Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

Last updated: February 16, 2026
Sponsor: Blueprint Medicines Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

Hives (Urticaria)

Urticaria

Treatment

Placebo

BLU-808

Clinical Study ID

NCT06931405
BLU-808-1201
2024-520031-33-00
  • Ages > 18
  • All Genders

Study Summary

This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that isinadequately controlled with second generation H1-antihistamines.

  • Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequatelycontrolled with second generation H1-antihistamines.

Exclusion

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 orsole trigger such as symptomatic dermographism and cold-induced urticaria.

  • Part A and Part B: Any other skin disease associated with chronic itching orangioedema that might influence the study evaluations and results, skin diseasesassociated with only wheals and no itch, or autoinflammatory diseases withurticarial lesions.

  • Part A and Part B: Significant medical, psychiatric, or surgical conditions, orphysical findings that may affect participant safety, study drug metabolism, studyparticipation, or assessment of study results.

  • Part A and Part B: Abnormal laboratory values that may pose risks or interfere withstudy participation.

  • Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.

Study Design

Total Participants: 105
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 28, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Odense University Hospital - Odense

    Odense 2615876, 5000
    Denmark

    Active - Recruiting

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

    Berlin 2950159, 12203
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden 2935022, 01307
    Germany

    Active - Recruiting

  • Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet

    Frankfurt am Main 2925533, 60596
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover (MHH)

    Hanover 2910831, 30625
    Germany

    Active - Recruiting

  • Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

    Mainz 2874225, 55131
    Germany

    Active - Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen 2820860, 72016
    Germany

    Active - Recruiting

  • Azienda Ospedale - Università Padova

    Padua 3171728, 35128
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Umberto

    Rome 3169070, 00161
    Italy

    Active - Recruiting

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

    Verona 3164527, 37134
    Italy

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona 3128760, 08907
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona 3128760, 08003
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga 2514256, 29010
    Spain

    Active - Recruiting

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu 1675151, 300
    Taiwan

    Active - Recruiting

  • Kaohsiung Veterans General Hospital (KSVGH)

    Kaohsiung City 1673820, 813414
    Taiwan

    Active - Recruiting

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City 12908892, 235
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung 1668399, 40402
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei 1668341, 100225
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital (CGMHLK)

    Taoyuan 6696918, 105406
    Taiwan

    Active - Recruiting

  • Allervie Clinical Research

    Birmingham 4049979, Alabama 4829764 35209
    United States

    Active - Recruiting

  • Acuro Research, Inc.

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Acuro Research, Inc.

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Active - Recruiting

  • Modena Allergy & Asthma Clinical Research - La Jolla

    La Jolla, California 92037
    United States

    Site Not Available

  • Allergy & Asthma Medical Group and Research Center

    San Diego, California 92123
    United States

    Site Not Available

  • Modena Allergy & Asthma Clinical Research - La Jolla

    La Jolla 5363943, California 5332921 92037
    United States

    Active - Recruiting

  • Allergy & Asthma Associates of Southern California

    Laguna Niguel 5364329, California 5332921 92677
    United States

    Active - Recruiting

  • Allergy & Asthma Medical Group and Research Center

    San Diego 5391811, California 5332921 92123
    United States

    Active - Recruiting

  • Allergy Affiliates Inc.

    Bradenton 4148708, Florida 4155751 34208
    United States

    Active - Recruiting

  • University of South Florida

    Tampa 4174757, Florida 4155751 33613
    United States

    Active - Recruiting

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Site Not Available

  • Treasure Valley Medical Research

    Boise 5586437, Idaho 5596512 83706
    United States

    Active - Recruiting

  • Endeavor Health

    Northbrook 4904056, Illinois 4896861 60062
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Active - Recruiting

  • Southern Indiana Clinical Trials

    New Albany 4262045, Indiana 4921868 47150
    United States

    Active - Recruiting

  • The Indiana Clinical Trials Center

    Plainfield 4263108, Indiana 4921868 46168
    United States

    Active - Recruiting

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky 42104
    United States

    Site Not Available

  • Equity Medical - Bowling Green

    Bowling Green 4285268, Kentucky 6254925 42104
    United States

    Active - Recruiting

  • Institute For Asthma & Allergy

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore 4347778, Maryland 4361885 21224
    United States

    Active - Recruiting

  • Institute For Asthma & Allergy

    Wheaton 4373349, Maryland 4361885 20902
    United States

    Active - Recruiting

  • Chesapeake Clinical Research

    White Marsh 4373426, Maryland 4361885 21236
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • The Clinical Research Center LLC.

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • The Clinical Research Center LLC.

    St Louis 4407066, Missouri 4398678 63141
    United States

    Active - Recruiting

  • Montana Medical Research, Inc.

    Missoula, Montana 59808
    United States

    Site Not Available

  • Montana Medical Research, Inc.

    Missoula 5666639, Montana 5667009 59808
    United States

    Active - Recruiting

  • Equity Medical (at Cameron Dermatology) - New York

    New York, New York 10023
    United States

    Site Not Available

  • Equity Medical (at Cameron Dermatology) - New York

    New York 5128581, New York 5128638 10023
    United States

    Active - Recruiting

  • Bernstein Clinical Research Center

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Active - Recruiting

  • Allergy & Clinical Immunology Associates

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Allergy & Clinical Immunology Associates

    Pittsburgh 5206379, Pennsylvania 6254927 15241
    United States

    Active - Recruiting

  • National Allergy, Asthma & Urticaria Centers of Charleston

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Medical University of South Carolina (MUSC)

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • National Allergy, Asthma & Urticaria Centers of Charleston

    Charleston 4574324, South Carolina 4597040 29407
    United States

    Active - Recruiting

  • Reveal Research Institute

    Dallas 4684888, Texas 4736286 75235
    United States

    Active - Recruiting

  • Austin Institute for Clinical Research

    Pflugerville 4718711, Texas 4736286 78660
    United States

    Active - Recruiting

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