In short
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.
Key points
- Clinical trials of LOLIUM PERENNE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT are studying allergen immunotherapy for people with allergic rhinoconjunctivitis, with or without asthma. Both studies are Phase 3 and are authorised. One trial focuses on grass and olive pollen, while the other focuses on grass pollen only. The main goal is to see whether treatment improves symptoms and reduces the need for allergy medicine during peak pollen season. One trial also looks at changes in the conjunctival provocation test after treatment. The studies plan to enroll 343 and 324 participants.
Trial overview
Two Phase 3 clinical trials are investigating LOLIUM PERENNE POLLEN, DEPIGMENTED POLYMERIZED EXTRACT in people with pollen allergy symptoms.
One trial studies people with allergic rhinoconjunctivitis, with or without asthma, linked to grass and olive pollen sensitization. The other studies people with allergic rhinoconjunctivitis, with or without controlled asthma, linked to grass pollen allergy.
Who is being studied
The first study, GOES, includes people with clinically relevant sensitisation to grass and olive pollen. The condition studied is allergic rhinoconjunctivitis with or without asthma.
The second study, GIRA, includes people with allergic rhinoconjunctivitis with or without controlled asthma. This means the study is focused on patients whose asthma is already under control if they have asthma.
How the trials are designed
Both studies are interventional, which means researchers give a study treatment and then measure the results.
Both trials compare active treatment with placebo, which is the solvent used in the investigational product formulation and acts as a comparison treatment.
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.
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.
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.
This score combines allergy symptoms and the medicines used to control them. In the trial data, symptom items include runny nose, sneezing, itchy nose, nasal congestion, itchy eyes, and tearing.
The GOES study measures cSMS at the peak of grass and olive pollen season after at least 8 injections of treatment. The GIRA study measures cSMS at the peak of grass pollen season after at least 8 injections of treatment.
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.
Target populations and treatment groups
The GOES trial plans to enroll 343 participants. It focuses on people with allergy to both grass and olive pollen, with or without asthma.
The GIRA trial plans to enroll 324 participants. It focuses on people with grass pollen allergy, with or without controlled asthma.
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.
Patient-friendly explanation of key terms
Allergic rhinoconjunctivitis means allergy symptoms in the nose and eyes, such as sneezing, congestion, itching, and watery eyes.
Controlled asthma means asthma that is already managed well enough to meet the study rules.
Peak pollen season is the time when pollen levels are highest and symptoms are often worse.
Open-label phase means people know what treatment they are receiving.
Positive conjunctival provocation test means the eye reacts to a small amount of allergen during testing.