A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites
This research study is testing a new treatment called ASP2390 for adults who are allergic to house dust mites. The main goals are to find out if the treatment is safe, how well people cope with it, and if it changes how your body's immune system reacts to dust mites. Participants will receive different doses of ASP2390 or a dummy treatment (placebo). They will be monitored closely after each dose, especially after the first one, to ensure their safety. Researchers will also check specific immune markers in the blood. If you are an adult with a house dust mite allergy, this study might be an option, but there are specific rules about who can join.
At a glance
What is this study about?
This study is about a new treatment, called ASP2390, for adults who are allergic to house dust mites. House dust mite allergy can cause symptoms like sneezing, a runny nose, itchy eyes, and sometimes even asthma. The researchers want to understand if this new treatment is safe for people to take and if it causes any unwanted side effects. They will also be looking at how well people's bodies handle the treatment.
The study will also investigate if ASP2390 can change your immune system's response to house dust mites. Your immune system is your body's defence mechanism. When you have an allergy, your immune system overreacts to something harmless, like dust mites. The researchers will be checking specific markers in your blood to see if the treatment helps to 're-train' your immune system to be less reactive to dust mites.
Participants in this study will either receive the new treatment, ASP2390, or a 'placebo'. A placebo looks exactly like the treatment but contains no active medicine. This helps the researchers understand if any changes or improvements are due to the actual treatment or other factors.
Key takeaways
- This study is testing a new treatment (ASP2390) for house dust mite allergy.
- The main goals are to check safety, how well people tolerate it, and its effect on the immune system.
- Participants will receive either the new treatment or a placebo.
- Close observation after each dose is a key part of the study for safety.
- It's for adults aged 18-65 with a confirmed house dust mite allergy.
Who may be eligible?
This study is looking for adults between 18 and 65 years old who have a clear allergy to house dust mites. To be considered, you must have had allergy symptoms like sneezing or itchy eyes from dust mites for at least a year. You'll also need to show positive results on specific allergy tests for dust mites, such as a skin prick test and a blood test.
There are also some general health checks. You'll need to have good lung function and be within a certain weight range. For women, it's important not to be pregnant or breastfeeding, and you'll need to use reliable contraception throughout the study if you could become pregnant. Men will also need to follow contraception rules if they have a female partner who could become pregnant.
Finally, you can't be taking part in another medical study while you're in this one. It's important to discuss all your health conditions and any medications you're taking with the study team to see if you can join.
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 between 18 and 65 years old?
- Have you had house dust mite allergy symptoms for at least a year?
- Have you had a positive skin prick test or blood test for dust mites?
- Are you able to use reliable contraception if needed?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you join this study, the first step is a 'screening' process, which can take up to six weeks. This is where medical checks and tests are done to make sure you're a good fit for the study.
Before your first dose, you might come to the clinic the day before for some initial checks. On the day of your first dose, you'll receive the treatment and then stay at the clinic for about 24 hours. This is so the doctors and nurses can watch you carefully for any immediate reactions or side effects. If everything is okay, you'll be able to go home after 24 hours.
For any doses after the first one, you'll need to stay at the clinic for at least an hour after receiving the treatment. Again, this is for your safety, to make sure you don't have any immediate problems. The total duration of your participation in the study will be explained in detail by the study team.
Potential risks and benefits
Locations (2)
- Site DE49001Verified postcodeBerlin, Germany
- Site DE49002Verified postcodeHanover, Germany
Common questions
What is ASP2390?
ASP2390 is a new treatment being tested for people who are allergic to house dust mites.
What is a 'placebo'?
A placebo looks like the study drug but contains no active medicine. It helps researchers compare the real treatment's effects.
Will I have to stay in the clinic?
Yes, after your first dose, you'll stay for about 24 hours. For later doses, you'll stay for at least an hour after each dose.
What age do I need to be?
This study is for adults aged between 18 and 65 years old.
Can women who are pregnant take part?
No, women who are pregnant or breastfeeding cannot take part in this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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