Ongoing Clinical Trials for Seasonal Allergy

This article provides detailed information about 11 ongoing clinical trials focused on treating seasonal allergies, including grass pollen, birch pollen, olive pollen, and house dust mite allergies. These trials are testing various immunotherapy treatments aimed at reducing allergy symptoms and improving quality of life for patients with moderate to severe allergic rhinitis and rhinoconjunctivitis. Trials are being conducted in Germany, Spain, and Poland.

Clinical trial locations

• Germany
  • Study of CLU-RX-PHL injection therapy for patients with moderate to severe grass pollen allergy to find the most effective and safe dose
  • Study on the Effectiveness and Safety of CLU-RX-DPT for Patients with Moderate-to-Severe House Dust Mite Allergy
  • Study of CLU-RX-BET injection therapy for patients with moderate to severe birch pollen allergies
  • Study of sublingual birch pollen extract (SLI-RX-BET) in different doses for patients with moderate to severe allergic rhinitis caused by birch pollen
  • Study of sublingual immunotherapy with Phleum pratense pollen extract spray in patients with moderate to severe grass pollen allergic rhinitis
  • Study on the Effects of Mannan-Conjugated Birch Pollen Allergoids for Adolescents and Adults with Birch Pollen-Induced Allergic Rhinitis or Rhinoconjunctivitis
• Poland
  • Study on the Effectiveness of Beltavac with Grass Pollen Extract for Patients with Allergic Rhinoconjunctivitis and Possible Asthma
• 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
  • Study on the Effectiveness and Safety of a Grass and Olive Pollen Allergy Vaccine for Patients with Allergic Rhinitis or Asthma
  • Study on the Effectiveness and Safety of Allergenic Extract of Olea Europaea Pollen for Patients with Moderate-to-Severe Olive Pollen Allergy
  • Study on the Effectiveness of Beltavac with Grass Pollen Extract for Patients with Allergic Rhinoconjunctivitis and Possible Asthma
  • See more trials

Study of CLU-RX-PHL injection therapy for patients with moderate to severe grass pollen allergy to find the most effective and safe dose

This trial is testing a treatment called CLU-RX-PHL for people with moderate to severe grass pollen allergies. The medication contains modified grass pollen extract and is given as an injection under the skin.

Main focus: The study aims to find the most effective and safest dose of CLU-RX-PHL by comparing three different strengths (high, medium, and low dose) against a placebo. Treatment will be given over 50 weeks, and effectiveness will be measured during the grass pollen season by tracking symptoms and use of additional allergy medications.

Who can participate: Adults aged 18-65 years with moderate to severe allergic rhinitis or rhinoconjunctivitis caused by grass pollen for at least 2 years. Participants must have a positive skin prick test to timothy grass, specific blood antibodies to grass pollen, and a positive nasal reaction test. Those with well-controlled mild to moderate asthma may also participate, provided their lung function (FEV1) is greater than 80% of normal.

Who cannot participate: People with a history of severe allergic reactions requiring emergency treatment, those who have received grass pollen immunotherapy in the last 5 years, individuals with uncontrolled asthma, pregnant or planning pregnancy, those with significant heart, liver, or kidney disease, autoimmune disorders, or current cancer.

Investigational drug: CLU-RX-PHL is an allergy immunotherapy treatment given as subcutaneous injections. It works by gradually exposing the immune system to grass pollen allergens to help reduce allergic reactions and symptoms during grass pollen season.

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

This trial is studying a vaccine made from a mixture of 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.

Main focus: The study aims to evaluate how well the vaccine works in reducing symptoms and medication use during the pollen seasons of grasses and cupressaceae plants. Participants will receive treatment over 12 months and will monitor their symptoms using a smartphone app.

Who can participate: People aged 12-65 years with moderate to severe allergic rhinitis or rhinoconjunctivitis caused by grass and cupressaceae for at least 12 months. Participants must have positive skin tests and specific blood antibodies to these allergens. Those with well-controlled mild to moderate asthma may participate. Women of childbearing age must use reliable birth control and have a negative pregnancy test.

