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Active, not recruitingPhase 2

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

Key facts

Who runs it
Blueprint Medicines Corporation
Where
Baltimore, Birmingham, Boise, Bowling Green, Bradenton, Charleston, Cincinnati, Dallas, Detroit, Indianapolis, La Jolla, Laguna Niguel, Little Rock, Missoula, New Albany, New York, Northbrook, Pflugerville, Pittsburgh, Plainfield, Rochester, San Diego, St Louis, Tampa, Wheaton, and White Marsh, United StatesSee the 27 sitesAlso in 5 other countries, 20 sites
Trial code
Status
Active, not recruiting
Phase
Phase 2
People taking part
105 people, planned
Started
28 May 2025
Expected to end
31 Dec 2026
Type of study
Interventional, 3 groups
Treatments tested
  • BLU-808
  • Placebo
Record updated
22 July 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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: 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: Pregnancy or plans for pregnancy; breastfeeding

Where in United States

Also in 5 other countries, 20 sites

  • Johns Hopkins UniversityBaltimore, United States
  • AllerVie Clinical ResearchBirmingham, United States
  • Treasure Valley Medical ResearchBoise, United States
  • Equity Medical Bowling GreenBowling Green, United States
  • Allergy Affiliates Inc.Bradenton, United States
  • Medical University of South Carolina (MUSC)Charleston, United States
  • National Allergy, Asthma & Urticaria Centers of CharlestonCharleston, United States
  • Bernstein Clinical Research CenterCincinnati, United States
  • Reveal Research InstituteDallas, United States
  • Henry Ford HealthDetroit, United States
  • Dawes Fretzin Clinical Research Group, LLCIndianapolis, United States
  • Modena Allergy & Asthma Clinical Research - La JollaLa Jolla, United States
  • Allergy & Asthma Associates of Southern CaliforniaLaguna Niguel, United States
  • Acuro Research, IncLittle Rock, United States
  • Montana Medical Research, IncMissoula, United States
  • Southern Indiana Clinical trialsNew Albany, United States
  • Equity Medical (at Cameron Dermatology) - New YorkNew York, United States
  • Endeavor HealthNorthbrook, United States
  • Austin Institute for Clinical ResearchPflugerville, United States
  • Allergy & Clinical Immunology AssociatesPittsburgh, United States
  • The Indiana Clinical Trials CenterPlainfield, United States
  • Mayo ClinicRochester, United States
  • Allergy & Asthma Medical Group and Research CenterSan Diego, United States
  • The Clinical Research Center, LLCSt Louis, United States
  • University of South FloridaTampa, United States
  • Institute For Asthma & AllergyWheaton, United States
  • Chesapeake Clinical ResearchWhite Marsh, United States

About the trial

What the trial wants to find out

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).

The 3 groups in the trial

  • Arm A1 (Part A): BLU-808Treatment being tested

    BLU-808 will be administered orally.

    Treatment: BLU-808

  • Arm A3 (Part A): BLU-808Treatment being tested

    BLU-808 will be administered orally.

    Treatment: BLU-808

  • Arm B (Part B): BLU-808/PlaceboTreatment being tested

    BLU-808 or matching placebo will be administered orally.

    Treatment: BLU-808 and Placebo

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 2 Study to Evaluate the Safety, Tolerability, and Clinical Activity of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria
Record updated
22 July 2026