Not recruiting

Study of BLU-808 tablets compared to placebo in adults with chronic inducible urticaria and chronic spontaneous urticaria

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Chronic Inducible Urticaria and Chronic Spontaneous Urticaria, which are conditions causing recurring hives and itchy skin rashes. The study will test a new medication called BLU-808, which is taken as a tablet by mouth. Some participants will receive BLU-808, while others will receive a placebo.

The main purpose of this research is to evaluate how safe BLU-808 is and how well patients tolerate it. The study is designed for people whose hives are not well controlled with standard antihistamine medications. The research will be conducted in two parts - one focusing on patients with chronic inducible urticaria and another on those with chronic spontaneous urticaria.

During the study, which lasts 12 weeks, participants will take the study medication and have their symptoms monitored. The researchers will track any changes in the participants' condition, including how the medication affects their hives and overall symptoms. They will also measure how the medication moves through the body and its effects on various biological markers.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial diagnosis confirmation
For chronic inducible urticaria: Your condition must be confirmed for at least 3 months before starting
For chronic spontaneous urticaria: Your condition must be confirmed for at least 6 months before starting
Your condition must be not adequately controlled with standard antihistamine medications
Step 2
Treatment period start
You will receive either BLU-808 tablets or placebo tablets (tablets without active medication)
The tablets are to be taken by mouth
The treatment period will last for 12 weeks
Step 3
Monitoring during treatment
Your health status will be regularly monitored for any side effects or adverse reactions
For cold-induced urticaria: Temperature threshold tests will be conducted
For symptomatic dermographism: Skin reaction tests will be performed
You will be asked to report your symptoms and experiences throughout the treatment
Step 4
Final evaluation
At the end of week 12, final assessments will be conducted
Your response to treatment will be evaluated
Blood samples will be collected to measure medication levels in your body
Changes in your condition will be compared to your initial status

Who can join the trial?

8 criteria

You must be an adult aged 18-64 years old
Both men and women can participate
For Part A: You must have been diagnosed with chronic inducible urticaria (hives triggered by specific stimuli) for at least 3 months before starting the study
For Part A: Your hives must not be adequately controlled with standard antihistamine medications
For Part B: You must have been diagnosed with chronic spontaneous urticaria (hives that appear without obvious triggers) for at least 6 months before starting the study
For Part B: Your hives must not be adequately controlled with standard antihistamine medications
You must be willing and able to comply with all study procedures and requirements
Additional eligibility criteria defined in the study protocol must also be met

Who cannot join the trial?

14 criteria

History of serious allergic reactions or anaphylaxis (severe, potentially life-threatening allergic reaction)
Current pregnancy or breastfeeding
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Significant heart problems or uncontrolled high blood pressure
Major surgery within the past 3 months
Current participation in other clinical trials or use of investigational drugs within the past 30 days
History of cancer within the past 5 years (except for successfully treated skin cancer)
Severe kidney or liver problems
Uncontrolled diabetes mellitus (high blood sugar condition)
History of blood clotting disorders
Active substance abuse or alcohol dependency
Mental health conditions that could interfere with study participation
Use of medications that could interact with the study drug
Unable to follow study procedures or attend scheduled visits

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Verified sites

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Verified
Azienda Ospedaliera di Padova
Padua, Italy
Responsive
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Frankfurt, Germany
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

Trial locations

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Investigated drugs

BLU-808 is an experimental medication that works as a KIT inhibitor. It targets a specific protein called KIT, which plays a role in certain types of urticaria (hives). This medication is being studied for its potential to help people with chronic inducible urticaria (hives triggered by specific stimuli) and chronic spontaneous urticaria (hives that appear without obvious triggers). BLU-808 is being tested to understand how safe it is and how well patients can tolerate it.

What is already known about the treatment

BLU-808 - A novel wild type KIT inhibitor medication that is currently being investigated in Phase 2 clinical trials for the treatment of Chronic Inducible Urticaria and Chronic Spontaneous Urticaria. This drug works by inhibiting the KIT receptor tyrosine kinase, which plays a crucial role in mast cell development and function involved in urticaria symptoms. As a targeted therapy, BLU-808 belongs to the class of kinase inhibitors and is being studied to evaluate its safety profile and potential effectiveness in managing chronic urticaria conditions. The medication is still in the experimental phase, and its specific administration form and complete safety profile are being established through ongoing clinical research.

Investigated diseases

Chronic Inducible Urticaria
A skin condition characterized by itchy wheals (hives) and swelling that appears in response to specific physical triggers such as cold, pressure, or friction. The symptoms typically develop within minutes of exposure to the trigger and can last for several hours. The condition is considered chronic when symptoms occur for more than 6 weeks.
Chronic Spontaneous Urticaria
A skin condition where itchy wheals (hives), angioedema (deep tissue swelling), or both appear without any specific external trigger for more than 6 weeks. The wheals can appear anywhere on the body, change location within hours, and each individual wheal typically resolves within 24 hours. The episodes of hives can occur daily or almost daily, significantly affecting quality of life.