NCT05641272

Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract

Prospective, Randomised, DBPC Clinical Trial to Evaluate the Efficacy and Safety of Polymerized and Mannan Conjugated Allergen Extract of Dermatophagoides for the Treatment of Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Prospective, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of polymerized and mannan conjugated allergen extract of Dermatophagoides for the treatment of allergic rhinitis/rhinoconjunctivitis with or without asthma. The main objective of the clinical trial is to evaluate the clinical efficacy of the investigational medicinal product, administered sublingually, compared to placebo for the treatment of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to moderate asthma and controlled using the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (R-CSMS).

Detailed description

Allergen-specific immunotherapy (AIT) has been shown to be effective in relieving symptoms, reducing medication use, and improving quality of life in patients with respiratory allergies). This is thought to be due to the induction of a state of tolerance to specific allergens with long-lasting effects after discontinuation of treatment. And it is accepted that immunotherapy is the only available method for allergists to improve or cure, partially or definitely, an allergic process The study population of this clinical trial will comprise subjects allergic to mites (Dermatophagoides pteronyssinus and/or D. farinae) with symptoms of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to severe controlled asthma, suitable to allergen immunotherapy. The primary efficacy endpoint will be the combined rhinitis/rhinoconjunctivitis symptom and medication score. Every single day from the beginning of the administration of the investigational drug (V2-VF), the subject will be asked to score and register his/her symptoms and record medication consumption in an electronic diary following the instructions of the application. This diary will provide the symptom score and medication consumption for each subject during the trial.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	3,000 MM09	Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 3.000 UTm/mL for sublingual immunotherapy.
BIOLOGICAL	9,000 MM09	Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 9.000 UTm/mL for sublingual immunotherapy.
OTHER	Placebo sublingual	The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2022-12-07
• Last updated: 2023-10-23

Locations

1 site across 1 country: Argentina