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BLU-808

Phase 2

Chronic Inducible Urticaria | Small molecule | Dermatology |Blueprint Medicines Corporation|Last Updated: Feb 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06931405Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)PHASE2 RECRUITING 105May 28, 2025Dec 31, 2026Feb 17, 202647 United States, Denmark +4
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Study Endpoints
Primary Endpoints
Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Day 1 through Week 16
Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A1 (Part A): BLU-808EXPERIMENTALBLU-808 will be administered orally.
Arm A3 (Part A): BLU-808EXPERIMENTALBLU-808 will be administered orally.
Arm B (Part B): BLU-808/PlaceboEXPERIMENTALBLU-808 or matching placebo will be administered orally.
Interventions
NameTypeDescription
BLU-808DRUGOral administration
PlaceboDRUGOral administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites47

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-antihista...

Countries:United StatesDenmarkGermanyItalySpainTaiwan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06931405primaryCompletionDate: changed
LOWMay 24, 2026NCT06931405studyFirstPostDate: changed