Who cannot participate: People with severe uncontrolled asthma, other serious health conditions requiring ongoing medical treatment, pregnant or breastfeeding women, those who have had severe allergic reactions to similar treatments, individuals currently in another clinical trial, those who received certain allergy treatments recently, or people with a history of drug or alcohol abuse.

Investigational drug: Polymerized Allergen Extracts are given as subcutaneous injections. This immunotherapy treatment aims to reduce allergic symptoms by modifying the immune system’s response to grass and cupressaceae allergens.

Study of sublingual birch pollen extract (SLI-RX-BET) in different doses for patients with moderate to severe allergic rhinitis caused by birch pollen

This trial is testing a medication called SLI-RX-BET, which is given as a spray under the tongue and contains birch pollen extract. The study aims to find the most effective and safest dose for treating birch pollen allergies.

Main focus: The study will test three different strengths (low, medium, and high dose) and compare them to a placebo. Treatment involves daily use of the spray for approximately 10 months. Participants will track their symptoms and medication use during the birch pollen season.

Who can participate: Adults aged 18-65 years with moderate to severe allergic rhinitis or rhinoconjunctivitis caused by birch pollen for at least 2 years. Participants must have a positive skin prick test (raised bump of 3mm or larger), blood test showing birch pollen antibodies, history of significant symptoms during birch pollen season, and positive response to nasal testing. Those with well-controlled mild to moderate asthma may participate if lung function (FEV1) is greater than 70% of normal.

Who cannot participate: People who participated in any clinical trial within the last 30 days, those with a history of severe allergic reactions, pregnant or breastfeeding women, individuals with serious heart, liver, or kidney disease, active autoimmune diseases, current or recent cancer, severe or poorly controlled asthma, history of substance abuse, mental health conditions affecting participation, recent major surgery, active infections, or allergies to the medication components.

Investigational drug: SLI-RX-BET is a sublingual immunotherapy treatment administered under the tongue. It works by gradually exposing the immune system to small amounts of birch pollen allergen to help build tolerance and reduce allergic reactions over time.

Study of sublingual immunotherapy with Phleum pratense pollen extract spray in patients with moderate to severe grass pollen allergic rhinitis

This trial focuses on testing SLI-RX-PHL, which contains timothy grass pollen extract and is given as a spray under the tongue. The study aims to determine how well different doses work and how safe they are for treating grass pollen allergies.

Main focus: The treatment will be tested in three different strengths (low, medium, and high dose) and compared to a placebo. The study will take place during grass pollen season, with treatment lasting up to 50 weeks. Effectiveness will be measured by tracking symptom reduction and decreased need for additional relief medications.

Who can participate: Adults aged 18-65 years with moderate to severe allergic rhinitis or rhinoconjunctivitis caused by grass pollen for at least 2 years. Participants must have positive skin prick test, blood test showing timothy grass antibodies, history of significant symptoms during grass pollen season, and positive nasal allergen challenge test. Those with well-controlled mild to moderate asthma may participate if lung function (FEV1) is greater than 70% of normal.

Who cannot participate: People under 18 or over 65 years old, those with a history of severe allergic reactions requiring emergency treatment, currently participating in another clinical trial, pregnant women or those planning pregnancy, breastfeeding women, individuals with poorly controlled asthma, those taking medications that could interfere with study results, people with serious heart, liver, or kidney conditions, individuals with allergies to medication components, those who received immunotherapy in the past 5 years, people unable to follow study procedures, current smokers or substance abusers, or those with planned major surgery.

Investigational drug: SLI-RX-PHL is a sublingual immunotherapy treatment given as drops or tablets placed under the tongue. It gradually exposes patients to small amounts of grass pollen allergens, helping the immune system become less sensitive over time.

