Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

Launched by BLUEPRINT MEDICINES CORPORATION · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BLU-808, which is being tested for its safety and effectiveness in people with chronic urticaria conditions. There are two parts to the study: Part A focuses on those with Chronic Inducible Urticaria (CIndU) and Part B on those with Chronic Spontaneous Urticaria (CSU). Both conditions can cause itchy hives, and this trial aims to see if BLU-808 can help individuals whose symptoms are not well controlled by current antihistamine treatments.

To be eligible, participants in Part A must have a confirmed diagnosis of CIndU for at least three months, while those in Part B need to have CSU for at least six months, and both must not be adequately managed with standard medications. Participants can expect to undergo assessments to monitor their health and the effectiveness of the treatment during the trial. It's important to note that individuals with certain medical conditions or specific types of urticaria may not qualify for this study. The trial is currently not recruiting participants, but it will take place globally and aims to provide valuable insights into managing these chronic itch conditions.

Gender

ALL

Eligibility criteria

• 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 ≥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 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.