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
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Allervie Clinical Research
RECRUITING
Birmingham
Arkansas
Acuro Research, Inc.
RECRUITING
Little Rock
California
Modena Allergy & Asthma Clinical Research - La Jolla
RECRUITING
La Jolla
Allergy & Asthma Medical Group and Research Center
RECRUITING
San Diego
Florida
Allergy Affiliates Inc.
RECRUITING
Bradenton
University of South Florida
RECRUITING
Tampa
Idaho
Treasure Valley Medical Research
RECRUITING
Boise
Illinois
Endeavor Health
RECRUITING
Northbrook
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
Southern Indiana Clinical Trials
RECRUITING
New Albany
The Indiana Clinical Trials Center
RECRUITING
Plainfield
Kentucky
Equity Medical - Bowling Green
RECRUITING
Bowling Green
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Institute For Asthma & Allergy
RECRUITING
Wheaton
Chesapeake Clinical Research
RECRUITING
White Marsh
Michigan
Henry Ford Health
RECRUITING
Detroit
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
The Clinical Research Center LLC.
RECRUITING
St Louis
Montana
Montana Medical Research, Inc.
RECRUITING
Missoula
New York
Equity Medical (at Cameron Dermatology) - New York
RECRUITING
New York
Pennsylvania
Allergy & Clinical Immunology Associates
RECRUITING
Pittsburgh
South Carolina
National Allergy, Asthma & Urticaria Centers of Charleston
RECRUITING
Charleston
Texas
Reveal Research Institute
RECRUITING
Dallas
Other Locations
Denmark
Odense University Hospital - Odense
RECRUITING
Odense
Germany
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
RECRUITING
Frankfurt Am Main
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
RECRUITING
Mainz
Italy
Centro Ricerche Cliniche di Verona s.r.l.
RECRUITING
Verona
Spain
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitari de Bellvitge
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Taiwan
Taipei Medical University - Shuang Ho Hospital
RECRUITING
New Taipei City
Contact Information
Primary
Blueprint Medicines
medinfo@blueprintmedicines.com
1-888-258-7768
Backup
Blueprint Medicines, EU Contact
medinfoeurope@blueprintmedicines.com
+31 85 064 4001
Time Frame
Start Date: 2025-05-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 105
Treatments
Experimental: Arm A1 (Part A): BLU-808
BLU-808 will be administered orally.
Experimental: Arm A3 (Part A): BLU-808
BLU-808 will be administered orally.
Experimental: Arm B (Part B): BLU-808/Placebo
BLU-808 or matching placebo will be administered orally.
Related Therapeutic Areas
Sponsors
Leads: Blueprint Medicines Corporation