Active Not Recruiting PHASE2 Chronic Inducible Urticaria

New treatment option for Chronic Inducible Urticaria

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

ClinicalTrials.gov ID: NCT06931405

What this study is testing

What is BLU-808?

BLU-808 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic inducible urticaria.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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

You likely can't join if

  • 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...
  • Part A and Part B: Any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin...
  • Part A and Part B: Significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug...
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Birmingham, Alabama, United States
  • Little Rock, Arkansas, United States
  • La Jolla, California, United States
  • Laguna Niguel, California, United States
  • San Diego, California, United States
  • Bradenton, Florida, United States
  • Tampa, Florida, United States
  • Boise, Idaho, United States
  • Northbrook, Illinois, United States
  • Indianapolis, Indiana, United States
  • New Albany, Indiana, United States
  • Plainfield, Indiana, United States
  • Bowling Green, Kentucky, United States
  • Baltimore, Maryland, United States
  • Wheaton, Maryland, United States
  • White Marsh, Maryland, United States
  • Detroit, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Missoula, Montana, United States

+ 24 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; Laguna Niguel, California, United States; San Diego, California, United States; Bradenton, Florida, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.