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Rhinitis allergic – Trials in Disease

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Ongoing Clinical Trials for Allergic Rhinitis

Currently, 14 clinical trials are investigating new treatments for allergic rhinitis (also known as hay fever). These studies are being conducted across multiple European countries and are testing various approaches, including immunotherapy vaccines, monoclonal antibodies, and allergen extracts. The trials focus on treating allergies caused by different triggers such as grass pollen, tree pollen, dust mites, and animal dander.

Clinical trial locations

Study of Lebrikizumab and Mometasone Furoate for Adults with Perennial Allergic Rhinitis

This trial is testing Lebrikizumab, a medication given by injection, for people who experience year-round allergy symptoms caused by indoor allergens like dust mites or pet dander. The study will compare Lebrikizumab to a placebo over 16 weeks.

Who can participate: Adults with perennial allergic rhinitis confirmed by a doctor must have a positive skin prick test or blood test showing sensitivity to indoor allergens. People with stable asthma that has been controlled for at least 3 months may also join if they are using allowed asthma treatments.

Who cannot participate: People with health conditions other than perennial allergic rhinitis, those outside the specified age range, pregnant women or those planning pregnancy, current participants in other trials, and those with a history of severe allergic reactions to medications are excluded.

Treatment approach: The study aims to measure how well Lebrikizumab reduces nasal symptoms compared to placebo. Lebrikizumab works by targeting a specific protein involved in the inflammatory response that causes allergy symptoms. Participants will also use mometasone furoate nasal spray as part of their treatment.

Study on the Effectiveness and Safety of a Grass and Juniperus Oxycedrus Allergy Vaccine

This Spanish trial is testing a vaccine containing modified allergen extracts from six types of grasses and Juniperus oxycedrus (a type of juniper plant). The vaccine is given as an injection under the skin over 12 months.

Who can participate: People aged 12 to 65 years with moderate to severe symptoms when exposed to grass and cupressaceae pollen must have positive skin prick tests and specific IgE levels showing sensitivity to these allergens. Participants may have mild to moderate controlled asthma.

Who cannot participate: People with severe uncontrolled asthma, other serious health conditions, pregnant or breastfeeding women, those with severe allergic reactions to similar treatments, current participants in other trials, and those with drug or alcohol abuse history are excluded.

Treatment approach: The study measures symptom and medication scores during the pollen seasons of cupressaceae (January-March) and grasses (May-June). Participants will record symptoms and medication use on a smartphone. The goal is to determine if the vaccine reduces symptoms and the need for other allergy medications.

Study on the Effectiveness and Safety of Sublingual MM09

This trial, conducted in Portugal and Spain, tests MM09, a spray used under the tongue containing extracts from house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae. Treatment lasts 12 months.

Who can participate: People aged 12 to 65 years with moderate to severe persistent rhinitis or rhinoconjunctivitis for at least one year, with or without mild to moderate controlled asthma, must have positive skin prick tests showing a reaction of at least 5 mm and specific IgE levels of 3.5 kU/L or higher to the dust mites. Participants must own a smartphone to record symptoms.

Who cannot participate: People with severe uncontrolled asthma, other serious health conditions, pregnant or breastfeeding women, current participants in other trials, those allergic to the study medication, people with a history of anaphylaxis, those who received certain allergy treatments recently, and those with drug or alcohol abuse history are excluded.

Treatment approach: The sublingual spray aims to gradually reduce sensitivity to dust mite allergens. The main evaluation focuses on daily symptom and medication scores during the last four weeks of treatment. Secondary assessments include quality of life questionnaires and immune system markers.

Study on Intralymphatic Immunotherapy with Vitamin D

This Swedish study tests intralymphatic immunotherapy (ILIT), where allergens are injected directly into a lymph node, combined with Vitamin D. The treatment uses Alutard SQ Timotej (a grass pollen product) and compares ILIT with Vitamin D to ILIT alone and to sublingual treatment (Grazax).

Who can participate: Adults aged 18 to 60 years with confirmed grass allergy and moderate to severe symptoms, measured by a Rhinoconjunctivitis Total Symptom Score greater than 8, must provide written consent.

Who cannot participate: People outside the age range of 18-65 years, pregnant or breastfeeding women, those with other significant health conditions, recent participants in other trials, those allergic to study medications, people unable to follow procedures, those with drug or alcohol abuse in the past year, people who received certain allergy treatments in the past 6 months, those with a history of anaphylaxis, and people with weakened immune systems are excluded.

Treatment approach: The study evaluates whether adding Vitamin D to ILIT improves symptom control during the grass pollen season. Vitamin D may enhance the immune system’s response to immunotherapy. Assessments include symptom scores, quality of life questionnaires, and immune cell measurements.

