A Phase 2 Study to Evaluate the Safety, Tolerability, and Clinical Activity of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria
Blueprint Medicines Corporation
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
- Age range
- 18+ years
- Sex
- All
- 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 s…
Interventions
- DrugBLU-808
Oral administration
- DrugPlacebo
Oral administration
Locations (47)
- Allervie Clinical ResearchBirmingham, Alabama
- Acuro Research, Inc.Little Rock, Arkansas
- Modena Allergy & Asthma Clinical Research - La JollaLa Jolla, California
- Allergy & Asthma Associates of Southern CaliforniaLaguna Niguel, California
- Allergy & Asthma Medical Group and Research CenterSan Diego, California
- Allergy Affiliates Inc.Bradenton, Florida