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 — DRUGOral administration
- Placebo — DRUGOral 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-808BLU-808 will be administered orally.
- Experimental: Arm A3 (Part A): BLU-808BLU-808 will be administered orally.
- Experimental: Arm B (Part B): BLU-808/PlaceboBLU-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
- Blueprint Medicines1-888-258-7768
- Blueprint Medicines, EU Contact+31 85 064 4001
Locations (27)
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