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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Blueprint Medicines Corporation
Study ID
NCT06931405
Phase
PHASE2
Status
Recruiting

Conditions

  • Chronic Inducible Urticaria
  • Chronic Spontaneous Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BLU-808 — DRUG
    Oral administration
  • Placebo — DRUG
    Oral administration

Study Details

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).

Key Dates

Start date
May 28, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
Allervie Clinical ResearchBirminghamAlabama35209-
Acuro Research, Inc.Little RockArkansas72205-
Modena Allergy & Asthma Clinical Research - La JollaLa JollaCalifornia92037-
Allergy & Asthma Associates of Southern CaliforniaLaguna NiguelCalifornia92677-
Allergy & Asthma Medical Group and Research CenterSan DiegoCalifornia92123-
Allergy Affiliates Inc.BradentonFlorida34208-
University of South FloridaTampaFlorida33613-
Treasure Valley Medical ResearchBoiseIdaho83706-
Endeavor HealthNorthbrookIllinois60062-
Dawes Fretzin Clinical Research Group, LLCIndianapolisIndiana46250-
Southern Indiana Clinical TrialsNew AlbanyIndiana47150-
The Indiana Clinical Trials CenterPlainfieldIndiana46168-
Equity Medical - Bowling GreenBowling GreenKentucky42104-
Johns Hopkins UniversityBaltimoreMaryland21224-
Institute For Asthma & AllergyWheatonMaryland20902-
Chesapeake Clinical ResearchWhite MarshMaryland21236-
Henry Ford HealthDetroitMichigan48202-
Mayo ClinicRochesterMinnesota55905-
The Clinical Research Center LLC.St LouisMissouri63141-
Montana Medical Research, Inc.MissoulaMontana59808-
Equity Medical (at Cameron Dermatology) - New YorkNew YorkNew York10023-
Bernstein Clinical Research CenterCincinnatiOhio45236-
Allergy & Clinical Immunology AssociatesPittsburghPennsylvania15241-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-
National Allergy, Asthma & Urticaria Centers of CharlestonCharlestonSouth Carolina29407-
Reveal Research InstituteDallasTexas75235-
Austin Institute for Clinical ResearchPflugervilleTexas78660-

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