BLU-808 for Chronic Urticaria
Recruiting at 5 trial locations
BM
BM
Overseen ByBlueprint Medicines
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Blueprint Medicines Corporation
Must be taking: Second generation H1-antihistamines
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
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).
Eligibility Criteria
This trial is for people who've had Chronic Inducible Urticaria (CIndU) for at least 3 months or Chronic Spontaneous Urticaria (CSU) for at least 6 months, and their symptoms aren't well-managed with common antihistamines. Participants must have a confirmed diagnosis.Inclusion Criteria
I have had chronic inducible urticaria for over 3 months not managed by antihistamines.
I have had chronic hives for 6 months or more and antihistamines don't control it well.
Exclusion Criteria
Part A: Any active urticaria that may interfere with study assessments
Part A: History of cold-induced anaphylaxis
Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation
See 4 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive BLU-808 or placebo orally to evaluate safety, tolerability, and clinical activity
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- BLU-808
Trial Overview The study tests BLU-808, a drug intended to inhibit certain cellular processes that may be involved in urticaria. It's compared against a placebo in two parts: one focusing on CIndU patients and the other on CSU patients.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Arm B (Part B): BLU-808/PlaceboExperimental Treatment2 Interventions
BLU-808 or matching placebo will be administered orally.
Group II: Arm A3 (Part A): BLU-808Experimental Treatment1 Intervention
BLU-808 will be administered orally.
Group III: Arm A1 (Part A): BLU-808Experimental Treatment1 Intervention
BLU-808 will be administered orally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Blueprint Medicines Corporation
Lead Sponsor
Trials
31
Recruited
6,000+
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.