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

Last updated: June 23, 2025
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 ≥6 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 A: History of cold-induced anaphylaxis.

  • 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

  • Modena Allergy & Asthma Clinical Research - La Jolla

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Allergy & Asthma Medical Group and Research Center

    San Diego, California 92123
    United States

    Active - Recruiting

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky 42104
    United States

    Active - Recruiting

  • Institute For Asthma & Allergy

    Wheaton, Maryland 20902
    United States

    Active - Recruiting

  • Montana Medical Research, Inc.

    Missoula, Montana 59808
    United States

    Active - Recruiting

  • Equity Medical (at Cameron Dermatology) - New York

    New York, New York 10023
    United States

    Active - Recruiting

  • Allergy & Clinical Immunology Associates

    Pittsburgh, Pennsylvania 15241
    United States

    Active - Recruiting

  • National Allergy, Asthma & Urticaria Centers of Charleston

    Charleston, South Carolina 29407
    United States

    Active - Recruiting

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