Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

Phase II-III study to assess the efficacy and safety of subcutaneous cluster-immunotherapy in patients suffering from Olea europaea pollen allergy

This study is investigating a new treatment for people who suffer from moderate to severe hay fever symptoms, specifically caused by olive tree pollen. These symptoms, like sneezing, runny nose, and itchy eyes, have to have been present for at least two years. The main goal is to see how effective a new injection, called CLU-RX-OLE, is at reducing these allergy symptoms compared to a dummy treatment (placebo). Researchers will also be checking the safety of CLU-RX-OLE at different doses. They'll measure symptom severity and how much allergy medication people need to take during the peak olive pollen season to understand if this new treatment helps people feel better and use fewer medicines.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

ROXALL Medizin GmbH

Enrolment target

Start

11 Jul 2024

Moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to olive pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline

What is this study about?

This study is for people who get moderate to severe hay fever from olive tree pollen. If you've been suffering from symptoms like sneezing, a runny or blocked nose, and itchy eyes for at least two years during olive pollen season, this study might be for you. The main aim is to test a new treatment called CLU-RX-OLE. This treatment is given as an injection under the skin. We want to find out how well it works to reduce allergy symptoms and if it's safe.

The researchers will compare different doses of CLU-RX-OLE with a 'placebo.' A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain the active ingredient. This helps us understand if any improvements are genuinely due to the CLU-RX-OLE or other factors.

During the study, we'll carefully measure how your symptoms change, how much allergy medication you need to take, and your overall quality of life during the peak olive pollen season. We'll also look at how many 'good' days you have (days with few symptoms and no need for extra medicine) compared to 'bad' days. All this information will help us determine if CLU-RX-OLE could be a helpful new option for people with olive pollen allergy.

Key takeaways

This study evaluates CLU-RX-OLE, a new injection for olive pollen allergy.
It aims to reduce hay fever symptoms and the need for other allergy medicines.
Different doses of CLU-RX-OLE are being tested against a placebo.
The study assesses both how well it works and its safety.
Participants must have moderate-to-severe olive pollen allergy for at least two years.
Open to adults aged 18 and older, both men and women.

Who may be eligible?

This study is looking for adults aged 18 and older.

To be considered, you must have moderate to severe allergic rhinitis (hay fever) or rhinoconjunctivitis (hay fever with eye symptoms) that is specifically caused by olive pollen. These symptoms need to have bothered you for at least two years.

Both men and women can take part in this study.

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?
Do you get moderate to severe hay fever symptoms (like sneezing, runny nose, itchy eyes) specifically from olive tree pollen?
Have you had these olive pollen allergy symptoms for at least two years?
Are you willing to potentially receive a placebo (dummy treatment)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the new treatment (CLU-RX-OLE) or a placebo injection. These injections are given under the skin. You will also use a nasal spray (Mometasone) and may be given other allergy medications like Loratadine or Prednisone if needed to control your symptoms.

Throughout the study, you'll have regular visits to the clinic for assessments. These will include check-ups, skin prick tests to see how your allergies react, and possibly a special nasal test where a small amount of pollen is put into your nose to measure your reaction.

You'll be asked to keep a diary of your symptoms and any medications you take, especially during the peak olive pollen season. The total duration of the study will involve treatments and follow-up appointments.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as a reduction in your olive pollen allergy symptoms and an improved quality of life if the new treatment is effective. However, as with any medication, there are potential risks, including side effects from the injections or other medications. These will be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What kind of allergy does this study focus on?

This study is specifically for people with hay fever caused by olive tree pollen.

What is CLU-RX-OLE?

CLU-RX-OLE is a new treatment given by injection that the study is testing to see if it helps relieve allergy symptoms.

What is a placebo?

A placebo is a dummy injection that looks identical to the real treatment but doesn't contain any active allergy medicine. It helps researchers compare results accurately.

Will I know if I'm getting the real treatment or the placebo?

No, it's a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving the active treatment or the placebo until the study is over. This ensures unbiased results.

What are the main things the researchers are looking for?

They mainly want to see if CLU-RX-OLE can reduce your allergy symptoms and how much other allergy medication you need, especially during the peak olive pollen season, and if it's safe.