Study to Test Safety and Effectiveness of Subcutaneous Immunotherapy for Allergies to Grass and Olive Pollen in People Aged 12 to 65 with Rhinitis or Mild to Moderate Asthma

What this Trial Is About

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy in patients aged 12 to 65 who have mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by sensitivity to grass and olive pollen. This randomized, double-blind, placebo-controlled phase 3 trial aims to study allergy treatments to improve symptoms and reduce medication use over one year. Participants are randomly assigned to one of three groups one receiving 10,000 TUmL MG01 plus 10,000 TUmL T517, another receiving 30,000 TUmL MG01 plus 10,000 TUmL T517, and a placebo group receiving the same solution without active ingredients. The allergen extracts come from a mixture of grasses and olive pollen, administered through subcutaneous injections. Treatment lasts for one year, evaluating different doses compared to placebo. During the study, participants will regularly record symptoms and medication use using a smartphone app. Researchers will monitor combined symptoms and medication scores as the primary outcome, along with medication-free days, symptom-free days, asthma exacerbations, quality of life tests for rhinitis and asthma, and immune response measures. Safety is closely followed through adverse reaction monitoring and immunological and security parameters over the 12-month treatment period.

Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen