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BLU-808 for chronic inducible and spontaneous hives

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

PHASE2 · Blueprint Medicines Corporation · NCT06931405

This trial will test whether BLU-808, a KIT-blocking medicine, is safe and reduces hives and itching in adults with chronic inducible or spontaneous hives that are not controlled by second‑generation antihistamines.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment105 (estimated)
Ages18 Years and up
SexAll
SponsorBlueprint Medicines Corporation (industry)
Locations47 sites (Birmingham, Alabama and 46 other locations)
Trial IDNCT06931405 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, two-part proof-of-concept trial testing BLU-808 versus placebo in participants with chronic inducible urticaria (Part A) or chronic spontaneous urticaria (Part B). The study will measure safety, tolerability, clinical activity, and the drug's pharmacokinetics and pharmacodynamics. Eligible participants must have had their condition for at least three months and remain inadequately controlled on second‑generation H1-antihistamines. The trial is sponsored by Blueprint Medicines and will be conducted at multiple clinical research sites.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of chronic inducible urticaria (Part A) or chronic spontaneous urticaria (Part B) for at least three months whose symptoms remain inadequately controlled on second‑generation H1-antihistamines.

Not a fit: Patients with other skin diseases that cause itching or angioedema, autoinflammatory urticaria, a clearly defined single trigger (such as symptomatic dermographism or cold-induced urticaria in Part B), or significant comorbid conditions excluded by the protocol may not benefit or be eligible.

Why it matters

Potential benefit: If successful, BLU-808 could offer a new option to reduce hives and itching for patients who do not respond to standard antihistamines.

How similar studies have performed: Targeting KIT to reduce mast cell activity in urticaria is a relatively novel approach with limited prior clinical data, while anti-IgE therapies like omalizumab have shown established benefit.

Eligibility criteria

Show full inclusion / exclusion 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 ≥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.

Where this trial is running

Birmingham, Alabama and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Inducible Urticaria, Chronic Spontaneous Urticaria, BLU-808, CIndU, CSU, Chronic Urticaria, CU, Cold Urticaria

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.