Study on Subcutaneous Immunotherapy with Der p 1, Der p 2, and Der p 23 Allergens

This Spanish trial tests purified allergen proteins from dust mites given as injections under the skin. Participants receive 12 maintenance doses over the study period.

Who can participate: People aged 12 to 65 years with moderate or severe persistent allergic rhinitis or rhinoconjunctivitis for at least one year due to Dermatophagoides dust mites must have positive skin prick tests with reactions at least 3 mm larger than the negative control and specific IgE levels of at least 0.7 kU/L. People with asthma must have lung function (FEV1) of at least 80%. Women of childbearing age must have a negative pregnancy test and agree to use contraception.

Who cannot participate: People with uncontrolled asthma, those who had severe allergic reactions to study medications, people with other serious health conditions, current participants in other trials, pregnant or breastfeeding women, those with drug or alcohol abuse history, and those who received other allergy immunotherapy within the last 12 months are excluded.

Treatment approach: The immunotherapy uses three specific dust mite allergen proteins to help build tolerance. The study aims to find the optimal dose that provides the best balance of benefits and safety, measuring changes in symptoms, medication use, and quality of life.

Evaluation of Alutard SQ Dog Allergen Immunotherapy

This one-year Swedish study tests Alutard SQ dog, an allergy treatment for people allergic to dogs. The treatment involves regular injections under the skin.

Who can participate: Adults aged 18 to 50 years with moderate to severe allergic symptoms when exposed to dogs (such as sneezing, runny nose, itchy eyes, or breathing difficulties) must provide written consent. A doctor must determine suitability for treatment. Women who can become pregnant must use effective contraception and have a negative pregnancy test.

Who cannot participate: People outside the age range of 18-65 years, those who received immunotherapy for dog allergy in the past 5 years, pregnant women or those planning pregnancy, people with severe asthma, those taking beta-blockers, people with serious heart or lung conditions, those with active autoimmune diseases, people with a history of severe allergic reactions requiring emergency treatment, current participants in other trials, those unable to follow study procedures, people with serious mental health conditions, those using medications that could interfere with treatment, people with a history of anaphylaxis, those with unstable medical conditions, and people with poor compliance with current treatments are excluded.

Treatment approach: The treatment gradually exposes the immune system to dog allergens to build tolerance. Participants may also use nasal spray, eye drops, and tablets to manage symptoms. The study measures symptom scores and breathing function 30 minutes after exposure to dog allergens.

Study on a Grass and Olive Pollen Allergy Vaccine

This Spanish trial tests a vaccine containing modified allergen extracts from six grass types and olive pollen, given as injections under the skin over 12 months.

Who can participate: People aged 12 to 65 years with moderate to severe intermittent or persistent allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, must have positive skin prick tests to grass or olive pollen and specific IgE levels greater than 3.5 KU/L. Women of childbearing age must have a negative pregnancy test and agree to use contraception. Participants must own a smartphone to record symptoms.

Who cannot participate: People with severe uncontrolled asthma, other serious health conditions, pregnant or breastfeeding women, those with severe allergic reactions to similar treatments, current participants in other trials, and those with drug or alcohol abuse history are excluded.

Treatment approach: The vaccine aims to reduce symptoms during the grass and olive tree pollen season (April-June). Participants record symptoms and medication use on a smartphone. The study evaluates symptom-free days, medication-free days, asthma control, and quality of life.

Study on Mannan-Conjugated Allergoids for House Dust Mite Allergies (Trial 1)

This trial, conducted in Portugal and Spain, tests EP-088_MM09, a vaccine containing modified dust mite allergen proteins given as injections under the skin.

Who can participate: People aged 12 to 65 years with moderate to severe persistent rhinitis or rhinoconjunctivitis for at least one year, with or without mild to moderate controlled asthma, must have positive skin prick tests showing reactions of at least 5 mm to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae and specific IgE levels of at least 3.5 kU/L. Participants must record a combined symptom and medication score of at least 2 out of 6 for at least 10 days. Women of childbearing age must have a negative pregnancy test and agree to use highly effective contraception.

Who cannot participate: People not allergic to the specific dust mites, those without moderate to severe persistent symptoms, those without mild to moderate controlled allergic asthma, people outside the age range, and vulnerable populations are excluded.

Treatment approach: The mannan-conjugated allergoid vaccine uses modified dust mite proteins to help the immune system become less sensitive over time. Participants keep a diary of symptoms and medication use. The study measures symptom scores, quality of life, and asthma control.

Study on Mannan-Conjugated Allergoids for House Dust Mite Allergies (Trial 2)

This trial, also conducted in Portugal and Spain, tests the same EP-088_MM09 vaccine with similar eligibility criteria and treatment approach as Trial 1. The vaccine is given as injections under the skin over approximately one year.

