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BLU-808

Phase 2

Chronic Inducible Urticaria | Small molecule | Dermatology |Blueprint Medicines Corporation|Last Updated: Jul 22, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

BLU-808 · 3 trials · 4 indications

Phase 2 2Phase 1 1
NCT06931405Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)Chronic Inducible Urticaria
ACTIVE NOT_RECRUITING105 Analytics
NCT06922448Study of BLU-808 in Allergic RhinoconjunctivitisAllergic Rhinoconjunctivitis
COMPLETED21 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
Chronic Inducible UrticariaUnlock trial analytics
PHASE2COMPLETED
Study of BLU-808 in Allergic Rhinoconjunctivitis
Allergic RhinoconjunctivitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Day 1 through Week 16
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Day 1 through Day 56
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Up to Day 20
Part 2: Number of Participants With TEAEs
Up to Day 50
Part 3: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t)
Up to Day 6
Part 3: Maximum Observed Plasma Concentration (Cmax)
Up to Day 6

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.
BLU-808 Dose 1EXPERIMENTALBLU-808 will be administered orally for 28 days.
BLU-808 Dose 2EXPERIMENTALBLU-808 will be administered orally for 28 days.
PlaceboPLACEBO_COMPARATORPlacebo will be administered orally for 28 days.
Part 1: BLU-808EXPERIMENTALBLU-808 will be administered orally.
Part 1: PlaceboPLACEBO_COMPARATORMatching placebo for BLU-808 will be administered orally.
Part 2: BLU-808EXPERIMENTALBLU-808 will be administered orally.
Part 2: PlaceboPLACEBO_COMPARATORMatching placebo for BLU-808 will be administered orally.
Part 2: Midazolam Alone Followed by BLU-808 and MidazolamEXPERIMENTALParticipants will receive oral midazolam in Period 1. Participants will then receive oral BLU-808 with midazolam in period 2.
Part 2: Midazolam Alone Followed by BLU-808 Matching Placebo and MidazolamPLACEBO_COMPARATORParticipants will receive oral midazolam in Period 1. Participants will then receive oral matching placebo for BLU-808 with midazolam in period 2.
Part 3: BLU-808 (Treatment D, E)EXPERIMENTALBLU-808 will be administered orally.
Part 3: BLU-808 (Treatment E, D)EXPERIMENTALBLU-808 will be administered orally.

Interventions

NameTypeDescription
BLU-808DRUGOral administration
PlaceboDRUGOral administration
MidazolamDRUGMidazolam will be administered per schedule specified in the arm description.
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Eligibility Criteria

Age Range18 Years to 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 StatesDenmarkGermanyItalySpainTaiwanCanada
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Recent Changes (Last 90 Days)

MEDIUMJul 22, 2026NCT06931405Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 22, 2026NCT06931405Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06931405primaryCompletionDate: changed
LOWMay 24, 2026NCT06931405studyFirstPostDate: changed

Frequently asked questions about BLU-808

What is BLU-808 used for?

BLU-808 is an investigational small molecule being developed by Blueprint Medicines Corporation for allergic rhinoconjunctivitis, chronic inducible urticaria, and chronic spontaneous urticaria. It is also being studied in healthy participants. The drug is currently in Phase 2 clinical development for these conditions.

What does BLU-808 target?

BLU-808 is a small molecule being developed by Blueprint Medicines Corporation. The specific molecular target of BLU-808 has not been disclosed in available clinical trial information. It is being studied for allergic rhinoconjunctivitis, chronic inducible urticaria, and chronic spontaneous urticaria.

Who makes BLU-808?

BLU-808 is being developed by Blueprint Medicines Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol BPMC. The company is conducting clinical trials of BLU-808 for allergic rhinoconjunctivitis, chronic inducible urticaria, and chronic spontaneous urticaria.

What phase is BLU-808 in?

BLU-808 is in Phase 2 clinical development. It has completed a Phase 1 study in healthy participants and a Phase 2 study in allergic rhinoconjunctivitis. A Phase 2 study in chronic inducible urticaria and chronic spontaneous urticaria is active but not recruiting. BLU-808 is investigational and not yet approved.

What clinical trials is BLU-808 in?

BLU-808 has been studied in three clinical trials. NCT06922448 is a completed Phase 2 study in allergic rhinoconjunctivitis. NCT06931405 is an active Phase 2 study in chronic inducible urticaria and chronic spontaneous urticaria. NCT06948032 is a completed Phase 1 study in healthy participants.

Is BLU-808 the same as any other drug?

BLU-808 is the only name provided for this investigational drug. No alternative names have been disclosed in the available clinical trial information. It is being developed by Blueprint Medicines Corporation for allergic rhinoconjunctivitis, chronic inducible urticaria, and chronic spontaneous urticaria.