NCT06931405

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Blueprint Medicines Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 inhibitor, in participants with CIndU (Part A) or CSU (Part B).

Conditions

• Chronic Inducible Urticaria
• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	BLU-808	Oral administration
DRUG	Placebo	Oral administration

Timeline

• Start date: 2025-05-28
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-04-17
• Last updated: 2026-02-17

Locations

47 sites across 6 countries: United States, Denmark, Germany, Italy, Spain, Taiwan

Regulatory

• FDA-regulated drug study