Study on the Effectiveness and Safety of a Grass and Olive Pollen Allergy Vaccine for Patients with Allergic Rhinitis or Asthma

This trial is testing a vaccine called MG01_T517, made from a mixture of modified allergen extracts from six types of grasses and olive pollen. The vaccine is given as an injection under the skin.

Main focus: The study aims to evaluate how well the vaccine works compared to a placebo over a period of up to 12 months. Participants will be monitored during the grass and olive tree pollen season (April, May, and June) for symptoms and medication use. The study will also assess quality of life and the vaccine’s safety.

Who can participate: People aged 12-65 years with moderate to severe allergic rhinitis or rhinoconjunctivitis caused by grass and olive tree pollen for at least 12 months. Participants must have positive skin prick test to grass or olive pollen mix, specific blood antibodies to these allergens, and may have mild to moderate controlled asthma. Women of childbearing age must use reliable birth control and have a negative pregnancy test.

Who cannot participate: People with severe uncontrolled asthma, other serious health conditions that could interfere with study results, pregnant or breastfeeding women, those who had severe allergic reactions to similar treatments, individuals currently in another clinical trial, or people with a history of drug or alcohol abuse.

Investigational drug: Polymerized Allergen Extracts are given through subcutaneous injections. This immunotherapy treatment aims to gradually desensitize the immune system to grass and olive tree pollen allergens, reducing allergic reactions over time.

Study on the Effectiveness of Beltavac with Grass Pollen Extract for Patients with Allergic Rhinoconjunctivitis and Possible Asthma

This trial is studying the effects of Beltavac, a mixture of grass pollen extracts, on patients with allergic rhinoconjunctivitis and possible asthma. The treatment is given through injections under the skin.

Main focus: The purpose is to determine the best dose of Beltavac by comparing it with a placebo. The study will last about 24 weeks, during which participants will have regular visits and keep a diary using a special app to record symptoms and medication use, particularly during the peak pollen season.

Who can participate: Adults aged 18-65 years in good physical and mental health with normal kidney and liver function. Participants must have a diagnosis of grass pollen allergy with a history of allergic symptoms for at least the last two pollen seasons, positive skin test for grass pollen, and specific blood antibodies. If asthmatic, the condition should be controlled with lung function at least 80% of expected value. Women of childbearing potential must use highly effective birth control and have a negative pregnancy test.

Who cannot participate: People with known allergy to the study medication or its ingredients, those with severe or uncontrolled asthma, individuals with other significant health issues that could interfere with the study or pose a safety risk, pregnant or breastfeeding women, anyone who participated in another clinical trial within the last 30 days, or people unable to comply with study procedures or follow-up visits.

Investigational drug: Beltavac contains a polymerized extract of grass pollen mixture designed to help the body become less sensitive to grass pollen through a rush regimen, potentially reducing allergy symptoms.

Study to Find the Best Dose of Beltavac with Grass Pollen Extract for Patients with Allergic Rhinoconjunctivitis, with or without Asthma

This trial is focused on finding the optimal dose of Beltavac, a mixture of grass pollen extracts, for treating allergic rhinoconjunctivitis with or without asthma. The treatment is given as injections under the skin.

Main focus: The study will compare the effects of Beltavac with a placebo over 24 weeks. Participants will have regular visits to monitor symptoms, and the study will measure changes in sensitivity to grass pollen through a Conjunctival Provocation Test and blood markers related to allergies.

Who can participate: Adults aged 18-65 years in good physical and mental health with normal kidney and liver function. Participants must have moderate to severe allergic rhinitis or rhinoconjunctivitis caused by grass pollen for at least two pollen seasons, confirmed by positive skin test, specific blood tests, and a positive conjunctival provocation test. Those with controlled asthma may participate if lung function is at least 80% of expected value. Women of childbearing age must use highly effective birth control and have a negative pregnancy test.

Who cannot participate: People with any other type of allergy besides grass pollen-related allergic rhinoconjunctivitis, or individuals who are part of a vulnerable population requiring special protection.

