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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Clinical trial to evaluate the efficacy and safety of Depigoid DUO Grass-Mix/Olea (1000 DPP/mL + 1000 DPP/mL) compared with placebo in patients suffering from allergic rhinoconjunctivitis with or without asthma due to clinically relevant sensitisation to grass and olive pollen.

This research is looking into a new treatment for people who suffer from hay fever and eye allergies due to grass and olive pollen. This could include those who also have asthma affected by these pollens. The treatment, called Depigoid DUO, is being compared to a 'placebo' (a dummy treatment containing only the liquid mixer) to see how well it works and if it's safe. The main aim is to see if the treatment reduces allergy symptoms like sneezing, runny nose, and itchy eyes during the peak pollen season. We're also checking how much allergy medicine people need to take. The study is in its final stages of testing before potentially becoming widely available.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
LETI Pharma S.L.U.
Enrolment target
343
Start
25 Mar 2026

What is this study about?

This clinical trial is all about understanding how a new potential treatment, called Depigoid DUO, can help people who suffer from specific allergies. Specifically, it's for those who experience hay fever (allergic rhinitis) and itchy, watery eyes (allergic conjunctivitis) when exposed to grass and olive pollen. This also includes people whose asthma might get worse because of these pollens.

The study aims to find out two main things: "efficacy" which means how well the treatment actually works to reduce your allergy symptoms, and "safety" which means how safe it is to use and what side effects, if any, it might have. Researchers will compare people receiving the active treatment with those receiving a placebo, which looks identical but contains no active ingredients. This helps them truly see the effect of the new treatment.

This is a 'Phase III' study, which means it’s one of the final steps before a new treatment can be approved and made available to the public. The findings from this research will help doctors and patients understand if Depigoid DUO is a helpful and safe option for managing these challenging pollen allergies.

Key takeaways

  • Tests a new treatment (Depigoid DUO) for grass and olive pollen allergies.
  • Aims to reduce hay fever, eye allergy symptoms, and potentially help related asthma.
  • Compares the new treatment to a dummy (placebo) to check effectiveness and safety.
  • Is in the final stage of testing before potential wider availability.
  • Requires regular symptom tracking and study visits over time.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or over. This study is open to both men and women.

The main requirement is that you experience allergic reactions, like hay fever or itchy eyes, specifically from grass and olive pollen. This means your body shows a clear allergic response to these particular pollens.

If you also have asthma that is affected by grass and olive pollen, you might still be eligible for the study. However, the study needs to confirm that your allergies are directly triggered by these pollens.

Quick self-check
  • Are you 18 years old or older?
  • Do you suffer from hay fever and itchy eyes specifically due to grass and olive pollen?
  • Has a doctor confirmed your allergy to grass and olive pollen?
  • Are you able to attend regular study appointments and record your symptoms?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be given either the active treatment (Depigoid DUO) or a placebo (a dummy treatment). You won't know which one you're receiving, and neither will the study team. You will receive at least 8 injections of the treatment over a period. Throughout the study, especially during the grass and olive pollen seasons, you'll be asked to keep track of your allergy symptoms. This includes things like how much your nose runs, if you sneeze, if your nose or eyes are itchy, and how blocked your nose is, or if your eyes are watery. You'll use a simple scoring system for this – for example, rating symptoms from 'none' to 'severe'.

You'll also need to record any allergy medicines you take, such as antihistamine eye drops, oral antihistamines, or nasal sprays, and how often you take them. For participants with asthma, there will be additional checks, including monitoring asthma symptoms, medication use, and potentially lung function tests (like FEV1).

There will be regular follow-up visits with the study team to check on your progress, review your symptom diaries, and ensure your safety. The total duration of your participation will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and contributing to medical knowledge that could help others. However, there are also potential risks, including side effects from the treatment (even from the placebo, though less likely), the need for regular visits, and the possibility that the treatment may not work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

  • Spain
  • Portugal

Common questions

What is allergic rhinoconjunctivitis?

It's the medical term for hay fever and itchy, watery eyes caused by allergies.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real thing but contains no active medicine, used for comparison.

What does 'Phase III' mean for a study?

It means the treatment is in its final stages of testing, being compared to existing treatments or a placebo on a larger group of people.

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

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're getting the active treatment or the placebo.

What type of treatment is Depigoid DUO?

It's an injection-based treatment, likely a form of immunotherapy (allergy shots), but details will be explained by the study team.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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