Study of Sublingual Immunotherapy MM09 for Treating Allergic Rhinitis and Rhinoconjunctivitis With or Without Mild to Moderate Asthma Caused by House Dust Mites in Ages 12 to 65

What this Trial Is About

This research aims to evaluate whether MM09, a sublingual immunotherapy, can help patients aged 12 to 65 with moderate-to-severe allergic rhinitis or rhinoconjunctivitis caused by house dust mites, with or without mild to moderate asthma. The trial is a phase III, randomized, double-blind, placebo-controlled study designed to assess if MM09 reduces symptoms and the need for rescue medications, while also monitoring safety. Participants will receive either the active MM09 sublingual spray or a placebo solution without the active ingredient. The treatment is given daily over 12 months. The study carefully compares the effects of MM09 against placebo to understand its impact on allergic rhinitisrhinoconjunctivitis and asthma symptoms. During the study, participants will record symptoms and medication use via a smartphone app. Researchers will measure combined symptom and medication scores, as well as separate scores for rhinitis, rhinoconjunctivitis, and asthma symptoms and medication intake during the last four weeks of treatment. Safety and any medical problems from inhaling MM09 will be closely monitored throughout the trial, which lasts up to 12 months.

Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df