Investigational drug: Beltavac contains a polymerized extract of grass pollen administered in a rush regimen. This allergen immunotherapy is designed to modify the body’s response to grass pollen allergens, reducing symptoms.

Study of CLU-RX-BET injection therapy for patients with moderate to severe birch pollen allergies

This study focuses on treating allergic rhinitis and rhinoconjunctivitis caused by birch pollen using CLU-RX-BET, which is given as an injection under the skin.

Main focus: The purpose is to find the most effective and best-tolerated dose by comparing three different doses (high, medium, and low) against a placebo. The treatment will be given through subcutaneous injections over 50 weeks. The medication contains modified birch pollen extract treated with glutaraldehyde. Effectiveness will be measured by monitoring symptom reduction and decreased need for other allergy medications.

Who can participate: Adults aged 18-65 years with moderate to severe allergic rhinitis or rhinoconjunctivitis caused by birch pollen for at least 2 years. Participants must have positive skin prick test, specific blood test showing birch pollen allergy, history of significant symptoms during birch pollen season, and positive nasal exposure test. Those with well-controlled mild to moderate asthma may participate if lung function (FEV1) is greater than 80% of normal.

Who cannot participate: People with a history of severe allergic reactions to any allergen, those who received birch pollen immunotherapy in the past 5 years, individuals with poorly controlled asthma, those with other significant respiratory conditions, people taking medications that could affect allergy symptoms, pregnant women or those planning pregnancy, participants in another clinical trial within the past 30 days, individuals with autoimmune diseases, those with serious medical conditions compromising safety, people with known allergies to medication components, those who used systemic corticosteroids in the past 3 months, or individuals unable to follow study procedures.

Investigational drug: CLU-RX-BET is an immunotherapy treatment administered subcutaneously using a cluster immunotherapy protocol. It works by gradually exposing the immune system to small amounts of birch pollen allergens to build tolerance and reduce allergic reactions.

Study on the Effectiveness and Safety of Allergenic Extract of Olea Europaea Pollen for Patients with Moderate-to-Severe Olive Pollen Allergy

This trial is testing CLU-RX-OLE, an immunotherapy treatment given through injections, for people with moderate to severe allergic rhinitis or rhinoconjunctivitis caused by olive pollen for at least two years.

Main focus: The study aims to find the most effective and well-tolerated dose of CLU-RX-OLE. Participants will receive either the active treatment or a placebo, and symptoms and medication use will be monitored to determine the treatment’s effectiveness in reducing symptoms and improving quality of life.

Who can participate: Adults aged 18-65 years with moderate to severe allergic rhinitis or rhinoconjunctivitis due to olive pollen for at least two years. Participants must have a positive skin prick test (wheal diameter at least 3mm), specific blood antibodies to olive pollen, a Retrospective Rhinitis Total Symptom Score of 2 or more, and positive nasal test response. Those with well-controlled mild to moderate asthma may participate if lung function (FEV1) is more than 80% of predicted value.

Who cannot participate: People who have not experienced moderate to severe allergic reactions to olive pollen for at least two years, those who do not meet the guidelines for allergic rhinitis or rhinoconjunctivitis, individuals not within the specified age range, or those who are part of a vulnerable population.

Investigational drug: CLUSTOID/CLUXIN Olea europaea is an immunotherapy administered under the skin in a series of doses. The goal is to gradually increase the patient’s tolerance to olive pollen, reducing allergic symptoms and the need for other medications.

Study on the Effectiveness and Safety of CLU-RX-DPT for Patients with Moderate-to-Severe House Dust Mite Allergy

This trial focuses on treating allergic rhinitis caused by house dust mites using subcutaneous cluster-immunotherapy with CLU-RX-DPT, which comes in three different doses (low, mid, and high).

Main focus: The purpose is to find the most effective and best-tolerated dose of CLU-RX-DPT for people with moderate to severe allergic rhinitis due to house dust mites. Participants will receive either one of the doses or a placebo. The study will monitor symptom reduction and need for allergy medications, as well as assess impact on quality of life.

