In short
Clinical trials are studying LEPIDOGLYPHUS DESTRUCTOR, POLYMERISED EXTRACT in people with dust mite and Lepidoglyphus destructor allergy. These studies look at whether the treatment is safe and effective for allergic rhinitis, rhinoconjunctivitis, and some mild-to-moderate controlled asthma. The main target group is adolescents and adults aged 12 to 65 years.
Key points
- Clinical trials of LEPIDOGLYPHUS DESTRUCTOR, POLYMERISED EXTRACT are studying allergy treatment in people with dust mite and Lepidoglyphus destructor allergy. The main trial is a Phase 3 study in 120 participants aged 12 to 65 years. It focuses on moderate-to-severe allergic rhinitis and rhinoconjunctivitis, with or without mild-to-moderate controlled asthma. The study compares the active treatment with placebo. The main result being measured is a combined score of symptoms and medicine use after one year of treatment.
Trial overview
The available study is an interventional clinical trial, which means researchers give a treatment and then measure the results. It is testing LEPIDOGLYPHUS DESTRUCTOR, POLYMERISED EXTRACT for people with allergy related to dust mite and Lepidoglyphus destructor.
The trial is designed to assess both efficacy and safety, with efficacy meaning how well the treatment works in real participants. The study is in Phase 3, which is a later stage of testing in a larger group of people.
Who can join the study
The study includes participants aged 12 to 65 years. It focuses on people with moderate-to-severe persistent allergic rhinitis or rhinoconjunctivitis.
Some participants may also have mild-to-moderate controlled allergic asthma. In simple terms, this means the asthma is present but is stable and not severe at the time of the study.
Treatment and comparison
The trial compares the active study product with a placebo, which looks the same but does not contain active ingredients. The active product is given as a suspension for injection under the skin.
This design helps researchers see whether any improvement is due to the study treatment and not to chance or expectation alone.
Outcomes being measured
The main outcome is the Rhinoconjunctivitis Combined Symptom and Medication Score, also called RCSMS. This score combines two important parts: how bad the allergy symptoms are and how much allergy medicine the participant needs.
The score is measured over 4 weeks after one year of treatment, and it is recorded in the participant diary. This helps researchers understand the treatment effect over time in daily life.
Trial status and size
The study status is Authorised. The planned enrollment is 120 participants, which means the trial is set up to include 120 people.
Because the trial is relatively small compared with many late-stage studies, each participant’s data will be important for understanding the results.
What this means for patients
For patients, this study is looking at whether LEPIDOGLYPHUS DESTRUCTOR, POLYMERISED EXTRACT can help reduce allergy symptoms in people with dust mite and Lepidoglyphus destructor allergy. The trial is especially relevant for people who have ongoing nose and eye allergy symptoms, with or without stable asthma.
The most important question in the study is whether the treatment can improve daily symptoms and lower the need for allergy medicine over time.