Clinical trial to evaluate the efficacy and safety of two concentrations (1000DPP/ml and 3000DPP/ml) of depigmented polymerized allergen extracts of Depigoid GrassMix / Depigoid FORTE GrassMix compared to placebo, in patients suffering from allergic rhinoconjunctivitis with or without controlled asthma due to clinically relevant sensitization to grass pollen
This study is looking into a new treatment for hay fever (allergic rhinoconjunctivitis) caused by grass pollen. It's for adults aged 18 and over who suffer from these symptoms, whether or not they also have mild, controlled asthma. We are comparing two different strengths of a treatment called Depigoid GrassMix to a dummy treatment (placebo). The main aim is to find out if the new treatment can reduce hay fever symptoms and the amount of medication people need to take during the grass pollen season. This is a Phase 3 trial, which means it's a key step in testing if the treatment is effective and safe before it could potentially be made widely available.
At a glance
What is this study about?
This research study is focused on people who get hay fever, especially when it's caused by grass pollen. This often means sneezing, a runny or blocked nose, and itchy, watery eyes – sometimes called allergic rhinoconjunctivitis. Some people in the study might also have mild asthma that's well controlled, meaning it doesn't cause severe problems and is managed with medication, but is also triggered by grass pollen.
The main goal of this study is to test a treatment called Depigoid GrassMix. We're looking at two different strengths of this treatment to see if they can effectively reduce hay fever symptoms and the need for other medications to manage those symptoms. To make sure the results are reliable, we are comparing these treatments to a 'placebo', which looks exactly like the treatment but doesn't contain any active medicine.
This is a 'Phase 3' study, which is a big step in medical research. It means the treatment has already shown some promise in earlier tests, and now we need to thoroughly check its effectiveness and safety in a larger group of people. The information we gather will help us understand if Depigoid GrassMix could be a good option for people suffering from grass pollen allergies.
Key takeaways
- The study tests a new hay fever treatment for adults with grass pollen allergy.
- It compares two strengths of Depigoid GrassMix to a dummy treatment (placebo).
- People with mild, controlled asthma may also be eligible.
- The main goal is to reduce hay fever symptoms during grass pollen season.
- This is a Phase 3 trial, a key step in testing new medicines.
Who may be eligible?
This study is looking for adult participants, meaning you must be 18 years old or older to take part. There is no upper age limit for joining this research study.
To be eligible, you must have hay fever (allergic rhinoconjunctivitis) that is specifically caused by grass pollen. This means your symptoms like sneezing, runny nose, and itchy eyes usually flare up when grass pollen counts are high.
You might still be able to join if you also have asthma, as long as your asthma is mild and well-controlled. This means your asthma symptoms are not severe and are managed effectively with your usual medication.
- Are you 18 years old or older?
- Do you suffer from hay fever specifically caused by grass pollen?
- Do you have symptoms like sneezing, runny nose, or itchy eyes when grass pollen is high?
- If you have asthma, is it mild and well-controlled with your current medication?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to participate in this study, you will be in the study for a period that includes at least one full grass pollen season. You will receive regular doses of the study treatment through injections. You will either receive one of the two active strengths of Depigoid GrassMix or a placebo. You won't know which one you are getting, and neither will the study team – this is called 'double-blind'.
Throughout the study, you will have regular visits to the clinic for assessments. These visits will involve checking your symptoms closely, evaluating how well the treatment is working, and monitoring your overall health and any side effects. You will also be asked to keep track of your symptoms and the use of any rescue medication (like antihistamines) in a diary.
One of the assessments will involve a 'Conjunctival Provocation Test'. This is a controlled way to see how your eyes react to a tiny amount of grass pollen extract. The total duration of your participation, including all follow-up, will be clearly explained by the study team.
Potential risks and benefits
Locations (2)
- —Portugal
- —Spain
Common questions
What is hay fever?
Hay fever is an allergy, usually to pollen, dust mites, or pet dander. It causes symptoms like sneezing, a runny or blocked nose, and itchy, watery eyes.
What is a 'placebo'?
A placebo is a dummy treatment. It looks just like the real medicine but contains no active ingredients. It helps researchers understand if the new treatment truly works better than nothing.
What does 'double-blind' mean?
It means that neither you nor your study doctor will know whether you are receiving the active treatment or the placebo. This helps prevent bias in the study results.
Will my asthma be affected?
This study is for people with controlled asthma. Your asthma will be carefully monitored to ensure it remains stable. If you have concerns, discuss them with the study team.
How is the treatment given?
The treatment will be given through injections, and you will receive several doses over the course of the 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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