NCT07348302

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

Prospective, Randomised, DBPC, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma, Allergic to Dpt and/or Df

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 736 (estimated)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if MM09 works to treat patients allergic to house mites, displaying rhinitis/rhinoconjunctivitis with or without mild to moderate asthma. It will also learn about the safety of MM09. The main questions it aims to answer are: Does MM09 reduce the symptoms and the need of rescue medication? What medical problems do participants have when inhaling MM09? Researchers will compare MM09 to a placebo (a look-alike substance that contains no drug) to see if MM09 works to treat rhinitis/rhinoconjunctivitis.

Detailed description

Sublingual MM09 is being investigated as an etiological treatment for moderate-to-severe allergic rhinitis and/or rhinoconjunctivitis (as classified by ARIA), with or without mild-to-moderate controlled allergic asthma (as defined by GINA 2022), caused by Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. This prospective, randomized, double-blind, placebo-controlled, multicenter phase III clinical trial aims to assess the efficacy of sublingual MM09 at a dose of 30,000 TU/mL compared to placebo, administered over 12 months, in participants aged 12 to 65 years.

Conditions

• Rhinitis
• Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	Allergen Immunotherapy Extract	Sublingual spray, solution

Timeline

• Start date: 2025-04-02
• Primary completion: 2029-04-27
• Completion: 2029-07-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

19 sites across 4 countries: Argentina, China, Portugal, Spain