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

February 16, 2026 updated by: Blueprint Medicines Corporation

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital - Odense
  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Fraunhofer-Institut fuer Translationale Medizin und Pharmakologie ITMP - Standort Berlin
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden
      • Frankfurt am Main, Germany, 60596
        • Recruiting
        • Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover (MHH)
      • Mainz, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
      • Tübingen, Germany, 72016
        • Recruiting
        • Universitaetsklinikum Tuebingen
  • Italy
      • Padua, Italy, 35128
        • Recruiting
        • Azienda Ospedale - Università Padova
      • Rome, Italy, 00161
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico Umberto
      • Verona, Italy, 37134
        • Recruiting
        • Centro Ricerche Cliniche di Verona s.r.l.
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital Del Mar
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga
  • Taiwan
      • Hsinchu, Taiwan, 300
        • Recruiting
        • National Taiwan University Hospital Hsin-Chu Branch
      • Kaohsiung City, Taiwan, 813414
        • Recruiting
        • Kaohsiung Veterans General Hospital (KSVGH)
      • New Taipei City, Taiwan, 235
        • Recruiting
        • Taipei Medical University - Shuang Ho Hospital
      • Taichung, Taiwan, 40402
        • Recruiting
        • China Medical University Hospital
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 105406
        • Recruiting
        • Linkou Chang Gung Memorial Hospital (CGMHLK)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Allervie Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Acuro Research, Inc.
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Modena Allergy & Asthma Clinical Research - La Jolla
      • Laguna Niguel, California, United States, 92677
        • Recruiting
        • Allergy & Asthma Associates of Southern California
      • San Diego, California, United States, 92123
        • Recruiting
        • Allergy & Asthma Medical Group and Research Center
    • Florida
      • Bradenton, Florida, United States, 34208
        • Recruiting
        • Allergy Affiliates Inc.
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Treasure Valley Medical Research
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Recruiting
        • Endeavor Health
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Dawes Fretzin Clinical Research Group, LLC
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Southern Indiana Clinical trials
      • Plainfield, Indiana, United States, 46168
        • Recruiting
        • The Indiana Clinical Trials Center
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Recruiting
        • Equity Medical - Bowling Green
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins University
      • Wheaton, Maryland, United States, 20902
        • Recruiting
        • Institute For Asthma & Allergy
      • White Marsh, Maryland, United States, 21236
        • Recruiting
        • Chesapeake Clinical Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • The Clinical Research Center LLC.
    • Montana
      • Missoula, Montana, United States, 59808
        • Recruiting
        • Montana Medical Research, Inc.
    • New York
      • New York, New York, United States, 10023
        • Recruiting
        • Equity Medical (at Cameron Dermatology) - New York
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Bernstein Clinical Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Recruiting
        • Allergy & Clinical Immunology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina (MUSC)
      • Charleston, South Carolina, United States, 29407
        • Recruiting
        • National Allergy, Asthma & Urticaria Centers of Charleston
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Reveal Research Institute
      • Pflugerville, Texas, United States, 78660
        • Recruiting
        • Austin Institute for Clinical Research

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A1 (Part A): BLU-808
BLU-808 will be administered orally.
Drug: BLU-808
Oral administration
Experimental: Arm A3 (Part A): BLU-808
BLU-808 will be administered orally.
Drug: BLU-808
Oral administration
Experimental: Arm B (Part B): BLU-808/Placebo
BLU-808 or matching placebo will be administered orally.
Drug: Placebo
Oral administration
Drug: BLU-808
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 through Week 16
Day 1 through Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12
Time Frame: Baseline, Week 12
CTT is the temperature at which CIndU symptoms appear.
Baseline, Week 12
Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12
Time Frame: Baseline, Week 12
TFS is a measure of CIndU trigger thresholds and disease activity.
Baseline, Week 12
Part A and Part B: Complete Response Rate
Time Frame: Week 12
Week 12
Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Part A and Part B: Area Under the Curve (AUC) of BLU-808
Time Frame: Day 1 to Day 57
Day 1 to Day 57
Part A and Part B: Maximum Plasma Concentration (Cmax) of BLU-808
Time Frame: Day 1 to Day 57
Day 1 to Day 57
Part A and Part B: Minimum Plasma Concentration (Cmin) of BLU-808
Time Frame: Day 1 to Day 57
Day 1 to Day 57
Part A and Part B: Apparent Clearance (CL/F) of BLU-808
Time Frame: Day 1 to Day 57
Day 1 to Day 57
Part A and Part B: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808
Time Frame: Day 1 to Day 57
Day 1 to Day 57
Part A and Part B: Terminal Half-life (t½) of BLU-808
Time Frame: Day 1 to Day 57
Day 1 to Day 57
Part B: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 12
Time Frame: Baseline, Week 12
UAS7 is a patient-reported outcome used to assess symptoms in participants with CSU.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blueprint Medicines Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLU-808-1201
  • 2024-520031-33-00 (Other Identifier: Clinical Trials Information System (CTIS))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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