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NCT Number: NCT06931405

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Inducible Urticaria Chronic Disease Chronic Spontaneous Urticaria Chronic Urticaria Cold Urticaria Disease Attributes Familial dermographism Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Odense University Hospital - Odense, Odense, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

BLU-808

Drug

Oral administration

Placebo

Drug

Oral administration

Primary outcomes

  1. Part A and Part B: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 1 through Week 16

Secondary outcomes

  1. Part A: Mean Change From Baseline in Critical Temperature Threshold (CTT) at Week 12

    Time frame: Baseline, Week 12

    CTT is the temperature at which CIndU symptoms appear.

  2. Part A: Mean Change From Baseline in Total Fric Score (TFS) at Week 12

    Time frame: Baseline, Week 12

    TFS is a measure of CIndU trigger thresholds and disease activity.

  3. Part A and Part B: Complete Response Rate

    Time frame: Week 12

  4. Part A and Part B: Absolute Change From Baseline in Serum Tryptase Concentration at Week 12

    Time frame: Baseline, Week 12

  5. Part A and Part B: Percent Change From Baseline in Serum Tryptase Concentration at Week 12

    Time frame: Baseline, Week 12

  6. Part A and Part B: Area Under the Curve (AUC) of BLU-808

    Time frame: Day 1 to Day 57

  7. Part A and Part B: Maximum Plasma Concentration (Cmax) of BLU-808

    Time frame: Day 1 to Day 57

  8. Part A and Part B: Minimum Plasma Concentration (Cmin) of BLU-808

    Time frame: Day 1 to Day 57

  9. Part A and Part B: Apparent Clearance (CL/F) of BLU-808

    Time frame: Day 1 to Day 57

  10. Part A and Part B: Apparent Volume of Distribution for the Central Compartment (Vc/F) of BLU-808

    Time frame: Day 1 to Day 57

  11. Part A and Part B: Terminal Half-life (t½) of BLU-808

    Time frame: Day 1 to Day 57

  12. Part B: Mean Change From Baseline in Urticaria Activity Score Over 7 Days (UAS7) at Week 12

    Time frame: Baseline, Week 12

    UAS7 is a patient-reported outcome used to assess symptoms in participants with CSU.

Sponsors and collaborators

Lead sponsor

Blueprint Medicines Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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