RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official 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

Quick Facts

Study Start:2025-05-28
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06931405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Part A: Confirmed diagnosis of CIndU for ≥3 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
  2. * Part B: Confirmed diagnosis of CSU for ≥6 months prior to Day 1 that is inadequately controlled with second generation H1-antihistamines.
  1. * Part A: Any active urticaria that may interfere with study assessments.
  2. * Part A: History of cold-induced anaphylaxis.
  3. * Part B: Participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria.
  4. * 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.
  5. * 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.
  6. * Part A and Part B: Abnormal laboratory values that may pose risks or interfere with study participation.
  7. * Part A and Part B: Pregnancy or plans for pregnancy; breastfeeding.

Contacts and Locations

Study Contact

Blueprint Medicines
CONTACT
1-888-258-7768
medinfo@blueprintmedicines.com
Blueprint Medicines, EU Contact
CONTACT
+31 85 064 4001
medinfoeurope@blueprintmedicines.com

Study Locations (Sites)

Modena Allergy & Asthma Clinical Research - La Jolla
La Jolla, California, 92037
United States
Treasure Valley Medical Research
Boise, Idaho, 83706
United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, 42104
United States
Montana Medical Research, Inc.
Missoula, Montana, 59808
United States
Equity Medical (at Cameron Dermatology) - New York
New York, New York, 10023
United States
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
United States

Collaborators and Investigators

Sponsor: Blueprint Medicines Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-28
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-05-28
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Chronic Inducible Urticaria
  • Chronic Spontaneous Urticaria
  • BLU-808
  • CIndU
  • CSU
  • Chronic Urticaria
  • CU
  • Cold Urticaria
  • ColdU
  • Symptomatic Dermographism
  • SD

Additional Relevant MeSH Terms

  • Chronic Inducible Urticaria
  • Chronic Spontaneous Urticaria