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
2 other identifiers
interventional
105
6 countries
47
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2025
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2025
CompletedFirst Posted
Study publicly available on registry
April 17, 2025
CompletedStudy Start
First participant enrolled
May 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 17, 2026
February 1, 2026
1.6 years
April 9, 2025
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Day 1 through Week 16
Secondary Outcomes (12)
Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12
Baseline, Week 12
Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12
Baseline, Week 12
Part A and Part B: Complete Response Rate
Week 12
Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12
Baseline, Week 12
Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12
Baseline, Week 12
- +7 more secondary outcomes
Study Arms (3)
Arm A1 (Part A): BLU-808
EXPERIMENTALBLU-808 will be administered orally.
Arm A3 (Part A): BLU-808
EXPERIMENTALBLU-808 will be administered orally.
Arm B (Part B): BLU-808/Placebo
EXPERIMENTALBLU-808 or matching placebo will be administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Allervie Clinical Research
Birmingham, Alabama, 35209, United States
Acuro Research, Inc.
Little Rock, Arkansas, 72205, United States
Modena Allergy & Asthma Clinical Research - La Jolla
La Jolla, California, 92037, United States
Allergy & Asthma Associates of Southern California
Laguna Niguel, California, 92677, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123, United States
Allergy Affiliates Inc.
Bradenton, Florida, 34208, United States
University of South Florida
Tampa, Florida, 33613, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Endeavor Health
Northbrook, Illinois, 60062, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Southern Indiana Clinical Trials
New Albany, Indiana, 47150, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, 42104, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Institute For Asthma & Allergy
Wheaton, Maryland, 20902, United States
Chesapeake Clinical Research
White Marsh, Maryland, 21236, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
The Clinical Research Center LLC.
St Louis, Missouri, 63141, United States
Montana Medical Research, Inc.
Missoula, Montana, 59808, United States
Equity Medical (at Cameron Dermatology) - New York
New York, New York, 10023, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 45236, United States
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
National Allergy, Asthma & Urticaria Centers of Charleston
Charleston, South Carolina, 29407, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Reveal Research Institute
Dallas, Texas, 75235, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
Odense University Hospital - Odense
Odense, 5000, Denmark
Fraunhofer-Institut fuer Translationale Medizin und Pharmakologie ITMP - Standort Berlin
Berlin, 12203, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt am Main, 60596, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, 30625, Germany
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Mainz, 55131, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72016, Germany
Azienda Ospedale - Università Padova
Padua, 35128, Italy
Azienda Ospedaliero Universitaria Policlinico Umberto
Rome, 00161, Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona, 37134, Italy
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, 300, Taiwan
Kaohsiung Veterans General Hospital (KSVGH)
Kaohsiung City, 813414, Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 235, Taiwan
China Medical University Hospital
Taichung, 40402, Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
Linkou Chang Gung Memorial Hospital (CGMHLK)
Taoyuan, 105406, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Arms A1 and A3 are non-randomized and open label. Arm B is randomized and double blind.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2025
First Posted
April 17, 2025
Study Start
May 28, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02