carolina, 28803, United States

  • Allergy and Asthma Specialists Medical Group

    Huntington Beach, California, 92647, United States

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241, United States

  • Allervie Clinical Research

    Destin, Florida, 32541, United States

  • Antelope Valley Clinical Trials

    Los Angeles, California, 90025, United States

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45236, United States

  • Bobby Buka MD, PC

    New York, New York, 11211, United States

  • Centre de Recherche Saint-Louis

    Québec, Quebec, Canada

  • Centre for Human Drug Research

    Leiden, South Holland, 2333 CL, Netherlands

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

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Chesapeake Clinical Research, Inc.

    White Marsh, Maryland, 21162, United States

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919, United States

  • Corning Center for Clinical Research

    Horseheads, New York, 14845, United States

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Evidence Based Medical Educator Inc

    Toronto, Ontario, M5G 1E2, Canada

  • First OC Dermatology Research, Inc.

    Fountain Valley, California, 92708, United States

  • Florida Center for Allergy and Asthma Research

    Miami, Florida, 33186, United States

  • Hospital Arnau de Vilanova

    Valencia, 46015, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Institut fur Allergieforschung Charite - Universitatsmedizin Berlin

    Berlin, 12203, Germany

  • Johns Hopkins University

    Baltimore, Maryland, 21224, United States

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89030, United States

  • Little Rock Allergy & Asthma Clinical Research Center

    Little Rock, Arkansas, 72205, United States

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808, United States

  • National Allergy and Asthma Research, LLC.

    North Charleston, South Carolina, 29420, United States

  • NuLine Clinical Trial Center

    Pompano Beach, Florida, 33060, United States

  • Pim Mswia

    Warsaw, Masovian Voivodeship, 02-507, Poland

  • Progressive Clinical Research, PA

    San Antonio, Texas, 78213, United States

  • Prywatna Praktyka Lekarska Ewa Ring

    Warsaw, Masovian Voivodeship, 02-482, Poland

  • Red Maple Trials Inc.

    Ottawa, Ontario, K1H1E4, Canada

  • Scottsdale Clinical Trials

    Scottsdale, Arizona, 85260, United States

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150, United States

  • The Clinical Research Center LLC

    St Louis, Missouri, 63141, United States

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168, United States

  • Toledo Institute of Clinical Research Inc.

    Toledo, Ohio, 43617, United States

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Universitatsmedizin Mainz der Johannes Gutenberg-Universitat

    Mainz, Rhineland-Palatinate, 55131, Germany

  • University of Miami Itch Center

    Miami, Florida, 33136, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, Saxony, 01307, Germany

  • Velocity Clinical Research, Overland Park, KC Asthma & Allergy

    Overland Park, Kansas, 66210, United States

  • Vital Prospects Clinical Research Institute, PC

    Tulsa, Oklahoma, 74136, United States

More trials for these conditions

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