NCT06931405 · Blueprint Medicines Corporation
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
What this study is about
This is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, how the drug moves through the body, and how the drug affects the body of BLU-808, a wild type KIT inhibitor, in participants with CIndU (Part A) or CSU (Part B).
View original scientific description
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).
Interventions
DRUG
BLU-808
Oral administration
DRUG
Placebo
Oral administration
Primary outcome measures
Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Week 16
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 ≥6 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 A: History of cold-induced anaphylaxis.
- 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 sa
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- La Jolla, California
- Laguna Niguel, California
- San Diego, California
- Bradenton, Florida
- Tampa, Florida
- Boise, Idaho
- Northbrook, Illinois
- Indianapolis, Indiana
- New Albany, Indiana
- Plainfield, Indiana
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations