This clinical trial is focused on studying the effects of a treatment called PQ Grass in children and adolescents who suffer from seasonal allergic rhinitis or rhinoconjunctivitis caused by exposure to grass pollen. These conditions are commonly known as hay fever, which can cause symptoms like sneezing, runny nose, and itchy eyes during certain seasons when grass pollen is in the air. The treatment being tested, PQ Grass, is given as an injection under the skin and is designed to help reduce these allergic reactions over time.
The purpose of the study is to evaluate how effective and safe PQ Grass is for children and teenagers with these allergies. Participants in the study will receive either the PQ Grass treatment or a placebo, which looks like the treatment but does not contain the active ingredient. The study will be conducted over several years to see if the benefits of the treatment last even after stopping the injections. During the study, participants will have regular check-ups to monitor their health and any changes in their allergy symptoms.
Throughout the trial, participants will be asked to visit the study site for assessments and to receive their injections. The study aims to provide valuable information on whether PQ Grass can offer long-term relief from grass pollen allergies in young people. This research could potentially lead to better treatment options for those affected by seasonal allergies.
1joining the study
Upon joining the study, the participant will be required to provide written informed consent from a legal representative. This is necessary to ensure understanding and agreement to participate in the trial.
2initial assessment
An initial assessment will be conducted to confirm eligibility. This includes a medical evaluation, spirometry or peak flow measurements, and a skin prick test to confirm sensitivity to grass pollen.
3treatment phase part A
During Part A of the treatment phase, the participant will receive the investigational product, PQ Grass 27600 SU, or a placebo. The treatment is administered as a subcutaneous injection.
The participant will be monitored for efficacy and safety, with regular visits to assess symptoms and any side effects.
4treatment phase part B
In Part B, the long-term efficacy of the treatment will be evaluated. This phase involves continued monitoring of symptoms and any side effects over a period of treatment-free follow-up.
The participant will not receive any active treatment during this phase, allowing for observation of sustained effects.
5follow-up assessments
Throughout the trial, follow-up assessments will be conducted to evaluate the participant’s response to the treatment. This includes measuring the quality of life and any changes in clinical laboratory values.
Regular visits will be scheduled to ensure the participant’s health and safety are maintained.
6completion of the trial
Upon completion of the trial, a final assessment will be conducted to gather comprehensive data on the participant’s experience and the treatment’s efficacy.
The trial is estimated to end by October 31, 2032.
Who Can Join the Study?
Written informed consent must be provided by a legal representative on behalf of the child.
The child should be between 4 to 16 years old when the consent form is signed and between 5 to 16 years old at the first visit.
Both boys and girls can participate.
Girls who can have children must have a negative pregnancy test at all visits and agree to use birth control if they are sexually active.
The child should be in good general health, as determined by a doctor after a medical check-up.
The child must have a history of moderate to severe seasonal allergies caused by grass pollen for at least one year or since their 5th birthday, even after using allergy medicine.
The child must have a positive skin test for grass pollen, which means a reaction of at least 3 mm in size, and no reaction to a negative control test.
The child must have a specific type of allergy antibody to grass pollen, shown by a test result of class 2 or higher.
The child must be able to perform breathing tests like spirometry or peak flow measurements.
The child must have a breathing test result showing a forced expiratory volume (FEV1) of at least 80% of what is expected, or a ratio of FEV1 to forced vital capacity (FVC) of at least 75%, or a peak expiratory flow rate (PEFR) of at least 75% of what is expected.
The child must be able to follow the schedule for taking the study medication and attending visits.
Who Cannot Join the Study?
Children who are not between the ages of 2 and 18 cannot participate.
Children who do not have seasonal allergic rhinitis (a type of allergy that causes sneezing, runny nose, and itchy eyes) caused by grass pollen cannot participate.
Children who have other health conditions that might interfere with the study cannot participate.
Children who are taking certain medications that might affect the study results cannot participate.
Children who have had a severe allergic reaction to similar treatments in the past cannot participate.
Children who are part of another clinical trial cannot participate.
Children who are unable to follow the study procedures cannot participate.
PQ Grass 27600 SU is a medication being studied for its effectiveness and safety in treating children and adolescents who suffer from seasonal allergic rhinitis or rhinoconjunctivitis caused by grass pollen. The trial aims to determine how well this medication works in reducing allergy symptoms and whether its benefits last over a long period.
Seasonal Allergic Rhinitis – This condition is an allergic reaction that occurs at certain times of the year, typically when pollen levels are high. It is characterized by symptoms such as sneezing, runny or stuffy nose, and itchy eyes. The condition is triggered by exposure to allergens like grass pollen. As the season progresses, symptoms may vary in intensity, often worsening during peak pollen times. The body’s immune system overreacts to the pollen, causing inflammation in the nasal passages. Over time, individuals may notice patterns in their symptoms corresponding to specific seasons.
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