Who can participate: Eligibility criteria are identical to Trial 1, including age range, symptom severity, positive allergy tests, and contraception requirements for women of childbearing age.

Who cannot participate: Exclusion criteria are identical to Trial 1.

Treatment approach: The treatment aims to modify the immune response to dust mite allergens through regular subcutaneous injections. Participants complete daily symptom diaries and undergo regular assessments of symptoms, quality of life, and immune markers.

Study on Mannan-Conjugated Birch Pollen Allergoids

This trial, conducted in Poland and Germany, tests a vaccine containing mannan-conjugated birch pollen allergoids given as injections under the skin. The study aims to reduce symptoms during the peak birch pollen season.

Who can participate: People aged 12 to 64 years (18-64 in Germany, with at least 10% aged 12-17 in Poland) in good physical and mental health with birch pollen allergy must have a history of moderate to severe allergic symptoms for at least two previous birch pollen seasons, positive skin tests, and specific IgE blood test results. Those with asthma must have controlled asthma with lung function (FEV1 or PEF) at least 80% of expected value. Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception.

Who cannot participate: People without birch pollen-induced rhinitis or rhinoconjunctivitis, those outside the specified age range, and those not fitting the specified clinical trial groups are excluded.

Treatment approach: The vaccine modifies the immune response to birch pollen allergens. The study is double-blind, meaning neither participants nor researchers know who receives the actual vaccine or placebo. The main goal is to reduce the Combined Symptom and Medication Score during the peak birch pollen season.

Study on the Effectiveness and Safety of Clustoid MM09

This Spanish trial tests Clustoid MM09, a vaccine containing modified extracts from dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae, given as injections under the skin over up to 12 months.

Who can participate: People aged 12 to 65 years with moderate to severe rhinitis or rhinoconjunctivitis, with or without controlled mild to moderate asthma, must have positive skin prick tests showing reactions of 5 mm or larger and specific IgE values greater than 3.5 KU/L to the specific dust mites. Participants must have asthma diagnosed according to GEMA 5.0 guidelines and own a smartphone. Women of childbearing age must have a negative pregnancy test and agree to use effective contraception if sexually active.

Who cannot participate: People with severe unrelated health conditions, those who had recent severe allergic reactions requiring emergency treatment, current participants in other trials, those with a history of severe side effects from allergy treatments, people with uncontrolled asthma, pregnant or breastfeeding women, those with other significant medical conditions, and people unable to follow procedures are excluded.

Treatment approach: The vaccine aims to gradually desensitize the immune system to dust mite allergens. Participants record symptoms and medication use on a smartphone. Regular assessments track progress, symptom scores, quality of life, and immune markers including blood tests for specific antibody levels.

Summary

The 14 ongoing clinical trials for allergic rhinitis demonstrate a strong focus on immunotherapy approaches across Europe. Spain leads with the highest number of trials (7 studies), followed by Germany and Poland. Most trials test allergen-specific immunotherapy, either subcutaneous (injections under the skin) or sublingual (under the tongue), targeting common allergens such as dust mites, grass pollen, tree pollen, and animal dander.

Several trials focus specifically on dust mite allergies, which cause year-round symptoms. These studies test various formulations including mannan-conjugated allergoids, purified allergen proteins, and polymerized extracts. Grass and tree pollen allergies are also well-represented, with trials examining seasonal immunotherapy approaches.

Most studies require participants to be aged 12-65 years and to have moderate to severe symptoms. Many trials allow participation of people with mild to moderate controlled asthma alongside their rhinitis. A common exclusion criterion across trials is pregnancy, severe uncontrolled asthma, and participation in other clinical trials.

The trials typically last 12 months and measure effectiveness through symptom scores, medication use, and quality of life assessments. Many studies require participants to use smartphones or electronic diaries to record daily symptoms, reflecting the integration of digital tools in modern clinical research.

Ongoing Clinical Trials on Rhinitis allergic

  • Study of sublingual immunotherapy with Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen mix for patients with dust mite allergic rhinitis

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of a Grass and Juniperus Oxycedrus Allergy Vaccine for Patients with Allergic Rhinitis or Rhinoconjunctivitis with or without Mild Asthma

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Evaluation of Alutard SQ dog allergen immunotherapy in patients with allergic rhinitis due to dog allergy – A one-year study in Swedish practice

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study of Lebrikizumab and Mometasone Furoate for Adults with Perennial Allergic Rhinitis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Poland

  • Study on the Effectiveness of Intralyphatic Immunotherapy with Vitamin D for Patients with Allergic Rhinitis Using Phleum Pratense and Colecalciferol

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on the Effectiveness and Safety of Sublingual Immunotherapy with Betula Pendula Pollen Extract for Patients with Birch Pollen Allergy

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

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