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Clinical Trials in China / NCT06931405
Active, not recruiting Phase 2

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

NCT06931405 · tracked via the Priya Life Science China tracker
Sponsor
Blueprint Medicines Corporation
Phase
Phase 2
Started
2025-05-28
Last updated
2026-07-22

Condition(s) studied

Chronic Inducible UrticariaChronic Spontaneous Urticaria

Investigational drug(s) / intervention(s)

BLU-808Placebo

BLU-808: Oral administration

Placebo: Oral administration

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (47)

FacilityCityRegionStatus
Allervie Clinical Research Birmingham Alabama
Acuro Research, Inc. Little Rock Arkansas
Modena Allergy & Asthma Clinical Research - La Jolla La Jolla California
Allergy & Asthma Associates of Southern California Laguna Niguel California
Allergy & Asthma Medical Group and Research Center San Diego California
Allergy Affiliates Inc. Bradenton Florida
University of South Florida Tampa Florida
Treasure Valley Medical Research Boise Idaho
Endeavor Health Northbrook Illinois
Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
Southern Indiana Clinical Trials New Albany Indiana
The Indiana Clinical Trials Center Plainfield Indiana
Equity Medical - Bowling Green Bowling Green Kentucky
Johns Hopkins University Baltimore Maryland
Institute For Asthma & Allergy Wheaton Maryland
Chesapeake Clinical Research White Marsh Maryland
Henry Ford Health Detroit Michigan
Mayo Clinic Rochester Minnesota
The Clinical Research Center LLC. St Louis Missouri
Montana Medical Research, Inc. Missoula Montana
Equity Medical (at Cameron Dermatology) - New York New York New York
Bernstein Clinical Research Center Cincinnati Ohio
Allergy & Clinical Immunology Associates Pittsburgh Pennsylvania
National Allergy, Asthma & Urticaria Centers of Charleston Charleston South Carolina
Medical University of South Carolina (MUSC) Charleston South Carolina
Reveal Research Institute Dallas Texas
Austin Institute for Clinical Research Pflugerville Texas
Odense University Hospital - Odense Odense Denmark
Fraunhofer-Institut fuer Translationale Medizin und Pharmakologie ITMP - Standort Berlin Berlin Germany
Universitaetsklinikum Carl Gustav Carus Dresden Dresden Germany
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet Frankfurt am Main Germany
Medizinische Hochschule Hannover (MHH) Hanover Germany
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz Mainz Germany
Universitaetsklinikum Tuebingen Tübingen Germany
Azienda Ospedale - Università Padova Padova Italy
Azienda Ospedaliero Universitaria Policlinico Umberto Rome Italy
Centro Ricerche Cliniche di Verona s.r.l. Verona Italy
Hospital del Mar Barcelona Spain
Hospital Universitario Vall d'Hebron Barcelona Spain
Hospital Universitari de Bellvitge Barcelona Spain

+ 7 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06931405 on ClinicalTrials.gov ↗ ← All trials in China