Status:
RECRUITING
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
Lead Sponsor:
Blueprint Medicines Corporation
Conditions:
Chronic Inducible Urticaria
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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 skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions.
- Part A and Part B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results.
- Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation.
- Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.
Key Trial Info
Start Date :
May 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06931405
Start Date
May 28 2025
End Date
December 31 2026
Last Update
January 8 2026
Active Locations (46)
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1
Allervie Clinical Research
Birmingham, Alabama, United States, 35209
2
Acuro Research, Inc.
Little Rock, Arkansas, United States, 72205
3
Modena Allergy & Asthma Clinical Research - La Jolla
La Jolla, California, United States, 92037
4
Allergy & Asthma Associates of Southern California
Laguna Niguel, California, United States, 92677