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New pill could tame stubborn hives that antihistamines Can't stop

NCT ID NCT06931405

Disease control Sponsor: Blueprint Medicines Corporation Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This study tests an experimental drug called BLU-808 for people with chronic hives (urticaria) that don't get better with standard antihistamines. The drug works by blocking a protein called KIT, which may help control the allergic reaction causing the hives. About 105 adults will take part to see if the drug is safe and reduces hive symptoms like itching and welts.

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

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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 years and older

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.

Key Inclusion Criteria: * Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines. * Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines. Key Exclusion Criteria: * Part A: Any active urticaria that may interfere with study assessments. * Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria. * Part A and Part B: Any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions. * Part A and Part B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results. * Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation. * Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria chronic inducible urticaria Chronic Urticaria Cold Urticaria familial dermatographia

As listed by the trial registrant

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

Chronic inducible urticaria Chronic spontaneous urticaria

Contacts and locations

Locations

  • Acuro Research, Inc.

    Little Rock, Arkansas, 72205, United States

  • Allergy & Asthma Associates of Southern California

    Laguna Niguel, California, 92677, United States

  • Allergy & Asthma Medical Group and Research Center

    San Diego, California, 92123, United States

  • Allergy & Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241, United States

  • Allergy Affiliates Inc.

    Bradenton, Florida, 34208, United States

  • Allervie Clinical Research

    Birmingham, Alabama, 35209, United States

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660, United States

  • Azienda Ospedale - Università Padova

    Padova, 35128, Italy

  • Azienda Ospedaliero Universitaria Policlinico Umberto

    Rome, 00161, Italy

  • Bernstein Clinical Research Center

    Cincinnati, Ohio, 45236, United States

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134, Italy

  • Chesapeake Clinical Research

    White Marsh, Maryland, 21236, United States

  • China Medical University Hospital

    Taichung, 40402, Taiwan

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Endeavor Health

    Northbrook, Illinois, 60062, United States

  • Equity Medical (at Cameron Dermatology) - New York

    New York, New York, 10023, United States

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky, 42104, United States

  • Fraunhofer-Institut fuer Translationale Medizin und Pharmakologie ITMP - Standort Berlin

    Berlin, 12203, Germany

  • Henry Ford Health

    Detroit, Michigan, 48202, United States

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, 08907, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Institute For Asthma & Allergy

    Wheaton, Maryland, 20902, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21224, United States

  • Kaohsiung Veterans General Hospital (KSVGH)

    Kaohsiung City, 813414, Taiwan

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Taoyuan City, 105406, Taiwan

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover (MHH)

    Hanover, 30625, Germany

  • Modena Allergy & Asthma Clinical Research - La Jolla

    La Jolla, California, 92037, United States

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808, United States

  • National Allergy, Asthma & Urticaria Centers of Charleston

    Charleston, South Carolina, 29407, United States

  • National Taiwan University Hospital

    Taipei, 100225, Taiwan

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu, 300, Taiwan

  • Odense University Hospital - Odense

    Odense, 5000, Denmark

  • Reveal Research Institute

    Dallas, Texas, 75235, United States

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150, United States

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 235, Taiwan

  • The Clinical Research Center LLC.

    St Louis, Missouri, 63141, United States

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168, United States

  • Treasure Valley Medical Research

    Boise, Idaho, 83706, United States

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet

    Frankfurt am Main, 60596, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, 72016, Germany

  • Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

    Mainz, 55131, Germany

  • University of South Florida

    Tampa, Florida, 33613, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.