NCT05400811

Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis

Prospective, Randomised, DBPC, Double-dummy, Multicenter CT of Efficacy and Safety With IT in Patients With Controlled Mild to Moderate Allergic Asthma and Rhinitis/Rhinoconjunctivitis, Allergic to D. Pteronyssinus and/or D. Farinae.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.

Detailed description

Prospective multicenter randomized double-dummy clinical trial of three active treatment groups compared to one placebo group. The principal objective of the clinical trial is the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The primary efficacy endpoint will be the symptom score and medication consumption required for the control of asthma and rhinitis/rhinoconjunctivitis symptoms. The study design consists of 3 active treatment groups and one placebo group. The trial population will include 400 subjects between the age of 12 and 60 years that will receive the treatment during 12 months.

Conditions

• House Dust Mite Allergy
• Perennial Allergic Rhinitis
• Allergic Rhinoconjunctivitis
• Allergic Asthma

Interventions

Type	Name	Description
BIOLOGICAL	MM09 allergoid-mannan conjugates subcutaneous (3.000 UTm/mL)	Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for subcutaneous administration.
BIOLOGICAL	MM09 allergoid-mannan conjugates Sublingual (3.000 UTm/mL)	Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 3.000 UTm/mL for sublingual administration.
BIOLOGICAL	MM09 allergoid-mannan conjugates Sublingual (9.000 UTm/mL)	Mixture of allergen extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae conjugated to mannan at 9.000 UTm/mL for sublingual administration.
BIOLOGICAL	Placebo subcutaneous	The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
BIOLOGICAL	Placebo sublingual	The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-07-01
• Completion: 2025-07-01
• First posted: 2022-06-02
• Last updated: 2022-11-18

Locations

16 sites across 1 country: Spain