Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)
This is an early-stage research study (Phase 2) looking at a new medication called BLU-808. It's for adults in the UK and worldwide who suffer from long-lasting hives, specifically chronic inducible urticaria (hives brought on by things like cold or pressure) or chronic spontaneous urticaria (hives that appear without a clear reason). The main goals are to check if BLU-808 is safe, if people can tolerate it well, and how it affects their hives. Researchers will also be learning how the body handles the medication. Half of the participants will receive BLU-808, and the other half will receive a dummy medication (placebo) for comparison. The study is divided into two parts, one for each type of urticaria.
At a glance
What is this study about?
This research study is looking at a new potential treatment called BLU-808 for two types of long-lasting hives: chronic inducible urticaria (CIndU) and chronic spontaneous urticaria (CSU). CIndU means your hives are triggered by specific things, like cold, heat, pressure, or even sunlight. CSU means you get hives without any obvious trigger. Both conditions can be very uncomfortable and affect daily life.
The study aims to understand BLU-808 better. Specifically, researchers want to see if the medication is safe and tolerated well by people with these conditions. They also want to understand how it works in the body and if it helps to reduce hive symptoms. This is an early-stage study, meaning it's one of the first times this medication has been tested in a larger group of people with these specific conditions. It will help us learn if BLU-808 could be a helpful new option in the future.
Participants will be split into two groups. One group will receive BLU-808, and the other will receive a 'placebo', which looks exactly like the study medication but contains no active drug. This allows researchers to compare the effects of BLU-808 directly. The study is being carried out in different countries, including the UK.
Key takeaways
- This is an early study of a new medication (BLU-808) for long-lasting hives.
- It's for people whose hives aren't well-controlled by usual antihistamines.
- Participants will receive either BLU-808 or a dummy drug (placebo).
- The study aims to check safety, how well it's tolerated, and if it helps symptoms.
- Regular clinic visits and health monitoring will be part of taking part.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To join this study, you must be 18 years old or older. You need to have had a confirmed diagnosis of either chronic inducible urticaria (hives with a trigger) or chronic spontaneous urticaria (hives without a trigger) for at least three months. Importantly, your current medication, which is usually a type of antihistamine, must not be controlling your hives well enough.
There are also some reasons why you wouldn't be able to join. For example, if you have other skin conditions that might make it hard for researchers to tell if the study medication is working, or if you have other serious health problems that could make taking part unsafe. If your chronic spontaneous urticaria has a single, very clear cause, like hives only from scratching your skin or only from cold, you might not be eligible for that part of the study. Also, if you are pregnant, planning to become pregnant, or breastfeeding, you cannot participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with chronic inducible urticaria OR chronic spontaneous urticaria for at least 3 months?
- Are your current antihistamine medications not fully controlling your hives?
- Are you not pregnant, planning to become pregnant, or breastfeeding?
- Do you have any other significant health issues or skin conditions that might interfere with skin assessments?
What does participation involve?
If you decide to take part in this study, you will have regular visits to the study clinic. During these visits, the research team will monitor your health, check your hive symptoms, and take blood samples to see how the medication is affecting your body. You will be given either the study medication (BLU-808) or a dummy medication (placebo) to take regularly, as directed by the study team. You'll receive clear instructions on how to take the medication.
The study will involve several appointments over a period of time, and you will have follow-up visits even after you finish taking the study medication to ensure your safety. The total length of your participation will be explained to you in detail by the study staff before you decide to join.
Potential risks and benefits
Locations (47)
- Allervie Clinical ResearchVerified postcodeBirmingham, United States· Recruiting
- Acuro Research, Inc.Verified postcodeLittle Rock, United States· Recruiting
- Modena Allergy & Asthma Clinical Research - La JollaVerified postcodeLa Jolla, United States· Recruiting
- Allergy & Asthma Associates of Southern CaliforniaVerified postcodeLaguna Niguel, United States· Recruiting
- Allergy & Asthma Medical Group and Research CenterVerified postcodeSan Diego, United States· Recruiting
- Allergy Affiliates Inc.Verified postcodeBradenton, United States· Recruiting
- University of South FloridaVerified postcodeTampa, United States· Recruiting
- Treasure Valley Medical ResearchVerified postcodeBoise, United States· Recruiting
- Endeavor HealthVerified postcodeNorthbrook, United States· Recruiting
- Dawes Fretzin Clinical Research Group, LLCVerified postcodeIndianapolis, United States· Recruiting
- Southern Indiana Clinical TrialsVerified postcodeNew Albany, United States· Recruiting
- The Indiana Clinical Trials CenterVerified postcodePlainfield, United States· Recruiting
Common questions
What's the difference between chronic inducible urticaria and chronic spontaneous urticaria?
Chronic inducible urticaria means your hives are caused by specific triggers like cold or pressure. Chronic spontaneous urticaria means your hives appear without a clear, obvious trigger.
What does 'inadequately controlled' mean?
It means your current medication, usually a type of antihistamine, isn't fully managing your hives, and you still experience symptoms regularly.
What is a placebo?
A placebo is a 'dummy' medication. It looks exactly like the study drug but doesn't contain any active ingredients. It helps researchers see if the real medication is actually having an effect.
Will I know if I'm getting BLU-808 or the placebo?
No, this is usually a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving BLU-808 or the placebo. This helps ensure the study results are fair and unbiased.
Can I continue my usual antihistamines during the study?
This will be explained by the study team. Often, your current treatment might need to be adjusted or stopped for the study to get clear results on the new medication.
How to find out more
Blueprint Medicines
Always speak to your GP or specialist before deciding to take part in a study.
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