Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
NCT ID: NCT06931405
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
105 participants
INTERVENTIONAL
2025-05-28
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A1 (Part A): BLU-808
BLU-808 will be administered orally.
BLU-808
Oral administration
Arm A3 (Part A): BLU-808
BLU-808 will be administered orally.
BLU-808
Oral administration
Arm B (Part B): BLU-808/Placebo
BLU-808 or matching placebo will be administered orally.
BLU-808
Oral administration
Placebo
Oral administration
Interventions
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BLU-808
Oral administration
Placebo
Oral administration
Eligibility Criteria
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Inclusion Criteria
* Part B: Confirmed diagnosis of CSU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Blueprint Medicines Corporation
INDUSTRY
Responsible Party
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Locations
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Allervie Clinical Research
Birmingham, Alabama, United States
Acuro Research, Inc.
Little Rock, Arkansas, United States
Modena Allergy & Asthma Clinical Research - La Jolla
La Jolla, California, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, United States
Allergy Affiliates Inc.
Bradenton, Florida, United States
University of South Florida
Tampa, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Endeavor Health
Northbrook, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
New Albany, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Institute For Asthma & Allergy
Wheaton, Maryland, United States
Chesapeake Clinical Research
White Marsh, Maryland, United States
Henry Ford Health
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
The Clinical Research Center LLC.
St Louis, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
Equity Medical (at Cameron Dermatology) - New York
New York, New York, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
National Allergy, Asthma & Urticaria Centers of Charleston
Charleston, South Carolina, United States
Reveal Research Institute
Dallas, Texas, United States
Odense University Hospital - Odense
Odense, , Denmark
Fraunhofer-Institut fuer Translationale Medizin und Pharmakologie ITMP - Standort Berlin
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt am Main, , Germany
Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Mainz, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Centro Ricerche Cliniche di Verona s.r.l.
Verona, , Italy
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Taipei Medical University - Shuang Ho Hospital
New Taipei City, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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2024-520031-33-00
Identifier Type: OTHER
Identifier Source: secondary_id
BLU-808-1201
Identifier Type: -
Identifier Source: org_study_id