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Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT06931405•Blueprint Medicines Corporation

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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 ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.

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 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.

Locations (47)

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 Associates of Southern California

Laguna Niguel, 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

Key Dates

Start Date

May 28, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

February 17, 2026

Enrollment

105

ESTIMATED participants

Conditions

Chronic Inducible UrticariaChronic Spontaneous Urticaria

Interventions

BLU-808

DRUG

Placebo

DRUG

Contacts

Blueprint Medicines

CONTACT

1-888-258-7768 medinfo@blueprintmedicines.com

Blueprint Medicines, EU Contact

CONTACT

+31 85 064 4001 medinfoeurope@blueprintmedicines.com

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NCT07266402

Chronic Inducible UrticariaCold Urticaria+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)

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