#1 Clinical Trials Search in Europe

LOLIUM PERENNE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT

Clinical trials are studying LOLIUM PERENNE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT in people with allergic rhinoconjunctivitis, with or without asthma. These studies aim to measure how well treatment works and how safe it is compared with placebo. The target groups include patients sensitized to grass pollen, olive pollen, or both.

Table of contents

Trial overview

Two Phase 3 clinical trials are investigating LOLIUM PERENNE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT in people with pollen allergy symptoms.[1][1]

One trial studies people with allergic rhinoconjunctivitis, with or without asthma, linked to grass and olive pollen sensitization.[1] The other studies people with allergic rhinoconjunctivitis, with or without controlled asthma, linked to grass pollen allergy.[1]

Who is being studied

The first study, GOES, includes people with clinically relevant sensitisation to grass and olive pollen.[1] The condition studied is allergic rhinoconjunctivitis with or without asthma.[1]

The second study, GIRA, includes people with allergic rhinoconjunctivitis with or without controlled asthma.[1] This means the study is focused on patients whose asthma is already under control if they have asthma.[1]

How the trials are designed

Both studies are interventional, which means researchers give a study treatment and then measure the results.[1][1]

Both trials compare active treatment with placebo, which is the solvent used in the investigational product formulation and acts as a comparison treatment.[1][1]

In the GOES study, the treatment arm includes Depigoid DUO Grass-Mix/Olea, and the study also uses conjunctival provocation tests with grass mix and Olea europaea.[1]

In the GIRA study, the treatment arms include Depigoid Grass-Mix and Depigoid FORTE Grass-Mix, and the study also uses a conjunctival provocation test with grass mix.[1]

What the trials measure

The main outcome in both studies is the combined symptom and medication score, also called cSMS, measured on a 0 to 6 scale during the peak pollen season.[1][1]

This score combines allergy symptoms and the medicines used to control them.[1][1] In the trial data, symptom items include runny nose, sneezing, itchy nose, nasal congestion, itchy eyes, and tearing.[1]

The GOES study measures cSMS at the peak of grass and olive pollen season after at least 8 injections of treatment.[1] The GIRA study measures cSMS at the peak of grass pollen season after at least 8 injections of treatment.[1]

The GIRA study also has an open-label phase, where it measures the change in the amount of allergen needed to obtain a positive conjunctival provocation test after the pollen season compared with baseline.[1]

Target populations and treatment groups

The GOES trial plans to enroll 343 participants.[1] It focuses on people with allergy to both grass and olive pollen, with or without asthma.[1]

The GIRA trial plans to enroll 324 participants.[1] It focuses on people with grass pollen allergy, with or without controlled asthma.[1]

These studies are designed to compare different treatment strengths and placebo, so researchers can see whether the active treatment improves allergy control during pollen season.[1][1]

Patient-friendly explanation of key terms

Allergic rhinoconjunctivitis means allergy symptoms in the nose and eyes, such as sneezing, congestion, itching, and watery eyes.[1][1]

Controlled asthma means asthma that is already managed well enough to meet the study rules.[1]

Peak pollen season is the time when pollen levels are highest and symptoms are often worse.[1][1]

Open-label phase means people know what treatment they are receiving.[1]

Positive conjunctival provocation test means the eye reacts to a small amount of allergen during testing.[1]

Trial ID Phase Condition studied Status Enrollment
2025-521709-42-00 Phase 3 Allergic rhinoconjunctivitis with or without asthma due to grass and olive pollen sensitization Authorised 343
2025-521736-10-00 Phase 3 Allergic rhinoconjunctivitis with or without controlled asthma Authorised 324

FAQ

  • What is being studied in trials of LOLIUM PERENNE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT? The trials are studying allergen immunotherapy for grass pollen, and in one study for both grass and olive pollen. They compare active treatment with placebo and measure symptom control and medication use.
  • Who can take part in these trials? The studies include people with allergic rhinoconjunctivitis, with or without asthma. One trial includes patients with clinically relevant sensitization to grass and olive pollen, while another includes patients with controlled asthma.
  • What phase are these trials in? Both trials are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups to check how well it works and to compare it with placebo.
  • What do the trials measure as the main result? The main result is the combined symptom and medication score, called cSMS, during the peak pollen season. One trial also measures the change in the amount of allergen needed to trigger a positive conjunctival provocation test, which is an eye test used to check allergy response.
  • How many people are in these studies? One trial plans to enroll 343 people and the other plans to enroll 324 people. These are interventional studies, which means participants receive a study treatment rather than only being observed.

Ongoing Clinical Trials on LOLIUM PERENNE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT

  • Study of Grass Pollen Extract and Olive Pollen Extract for Patients with Hay Fever and Asthma caused by Grass and Olive Pollen Allergies

    Not yet recruiting

    3 1
    Investigated drugs:
    Portugal Spain

  • Study of the efficacy and safety of depigmented polymerized grass pollen extracts for patients with allergic rhinitis and controlled asthma.

    Not yet recruiting

    3 1
    Investigated drugs:
    Portugal Spain

Glossary

  • Allergic rhinoconjunctivitis: An allergy that causes nose and eye symptoms, such as sneezing, runny nose, itching, and watery eyes.
  • Asthma: A condition that can make breathing hard because the airways become narrow and swollen.
  • Sensitisation: When the immune system becomes likely to react to a substance, such as pollen.
  • Grass pollen: Tiny particles from grass plants that can trigger allergy symptoms in some people.
  • Olive pollen: Pollen from olive trees that can also cause allergy symptoms in sensitive people.
  • Phase 3: A late stage of clinical testing that studies how well a treatment works in larger groups of people.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.
  • Interventional study: A clinical trial where researchers give a treatment and then measure the results.
  • Combined symptom and medication score (cSMS): A score that adds together allergy symptoms and the medicines needed to control them.
  • Conjunctival provocation test (CPT): An eye test that checks how much allergen is needed to cause a reaction.
  • Peak pollen season: The time of year when pollen levels are highest and allergy symptoms may be worse.

References