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

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What is this study about?

This study aims to evaluate the efficacy and safety of grass pollen immunotherapy for individuals living with allergic rhinoconjunctivitis, which is an allergic reaction affecting the nose and eyes, and may occur with or without controlled asthma. The treatment involves the use of Depigoid Grass-Mix and Depigoid FORTE Grass-Mix, which are suspensions for injection containing extracts from various grass pollens. These extracts have undergone a process to remove color and change their structure to be used for subcutaneous use, meaning they are administered by injection under the skin. A placebo will also be used during the investigation.

The research is conducted in different stages. Initially, a phase involves a double-blind process, where neither the participants nor the researchers know who is receiving the active medication or the placebo. During this stage, participants receive regular injections, and their symptoms and use of medications like antihistamines or intranasal corticoids are monitored. This is followed by an open-label phase, where the treatment details are known to everyone involved. This part of the study looks at how the body responds to different amounts of pollen through a conjunctival provocation test, which is a method used to see how the eyes react when exposed to allergens.

Who Can Join the Study?

  • You must be at least 5 years old at the time you agree to participate.
  • You must have moderate or severe allergic rhinoconjunctivitis, which is a condition involving hay fever symptoms like sneezing, itching, or watery eyes and redness in the eyes.
  • If you have asthma, your condition must be controlled, meaning your breathing issues are well-managed and stable according to standard medical guidelines.
  • You or your legal representative must sign a document called informed consent, which means you have understood all the details of the study before joining.
  • You or your guardian must own a mobile phone that can run the specific study app and has access to the internet.
  • You must be able to stay living in your usual home for most of the season when grass pollen levels are high.
  • You must be able to follow the study protocol, which is the set of rules and steps required to participate in the trial.
  • Any preexisting stable disease is allowed, meaning any health conditions you already have must not have required a change in your medicine or a hospital visit in the 28 days before starting the study.
  • You must agree to stay in regular contact with the medical team throughout the study to ensure your safety.

Who Cannot Join the Study?

  • You cannot join if you have had any type of allergen immunotherapy (a treatment that uses small amounts of an allergen to reduce allergy symptoms) in the last 5 years.
  • You cannot participate if there is any medical reason why you should not receive subcutaneous allergen-specific immunotherapy (allergy injections given under the skin).
  • You cannot participate if you have used systemic corticosteroids (strong medicines used to reduce inflammation throughout the entire body) in the 12 weeks before joining the study.
  • You cannot participate if you previously had a serious systemic reaction (a widespread body reaction that affects more than just one area) during a skin prick test (a test where a tiny amount of an allergen is placed on the skin to check for a reaction).
  • You cannot participate if you are currently unwell, such as having an acute asthmatic exacerbation (a sudden worsening of asthma symptoms), a respiratory infection, a fever, or acute urticaria (sudden hives or itchy red bumps on the skin).
  • You cannot participate if the doctor believes any other health condition makes it too risky for you to join.
  • You cannot participate if you have chronic urticaria (long-lasting hives), severe dermographism (a condition where skin becomes raised/swollen when rubbed), severe atopic dermatitis (a chronic itchy skin condition), a sunburn, active psoriasis (a skin condition causing red, scaly patches) in areas where skin tests are done, or a history of hereditary angioedema (a genetic condition causing deep swelling under the skin).
  • You cannot participate if you have any condition that makes it unsafe to use adrenaline (a medicine used to treat severe allergic reactions), such as heart disease.
  • You cannot participate if you are taking immunosuppressive treatment (medicines that lower the body’s ability to fight infection), though topical medicines (applied to the skin) are allowed.
  • You cannot participate if you have other serious diseases that could interfere with the study, such as epilepsy (a brain disorder causing seizures), kidney diseases, or other major medical issues.
  • You cannot participate if you have a confirmed or suspected immunosuppressive or immunodeficient condition (a weakened immune system).
  • You cannot participate if you are sensitive to Alternaria alternata (a type of common mold).
  • You cannot participate if you have severe psychiatric disorders (mental health conditions) that prevent you from cooperating with the study.
  • You cannot participate if you are allergic to any components of a vaccine other than the grass extract.
  • You cannot participate if you have chronic lung diseases other than asthma, such as emphysema (damage to the air sacs in the lungs) or bronchiectasis (widening of the airways in the lungs).
  • You cannot participate if you are a direct relative of the person leading the study.
  • You cannot participate if you are sensitive to mites (tiny insects) or epithelia (particles from animal skin or hair) if these are clinically relevant to your health.
  • You cannot participate if you are sensitive to other allergens that are active at the same time as grass pollen.
  • You cannot participate if you are receiving biologics (special medicines made from living organisms used to treat specific diseases).
  • You cannot participate if your asthma is uncontrolled (symptoms are not well-managed) or unstable at the time of treatment.
  • Female participants who are lactating (breastfeeding) cannot participate.
  • Female participants who are able to become pregnant must use adequate contraception (methods to prevent pregnancy) and have a negative pregnancy test before starting.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Infanta Leonor Madrid Spain
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Hospital General Universitario De Albacete Albacete Spain
Hospital Particular do Algarve S.A. Faro Portugal
Consorci Sanitari De Terrassa Terrassa Spain
Hospital Universitario Del Sureste – Empresa Publica Hosptial Del Sureste Arganda Del Rey Spain
Hospital Universitario San Juan De Alicante Sant Joan D'alacant Spain
Hospital General Universitario De Valencia Valencia Spain
Hospital General Universitario De Castellon Castello De La Plana Spain
Hospital Universitario General De Villalba Madrid Spain
Hospital Nuestra Senora De Sonsoles Avila Spain
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Hiebcfsq Urfhlmkpwuoyi Dt Bepyvad Badajoz Spain
Cdpodueu Hlooebyxpav Dy Vyw Vic Spain
Hyzzbtlu Di Lq Sxmtl Cnuu I Sfkg Paz Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Portugal Portugal
Not yet recruiting
01.04.2026
Spain Spain
Not yet recruiting
01.04.2026

Trial locations

Depigoid Grass-Mix is an immunotherapy treatment consisting of a mixture of grass pollen extracts that have been processed to remove color. It is administered through injections under the skin to help the body build a tolerance to grass allergens.

Depigoid FORTE Grass-Mix is a more concentrated version of the grass pollen immunotherapy. Like the other version, it contains processed grass pollen extracts and is given via injections under the skin to help reduce allergic reactions to grass.

Allergic rhinoconjunctivitis with or without controlled asthma – This condition involves an allergic reaction affecting the nose and the eyes, often occurring alongside managed asthma symptoms. It is triggered when the immune system overreacts to inhaled substances like pollen. Common symptoms include sneezing, a runny or stuffy nose, and itchy, watery eyes. The condition typically worsens during specific seasons when allergen levels are high in the air. As it progresses, the inflammation in the nasal passages and airways can lead to increased sensitivity to various environmental triggers.

Trial ID:
2025-521736-10-00
Protocol code:
0600-PG-PSC-218
Trial Phase:
Therapeutic confirmatory (Phase III)

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