NCT04435990

Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Clinical Trial With SCIT in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to Dpt. and/or D. Farinae

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Inmunotek S.L. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.

Detailed description

Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 12 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS

Conditions

• Rhinitis, Allergic
• Rhinoconjunctivitis
• Asthma, Allergic

Interventions

Type	Name	Description
BIOLOGICAL	10,000 MM09	Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
BIOLOGICAL	30,000 MM09	Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
BIOLOGICAL	Placebo subcutaneous	The same solution and presentation as the active treatment, but without active ingredients.

Timeline

• Start date: 2020-10-06
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-06-17
• Last updated: 2025-05-13

Locations

32 sites across 1 country: Spain