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

Description

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).

Conditions

Chronic Inducible Urticaria, Chronic Spontaneous Urticaria

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Chronic Inducible Urticaria
Intervention / Treatment

-

Contacts and Locations

La Jolla

Modena Allergy & Asthma Clinical Research - La Jolla, La Jolla, California, United States, 92037

Boise

Treasure Valley Medical Research, Boise, Idaho, United States, 83706

Bowling Green

Equity Medical - Bowling Green, Bowling Green, Kentucky, United States, 42104

Missoula

Montana Medical Research, Inc., Missoula, Montana, United States, 59808

New York

Equity Medical (at Cameron Dermatology) - New York, New York, New York, United States, 10023

Pittsburgh

Allergy & Clinical Immunology Associates, Pittsburgh, Pennsylvania, United States, 15241

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 ≥6 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
  • * 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 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Blueprint Medicines Corporation,

Study Record Dates

2026-12-31