Who can participate: Adults aged 18-65 years with moderate to severe allergic rhinitis or rhino-conjunctivitis caused by house dust mites for at least one year. Participants must have positive skin prick test and blood test showing sensitization to Dermatophagoides pteronyssinus, a Retrospective Rhinitis Total Symptom Score of 2 or more, and positive response to nasal test. Those with well-controlled mild to moderate asthma may participate if lung function (FEV1) is more than 80% of normal.

Who cannot participate: People who do not have moderate to severe allergic rhinitis or rhino-conjunctivitis caused by house dust mites for at least one year, those who do not meet the age requirements, individuals who are part of a vulnerable population, or those who do not fit into the specified clinical trial groups.

Investigational drug: CLU-RX-DPT is administered as subcutaneous injections for cluster-immunotherapy. It is an immunotherapy agent that works by modulating the immune system’s response to house dust mite allergens, aiming to reduce sensitivity and improve tolerance.

Study on the Effects of Mannan-Conjugated Birch Pollen Allergoids for Adolescents and Adults with Birch Pollen-Induced Allergic Rhinitis or Rhinoconjunctivitis

This trial is testing T502, a special type of vaccine made from birch pollen, for people with birch pollen-induced allergic rhinitis or rhinoconjunctivitis. The treatment is given as an injection under the skin.

Main focus: The study aims to see how well T502 works in reducing allergy symptoms and the need for other allergy medications during the peak birch pollen season. Participants will receive either the T502 treatment or a placebo, and symptoms and medication use will be compared between the two groups.

Who can participate: Adolescents and adults aged 12-64 years in good physical and mental health. At least 10% of participants should be aged 12-17 years. Participants must have a diagnosis of birch pollen allergy with a history of moderate to severe allergic reactions for at least two previous seasons, use of anti-allergic medication for at least two birch pollen seasons, and a positive skin prick test. Those with controlled asthma may participate if lung function is at least 80% of expected value. Females of childbearing potential must use highly effective contraception and have a negative pregnancy test.

Who cannot participate: People who do not have birch pollen-induced allergic rhinitis or rhinoconjunctivitis, those not within the specified age range, individuals who are part of a vulnerable population, or people who do not meet other specific health criteria set by the study.

Investigational drug: T502 is an immunotherapy treatment given as injections under the skin. It works by modifying the immune system’s response to birch pollen, potentially reducing allergic reactions. The treatment is designed to reduce symptoms and the need for other allergy medications during birch pollen season.

Summary

These 11 ongoing clinical trials represent a comprehensive effort to develop effective immunotherapy treatments for various types of seasonal allergies. The trials are concentrated primarily in Germany and Spain, with one trial also taking place in Poland. Most studies focus on grass pollen and birch pollen allergies, with additional trials addressing olive pollen and house dust mite allergies, as well as combination allergens.

A notable observation is the emphasis on immunotherapy approaches, with trials testing both subcutaneous injections and sublingual administration methods. Several trials are investigating cluster immunotherapy protocols, which aim to build tolerance more quickly than traditional immunotherapy. Many studies are testing multiple dose levels to identify the most effective and best-tolerated treatment regimens.

The trials primarily target adults aged 18-65 years, though some studies include adolescents as young as 12 years. Most trials require participants to have moderate to severe symptoms for at least two years, and many allow participation of individuals with well-controlled mild to moderate asthma.

Common investigational drugs across multiple trials include CLU-RX series medications for various allergens, SLI-RX sublingual treatments, and Beltavac formulations. These represent different pharmaceutical approaches to allergen-specific immunotherapy, each designed to modify the immune system’s response to specific allergens.

The concentration of trials in Germany reflects that country’s strong position in allergy research, while Spain’s participation is particularly relevant given the prevalence of grass, olive, and cypress pollen allergies in Mediterranean regions. The diversity of allergens being studied and the variety of treatment approaches suggest an evolving understanding of how best to treat seasonal allergies through immunotherapy rather than just symptom management.