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

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What is this study about?

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.

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Medizinische Hochschule Hannover	Hanover	Germany
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany

Other Sites

Site Name	City	Country
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital Del Mar	Barcelona	Spain
Azienda Ospedaliera di Padova	Padua	Italy
Odense University Hospital	Odense	Denmark
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP	Frankfurt	Germany
Gxqncf Uxnaseycjh Frbuqeyhh	Frankfurt	Germany
Umjpigmkzv Dmpww Syust Dc Rgiz Ly Srritzfu	Rome	Italy
Hzlnjobv Vpna dbtkvbkv	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	29.08.2025
Germany	Not recruiting	29.08.2025
Italy	Not recruiting	29.08.2025
Spain	Not recruiting	29.08.2025

Trial locations

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.

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.

Trial ID:

2024-520031-33-00

Protocol code:

BLU-808-1201

NCT ID:

NCT06931405

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?